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eHealth Governance Initiative:

Joint Action JA-EHGov & Thematic Network SEHGovIA

DELIVERABLE

JA D6.1: Global Briefing Document

WP6 (JA): Trust & Acceptability

Version: 1.0

Date: 16.10.2012

Project co-funded by the European Commission within the ICT Policy Support Programme

and the Health Framework Programme by the European Community

eHealth Governance Initiative WP 6

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COVER PAGE

Document name Global Briefing Document

Document short name Global Briefing Document

Distribution level PU

Status Draft

Author(s) & Organisations David Garwood, Stephan Schug, Luc Nicolas, Michael Wilks, Charles Parisot and other WP 6 members

Contact eHGI-Coordination <[email protected]>

Status: Draft / In Progress / Final

Distribution level: PU = Public, PP = Restricted to other programme participants, RE = Restricted to a group speci-

fied by the consortium, CO = Confidential, only for members of the consortium.

Change History

Version Date Status From Details Review

0.11 15.06.2012 Adapted to eHGI

Deliverable For-

mat

Stephan Schug, EHTEL

0.11 v04 09.07.2012 Added service

"FMK", Denmark

David Garwood, EHTEL

0.11 v05 09.07.2012 Editorial Revision Stephan Schug, EHTEL

1.0 16.10.2012 Final Version

(for submission)

Stephan Schug, EHTEL Uptake of messages by

SUSTAINS to section 4.1;

new section 6.5/Annex A

on Patient Access to EHR


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ABBREVIATIONS

ANSI American National Standards Institute

AT Austria

ATNA Austrian National Authority

BE Belgium

CA Consortium Agreement

CEN European Committee for Standardization

CENELEC European Committee for Electrotechnical Standardization

CO Coordinator

COCIR European Radiological, Electromedical and Healthcare IT Industry

DG Directorate General

DG CONNECT Directorate General f. Communications Networks, Content and Technology

DG INFSO (former) Directorate General for Information Society and Media

DG SANCO Directorate General for Health and Consumers

DICOM Digital Imaging and Communication in Medicine

DK Denmark

EAHC European Agency for Health and Consumers

EB Editorial Board

EC European Commission

EESSI Electronic Exchange of Social Security Information

eHGI eHealth Governance Initiative

EHTEL European Health Telematics Association

EPSCO Employment, Social Policy, Health and Consumer Affairs Council

epSOS European Patients – Smart Open Services

ES Spain

ETSI European Telecommunications Standards Institute

EU European Union

EVA Evaluation

EXCO Executive Committee

FR France

GE Germany

Gov Governance


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HL Greece

IHTSDO International Health Terminology Standards Development Organisation

IEC International Electrotechnical Commission

ISM Interoperability, Standardisation and Market (eHGI Work Package)

ISO International Organization for Standardization

IT Information Technology

ITU International Telecommunication Union

JA Joint Action

JA-EHGov Joint Action – eHealth Governance Initiative

LPPD Legal and Protection of Personal Data

M403 eHealth Interoperability Standards Mandate

MS Member State(s); also not EU-Member States and other participating

countries are included within this term

NeHP National eHealth Plan

NHIC National Health Information Centre (local abbreviation NCZI)

OECD Organisation for Economic Co-operation and Development

PSC Project Steering Committee

PS Policy Development and Strategy Alignment

RM Roadmapping

RSS Really Simple Syndication

SE Sweden

SEHGovIA Supporting the European eHealth Governance Initiative and Action

SK Slovakia

SNOMED - CT Systematised Nomenclature of Medicine – Clinical Terms

SOS Secretary of States

STePS Mixed acronym of STORK and epSOS for collaborative activities

STORK Secure idenTity acrOss boRders linKed

TA Trust and Acceptability

TN Thematic Network

WEF World Economic Forum

WHO World Health Organisation

WoHIT World of Health IT

WP Work Package


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Prologue: Trust and Acceptability of eHealth Services and Systems

The Patient:

“To be able to trust the healthcare system, I need guarantees

that my privacy is protected, my personal preferences are ob-

served, the information needed to care for me safely is avail-

able as appropriate and I am part of any decision respecting my

condition”

The Healthcare Professional:

“(I need to be sure that) services are user‐friendly and designed

to help me minimise the risk of errors, especially in cases with

patient communication barriers and allow me to assign my

time to the benefit of patients. I know how many people I am in

charge of today, and that I am able to plan my day with peace

of mind in the knowledge that I can share information with my

colleagues, within a trustworthy and secure environment that

also allows me to guarantee my patients’ right to privacy”

The ICT Service Provider

“I am also a contributor to the value chain. As a member of the

EU ICT industry, I enjoy the benefits of policy‐coordination for a

borderless market, an integrated economic area, supported by

legal certainty and harmonised rules, standards and guidelines.

I am both a key contributor to and beneficiary of the develop-

ment, use and testing of such standards and guidelines”


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Contents

0 Executive Summary .................................................................................................. 8

1 Introduction and Background ................................................................................... 10

1.1 The eHealth Governance Initiative ...................................................................................... 10

1.2 Work Package 6: Trust and Acceptability ............................................................................ 10

1.3 Approach to the Work ......................................................................................................... 11

2 Users of eHealth Systems: Stakeholder Identification ............................................... 12

2.1 Patients ................................................................................................................................ 12

2.2 Medical and Other Healthcare Professionals ...................................................................... 12

2.3 Organisations Concerned with the Implementation of eHealth Systems ........................... 13

2.4 ICT Service Providers ............................................................................................................ 13

3 Elements of Trust and Acceptability ......................................................................... 13

3.1 Application Characteristics and Safety ................................................................................ 14

3.1.1 Security ................................................................................................................................. 14

3.1.2 Usability ................................................................................................................................ 16

3.1.3 Patient Access to Data .......................................................................................................... 17

3.1.4 Training and User Empowerment ......................................................................................... 18

3.1.5 Mobility ................................................................................................................................ 20

3.2 Ethical and Legal Aspects ..................................................................................................... 22

3.2.1 Data Sharing and Informed Consent .................................................................................... 22

3.2.2 Privacy .................................................................................................................................. 23

3.2.3 Liability ................................................................................................................................. 24

3.2.4 Accountability ....................................................................................................................... 25

3.3 Organisational Issues ........................................................................................................... 25

3.3.1 Orchestration and Collaborative Design ............................................................................... 26

3.3.2 Change and Benefits Management ...................................................................................... 26

3.3.3 Buy-In Strategies ................................................................................................................... 28

3.4 Economic and Financial Aspects .......................................................................................... 29

3.4.1 Meaningful Use..................................................................................................................... 29

3.4.2 Funding and Incentives ......................................................................................................... 30

4 Determination of Future WP Work ........................................................................... 33

4.1 Selection of Projects ............................................................................................................ 34

4.1.1 Picture Archiving and Communication System ..................................................................... 34

4.1.2 Health Network Walloon ...................................................................................................... 37

4.1.3 Danish "Shared Medication Records" (FMK, Fælles Medicinkort) ....................................... 40

4.1.4 Project IZIP ............................................................................................................................ 42

4.1.5 Estonian EHR (e-Tervis - Estonian eHealth Foundation) ....................................................... 44


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5 Selection of Future Work Package Activity ............................................................... 46

5.1 Information Governance (Ethical and Legal) ....................................................................... 47

5.2 Patient Access to Personal Health Records ......................................................................... 49

5.3 Useful Clinical Documentation and Data Mobility (Meaningful Use) .................................. 50

5.4 Communication strategies ................................................................................................... 53

5.5 Lessons learned on the access of health data in EHR by patients ....................................... 54

6 Timeline of Future Work Package Activity ................................................................ 55

7 Annex A – The electronic patient record - What role for the patient: Main conclusions from a Symposium in Brussels, June 15, 2012 ........................................................................................................... 56

8 Annex B – Example Questionnaire Used for the Selection of Projects ................................................................................................................... 61


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0 Executive Summary

This Global Briefing Document is an output of Work Package 6 Trust and Acceptability (WP6)

of the eHealth Governance Initiative (eHGI). The eHGI is a European‐wide project with 39

beneficiaries including Ministries, Competence Centres, Users and Industry. The general ob-

jectives of WP6 are to:

Provide stakeholders' representatives with the methodology to identify and implement

ways of enhancing trust in new eHealth services ;

Make proposals to Member States and to the European Commission on how the needs

of users shall be best taken into account into all eHealth related developments, strate-

gies and initiatives.

And to identify those trust and acceptability-related barriers and drivers to eHealth

adoption that are common to most members of the initiative.

This document considers the issues of trust and acceptability in relation to four groups of

stakeholders, namely patients, healthcare professionals, organisations concerned with the

implementation of eHealth systems and ICT service providers.

It recognises the four main domains of actions adopted by eHGI, namely 1) Legal, ethical and

regulatory issues, 2) Semantics and terminology, 3) Identification and authentication and 4)

Standardisation and identifies further work that has to be undertaken in specific areas and

against specified criteria. To this end, the Work Package has prioritised and decided to exam-

ine four areas that are central to various trust and acceptability issues. These are:

Information Governance (Ethical and Legal Aspects)

Patient Access to Personal Medical Records

Useful Clinical Documentation and Data Mobility (Meaningful Use Strategies)

Communication strategies

One of the guiding principles for the future work is that the Work Package should not

seek to be involved with developing new and innovative approaches to trust and ac-

ceptability within eHealth but rather to consolidate already mature actions, to identify

gaps and blocks to the delivery of eHealth, and propose achievable actions.

WP 6 adopted thus the following approach to determining their future work:

Determine the representative stakeholder groups that have a major interest in issues of

trust and acceptability influencing the deployment of eHealth systems;

Confirm the areas of trust and acceptability that impact upon the successful delivery of

eHealth services;


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Identify successful projects within Member States that have addressed the key issues

and areas of activity that act as both drivers and barriers to the successful delivery of

eHealth services;

Determine the most effective and valuable activities to pursue in order to meet the ob-

jectives of the Work Package through an analysis of those identified projects, their ap-

proach to trust and acceptability and to identify key lessons for promotion and sharing

for the EC and relevant organisations within Member States;


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1 Introduction and Background

1.1 The eHealth Governance Initiative

This Global Briefing paper is an output of Work Package 6 Trust and Acceptability (WP6) of

the eHealth Governance Initiative (eHGI). The eHGI is a European‐wide project with 39 ben-

eficiaries including Ministries, Competence Centres, Users and Industry . It began its work in

2011 and has, at its heart, four key objectives, which are to provide:

Member States (MSs) with a consolidated approach and a strong political commitment

to eHealth governance at three levels - policy, strategy and operational;

MSs, the European Commission (EC) and other relevant stakeholders a political platform

and a “strategy think-tank” for current and emerging challenges which should lead to a

strong consolidated Roadmap of concrete actions and the description of potential fu-

ture projects and partnerships;

MSs, the EC, Competence Centres, IT industry and other relevant stakeholders a politi-

cal process toward a European eHealth interoperability framework;

The EC, EPSCO Council and other relevant stakeholders targeted support for activities

requiring broad convergence across Europe, such as future LSP eHealth projects and

common interoperable service solutions at MS level.

It is important to stress that underlying the work of the eHGI is the need to deploy eHealth in

ways that support a measurable improvement in the health status of European citizens,

and in the quality and sustainability of European health systems.

The Initiative has commissioned six Work Packages to undertake core elements of its work.

1.2 Work Package 6: Trust and Acceptability

The general objectives of Work Package 6 Trust and Acceptability (WP6) are to:

provide stakeholders' representatives with the methodology to identify and implement

ways of enhancing trust in health information technology (hereon referred to as

“eHealth”);

make proposals to Member States (MSs) and to the European Commission (EC) on how

the needs of users shall be best taken into account in the developments of national

strategies or EU-funded initiatives.

WP6 will identify those trust and acceptability-related barriers and drivers to eHealth adop-

tion that are common to most members of the initiative. The active participation of both MS

representatives and stakeholders (EU and National levels) in this WP will bring the experi-

ence of others to bear on a complex domain where the “perception” of eHealth users will

influence their trust in systems in widely different ways.


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This paper provides an assessment of current Trust and Acceptability issues identified by the

Call for Proposal 2. It recognises the four main domains of actions adopted by the eHealth

Governance Initiative:

Legal, ethical and regulatory issues

Semantics and terminology

Identification and authentication

Standardisation.

Some specific work within these four areas has already been carried out (e.g. on eID) that

focused on domains 2, 3, and 4; this document, while referencing all four domains identifies

the further work that needs to be undertaken . The primary purpose of the paper is there-

fore to identify further work for WP6 that is required in specific areas, matched to specified

criteria.

This document has as its starting position the Calliope Roadmap and the personal position

statements from three key stakeholders interfacing with the healthcare delivery process

quoted above. The work of the WP is not technical per se; trust and acceptability are of par-

amount importance in encouraging and fostering eHealth adoption and use. We hope that

by identifying the main elements of trust and acceptability , defining the stakeholder groups

that interact with them and the key issues that could impact upon their use of systems, we

will capture the key drivers and gaps that exist to prevent their successful introduction.

Finally, the paper identifies criteria for the selection of specific actions for the Work Package

to move forward as its to the main Initiative.

1.3 Approach to the Work

The Work Package agreed on the following approach to determining their future work:

Determine the representative stakeholder groups that have a major interest in issues of

trust and acceptability influencing the deployment of eHealth systems;

Confirm the areas of trust and acceptability that impact upon the successful delivery of

eHealth systems and activity;

Identify successful projects within Member States that have addressed the key issues

and areas of activity that act as both drivers and barriers to the successful delivery of

eHealth systems;

Undertake an analysis of the maturity of activity and work that has already been under-

taken in the confirmed areas together with existing experience (e.g. successful and well

established projects) and identify gaps in that experience that may affect eHealth im-

plementation;


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Determine the most effective and valuable activities to pursue in order to meet the ob-

jectives of the Work Package through an analysis of those identified projects, their ap-

proach to trust and acceptability and to identify key lessons for promotion and sharing

for the EC and relevant organisations within Member States;

Devise a project plan/timeline for the Work Package to undertake in order to address

the key issues that act as barriers and as drivers to successful eHealth implementation

and to disseminate the findings through the Initiative to the appropriate political and

strategic levels within the European Commission and Member States.

2 Users of eHealth Systems: Stakeholder Identification

In the following paragraphs the key stakeholder groups are identified together with their

role in the various elements of trust and acceptability associated with eHealth systems.

While users are necessarily described here as discrete groups it should be kept in mind that

roles will inevitably change and overlap; and as patients have more involvement in their care

and, as a consequence more access to their health records, they will move towards full

membership of the healthcare team. For the purposes of this paper, the four main stake-

holder groups have been identified as:

2.1 Patients

Patients are not only receivers of care but also the most important constituents within

healthcare systems. However, they are not currently “users” of eHealth systems in the nor-

mally accepted sense of the word. For most patients, their contact with the system is usually

limited to a verbal interaction with a health professional who has overall control over the

record. Some groups of patients however, who currently use tele-health services, such as

home monitoring, are working as equals within a defined team.

Accordingly, the views of patients must be considered more actively through engagement

with them and their representative groups.

2.2 Medical and Other Healthcare Professionals

This group includes doctors and all other professionals involved with the delivery of health-

care to patients. In the main, this group represents the frontline users of eHealth systems

who will have a reasonable understanding of how information is shared between profes-

sional groups and for what purpose.

Main concerns within this group will be the safety of the system in terms of reliability, accu-

racy and training as well as needing assurances that the eHealth system fits within an envi-

ronment that enables professional and ethical standards to be met. Issues such as usability,

legal and regulatory liability and cost-effectiveness will also feature.


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2.3 Organisations Concerned with the Implementation of eHealth Systems

In the main, this group will comprise national, regional and local healthcare delivery organi-

sations focused on installing and implementing eHealth systems in order to gain efficiency

and effectiveness in healthcare delivery at all levels. They will have primary concerns fo-

cused around costs, benefits, change management, procurement and, increasingly, mean-

ingful use of systems. As well as working to balance costs and quality of healthcare delivery,

their primary use of the system will be with the secondary use of information for manage-

ment purposes and possibly for research.

2.4 ICT Service Providers

This grouping is taken to be those organisations that provide eHealth hardware, software,

integration and consultancy services for the delivery of services required by the policy and

implementation bodies described above. In addition to the delivery of commercial activities,

such organisations will also be engaged in the development of interoperability and other

standards.

3 Elements of Trust and Acceptability

In the following paragraphs various elements of trust and acceptability associated with

eHealth systems and environments have been identified. For the purposes of this paper, the

terms trust and acceptability describe transparent attributes that include safety, security,

and adherence to legal and ethical constraints.

While different users’ roles will give them different concerns about trust, there are five per-

spectives common to all:

An accepted description of the individual area of trust and acceptability;

The level of maturity of each of the areas in terms of its state of development;

The level of experience in each of the areas in terms of how they have been addressed

by various national programmes for eHealth across the European Union and how suc-

cessful those initiatives have been;

What gaps exist in the level of experience;

An identification of links to other Work Packages in the Initiative.

The sections that follow provide a brief description of the key elements of trust and accept-

ability that impact upon patients, health care professionals and the other organisations iden-

tified above. They are grouped as follows:

Application Characteristics and Safety

Security

Usability


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Patient Access to Data

Training and User Empowerment

Mobility

Ethical and Legal Aspects

Privacy

Data Sharing and Informed Consent

Legal Certainty

Liability Issues

Accountability

Organisational Issues

Orchestration and Collaborative Design

Change and Benefits Management

Buy-In

Economic and Financial Aspects

Meaningful Use

Funding and Incentives

3.1 Application Characteristics and Safety

3.1.1 Security

A robust, properly implemented and well managed security policy is an important tool for

engendering trust in an eHealth system. Covering all aspects of security from both the tech-

nical and human/user perspective such a policy is designed against a formal risk assessment

with a view to addressing all threats but recognising that there will always be a degree of

residual risk; there can never be a guarantee of 100% security.

Security is widely accepted to comprise four elements, namely confidentiality, integrity,

availability and auditability. These four terms, taken together, might also be used to deter-

mine the reliability of the system (and thus trust in it) viewed from a number of perspec-

tives.

The level of security within eHealth can be reasonably assumed to vary widely across differ-

ent systems and different Member States. Viewed globally and from a technical perspective,

data security techniques have been developed over many years and range from the basic

application of passwords to sophisticated encryption techniques and will encompass issues

such as human factors and physical protection. The degree to which they are applied within

individual systems is variable. Formal standards exist for defining system security (e.g. ISO

27001 and 270021) in the general domain. In addition the ISO standard 27009 provides regu-

lations specific for healthcare. ISO 27009 is a comprehensive regulation that is complex to 1 http://www.iso.org/iso/catalogue_detail?csnumber=42103


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apply in full. Hence there is a need for understandable and acceptable “good practices”

demonstrating realistic implementations of that standard. Some operational support tools

have been developed by some member states.

Security policies and operational guidelines are not in themselves a guarantee of effective

information protection as the aspiration of the policy has to be matched by effective imple-

mentation.

In addition, there is increasing concern about the security weaknesses inherent in mobile

devices which are becoming a feature of eHealth developments. Several sources raise this

issue including CIO.com that holds, “The mobile device, now the dominant technological tool

in American enterprise, will become more dominant in 2012 and beyond. Industry analysts

say mobile device shipments will top 1 billion in 2015, leaving PC shipments in the dust.

Its benefits for user convenience and productivity are obvious and irresistible -- a smart

phone can handle everything from email to collaboration to video chat. ……But it is not very

secure, which puts users and the enterprises that employ them at greater risk.

The combination of relative defencelessness and ubiquity means mobile devices will be an

increasingly tempting target for attacks ranging from spyware to rogue applications.”2

Mobile computing is inevitably linked to the use of cloud computing. Cloud computing also

implies specific security risks and triggers e.g. privacy and liability concerns (cf. ongoing dis-

cussion between Google, the European Commission and European Member States). On the

other hand, cloud computing – or more broadly outsourcing to large computing centres –

offers also substantial opportunities for security improvements: As security is often not a

priority for stand-alone systems (no back up, no policy of access etc…) those aspects are

usually integrated in professional service level agreements offered by cloud-based solutions;

the quality of those services is then subject to monitoring, quality assurance and certifica-

tion. While the technical aspects are usually managed in a professional manner (strict pri-

vacy rules, access policy, mirroring of data etc..) there may be cultural challenges for health

professionals as well as legal and liability challenges when health care data become virtual

and are stored outside medical institutions.

Given the overall power of mobile and cloud solutions their risks should be assessed and

overcome. Furthermore, strategies for securing the continuity of medical care in case of

network outages should be established.

An additional influence on the shaping of data security within eHealth is the recent Commu-

nication and associated regulations by the European Commission3 seeking to reform and

strengthen the 1995 Directive on Data Protection. This includes a provision to introduce a

legal obligation to report data protection/security breaches within 24 hours. Greater open-

2 http://www.cio.com/article/695170/In_2012_a_Mobile_Security_Minefield

3 http://www.statewatch.org/news/2011/dec/eu-com-draft-dp-communication-28-11-11.pdf

http://www.csoonline.com/article/630265/sector-2010-touring-and-surviving-the-mobile-app-minefield

http://www.csoonline.com/article/630265/sector-2010-touring-and-surviving-the-mobile-app-minefield

http://www.cio.com/article/695170/In_2012_a_Mobile_Security_Minefield

http://www.statewatch.org/news/2011/dec/eu-com-draft-dp-communication-28-11-11.pdf


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ness in this area has huge implications for compensation because of the volume and nature

of medical information. The ETHICAL project identified discussions where stakeholders say

such openness can be seen as reinforcing trust in the system but it was also noted that if

such breaches were perceived as commonplace this could have the opposite effect.

Finally, and perhaps most significantly, the existence of good security policy and practice

within the eHealth environment can only engender trust if people know that it exists. Such

knowledge will exist close to those who implement the system but will not be known or ac-

cepted by those individuals who impart their personal and sensitive information into it – the

patient.

3.1.2 Usability

The International Organisation for Standardisation (ISO) defines usability as, "The extent to

which a product can be used by specified users to achieve specified goals with effectiveness,

efficiency, and satisfaction in a specified context of use”. In the paper, “Usability 101 – Intro-

duction to Usability”4, Jakob Nielsen further defines usability as consisting of five quality

components, namely:

Learnability: How easy is it for users to accomplish basic tasks the first time they en-

counter the design?

Efficiency: Once users have learned the design, how quickly can they perform tasks?

Memorability: When users return to the design after a period of not using it, how easily

can they re-establish proficiency?

Errors: How many errors do users make, how severe are these errors, and how easily

can they recover from the errors?

Satisfaction: How pleasant is it to use the design?

Taking healthcare professionals to be primary users of eHealth systems, these five compo-

nents would seem to be important and relevant to this stakeholder group. Ensuring usability

reduces disruption and improves patient trust.

One European project, RENEWING HeALTH, has identified three key elements that increase

usability:

A patient-centred approach in which applications enable a partnership among practi-

tioners, patients, and their families (when appropriate) to ensure that procedures and

decisions are made based on patients’ needs and preferences;

Encouraging patient commitment to treatment and monitoring regimes, particularly

when dealing with self-administered devices;

4 http://www.useit.com/alertbox/20030825.html


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Learnability as the ability to easily memorise tasks to be performed within the telemedi-

cine service / application and that these are easy to understand.

There are several studies into the way in which poor usability can impair the take-up of

eHealth systems. A typical, high level and easy to digest guide is “eHealth 101” produced by

an eHealth support unit in Australia5. Typical entries include:

“Unfairly to those who use them, it is rarely acknowledged that use of an electronic sys-

tem slows down clinical work while data capture is taking place. It is important that this

slowing down not be overlooked and that the benefits of data entry (for efficient proc-

esses, governance and research) are known and considered as worth the time sacrifice

(providing it does not compromise care). (Of course, this does not ignore the imperative

for system designers to include consideration of ways to improve the usability of the user

interface so that it does not slow down data entry.)”

“Usability is as important a consideration for communication systems as it is when de-

signing a computer interface. Cognitive overload represents a real risk for clinicians

overwhelmed by too much information that is only made worse when it is poorly struc-

tured.”

“Poor usability can contribute to adverse patient outcomes.”

It is clear that usability is a key component in promoting the acceptability of eHealth sys-

tems. There are many studies and organisations promoting good design and usability around

the world including Victoria University, Wellington, Information Resources Management

Association (IRMA) and the eHealth Lab in Copenhagen, Denmark.

3.1.3 Patient Access to Data

Patient access refers to the right and ability of individual patients to access their medical

records either held as a full or summary record. Such access may be enabled through the

provision of a paper transcript or copy, or through electronic access to the record. The pur-

pose of such access is to engender trust in the accuracy and completeness of the record and

implies the provision of some mechanism or process whereby the patient may request and

obtain changes to factual errors in the record. There are implications both for patient safety

and professional liability if the process of deletion or suppression of a record prevents com-

prehensive care based on full knowledge of the patient’s history. Nevertheless, access to

personal medical records is a major step forward in empowering patients. The right to see

what has been written about you, and the opportunity to correct errors of fact, are very

strong drivers of trust.6

5 eHealth 101, Tutorial Companion, Brendon Wickham, Program Consultant, ehealth Support, Gene-

ral Practice Victoria, http://www.gpv.org.au/files/downloadable_files/Programs/IM-ICT/rm_eHealth%20101_BW.pdf 6 The Health Foundation, UK (a medical policy unit) is running a trial to enable such patient access. Their opin-

ion on such access is summarised as follows, “For many, the notion of allowing patients access to their own medical records raises fears of increased workloads, misuse of data and harm to patients or the practice. But


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The concept of providing access to records is now enshrined in both national and EU legisla-

tion and is a key component in the EU Directive 2011/24/EU on patients’ rights in cross-

border healthcare. Examples of national legislation include the Access to Medical Records

Act 1988 (UK) and the Health Information Portability and Accountability Act (HIPAA) in the

USA.

A number of projects are now underway to trial various ways of enabling patient access to

medical records. Notable amongst these are the SUSTAINS project based in Denmark, the

PALANTE project and OpenNotes in the USA.

The most important gap in this area is the lack of a clear and sustained communication proc-

ess regarding access, and the benefits it will bring. This is likely to be a primary output from

the SUSTAINS project.

3.1.4 Training and User Empowerment

In order for the benefits of eHealth to be fully realised and for its full potential to be re-

leased, the meaningful involvement of patients is essential. Such involvement only becomes

possible if eHealth developments and implementation meet the needs and expectations of

professionals and patients who will ultimately use them.

The European Commission in its report, “European Countries on Their Journeys Towards

National eHealth Infrastructures: Final Progress Report” published in 2011, recognises that

education, training and continuous professional development for all, including for those citi-

zens and patients which are capable and motivated to become engaged in their own care,

must be strongly promoted: “There is a strongly felt need to improve eHealth training and

education for professionals, but also to focus on reducing the asymmetry in capabilities, in-

formation and knowledge between health professionals and patients, and thereby

evidence and experience shows that these concerns are unfounded, and that the approach improves quality of care, shared decision making, safety, effectiveness and patient experience”. Specifically they expect to see, “Altered relationships: People will feel more confident dealing with clinicians and the NHS through a more equal patient–professional partnership in which information and power is shared”.

A notable example of how trust in the health system can be restored exists in the UK. Dr

Amir Hannan, a general practitioner, took over the practice of another GP (Harold Shipman)

who had been convicted of the deliberate killing of many his patients. Dr Hannan decided

that by providing patients with access to their records they could confirm their accuracy and

ensure that they were receiving the best possible care. According to a BBC news report: “Dr

Hannan said he “took over a practice where the patients had lost complete trust in the me-

dical profession. He implemented an online system allowing patients to access records and

involved them more in his note-taking while he was practising. What I learned was by

allowing people to go online – put passwords into a secure system so that they can see what

was being recorded about them – it’s led them to regain that trust between ourselves and

the patients,” he said.”


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strengthen stakeholder engagement”. The report further acknowledges that skills of health-

care staff and ICT suppliers staff also need to be expanded

For professionals, education and training in the delivery and support of more personalised

healthcare and the use of eHealth solutions in the home are likely to come to the fore in the

next few years. This has implications for the medical curriculum and the need to include the

use of tele-health services. This has already been recognised, notably by the British Medical

Association, which issued its own recommendations for training in this area in 2007.

For patients such training needs to ensure that they:

Understand how to use such systems;

Understand the benefits associated with such systems and how they can enhance the

patient/professional relationship;

Learn how the use of eHealth systems can improve their own health literacy and thus

promote personal healthcare and healthier lifestyles;

Are fully informed about information flows;

Have trust in the safety of such systems either both from a privacy and a safety perspec-

tive.

More specific objectives for such a training -supporting patient empowerment – can be de-

rived from focus group work within the EU-co-funded large scale pilot SUSTAINS (Support

USers TI Access Information and Services). Preliminary findings presented by Walter Atzori

(EPF) shown at the Symposium on "The electronic patient record - What role for the patient"

at, Brussels, 15 June 2012 indicate the following dimensions and elements:

Health literacy

to understand specific health information better

to understand their disease/condition and its implications better

to distinguish between quality health information from information pollution

to understand how changes in lifestyle could impact on patient health

Patient control

to monitor their treatment progress

to feel less anxious about the health condition

to feel more responsible for the management of their disease

to be more aware and understand test results and the relevance of the tests done

Patient participation

to better prepare for consultations with health professionals and meaningful en-

gage in discussions with HCP

to participate in defining treatment plans in partnership with HCP (concordance)


20

to be able to attract HCP attention to issues considered important by the patient

In order to meet these requirements within eHealth services, the developers and implemen-

ters of eHealth systems will need to factor into their work training programmes that address

these critical areas.

A notable example of training for telehealth is quoted in the report compiled by

2020health.org in its report, “Telehealth: What can the NHS learn from experience at the US

Veterans Health Administration?”7. This report describes the work of the national training

centre operated by the VA in Florida where Care Co-ordinators (usually experienced nursing

staff who work with groups of patients receiving care at home) and patients receive training

in the use of telehealth.

The 2020health.org report concludes that training is vital to ensure an effective, stable and

consistent level of service and that national or common training support and access to online

training facilities are important prerequisites. Whilst this report is targeted at the UK NHS,

there seems to be no reason to assume that these messages are not important for all Mem-

ber States.

In terms of documented gaps, a summary contained in a progress report by the Common-

wealth Secretariat to Commonwealth Health Ministers8 (who had commissioned a review of

eHealth in 2008) identified:

Inadequate ICT skills in health sector, such as ICT maintenance staff;

Shortage of skills in health informatics;

Lack of ICT in health professionals’ curricula;

Re-tooling of ICT skills for health workers;

ICT as tool for expanding health sector training programmes;

There is a need to raise awareness of ICTs in the health sector.

Again, whilst this report is specific to Commonwealth countries, it may be indicative of ca-

pacity and capability issues within Europe.

3.1.5 Mobility

Information mobility can be viewed in two ways. First, information can follow the patient as

he or she travels either within their country of residence or within the European Union. Sec-

ondly, mobility can refer to the use of mobile devices to improve efficiency and convenience.

In the first case much work has been carried out at the legal level to preserve the rights of

7 http://www.2020health.org/2020health/Publication/NHSit/Telehealth.html

8 http://www.thecommonwealth.org/files/189921/FileName/HealthProgressReports-E-Health.pdf


21

patients as they travel across borders. Projects such as CALLIOPE9 and epSOS10 have already

considered in considerable detail the many technological legal and ethical issues associated

with cross-border mobility.

In the case of mobile devices, the advantages of being able to input, store and access clinical

and general health information are still being investigated within a developing technical en-

vironment. Perceived benefits of mobile technology within eHealth include:

Reduced paperwork;

Increased time on patient care;

Increased care at home, meaning less travel for patients;

Greater access to general health care information;

Potential for home monitoring.

The UK recently conducted a national study into the use of mobile devices by community

care workers, “The National Mobile Health Worker Project” that investigated the use of mo-

bile technology by home and community care workers across a number of different locations

This study concluded, amongst other things, that:

The majority of sites demonstrated increased productivity after mobile devices were

implemented (contacts increased) ;

More time was spent with patients following deployment of mobile devices;

Journeys and total journey time were increased, although to a lesser degree than activi-

ty, indicating improved efficiency

In terms of financial savings the project concluded:

“Whilst there are some clear financial benefits associated with the adoption of mobile

working, it is stressed that just as the solutions are not ‘one size fits all’, neither are the

benefits. Financial savings will vary greatly across different sites and the different ser-

vices within them, as demonstrated by this report.”

The security of data held on mobile devices, and the legal issues surrounding their use are

barriers to their implementation. A WHO report (ref) concluded that “The European (56%)

and Americas (50%) Regions reported the absence of legal guidelines on privacy and confi-

dentiality in the mHealth domain as the two most important barriers to mHealth implemen-

tation. Legal frameworks that govern the integrity of health data transfer and storage, in

addition to identifying access control and medical liability, are critical to enabling eHealth

(and therefore mHealth) in countries in these regions.”

9 http://www.calliope-network.eu/

10 http://www.epsos.eu/


22

3.2 Ethical and Legal Aspects

3.2.1 Data Sharing and Informed Consent

In the health context, consent (an ethical principle) is given for data sharing as well as for

care. Frequently, and especially when care is given by a defined team, there is an implicit

assumption (based on implied consent) that permission has been given for whatever data

sharing is necessary in order to optimise care. A typical example would be where a patient

presents herself for treatment with a family practitioner. Here it would be reasonable for

information to be recorded and shared with other healthcare professionals for the purpose

of that treatment and within an environment which can be reasonably assumed to be secure

with professional duties of confidentiality operating correctly. This is a standard model appli-

cable across all EU health providers.

What is less clear is whether the data generated and shared as a result of a care-based con-

tact, can be shared beyond the immediate team on the basis of implied consent. Such use

might include financial reimbursement, audit, clinical governance and research.

An agreed starting point for the WP’s work is that implied consent may be given, and is ade-

quate, for immediate care, and for the sharing of data between a clearly identified group

(which will include non-healthcare professionals such as administrative staff), but that the

healthcare provider gives a guarantee that any further (“secondary”) use will be subject ei-

ther to explicit (“informed”) consent, or anonymisation.

By definition, explicit (“informed”) consent needs to be based on the fullest possible infor-

mation being provided to the patient regarding the use of their data. Trust will be enhanced

by the developing work on patient access to the medical record which will also provide an

audit trail that will record when patient data are accessed, and by whom.

The general principles of consent have been considered by the European Commission’s Data

Protection Working Party (The Article 29 Group). Their opinion, ratified in July 2011, was

designed to remove some of the ambiguity surrounding the principles of consent with data

protection legislation. For health records, the WP’s opinion was as follows:

“In many Member States there is a move to create an electronic summary of patients’ health

records. This will allow healthcare providers to access key information wherever the patient

needs treatment.

In the first scenario, the creation of the summary record is absolutely voluntary, and the

patient will still receive treatment whether or not he or she has consented to the crea-

tion of a summary record. In this case consent for the creation of the summary record is

freely given because the patient will suffer no disadvantage if consent is not given or is

withheld.

In the second scenario, there is a moderate financial incentive to choose the e-health

record. Patients refusing the e-health record do not suffer disadvantage in the sense


23

that the costs do not change for them. It could be considered here as well that they are

free to consent or not to the new system.

In the third scenario, patients refusing the e-health system have to pay a substantial

extra cost compared to the previous tariff system and the processing of their file is con-

siderably delayed. This signifies a clear disadvantage for those not consenting, with the

purpose to bring all citizens within the e-health system in a scheduled deadline.

Consent is therefore not sufficiently free. One should therefore also examine the existence

of other legitimate grounds to process the personal data or examine the application of Arti-

cle 8.3 of Directive 95/46/EC.”

The duty of confidence has been examined most recently in terms of data collection, and the

use and retention for biometric and medical applications, by the FP7 project ETHICAL11.

While the ethical principles are clear, the variation in implementation of the Data Protection

Directive within national legislation (concerning both health records or otherwise) will create

a conflict between ethical and legal approaches to confidentiality. The WP recognises that all

data processors must obey the law; however it intends to identify areas of ambiguity need-

ing further work.

3.2.2 Privacy

The right to privacy is fundamental. It is protected by national legislation, but also by Article

8 of the European Convention on Human Rights, which states that, “Everyone has the right

to respect for his private and family life, his home and his correspondence”. The recently

completed 7th Framework Programme, ETHICAL took as its definition of privacy the follow-

ing:

“…The right of individuals to be left alone and to be protected against physical or psycho-

logical invasion or the misuse of their property. It includes freedom from intrusion or ob-

servation into one’s private affairs, the right to maintain control over certain personal in-

formation, and the freedom to act without outside interference…”

It is important to understand that privacy, whilst linked, is different from confidentiality. An

individual is private in that they hold information about themselves and has a legal right to

choose what and how much of that information they wish to impart to another person or

individual. Such a right is protected by privacy legislation. Having released that information

they may or may not place an ethical duty of confidentiality upon that third party expecting

them to protect it and not share it. It is this legal and ethical duty of confidentiality that un-

derpins trust in the patient/professional relationship. The legal scope of the incoming EU

Data Protection Regulation and Directive, and the extent to which the concept of “privacy by

design” adequately protects patient data will be explored by the WP.

11

http://www.ethical-fp7.eu/


24

3.2.3 Liability

The emergence of eHealth products and services raises many issues regarding legal liability .

This may affect the healthcare professional, product manufacturer or information provider.

One of the definitive pieces of work in this area is the publication “Legally eHealth” pub-

lished by the European Commission in 200812. This report considers the complex issues of

eHealth delivery and considers what legislation applies in terms of legal liability.

The report sums up the present position relating to potential damage arising from eHealth

very concisely as:

“An eHealth service might be passive, such as delivering general medical information

through a Website, or might be active in giving medical advice or specific decision sup-

port to clinicians, or might involve the collection of biomedical data for remote monitor-

ing by a clinician. Such a service might conceivably cause damage to someone relying on

the service. A citizen might follow bad advice and fall ill, or even die; a clinician might fol-

low the recommended procedure after using a decision support tool and might harm a

patient; or a remote monitoring service might fail to transmit relevant data, thereby put-

ting a patient’s life at risk.

In many such cases, a causal link will exist between the harm suffered and a defective

product. Thus, if an error exists in decision-support software, the doctor who relied on

the software would have a claim based in Council Directive 85/374/EEC, …..”.

One of its primary findings is that “There currently is no general European harmonisation of

liability rules for services in which no defect can be found in a device. Therefore, liability for

services is governed by ordinary rules of law applicable in the Member States”. This can be

considered to be a serious gap that has implications for legal certainty and thus impacts

upon both trust and acceptability if it is not clear which organisation or individual can be

held responsible should any harm result from the use of the goods or services concerned.

Other services provided to a patient via the Internet may be defined as an “information soci-

ety service”. This is a service provided remotely by electronic means where an individual has

requested such a service and remunerates the provider for it. This might include online ad-

vice and the online selling of medicines. According to the Legally eHealth publication, any

provider of an information society service has certain duties including one of transparency

and the need to adhere to professional rules of conduct. Such transparency is covered by

Commission’s Communication on Quality Criteria for Health-related Websites (COM

2002/667).

The position relating to an Internet Service Provider is less onerous where such a provider

restricts their activity to that of a “Mere Conduit” that encompasses not initiating the trans-

mission of information, not selecting the receiver of it and not selecting or modifying the

information transmitted

12

http://www.epsos.eu/uploads/tx_epsosfileshare/Legally-eHealth-Report_01.pdf


25

Clearly, the need for harmonisation and a possible Code of Conduct in this area impacts

upon all stakeholders. Healthcare professional will have concerns regarding their legal liabil-

ity and their duty of care and safety towards their patients. Manufacturers of medical de-

vices and ICT service providers are also affected in the event of security issues such as data

integrity or interoperability issues and patients need to know what their legal rights are

should they suffer harm in the event of a product or service failure. Determination and reso-

lution of these issues represents a significant body of work and the European Commission

through DG INFSO has already been alerted to the existing situation.

3.2.4 Accountability

As eHealth information networks become more diverse and personal records are managed

and stored in a number of, often, remote locations, the application of effective data security

becomes more difficult. In such circumstances, the need for an effective accountability

framework becomes more necessary.

One definition of information accountability holds that:

“the use of information should be transparent so it is possible to determine whether a

particular use is appropriate under a given set of rules and that the system enables indi-

viduals and institutions to be held accountable for misuse.”13.

This implies the establishment not only of an open and visible system of information man-

agement but the establishment of a visible and accessible set of processes enabling the indi-

vidual or organisation to bring “offenders” to account. It could be argued that this links to

the need for increased transparency regarding the use of personal medical information

within an eHealth system as addressed elsewhere in this report.

This situation is also recognised by the World Medical Association14 which has published

guidelines relating to the use of telemedicine by physicians and which includes a section on

the accountability and responsibilities of the physician in this area. This is, however, focus-

sed on remote monitoring and does not encompass wider areas of eHealth.

In the context of Cross-Border Healthcare, the issue of liability for untoward medical compli-

cations has been addressed to some extent in the Directive. However, a new ethical issue

arises in terms of the consent given for the transfer of identifiable health data across bor-

ders. Harmonisation of data processing regulations is desirable, since at present a healthcare

professional’s knowledge of data processing procedures in the country to whom data is sent

may be insufficient to see consent for such a transfer as “informed”. Recognising the princi-

ples of subsidiarity that apply to health provision within a MS, an agreed framework for deal-

ing with liability for unplanned data flows cross borders will need development .

3.3 Organisational Issues

13

http://groups.csail.mit.edu/mac/users/hal/misc/cacm-late-draft.pdf 14

http://www.wma.net/en/30publications/10policies/20archives/a7/


26

3.3.1 Orchestration and Collaborative Design

Customisation and organisation in the area of trust and acceptability implies the existence of

a formal method of engaging stakeholders with the ongoing development of eHealth appli-

cations. Consensus in areas such as usability, safety or indeed any area where agreement is

required to ensure the successful introduction of such systems is essential. In this area it

might be expected to see groups of clinical and administrative expert users that support the

development, testing and customisation of eHealth applications and services. In addition,

the health care organisation would continuously analyse the change management needs

implied by eHealth services and applications and would establish an organisation-wide con-

cept of service orchestration that considers the needs and requirements of all users includ-

ing patients.

3.3.2 Change and Benefits Management

The introduction of eHealth into any health management environment implies change. Un-

familiarity can build significant resistance to the introduction of new ways of working and

the deployment of new technology. Thus, before any change is made it should be properly

planned and be subject to a change management process.

The Scottish Government and the NHS in Scotland has produced a very comprehensive in-

troduction to the process for eHealth.15 It identifies the key components for properly defin-

ing and implementing change as:

Proposing a Change

Summarising the Impact

Taking the Decision

Implementing a Change

Within those four over-arching steps are a number of key components that have to be ad-

dressed in order to effect successful change. They include, but are not restricted to:

Development of a business case

Benefits realisation management

Business continuity planning

Project governance

System ownership

Quality management

Risk management

Testing 15

at http://www.ehealth.scot.nhs.uk/?page_id=1720

http://www.ehealth.scot.nhs.uk/?page_id=1720


27

Training

Change Management is complex and often requires specific and specialist expertise to

achieve positive results.

Closely linked to the management of change is benefits management. Benefits management

is an important component of change management but needs some separate consideration

because it is a powerful tool, if used properly, for gaining acceptance within eHealth devel-

opments. Many eHealth projects fail to achieve large scale deployment because they are

technology driven with a lack a focus on the business or strategic objectives of the organisa-

tion whether at national, regional or local level.

One answer might lie in a model that truly brings together strategic objectives for healthcare

and enablers such as new processes, people-based change and, at the right point, supportive

technology. eHealth has, in the main, been technology driven with the focus on implementa-

tion rather than on achieving specific benefits. There is a mindset that believes new technol-

ogy will always result in improvements to healthcare delivery rather than determining what

improvements are sought, what organisational, cultural and other changes are required to

achieve those improvements and what are the most appropriate, supportive combination of

technologies.

One project that encapsulated this principle is eHealth Impact that reported in 200616. This

project was concerned with developing an evaluation model for eHealth with a focus on

economic outcomes. In considering process change it concluded,

“Neither ICT applications, nor information by itself bring benefits. The gains ….come from

changes in processes or working practices that are more substantial than replacing pa-

per with an electronic document, which may have been the trigger to benefit realisa-

tion…..

It is this change that brings about the impact seen at the end. The impact for the 10 eHI

[assessed] sites was realisation of benefits. This was the expected outcome for these

proven eHealth application sites. It must be stressed, however, that the impact can also

be negative. Not every eHealth application will lead to realisation of substantial benefits,

let alone sustainable net benefits.”

Benefits management is relatively well understood and is supported by a number of estab-

lished models but it is not widely applied because it can be complex and often needs experts

to guide and advise the process. One example of a benefits management model is that de-

veloped by Cranfield Business School that is widely used in business environments but which

has also been trialled in the health sector, particularly in the UK (the Integrated Service Im-

provement Programme) .

16

http://www.ehealth-impact.org/download/documents/D6_2_Final_Report_ext.pdf


28

One lesson learnt from the UK experience was that cost and benefits management can be

made to be overly complex thus bringing about resistance to the approach. This links to the

Accenture conclusion (see Meaningful Use below) that the culture for adoption needs to be

right.

There are, however, relatively simple models linking strategic objectives to the user of

eHealth/ICT as drivers and enablers in eHealth projects that may provide positive examples

for further work.

3.3.3 Buy-In Strategies

Buy-in or enrolment strategies can be seen as operating at two levels: either convincing pol-

icy-makers, managers or the workforce in general of the benefits associated with eHealth or

in engaging patients through the use of strategies to elicit their participation in new but un-

familiar healthcare processes. The free movement of patients across borders is one example

of the new arrangements raising new demands for interoperability between systems. How-

ever, technology is only one issue with any number of cultural, philosophical and historical

barriers to overcome.

A crucial element in change management is communication. Communicating the benefits of

eHealth in an open way, while stressing the steps needed to implement it, requires a well-

though through and sustainable, repetitive information campaign. Identifying benefits that

are uncertain or unproven should be resisted, as such an approach creates mistrust. The

messages of such a campaign should be tailored to the target audience. For instance, medi-

cal professionals will, by virtue of their training, wish to understand the evidence of benefit,

and the degree of disruption needed to reach a specific target. Patients will be more con-

cerned about privacy. An approach to patients that stresses the guarantees made regarding

the levels of consent needed for the sharing of data, and an easily managed process for ac-

cess to records, will enhance trust. Healthcare providers have much more to gain from

openness. A cautious approach to communication - sometimes unjustifiably driven by a fear

that patients will opt-out from having electronic records - can easily generate mistrust.

Buy-in strategies can come in any number of forms including legal protection for patient

safety, privacy and consent, communication programmes to increase transparency and thus

trust, patient empowerment by providing access to their personal health records or provid-

ing the right to opt-out of certain processes such as data sharing.

Examples of various strategies have been documented by the EC’s eHealth Strategies pro-

ject17. The final report summarises the position with regard to opt-in/out and consent across

various Member States, as:

“In all countries trust in eHealth systems by both citizens and professionals has been identi-

fied as one of, if not the key challenge; privacy is recognised as the most sensitive aspect of

17

http://ehealth-strategies.eu/report/eHealth_Strategies_Final_Report_Web.pdf


29

electronic health record systems. The question, whether the creation of a (share-

able/national) electronic record for a specific patient should be opt-in based (the citizen has

to explicitly agree to its creation) or opt-out based (the record will be established unless the

patient explicitly refuses) is the most controversial one being addressed around the world

and not only in Europe.”

“Many countries are still debating what type of option to introduce. Belgium, France, Italy,

Spain, Iceland and Switzerland do require the patient to consent explicitly orally or in writing

before an electronic health record may be created for her/him. In Spain, the requirement for

explicit consent follows from the Health Law enacted in conjunction with the Data Protec-

tion Legislation. In Iceland, the Health Sector Database Act, enacted in 2002,66 was heavily

criticized for the fact that citizens were identifiable in the national opt-out database; the

recently enacted Patient Rights Act67 now requires the prior consent of the patient before

information can be stored in any database. In France, an electronic health record can only be

created after the consent of the patient, but once created the reimbursement rates are

linked to the use of the record.”

Other countries have chosen to install an opt-out based system. Examples include:

Estonia: the Amendment Act (Amending the Health Services Organisation Act)68 lays

down the general principles for the management of health information and sets ground

for the automatic creation of electronic health records in the central Health Information

System unless the patient objects to it;

Scotland: there is no explicit provision for the consent of the patient with regard to the

creation of a health record. The dominant view in Scotland is that although the UK Data

Protection Act69 (which is in force in Scotland) does require explicit consent, this does

not preclude obtaining consent on an opt-out basis;

The Slovak Republic: the Act on Health Care70 states that maintaining medical records

is an integral part of the healthcare provision and therefore, consent from the patient is

not necessary in order to create a medical record, whether written or electronic”.

3.4 Economic and Financial Aspects

3.4.1 Meaningful Use

The HITECH Act that forms part of the American Recovery and Reinvestment Act of 2009*

specifies three main components of Meaningful Use:

1 The use of a certified EHR in a meaningful manner, such as e-prescribing.

2 The use of certified EHR technology for electronic exchange of health information

to improve quality of health care.

3 The use of certified EHR technology to submit clinical quality and other measures.


30

Simply put, "meaningful use" means providers need to show they are using certified EHR

technology in ways that can be measured significantly in terms of quality and in quantity.

Meaningful use in the USA is further categorised as:

Improve care coordination

Reduce healthcare disparities

Engage patients and their families

Improve population and public health

Ensure adequate privacy and security

In the USA, the Centers for Medicare and Medicaid Services provide detailed criteria for the

content and use of EHR technology and set the standards required to meet the terms of

“Meaningful Use”.

The ultimate aim, however, is to stimulate or, indeed, enforce the use of interoperability

standards and procedures that enable accurate and reliable sharing of information to bring

about efficiencies and improvements to healthcare delivery

The American Recovery and Reinvestment Act of 2009 was prepared to respond directly to

the current economic climate. It has as one of its aims to, “Foster unprecedented levels of

accountability and transparency in government spending” and within the overview it specifi-

cally covers the computerization of medical records.

Within Europe there does not appear to be, at the moment, any similar legislation to the

HITECH Act. However, whilst this may be taken as a gap in the eHealth legislative arena,

there uis a growing awareness of the importance of meaningful use and a recognition that it

links closely to benefits management.

3.4.2 Funding and Incentives

A major driver supporting the acceptability of eHealth systems is the provision of incentives

to stimulate their adoption. These include the development of sustainable financial models

for eHealth implementation.

In 2010, the Organisation for Economic Cooperation and Development (OECD) published a

detailed report analysing , “Improving Health Sector Efficiency: The Role of Information and

Communication Technologies”18. While not focussed specifically on eHealth it offered some

detailed insights into funding issues and incentive models for encouraging the introduction

of ICT in healthcare. These insights offer some potential solutions for stimulating the adop-

tion of eHealth technologies outside of the traditional ICT solutions and including telemedi-

cine, telecare and telemonitoring.

18

http://ec.europa.eu/health/eu_world/docs/oecd_ict_en.pdf


31

OECD identified three ways in which national governments could stimulate the introduction

of ICT into healthcare, namely:

Direct regulation: enforcing compliance by determining expected outcomes;

Economic instruments: persuasion through economic incentive and market stimuli;

Persuasive measures: often combined with economic instruments and might encom-

pass training and education, peer pressure and recognition of achievement.

The report recognises that there has been no formal study of the outcomes of these ap-

proaches but cites a number of examples where financial incentives (i.e. economic instru-

ments) have been used to stimulate the adoption of ICT in healthcare.

These fall into four categories:

Direct subsidy through private and/or public grant programmes: which was the main

mechanism used to encourage the implementation and adoption of health ICT by Gen-

eral Practitioners in the areas studied;

Payment differentials: bonuses or add-on-payments that reward providers for adopting

and diffusing ICTs;

Payment for electronically-delivered care (e.g. consultations by email): which offers di-

rect payment for new categories of care or services related to the use of ICTs (e.g. use

of emails or telemedicine);

Withholding payments from providers: which amounts to financial “penalties” following

poor compliance,

Of these, direct grants and subsidies were the most popular form of incentive proving to be

least complex and most flexible to operate and can be awarded at any level of government

including Regions. OECD noted that these are not without problems in that they are best

applied where there is a clearly identifiable capital investment. Also setting the right level of

subsidy can be difficult and they do not necessarily support the on-going use of ICT. One

quoted example in this area was the strategy adopted by the Government of British Colum-

bia:

“...that included bonuses linked to the electronic reporting of quality of care measures

targeting priority health areas, payment to attend learning sessions, training and sup-

port, etc.”

One example of the use of payment differentials is the Quality Outcomes Framework in the

UK that is a payments-by-results and payment-for reporting scheme cited as being:

“one of the clearest examples of how incentives can be put in place to reward both qual-

ity measurement and quality improvement, and at the same time act as a stimulus for

ICT adoption”.


32

The infrastructure and almost total computerisation of primary care in the UK are seen as

being responsible for its success. Other examples of successful payment differential exam-

ples are the Australian Practice Incentive Programme and the Physician Information Tech-

nology Office in Canada.

The OECD report recognises that once the initial funding runs out, the most significant chal-

lenge is developing a sustainable business model. One of the major challenges in this process

is the time lag between the initial investment and the visible delivery of benefits. Healthcare

organisations need “financial, institutional and political support” for their ICT strategies but

often find it hard to demonstrate hard economic benefits. The Catch 22 is that health care

organisations are reluctant to invest in ICT unless they can be assured of better quality and

improved margins but this cannot be demonstrated until after the system is implemented. A

number of models are put forward for addressing this situation:

Not-for-profit: the not-for-profit initiatives are driven by their charter to help the pa-

tients and the community in which they provide services. Their tax-exempt status can

help to reduce funding challenges and costs, may also provide special tax cred-

its/incentives;

Public utility: these initiatives are created and maintained with the assistance of central

government/local state funds. This is the case in most European initiatives;

Physician and payer collaborative: this type of collaborative model is created for/by

physicians and payers within a geographical region. These initiatives can be set up as ei-

ther for-profit or not-for-profit organisations; however, the key to this category is the

collaboration between and mutual benefits for participating payers and physicians;

For-profit: created with private funding. These organisations look to reap financial bene-

fits from their transactions.

It is clear from the OECD report that there is no single model that fits every solution. Funding

and incentives need to be matched to individual position relating to political cultural and

economic circumstances that change rapidly in today’s dynamic position.

A recent report by the Think Tank 2020health.org “Healthcare Without Walls: A Framework

for Delivering Telehealth at Scale”19 has this conclusion:

“With NHS savings of £20bn to achieve within the next three years, an ageing population

increasingly living with ill health, and adult social care budgets under threat, this is an is-

sue that requires firm strategic leadership from the Coalition to enable the NHS to deliver

better care for less. It cannot rely on a hope that local communities will work it out for

themselves. This would mean that the fractured, small, uncoordinated market that has

emerged in the past few years perpetuates, and the benefits of scale, interoperability

and cooperation are squandered.

19

http://www.2020health.org/2020health/Publication/NHSit/telehealth.html


33

In our opinion, a prevailing view that initiatives such as this can be left to the market to

sort out will lead to a slower roll-out with much more duplication and higher costs in-

stead of rapid efficiency savings. Our report therefore recommends specific action by the

Coalition Government and others to create the right conditions for an innovative, tele-

health market to thrive and be of sufficient scale to make a genuine impact. Key

amongst the actions that only government can take will be to align the incentives and

tariffs that will encourage local NHS commissioners and providers to embrace tele-

health.”

It would seem therefore that financial and, indeed other, incentives have an important role

to play in supporting the implementation of eHealth. The art is now to find the model that

overcomes the reticence of investors (at whatever level) by providing confidence in the eco-

nomic returns.

4 Determination of Future WP Work

As identified earlier, there are four main groups of stakeholders involved with eHealth ser-

vices. The WP considers that the key issues of trust and acceptability for each group are as

follows:

Patients:

No reduction in quality of care

Use of IT does not diminish the personal nature of the patient/professional relationship

Privacy of sensitive information is guaranteed

Ability to know how personal data are stored and shared, and who has had access

Health Care Professionals:

Evidence of benefit to patient care

Easy to integrate innovative IT into daily practice (Usability)

Data are accurate and consistent across clinical domains

Reliability

No implications for professional liability

Health Care Providers:

Cost-effectiveness and return on investment

Conducive to change and benefits management

Possible to incentivise deployment

Benefits describable easily and consistently in communication programmes


34

Incorporation of new technology into reimbursement systems

System Suppliers:

Contractual and financial certainty (sustainability)

Encourage introduction of innovative technology (HTA, seed-funding)

In order to determine what work to pursue as part of its main activity the Work Package

members agreed on a process of selection based on their experience of projects demon-

strating success in the area of Trust and Acceptability. To aid this process a questionnaire

was produced against which candidate projects could be assessed. A copy of this scoring

document is attached at Annex A. The objective of the assessment was to identify likely pro-

jects, assess their suitability, select a small number and then to investigate:

Why they had been successful in the areas of T and A;

Identify approaches they had taken that enhanced project trust and acceptability within

the various stakeholder groups;

Synthesise those approaches in such a way that they could be translated as lessons for

the EC , national authorities and individual projects by providing case studies and guid-

ance notes.

4.1 Selection of Projects

A number of projects were considered for investigation using the questionnaire. The WP

noted that the issues of trust and acceptability that emerged from these projects related to

eHealth developments within a MS. A working assumption, which the WP needs to review

during the life of the Initiative, is that the major drivers and barriers to trust are equally ap-

plicable in cross-border exchanges of patient data. There are, for instance, differences on the

consent and privacy aspects between the two scenarios, but common principles apply to

both. After a process of elimination the following four projects were selected as exhibiting

strong characteristics of trust and acceptability. They further spanned, between them, many

of the elements of T&A described in earlier sections. The projects are:

The Picture Archiving and Communication System (PACS), as implemented by the Na-

tional Programe for IT in the UK;

Reseau Sante Walloon, Belgium;

Danish "Medication Card" FMK, a Shared National Medication Database

IZIP, Czech Republic;

e-Tervis, Estonia.

These are described, and the trust and acceptance elements identified, in the next sections.

4.1.1 Picture Archiving and Communication System


35

The Picture Archiving and Communication System (PACS) is a flagship project of the NHS Na-

tional Programme for IT as administered by the Connecting for Health Programme (CfH).

According to CfH PACS works with x-ray and scanning technology such as computerised to-

mography (CT), magnetic resonance imaging (MRI) and ultrasound to make x-rays and

scanned images available to view on screens within radiology, and to share with other hospi-

tal departments like accident and emergency, neurology and orthopaedics. With PACS, clini-

cal images are instantly and simultaneously available for study at multiple locations within a

trust. PACS supports more effective team working between clinicians and therefore aids

swifter and more accurate diagnoses and treatment for patients.

In radiology, PACS is combined with a radiology information system, or RIS. Radiologists re-

port on the x-rays and scanned images they can view on PACS, and the subsequent reports

they produce are then accessible from the images with which they are associated.

PACS allows for a near filmless process, with all of the flexibility of digital systems. It also

removes the costs associated with hard film processing and releases valuable space previ-

ously used for film storage. Most importantly, PACS is helping to transform patients' experi-

ence of the care they receive across the NHS. It does this by enabling a speedier diagnosis

and by removing the risk of images being lost or misplaced. Key aspects of the PACS system

relevant to trust and acceptability are:

(i) Usability

PACS has achieved significant and positive results in the area of usability. One of the key rea-

sons, supported by clinicians, is the amount of time they save through smooth workflow and

through the eradication of time spent looking for lost images. Indeed some cite the fact that

the cancellation of clinics due to image loss has been much reduced.

Specific benefits are:

Faster accessibility to medical images for the clinicians who evaluate and report on

them. This can lead to the speedier availability of results;

No lost or misplaced images, which means fewer patients having their consultations or

operations postponed or cancelled;

Flexible viewing, with the ability to manipulate images on screen, ensuring that patients

can be diagnosed more effectively;

Instant access to historic images, so that new and old images can be compared and the

progress of patients' treatment and condition(s) monitored;

Faster delivery of medical images, which can lead to speedier availability of results;

No lost or misplaced images;


36

Information only needs to be entered into the system once. This reduces some of the

administrative tasks currently undertaken by radiographers, thereby freeing up time to

focus on caring for the patient.

(ii) Mobility

One of the most applauded features of the PACS implementation within the UK National

Programme and one that has hastened its acceptability across multiple organisations, is its

ability to make images available at several locations and, if necessary, at the same time. This

promotes the notion of multi-disciplinary care as well as providing convenience for clinicians

and aiding emergency treatment

An award winning feature of PACS UK is the use of the Image Exchange Portal (IEP). The IEP

is a web-based solution that enables the transfer of digital images between NHS organisa-

tions and independent health providers. It improves the ability to share patients' diagnostic

information. It has been deployed across the UK since January 2010. It is recognised as an

important contributor to interoperability within and outside the NHS health system envi-

ronment.

Features of the PACS UK implementation supporting mobility through the treatment at mul-

tiple and sometimes remote locations are:

Better teamwork and collaboration because images can be viewed from multiple termi-

nals and locations within a trust by a range of clinicians. The vast majority of Health

Trusts now have the ability to share images electronically with other trusts;

Patients not having to carry packets of film around the hospital and between sites dur-

ing the course of their care pathway;

Information only needs to be entered into the system once. This reduces some of the

administrative tasks currently undertaken by radiographers, thereby freeing up time to

focus on caring for the patient;

PACS meets NHS requirements at a national and local level, and is compatible with oth-

er IT, both now and in the future;

Instant access to patient images, regardless of location;

Better collaboration and an increase in consultation between radiologists and clinicians;

Experience shows patients feel more engaged and better informed when they can see

their images on screen, this can lead to better quality consultations for both the patient

and the consultant.

(iii) Training

Along with many other national projects in the UK, PACS benefits from an extensive training

programme. Co-ordinated centrally, the training is provided at the local level through a vari-


37

ety of means ranging from “on the job” approaches to dedicated PACS training rooms and

facilities. One of the key features of the early implementation of the PACS system was some

resistance on the part of clinicians to change working practice and to the introduction of IT

to the process. However, the extensive training support contributed to gaining acceptance

and, indeed, to promoting the use of the system. One clinician is quoted as saying:

“PACS really came on in - we were building up towards PACS - in about the early part of 2004

and I sort of threw up my arms in horror saying 'I'm not a computer geek, I don't understand

the things, I can just about manage my computer at home'”.

"And when it was first mooted. I thought ……… I can't cope with this, I'm not going to be able

to manage at all. And when we started definitively a year ago, the IT department bent over

backwards with the training and I found that in fact, apart from a few starting glitches, it ran

reasonably well.”

Training in this context, therefore, has not only had the effect of making people (at whatever

level) proficient in the use of the software and system, it has also helped to remove many of

the perceived objections to PACS implementation. Furthermore, it has contributed to the

change management process so often required with the introduction of technology that

“challenges” well established systems of clinical procedure.

In addition to the above, the PACS environment offers improved learning and training op-

portunities, both for trainee radiologists as they develop their skills and for existing radiolo-

gists as there is more opportunity to collaborate with colleagues and share learnings and

experience

The training element of PACS represents a worthy candidate for understanding how success-

ful implementation was achieved through a co-ordinated training programme at national

and local level.

4.1.2 Health Network Walloon

The Health Network Walloon (Reseau Sante Walloon, RSW) has been in existence for only a

short period of time. That said, it has already undertaken an evaluation exercise in order to

identify those factors that might impede the effectiveness and progress of the implementa-

tion of the RSW. Whilst viewed from a negative perspective the evaluation exercise identi-

fies some valuable indicators relating to Trust and Acceptability.

The Network was set up to establish a federated network bringing together a number of

disparate telemedicine associations and to facilitate interconnections between them. The

Telematics associations involved were:

ACTH. Covers the area of Charleroi: 31% of hospitals adhere;

Altem. Covers the area of Liege: 22% adhere;

ANATEM. Covers the Namur-Ardennes region: 17% adhere;


38

MEDITEL. Covers the area Verviers: 8% adhere;

UMT. Covers the area of Tournai: 3% adhere;

ATMB. Covers the area of Mons Borinage: 11% adhere.

The Network was established because of an increasing need for instant communication be-

tween healthcare professionals arising from integration of hospitals in areas of care and the

shortening of stays in hospital. Using the network, hospitals can send patient protocols and

test results via Internet messaging directly into GP systems. This is a one-way transaction as

information moves from hospital to GP but not vice versa.

Information held on the RSW is as follows:

Patient identification and a record of their consent;

Identification of health professionals and a record of their consent;

The index (and only that) of medical documents that professionals wanted to share in

accordance with the wishes of the patient;

Copies of summary emergency records;

History and the access rights of access.

The Walloon Network aims ultimately to interconnect all hospitals in the Region and allow

all licensed physicians to examine a patient’s record in accord with secure protocols and in

accordance with ethical rights such as privacy and patient consent. A key feature is that pa-

tients have control over their data and who can have access to it.

The evaluation exercise – consisting of two surveys relating to “caregivers” and “citizens”

identified a number of factors that might inhibit the use of its facilities as described below.

(i) Communication and Awareness

The survey of caregivers indicated that, at the time it was undertaken, 70% of GPs and 75%

of hospital specialists were unaware of the RSW. Furthermore, 53% of GPs have indicated

that they do not wish to access the network in its present form. Perhaps unsurprisingly, the

majority of those resistant to joining the network are older, single-handed doctors are

averse to the use of ICT. There is also a traditional lack of communication between GPs. The

survey report concludes that, in order to overcome this resistance, a communication exer-

cise explaining the purpose and facilities of the RSW is required as well as the benefits the

service offers.

In terms of the response from the citizens – the potential patients – it was found that some

43% of them would be resistant to the sharing of their medical data. Perhaps more signifi-

cant, practically none of those surveyed had actually heard of the RSW and could not even

begin to appreciate the benefits it might offer them. These two points are likely to be inter-

linked. Again, it has been recommended that a communication plan is designed to explain


39

the purpose and advantages of the RSW and reassuring people about the retention of their

control over how their personal data is used. In addition, it should explain that data will not

be shared outside of the direct healthcare context and should spend significant in seeking to

convince the elderly as the largest healthcare consumer group.

Some work has been undertaken with GPs acting as advocates for the service but the proc-

ess of engaging patients had proved very time consuming

(ii) Buy-in

Like many other healthcare services and implementers, Walloon has spent some consider-

able time considering how to achieve patient engagement. This is considered vitally impor-

tant as a critical mass in terms of patient adoption has to be achieved if the system is going

to work. The primary argument rests in the area of opt-in/opt out strategies. RSW has a phi-

losophy of voluntary adoption by the patient but some institutions oppose this and are argu-

ing for an opt-out system. From a systems thinking perspective, it is interesting that the insti-

tutions are seeking to drive this approach rather than seeking to sell it as an advantageous

option (i.e. the patient is subservient to the network). In Flanders, there is a principle that if

you have a medical record on the system you, as a patient, are expected to adhere to the

needs of the system.

There is a further aspect to buy-in in that, unlike other systems where the State decides to

implement electronic medical records, there is currently no national decree or directive that

organisations must conform to the exchange of medical data between institutions. Thus,

there is a conflict between the need to apply legislative incentives or to encourage voluntary

buy-in

(iii) Patient consent to data sharing

The RSW has a number of features relating to patient consent. Whilst there appears to be no

requirement for a patient to give his or her consent at each encounter, the RSW gives the

patient control over the exchange of medical data:

She/he can restrict access to her doctor(s) of choice;

She/he has a right to know who has accessed their documents;

The service provides access to the list of relevant documents and can filter access;

She/he can unsubscribe.

The RSW approach (that may of interest elsewhere) is that:

“When a patient presents to a hospital admission, he was asked who is his doctor, which

enables access to DMIh (hospital index) for the GP. Now, the therapeutic relationship will be

induced if both the GP and the patient joined the RSW. This adhesion can be achieved by


40

various means: by paper signed and scanned or electronic identity card to the GP, the hospi-

tal admissions desk or in specific terminals, or directly on the website of the RSW. “ 20

The evaluation exercise noted that within this patient control environment there need to be

technical adjustments to the hospital and GP systems. It further notes that there needs to be

a facility to ensure that all institutions are aware of the patient’s consent status: have they

opted out since initially opting in? These raise issues for other States considering the patient

consent issue and are likely to have legal implications if such arrangements if not sufficiently

robust.

(iii) Privacy

The Walloon evaluation has also pointed up two interesting elements relating not just to

patient privacy but also to professional secrecy. As would be expected by most patient rep-

resentatives, some patients have denied access to some sensitive information about them-

selves including psychiatric treatment, STDs and pregnancy terminations. However, as the

report has indicated, such shielding can have an adverse effect of the quality of care through

incomplete information leading to incorrect diagnoses. The balancing of a patient’s right to

suppress part of the medical record and the fact that the healthcare professional’s access to

incomplete data risks providing sub-optimal care (and a possible threat to professional liabil-

ity) has not yet been fully explored.

More interestingly has been the impression that some healthcare professionals are con-

cerned that wider access could lead to peer analysis of their performance. Although such

audits are part of clinical governance, mistrust and the perception of competition is likely to

hinder transparency.

4.1.3 Danish "Shared Medication Records" (FMK, Fælles Medicinkort)

The Danish health system recognised the many advantages of utilising electronic prescrip-

tions some years ago. These include benefits such as patient safety, medication compliance

accuracy of data and reduced costs through the use of generics and reductions in the num-

ber of adverse reactions. The use of such prescribing has proved so successful that 84% of

the traffic carried by the Danish Health Data Network (cf. MedCom) now relates to prescrip-

tions/prescribed medication.

Still, also in the Danish system, lack of full knowledge about a patient’s medication often led

to medication errors and hospital admissions. The incomplete knowledge is often due to the

fact that the main source of information on the patient’s medication typically is the patient

him or herself. As a patient, it can be difficult to remember all currently prescribed medica-

tion as well as the correct name of the medicine. As a consequence, the clinician often re-

ceives incorrect or incomplete information. This can potentially be harmful to the patient.

20

http://www.awt.be/web/dem/index.aspx?page=dem,fr,b11,hop,040 (translated using Google Translate)

http://www.awt.be/web/dem/index.aspx?page=dem,fr,b11,hop,040


41

To counter this problem, the Shared Medication Record (“Fælles Medicinkort” - FMK) has

been implemented across the Danish health system. It answers the following drawbacks and

gaps left open by the otherwise quite successful electronic prescribing systems in Denmark:

No medication data to/from hospitals

No medication data to/from ”out of hours service” call centres

No medication data to/from Home Care

No dosage change

No information on discontinued medicine

Only prescribed medicines were recorded

Difficult access, log on procedures

No integration with existing IT systems, only look up

In order to address these issues, the FMK Shared National Medication Database was created.

The system consists of a central database containing information on all Danish citizens’

medicine dispensed during the previous two years as well as an updated list of every pa-

tient’s current medication. The system is designed to share patients’ medication data across

and between a number of different organisations within Denmark. These include:

General Practitioners

Medical Specialists

Hospitals

Citizens

Public and Private Hospitals

Dentists

Emergency hysicians

Institutions and Residential Homes

Pharmacies

Home Nursing Organisations

At the heart of the FMK is the Patient Electronic Medicine Profile (PEM) that holds a record

of all drugs prescribed to a patient by any organisation. This represents a Common Data

Foundation meaning that all parties involved in patient care (including the patients them-

selves) can have the assurance that they are working with accurate and up-to-date informa-

tion. The FMK system reflects the citizen’s current medication and is shared by all parties

through their various IT systems.


42

As an example of how the system works, it is possible to examine a case where the citizen

consults with his or her GP and is subsequently admitted to hospital. During the GP consulta-

tion, the GP updates the actual medication record including indication and dosage on his

electronic medical record. Once complete, the GP system updates the medication record on

the FMK meaning that both systems are up-to-date. Should the patient subsequently be ad-

mitted to hospital, the hospital first updates its system from the information held on the

FMK. At this point the FMK record is suspended. Upon discharge, the hospital updates the

FMK with information about the patient’s medication whilst in hospital and the FMK is then

activated again.

The benefits associated with the FMK are as follows:

Updated medicine information – on-line

Integrated in IT systems

”automatic” logon

Everybody working on same database

Less medication errors

Increased trust in the medication information

The challenges faced by the FMK are that it is a new technology and presents some technical

difficulties for software vendors. It is also still under development and is not fully ready for

large-scale implementation. As a new concept there is no reference to other systems any-

where else in the world ie it is leading edge technology and, as with all new systems, there is

a very large implementation challenge including training and change management.

The use of the FMK is currently extended in hospitals within the Danish Regions, the many

GP’s in the MedCom coverage and also in home care management within the Municipalities.

4.1.4 Project IZIP

Project IZIP is based in the Czech Republic and began its life in 2002. The principal aim of the

project is to transfer the “ownership” of the medical record from healthcare professionals

and institutions providing healthcare into the hands of the citizen. The project has been the

subject of a detailed evaluation, in terms of its benefits, by the eHealth Impact project and

the following assessment reflects its findings. The primary feature of the project is the trans-

fer all for medical records from paper to electronic files held on the Internet. The philosophy

behind patient ownership is that:

“a well informed patients he is able to make responsible decisions, co-operate better and

gain a picture of the technical and even financial limitations of the proposed or available

services and procedures”.

Although the patient has access to his or her medical record, only healthcare professionals

are able to amend it. Updates to the record can be made from a number of locations includ-


43

ing emergency rooms, laboratories, complementary services, and pharmacies. The system

holds information about:

Medical History

Examination results

Laboratory tests

Medication

X-rays, scans and other images

Reports regarding hospitalisation episodes

Vaccinations

At the time that the eHealth impact project report was written, updates to the system in-

cluded e-prescribing, emergency services support and messaging. In addition, future plans

included the use of smart cards and digital signatures and improving the overall structure of

the health record in order to facilitate statistical and clinical analyses.

Another significant change to the traditional method of medical records management is that

once information has been entered into the medical record it is immediately available to the

patient electronically via the Internet. Any sharing of information between Healthcare pro-

fessionals is under the control of the patient in that he or she has to authorise such a trans-

action. A significant benefit of the system is that because the record is held centrally on the

Internet and is a single entity updated by all those professionals associated with the pa-

tient’s care, it is a complete and easily accessible record. This ensures that all concerned with

the patients treatment have access to a comprehensive record. As recognised by the eHealth

impact project, instead of spending time on arranging the relocation of physical paper files

from one institution to another, with IZIP the professional goes online and accesses the rele-

vant data directly in electronic form.

The following issues are identified as relevant to trust and acceptability:

(i) Training

A key feature of the IZIP project is its formal training programme. Healthcare professionals

receive training from technical staff about how to use all of the system’s facilities including

how to upload new files, access existing information as well, interestingly, as being advised

on how to brief citizens on the potential of the system. Training is on-going to include up-

dates to the system and all healthcare professionals have access to full technical support.

There is no direct face to face coaching for citizens but if they are interested in using the

system they have access to written material which comes them as part of the registration

package. Further information is a available online or three telephone support.

(ii) Change Management and Buy-In


44

As identified for the RSW project in Belgium, the IZIP initiative recognised that it needed to

ensure that a critical mass of healthcare professionals and citizens were involved if the pro-

ject were to be a success. In order to address this issue, a number of people were employed

with V responsibility of increasing participation by both Healthcare professionals and citi-

zens. This was achieved by explaining the significant benefits to be obtained from utilising

the centrally held electronic records and the fact that the patient strokes citizen what have

control over how their personal information was used. As a supplement to this process, citi-

zens also receive information through the Internet and by briefings from by their doctors.

(iii) Data Security

Because highly sensitive information is being stored on the Internet strong security meas-

ures are a key feature of the IZIP system. This is both to protect patient privacy but also

brings reassurance and encourages buy-in to and take-up of the system. The security is de-

scribed on the IZIP website as follows:

The medical file belongs to the patient and as such she decides which doctors will have

access. It is not possible to peruse patient records in medical files without permission;

In order for a patient to peruse their medical file, they must enter their identification

number (birth registration number), PIN - which they will have received via registered

mail, and personal password - which they can create themselves;

Should a patient decide not to tell a doctor a password or enter it into a computer, the

doctor will not be able to read the medical file. They can however send enter the results

of the examination into IZIP. The doctor can open a blank form, into which they write

the results and send it to the patient's medical file. This is all without accessing the rec-

ords written by other doctors.

It should be noted that the future status of the IZIP services is currently under review by the

Government of the Czech Republic.

4.1.5 Estonian EHR (e-Tervis - Estonian eHealth Foundation)

Estonia has established itself as a leader in the field of eGovernment and its range of services

includes a comprehensive Electronic Health Record (EHR). The Tervis eHealth Foundation

website21 makes the following points:

The Government of Estonia has already established and maintains a nationwide technical

infrastructure called the X-road platform. X-road is a platform independent standard inter-

face for secure data processing, connection of all Estonian public sector databases and in-

formation exchange. Other IT-solutions such as digital signatures and ID-card authentication

are recent innovations, and their use is comprehensively regulated by national law. These

21

http://eng.e-tervis.ee/overview.html


45

developments are the basis of implementing sectoral policies such as creating a countrywide

electronic health record.

The idea of eHealth and electronic health record dates back to 2002. The purpose was to

develop a nationwide framework (database) to facilitate the exchange of digital medical

documents and diffuse health information available so far only in local databases and infor-

mation systems that were not able to communicate with each other. In 2005, as the recipi-

ent of the structural aid, the Estonian Ministry of Social Affairs launched a new e-health con-

cept by phasing in four projects:

Electronic Health Record

Digital images

Digital Registration

Digital Prescription (eHealth projects)

The result of implementing eHealth projects is the Electronic Health Record that was

launched on December 17th 2008, with the following goals:

Decreasing the level of bureaucracy in the doctors work process

Increasing the efficiency of the health care system

Making time-critical information accessible for the attending physician

Developing health care services that are more patient friendly and have higher quality

Early eHealth projects were complex multi-annual projects involving a number of partners.

The Ministry of Social Affairs fulfilled the coordinating and directing rule in implementing the

eHealth projects. These were not just large IT projects, but addressed social development,

and therefore involved large partnerships.

Alongside implementation of new information technology concepts, other aspects were in-

troduced, such as medical standardisation, ethics and legislation. To ensure effective man-

agement of the eHealth projects the Estonian E-Health Foundation was established in 2005

by the Ministry of Social Affairs and several other healthcare providers for leading the four

eHealth projects.

From September 2008 the health care service providers were required to forward medical

data to the EHR.

Patients can use the Patient's Portal to exercise their right to set restrictions of access to

their health data. In this case the patient will be informed by the information system at the

time of setting the restriction that it is dangerous to his/her life and health to provide health

care services based on insufficient information. There will be no access allowed to initial

documents even in the emergency situation and the patient will take full responsibility re-

garding possible consequences that may arise from banning access to data.


46

Relevant trust and acceptability issues are:

(i) Liberated Data and Meaningful Use

The Estonian model and particularly the X Road infrastructure is an example of how informa-

tion can be released from locally based silos and made to follow the patient. Furthermore,

the primary goal of ensuring that time critical information is available to the healthcare pro-

fessional at the point of care and making the service more patient friendly and of higher

quality all accord with the notion of meaningful use.

The Estonian approach also illustrates how regulatory incentives can be used to make the

system work; as already mentioned, all healthcare providers are mandated to forward in-

formation to the EHR. This is a model that is likely to be seen more and more if health sys-

tems are to transform themselves through the opening up of data that can then be held and

used in a standardised way.

5 Selection of Future Work Package Activity

The issues associated with Trust and Acceptability in eHealth are varied and complex. It is

rare, for example that one single factor results in an eHealth service’s total acceptance

through trust or other factors. Often it will be a combination of the nature of the service

offered, the influence of a particular stakeholder group, the political and economic climate

and how far a system has achieved acceptance among the key stakeholders

The resources available to the Work Package are limited both in terms of finance and time.

Accordingly, in order to obtain the maximum return on its investment, the selection of ac-

tivities to proceed with has been carefully considered against defined criteria.

The Work Package’s aim is not to be involved with developing new and innovative ap-

proaches to trust and acceptability within eHealth but rather to consolidate already mature

actions, to identify those gaps and blocks to the delivery of eHealth, and propose achievable

actions.

In addition, the Work Package seeks to build upon existing good practice by identifying those

projects and initiatives across the Member States in any areas selected for review and inves-

tigation.

The four projects chosen demonstrate key trust and acceptability issues, all of which require

further examination. The Work Package has settled on four key areas that it considers

should be prioritised as they are central to trust and acceptability. These are:

Information Governance (Ethical and Legal Aspects)

Patient Access to Personal Medical Records

Useful Clinical Documentation and Data Mobility (Meaningful Use Strategies)


47

Communication strategies

The following paragraphs describe the value of work in these areas and why they are signifi-

cant for future work within Europe.

5.1 Information Governance (Ethical and Legal)

A patient’s right to privacy and an expectation that their personal medical information will

be handled in a confidential manner are key elements of ensuring trust and acceptability of

eHealth systems. As a higher volume of data is shared between an increasing number of

people and agencies, , the ability to control who sees identifiable (or pseudonymised and

aggregated) information and for what purpose becomes more and more difficult. This is fur-

ther complicated once sensitive personal information moves across national borders.

Cross-border data transfer creates a new dilemma for the healthcare professional who is

required to ask, for the patient’s consent to share their information with other professionals

in an ethical and legal environment of which he (the HCP) has limited knowledge. There is

uncertainty about professional liability in such a situation. Uncertainty generates mistrust.

The WP believes that there are significant theoretical and practical differences between data

protection legislation and the consent process. The process of obtaining consent represents

a “contract” between the professional and the patient, and precedes the treatment process.

It builds trust and encourages working together. Data protection, on the other hand, creates

a contract between the professional and the law. It is retrospective in that any repercussions

come after the event; because it is based on penalties, it can reduce trust.

Areas for examination:

The use of implied consent for a defined treatment episode or chronic care pathway. A

patient presenting for treatment is, it could be argued, giving implied consent for their

information to be shared as part of the treatment process. How widely this information

is shared will depend on different concepts of the size of the healthcare team, and

therefore the number of people entitled to access on a “need to know” basis. In addi-

tion, it should be noted that trust is increased in the “immediate care” scenario if the

record sharing is handled by a HCP as “data controller” .From the legal perspective, re-

cent proposals for changes in European Data Protection legislation include:

Greater control of information by the individual

A legal obligation to report data protection/security breaches within 24 hours

Explicit consent as the norm

National data protection authorities will handle complaints relating to breaches oc-

curring in other Member States

A “right to be forgotten” – deleting data when there is reason for it to be retained


48

As can be seen, the implications for practice arising from these proposals imply a signifi-

cantly different process for seeking consent for data sharing when compared to the standard

ethical model.

The level of consent required for “secondary use”: When information relating to pa-

tients is further used for statistical analysis, management purposes, and then stored on

servers operated by third party organisations, more informed consent is needed. It can

be argued that the further the information moves from the original consultation, and

therefore from the purpose for which it was collected, the more specific is the level of

consent required.

The practical reality of “informed” consent. There is a need for clear strategies to ex-

plain how information is to be used in both a primary and secondary care setting.

Terminology. For patients, terms such a “opt-in” and opt-out”, “anonymisation” and

“aggregation of data” cause confusion and therefore reduce trust. Communication of

these concepts is vital, but must be done in more accessible language. The use of ex-

plicit consent should increase trust. This might include the use of specific and opt-in ar-

rangements whereby the patient gives explicit permission for their personal information

to be used for treatment on the understanding that if it is used for any other purpose,

explicit consent will be sought again. The Data Protection Directive and its impact on

consent, privacy and cross-border sharing of data22. As indicated, the identification of

potential areas of conflict between existing and proposed data protection legislation

and a healthcare professional’s ethical and regulatory duties, an assessment of the im-

plications of data protection and consent in relation to cross border care, and a con-

sistent application of standards and processes in this area are all needed.

Professional liability. Key elements here are the potential liability of HCPs faced with

patients who suppress information in their electronic record (with or without a “mark-

er”), and the uncertainty of how data is shared, stored and handled in other jurisdic-

tions, once they leave the home country’s IT system(s)

In summary, therefore, the areas for examination are:

The use of implied consent for a defined treatment episode or chronic care pathway

The level of consent required for “secondary use”

The practical reality of “informed” consent

“Opt-in” and Opt-out”

Anonymisation, pseudonymisation and aggregation of data

22

In relation to health, the draft Directive will require greater control of information by the individual, a legal obliga-

tion to report data protection/security breaches within 24 hours, explicit consent as the norm, a requirement that national data protection authorities will handle complaints relating to breaches occurring in other Member States, and a “right to be forgotten” (suppressing data that is seen by the patient to be private)


49

The Data Protection Directive and its impact on consent, privacy and cross-border shar-

ing of data

Professional liability

Deliverable: a report detailing the work undertaken together with evidence-based rec-

ommendations regarding actions required for a trust framework for data protection and

professional considerations. The approach to this work will be to review exemplar pro-

jects undertaking work in this area, to consolidate their experience and to ensure that

any recommendations are focused on putting in place procedures that engender trust

rather than implying mistrust.

5.2 Patient Access to Personal Health Records

As stated in key action 13 of the Digital Agenda for Europe, the deployment of eHealth tech-

nologies in Europe can improve the quality of care, reduce medical costs and foster inde-

pendent living in remote places. New telemedicine services, including online medical consul-

tations and improved emergency care, with the help of portable devices have allowed free-

dom of movement that patients have not previously enjoyed until now. As with any online

service, user empowerment is a prerequisite for its success. That said, 'real' empowerment

of users as citizens and patients, in the sense of being able to 'own' or to consult their own

electronic medical record, and even make efforts to self-manage their own health condi-

tions, is still pending. Within the following years, it is the European Commission's priority to

cooperate with the Member States in order to equip Europeans with secure online access to

their medical health data by 2015.

Access to their own medical records has the effect of empowering the patient. By being able

to see what has been written about them and who has had access to the record and, to

some degree, for what purpose gives them confidence that they are being treated on the

basis of full and accurate information. It further enhances the relationship between the pa-

tient and the healthcare professional that in turn builds trust in and acceptability of the sys-

tem and service.

In addition, there is a growing tendency by patients and the public to question information

from the health system, ask for a second opinion, demand respect and dignity in their

treatment and to expect convenience from the whole treatment process. There is a growing

demand from patients/citizens for improved efficiency and economy. These have the poten-

tial to have a significant impact on the way services operate in the future, the patient profes-

sional relationship and the new processes and procedures required to deal with them.

However, for such access schemes to be successful it is imperative that patients understand

their rights and are given sufficient training to understand how they go about achieving such

access. They also need to understand about how the “system” operates in terms of how

their information is shared and for what purpose. Without such background there is a dan-

ger that they may become concerned about how widely the record is shared. They also need


50

to understand their rights regarding the amendment or removal of incorrect information.

There is also a need for an examination of the proposed provisions of the new Data Protec-

tion Directive relating to the “right to be forgotten”. There are significant implications for

patient safety and for professional accountability if the patient insists on part or all of their

information to be removed from the record. This raises issues of how such implications are

explained to the patient and who has the responsibility for handling the process of explana-

tion and removal.

Other issues that need to be investigated are what information must be withheld from the

patient such as sensitive information that might, for certain patients, be considered harmful

to their mental health or information provided by third parties.

WP 6 considers the right and ability of patients to access their own medical records, either in

full or summary form, associated with the ability to track who has accessed their record

through a robust audit trail, to be a crucial driver of trust. Indeed, without further develop-

ment, eHealth development is likely to be limited. A number of Regions across Europe have

implemented such features as patient access to simple administrative data through to full

access and control over the use of their medical details.

Areas for examination:

Empowerment of patients through education strategies

What are the main issues for patients that improve their quality of care?

What has to be excluded from records accessed by patients (such as third party infor-

mation)

The principles and practice underlying the “right to be forgotten”

The nature of informed consent, and patients’ attitude towards secondary use of data

5.3 Useful Clinical Documentation and Data Mobility (Meaningful Use)

Directive 2011/24/EU on patients’ rights in cross-border healthcare due for implementation

by 2013, seeks to boost the digital economy by enabling all Europeans to have access to

online medical records anywhere in Europe by 2020. For this to happen, interoperability of

systems across the European Union has to become a reality and significant components of

that process are Useful Clinical Documentation and the mobility of data. Both elements in

combination support also the idea of "meaningful use" that can be defined as a process of

encouraging the adoption of new technologies and the engagement of the patient and local

systems in healthcare to improve and exploit efficiencies, improve care and increased shar-

ing of transparency of information. This means that information follows the patient either

within a Member State or across national borders. It can be further developed to improve

decision making and to ultimately improve healthcare outcomes.


51

In practical terms, all stakeholders in the healthcare delivery process have an investment in

ensuring that information is being used properly and appropriately to ensure the highest

quality of care and in the most efficient manner. Investment brings demands driven by the

well recognised demographic issue, rising healthcare costs and greater mobility and in-

creased expectation in the ability of technology to address these issues. Thus, all those in-

volved in the delivery of healthcare and the development of eHealth systems to support it

need to expand their horizons and broaden their thinking in order to meet the rapidly evolv-

ing stakeholder demands:

A patient will expect that every healthcare professional or carer involved in the delivery

of treatment of care needs to know all of the relevant information regarding his or her

condition regardless of where the encounter takes place;

The Healthcare Professionals will expect to find accurate and understandable infor-

mation in a timely, efficient and usable manner. What has been so far a bit underesti-

mated in discussions around use cases such as patient summary, is that we urgently

need and best practices on best strategies to stimulate production of useful clinical

documentation that can serve as information for others than just the healthcare profes-

sional on site. For that process to support data mobility a sensible approach to the pro-

duction of structured coded information is also urgently needed (cf. semantic interop-

erability).

The policy maker, planner or payer will expect significant increases in efficiencies and

reductions in duplication or unnecessary treatment.

This implies a paradigm shift in the thinking, planning and design of future eHealth support

systems and a focus on the meaningful use of information.

At the heart of meaningful use lies the concept of a continuum of care whereby, regardless

of where the patient is receiving treatment, the health professional concerned can access

information relevant to his needs regardless of where those data were first input or informa-

tion created. This implies a significant shift in the thinking at the heart of system design and

service delivery: a focus on finalities or ultimate outcomes from a continuum of care. System

design can no longer focus on the single institution or, indeed, a recognised community of

carers linked by a traditional model of localised care. Rather, it requires an approach that

designs systems with the continuum of care in mind and the multiple use of data for distinct

finalities. In a future of greater integration of care and wider mobility of patients, if a health-

care professional looks for - and expects to find - information that is not there they will lose

trust in the system and it becomes unacceptable and thus unused.

Interoperability is key to the delivery of meaningful use and a key component of it is the

sharing of healthcare information in a manner that ensures accuracy, security and reliability.

In order to achieve this goal, there are many hurdles to overcome including the ability of

different health information systems to be able to communicate at a functional and seman-

tic level. This issue is difficult to address within a single State or region but becomes increas-


52

ingly complex when systems in different States have to be operating to the same standards.

Thus the desire to achieve efficiencies and better care must be matched by a strategy for

encouraging the development and use of interoperable health information systems including

the requirement for standardised interfaces enabling the capture of structured and coded

data.

The US government has recognised the need for meaningful use as described elsewhere in

this report and has adopted an approach using legal and financial incentives to stimulate

health information exchange. The situation in the USA is summed up by Dr David Blumen-

thal, National Coordinator for Health Information Technology as follows:

“Private and secure health information exchange enables information to follow the pa-

tient when and where it is needed for better care. The federal government is working to

enable a wide range of innovative and complementary approaches that will allow secure

and meaningful exchange within and across states, but all of our efforts must be

grounded in a common foundation of standards, technical specifications, and policies.”

It is already possible to achieve results with meaningful use with functionalities available in

local systems and limited levels of interoperability. One example is the definition of key mes-

sages such as the patient summary. Accordingly, whilst a global demand or expectation for

meaningful use through large-scale interoperability may be some way off, it is possible to

satisfy less demanding expectations at lower levels.

Currently within Europe there is no central strategy for meaningful use and most local in-

formation strategies do not address it as a topic but this is not to say that it cannot be ad-

dressed at more local levels. This means that there is no co-ordinated consideration of what

information should follow the patient with the result that vital information is not available to

the treating doctor. One recognisable minimum dataset being used in this area is that used

by the epSOS project but that is limited in scope and confined to the project, ie it does not

feature within local strategies.

Defining a meaningful use policy can be linked to national or regional health systems as it

represents an extension to any use case by adding specific requirements. These can be de-

fined as:

i. Stimulating the production of information that satisfies the need of others and

not just the local organisation;

ii. Working towards and ultimately producing that information in an appropriately

structured and coded manner.

The use of incentives – financial or otherwise – will be essential to drive the process of work-

ing towards meaningful use. While the benefits of mobile and transparent data may be ob-

vious to some it is unlikely to be recognised universally. The OECD has described the “carrot

and stick” approach used by the Government of the USA to move interoperability and mean-

ingful use utilising a combination of regulation and funding. Similar initiatives will be re-


53

quired in Europe although what form they should take has yet to be defined. What is clear is

that whatever incentives are settled upon are likely to have a fixed term and will need to

evolve to meet the requirements of new technologies and other developments.

Meaningful use of information is set to become a key area of acceptability in future health

systems if issues of integration and mobility are to become a reality. The growing expecta-

tions of clinicians and, indeed, patients will demand mobile and transparent data. Accord-

ingly, the Work Package believes that there would be merit in investigating and consolidat-

ing the work that has been done so far by exemplar projects in the following areas.

Areas for Examination:

Mechanisms required to stimulate the introduction of meaningful use across the EU

and, indeed, across the globe using information about strategic drivers from organisa-

tions such as MSF and OECD including the need for appropriate strategies backed by

supporting legal and financial incentives;

Other “natural” drivers such as patient demand and shared service/practices;

Consideration of the legal liability and accountability issues associated with its introduc-

tion;

Identification of “trust initiatives” required to support the stimulation of meaningful use

such as Trust Agreements

Other quantitative and qualitative evaluation criteria (internal and external) linked to

specific services and designed to assess the effectiveness of the various meaningful use

strategies employed to date.

The aim of the exercise will be to undertake a comprehensive examination of a selection of

projects active in this area in order to identify and understand the key principles involved

and to put them into a relevant context.

5.4 Communication strategies

Health professionals and patients sometimes get the feeling to be part of a public laboratory

or beta test of Health IT. That does not necessarily help to establish trust and acceptability

for eHealth services. Thus the roll-out of large scale eHealth services should be accompanied

by a well defined communication strategy:

Creating and maintaining trust requires both effort and consistency. Losing it is not hard; and

once lost, trust is very difficult to restore. Faced with this challenge, organisations frequently

act defensively, thereby and perversely creating mistrust. There are complex “messages” to

be transmitted about eHealth, and the nature of the messages depends on the recipient.

Organisations that are confident that there are benefits in eHealth deployment - either gen-

erally or in relation to specific projects - should have nothing to hide. The challenge is to de-


54

scribe these in terms that are free from “hype”, and which are presented clearly and con-

cisely. Part of that challenge lies in being open and honest about uncertainties.

As has been identified, the key drivers of trust are different (for instance) for patients than

those for healthcare professionals. A message targeted at doctors will need to address the

evidence of benefit and the lack of disruption; that for patients will need to deal with their

concerns about privacy, and their wider involvement as active users of eHealth.

Having identified the main components of trust and acceptability for individual user groups,

the WP will identify how these need to be systematically addressed. The choice of method-

ology is very wide. What works best will depend on the target audience, the type of health-

care and IT systems in use, and existing deployment, to name but a few.

A major issue to be communicated is that of consent for data sharing. Terms such as “im-

plied”, “informed”, “opt-in/opt-out” are unfamiliar to the great majority of patients. Explain-

ing ethical concepts in every-day language is not easy; more accessible is describing them in

a practical context (a word such as “permission” is preferable to “consent”). A fear that often

results in an attitude of defensiveness is that patients may opt-out of holding eHealth re-

cords, thereby creating a “two-tier” record system, and an inadequate sample for research.

The actual level of opt-out is very small. It will actually be increased by any perception, how-

ever mistaken, that healthcare providers or ministries are withholding facts, or being overly-

paternalistic.

Patients are far more receptive than many healthcare professionals are ready to acknowl-

edge to the idea that their data can(and should) be used to benefit the health care of others

with similar conditions. The reaction to the lack of openness around the retention of organs

at Alder Hey Hospital and the Bristol Royal Infirmary (both in the UK) created a counter-

reaction towards stressing the centrality of patient autonomy in a way that some find exces-

sive. Arguably it has also prevented a wider discussion about the fact that the right to health

care carries with it a responsibility to allow outcomes to be used in the better planning and

delivery of healthcare. A debate on the extent of that responsibility or duty, and how it

might affect the use of patient data, is both necessary and overdue.

5.5 Lessons learned on patients’ access to their health data/EHR

Experiences drawn from pilots running in Sweden in the framework of the "SUSTAINS" since

1992 and also in other European countries demonstrate that providing patients with access

to their own Electronic Health Records (EHR) does not result in any specific issues and has at

the same time a number of documented and proven added values:

Improvement of the quality of the information available in the EHR (adding a free audit

function).

Improvement of the communication between citizens/patients and Health care profes-

sionals / health care providers.


55

Increase of patient’s autonomy and hence a more balanced relationship between the

patients and their physicians, e.g. General Practitioners.

Additional time for the patients gained for health care providers thanks to an decrease

of administrative burdens.

Better accessibility of health care services for the patient

Potential gains for treatment adherence and patient safety.

Also, the majority of other existing research indicates a significant impact on the quality of

data and of the communication. Nevertheless, significant tasks remain - in principle - with

regards to protection of privacy, options for control and the management of cost-efficiency.

Although these benefits have been demonstrated since more than 20 years, initiatives to

strengthen the patients’ autonomy have only made limited progress in the last years. While

the interest for Electronic Health Records is known to have evolved nearly exponentially, and

despite strong engagement, the field of patient access has nearly stagnated since 2002.

The existence of a life-long and shared EHR is an indispensable precondition with significant

implication on the citizen/patient. Besides issues of infrastructure, legal regulations and se-

curity, the existence of the EHR is also relevant to certain sectors like insurances, industry

(pharmaceutical), employers etc.

All countries that tried to implement EHR without putting in place in parallel the governance

that guarantees the trust among all health care providers and the citizen/patient are known

to have encountered significant difficulties [cf. Annex A for examples].

6 Timeline of Future Work Package Activity

[To be completed as part of a future iteration step of deliverable D6.x].


56

7 Annex A – The electronic patient record - What role for the patient: Main conclusions from a Symposium in Brussels, 15 June 2012

The event has been organised by Luc Nicolas from the Federal Public Service (FPS) Health,

Food Chain Safety and Environment of Belgium in Brussels on 15 June 2012. The abstracts of

all presentations as well as the presentation files are online23. The English version of the ex-

tended summary by the organiser is made available through this deliverable.

Experiences drawn from pilots running in Sweden in the framework of the "SUSTAINS" since

1992 and also in other European countries demonstrate that providing patients with access

to their own Electronic Health Records (EHR) does not result in any specific issues and has at

the same time a number of documented and proven added values:

Improvement of the quality of the information available in the EHR (adding a free audit

function).

Improvement of the communication between citizens/patients and Health care profes-

sionals / health care providers.

Increase of patient’s autonomy and hence a more balanced relationship between the

patients and their physicians, e.g. General Practitioners.

Additional time for the patients gained for health care providers thanks to an decrease

of administrative burdens.

Better accessibility of health care services for the patient

Potential gains for treatment adherence and patient safety.

On the other hand, the Swedish project could demonstrate that no particular difficulties

arose by the introduction into general medical practice and that the use of the available

functions neither posed problems to physicians and other health care providers nor to the

patients themselves.

The main functionalities provided to the citizens/patients were the following:

Hide certain personal data that was considered as sensitive.

Trace the references i.e. understand where which information originated.

Check the content of the Electronic Patient Record.

Change the attending physician

Schedule or re-schedule a patient encounter with a health care provider.

Pay fees or co-payments for the consultation.

23

http://www.health.belgium.be/eportal/Healthcare/Telematics/Events/symposium2012/index.htm?&fodnlan

g=en


57

Ask a question to the attending physician.

Fill in a form on demand.

Check for details (audit) of any access to personal data.

Certain open issues and questions remained and got the following answers:

Teenagers under 18 are not granted direct access to their health data except if they

suffer from chronic conditions

By default, parents can access the information of their children up to 12 years old. The

access to the health data of adolescents needs to be considered on a case by case basis

Situation of vulnerable patients and patients under custody: These persons are offered

with the option to lock out all access. Once a lock-out has been established it can only

be reversed by observing a defined, special procedure.

“Personal notes” of health providers are by default excluded from the Shared Electronic

Health Record.

Immediate access or delayed access to information: Patient Associations are generally

in favour of providing immediate access as opposed to health care providers who re-

commend to delay the access by 14 days in order to allow in the mean time a personal

communication with the patient. The currently envisaged solution foresees to allow pa-

tients themselves to decide between immediate and delayed access.

Health care providers do also have the option to share with other health care providers

information that is hidden to the patient. However, this option is limited to so-called

"thought processes" only.

Other functionalities could be added as long as they are supported by the legislation:

Repeat prescriptions of medicines

The capability to manage directly (exclude) accesses by individual health professionals.

Besides these lessons learned, the majority of other existing research did not come to defini-

tive conclusions but still indicates a significant impact on the quality of data and of the

communication. Nevertheless substantial concerns remain - in principle - with regards to

protection of privacy, options for control and the management of cost-efficiency.

Although these benefits have been demonstrated since more than 20 years, initiatives to

strengthen the patients’ autonomy have only made limited progress in the last years. While

the interest for Electronic Health Records is known to have evolved nearly exponentially, and

despite strong engagement, the field of patient access has nearly stagnated since 2002

The existence of a life-long and shared EHR is an indispensable precondition with significant

implication on the citizen/patient. Besides issues of infrastructure, legal regulations and se-


58

curity, the existence of the EHR is also relevant to certain sectors like insurances, industry

(pharmaceutical), employers etc.

All countries that tried to implement EHR without putting in place in parallel the govern-

ance that guarantees the trust among all health care providers and the citizen/patient are

known to have encountered significant difficulties:

In the Netherlands the initial implementation plan for the EHR did not foresee any

measure that would have allowed the access to the health data only in the case of a

therapeutic relationship. Neither did it provide the patient with options to manage ex-

clusions and proposed just a strategy of opt out. As a reaction, a strong opposition of

health professionals has urged the authorities to develop a less binding version of the

EHR that made a pre-existing informed consent of patients necessary.

Similarly in the United Kingdom, the first strategies in the year 2009 did not foresee the

necessity of informed consent and proposed just an opt-out approach. The possible use

of health data of the NHS for other purposes than clinical ones was defined as unac-

ceptable. Facing opposition, it was decided that the patient will get unconditioned ac-

cess to all data implemented from the year 2014 on.

In Austria the extent of earlier investments constitute an important driving force to ac-

celerate the deployment. The use of an opt-out approach and missing granularity of the

options that were proposed to the actors stimulated in turn distrust by the actors.

In Denmark, no regulations are in place, that foresee an operational approach to man-

age the granularity of the privacy of data (access to all data by all). Yet – on the other

hand - there exists a quiet solid trustful relationship of the population towards the gov-

ernment/authorities.

In Belgium, after a first attempt to create a shared health record in 2006 has failed, now a

bottom-up approach has been chosen. With a quite limited budget the implementation

builds on a voluntary model which relies on an appropriate ownership by the actors and

which puts in place a strategy that foresees to operationalise questions of privacy and pa-

tient rights - the latter being a result of a consensus finding process with the main stake-

holders active in the field.

The key elements of this consensus are the following:

Secured and non-ambiguous identification and authentication of actors

Explicit procedure of informed consent with a clear definition of the scope (finality).

An operational definition of the notion of “therapeutic relationship”.

A granular access by the patient (at document level) to all the log files

Possibility to include/exclude specific Healthcare Providers.


59

Granular access to documents

Management of the mandates (legal representative, person of trust).

However in the current situation, patients in Belgium have still no access to the content of

their health data. The last opinion of the Medical Association (Chamber of Physicians) on the

subject dates back from January 2007. This position refers to the legislation on patient rights

and reaffirms the following principles:

Information has to be communicated to patients:

In a way that it is understandable by them

Only if it does not constitute a psychological or health threat to them

Without giving access to data which belongs to third persons

Without communicating personal notes of the physician/health professionals

Only in absence of pressure that would be enacted by employers or insurances

This position makes currently all direct access to the data very difficult. Nevertheless, ac-

cording to the remark made by a representative of the medical association at the sympo-

sium of June 15th, this position has been produced in a moment of time when the shared

medical record was far away from becoming a reality. Thus, this position needs to undergo a

revision to take into account the important evolution in this field that happened over the

last years.

The experiences that have been gathered since some years now with regards to the

strengthening of the role of the patient, particularly in the field of chronic conditions

could demonstrate a potentially important impact both in clinical and economic terms

as well as for the patient satisfaction if the results across multiple conditions are jointly

evaluated.

At the same time it is commonly understood how important it is to invest in patient

education (health literacy). The access to the personal health data in the shared medical

record is a prerequisite for this. The patients demonstrated furthermore that they were

ready to accept numerous compromises if they can at the same time benefit from new

advantages.

It is important to pay specific attention to the way how the service is put in place.

It affects the relationship between patient and health professionals

It also renders new benefits in relation to conventional solutions

Responds to the real needs as expressed by the users.

The request to make the information understandable by citizen/ patients must also find

a satisfactory answer vis-à-vis the availability of tools to translate the terminology, of


60

valid references as well as the option to be supported by dedicated professionals. Spe-

cial attention must also be paid to patients with certain disabilities.

Patients want to be able to enter themselves data into the medical record and insist

also on the importance of being able to document subjective data (perceived effects).

Thinking further on this requirement implies to find an adequate solution to avoid the

creation of confusion. On the other hand the question of the status of those data with

regard to the professional responsibility must find an answer acceptable by all.

The strengthening of the patient's autonomy builds on an investment in patient educa-

tion that allows him on one hand to have an effective control on the therapy and to ac-

tively participate into its implementation.

Preliminary conclusions:

Taking into account the existing experience, the access of patients to their own EHRs

poses no important problems and brings about a real added value, at least in terms of

quality of information and improvement of communication.

Belgium thus has to analyse the feasibility of this option on short term (2013) in cooper-

ation of all actors in the field, the patient associations and the concerned institutions.

The modalities necessary for the implementation have to be defined by a special opera-

tional strategy. The questions and answers proposed by Sweden should be used as a

starting point of this work.

Options for the patient either to provide certain information spontaneously and/ or

following the demand by health professionals should both be taken into account.

9 Annex B – Example Questionnaire Used for the Selection of Projects

Work Package 6

Trust & Acceptability

Questionnaire Version 03 of 12 April 2012

Please describe one T & A validation project/service

Fulfilling its tasks within the eHealth Governance initiative, WP 6 Trust and Acceptability identifies key criteria that help to assess if and how the needs of users in relation to Trust and Acceptability are being taken into account by national and regional eHealth strategies and services. Important steps are e.g. to

1 Confirm the areas of trust and acceptability that impact upon the successful delivery of eHealth systems and activity;

2 Identify key issues and areas of activity that act as both drivers and barriers to the successful delivery of eHealth systems;

3 Undertake an analysis of the maturity of activity and work that has already been undertaken in the confirmed areas together with existing experience (e.g. successful and well established projects) and identify gaps in that experience that may affect eHealth implementation.

Having established a first, coherent set of key criteria we would like to use it to identify projects

that have demonstrated success in various fields of Trust and Acceptability.

To this end, this questionnaire provides definitions of various elements of Trust and Acceptability

combined with a simple scoring system that enables you to assess specific projects/services you

are aware of and to show in what areas they have demonstrated success. By analysing the pro-

jects and their success factors, we will gain further insight into the Trust and Acceptance domain

of eHealth and hence the Work Package will be assisted in determining its future work.

!!!Each person in the WP6 constituency is invited to apply this questionnaire's criteria

to one familiar service and thus to contribute to a small set of WP6 demonstrator services.

NB: The eHealth service as experienced by the user results most often from a combined setting of a

local Point of Delivery System, the eHealth Information Exchange Infrastructure and remote Point

of Delivery Systems. If in doubt please take on the perspective of a user who perceives the ele-

ments of trust and acceptance of such an eHealth service in its totality - without being too analytic.

Contents / Criteria Overview

0 Name of the eHealth project/service ......................................................................................62

1 Service Characteristics and Safety ...........................................................................................63

2 Ethical Aspects ........................................................................................................................69

3 Organisational Issues ..............................................................................................................72

4 Economic and Financial Aspects ..............................................................................................75

5 Legal Aspects ...........................................................................................................................77

6 Technical Issues .......................................................................................................................81


62

0 Name of the eHealth project/service

Name of the eHealth project or service (overwrite)

NB: We of course prefer you to fill this questionnaire with your text editor - but we will accept also legible handwriting

Abstract of the project/service - feel free to copy/paste from a website or so.

Abstract of the service (overwrite) -box can grow also onto multiple pages


63

1 Service Characteristics and Safety

1.1 Security

Definition: A robust, properly implemented and well managed security policy is an important tool for

engendering trust in an eHealth system. Covering all aspects of security from both the technical and

human/user perspective such a policy is designed against a formal risk assessment with a view to

addressing all threats but recognising that there will always be a degree of residual risk, i.e. there can

never be a guarantee of 100% security.

The following criteria represent suggested requirements for the successful implementation of an

eHealth security policy . Please indicate how successful you think the project/service has been in this

area (1 = Very Low Level of Success, 5 = Very High Level of Success.

(1-1) Data Security Tick or

rate 1-5

The service operates within a formal security policy with security measures based on a

risk assessment and which is reviewed regularly

The service has a formal programme of training in security and data protection covering

all personnel and designed to meet their specific roles and responsibilities

The security policy associated with the service and the security policy of the eHealth

information exchange with other organisations have been harmonised so they can be

used jointly without significant disruption to the health professional practice.

The service/organisation operates a system of “no blame” incident and security breach

reporting

What other factors do you think have also contributed to the success of the service in this area?


64

1.2 Usability

Definition: The International Organisation for Standardisation (ISO) defines usability as, "The extent

to which a product can be used by specified users to achieve specified goals with effectiveness, effi-

ciency, and satisfaction in a specified context of use”.

In the paper, “Usability 101 – Introduction to Usability” Jakob Nielsen further defines usability as

consisting of five quality components, namely: Learnability: How easy is it for users to accomplish

basic tasks the first time they encounter the design? Efficiency: Once users have learned the design,

how quickly can they perform tasks? Memorability: When users return to the design after a period

of not using it, how easily can they re-establish proficiency? Errors: How many errors do users make,

how severe are these errors, and how easily can they recover from the errors? Satisfaction: How

pleasant is it to use the design?

The following criteria represent suggested requirements for an eHealth implementation to demon-

strate good and acceptable usability. Please indicate how successful you think the project has been

in this area (1 = Very Low Level of Success, 5 = Very High Level of Success.

(1-2) Usability Tick or

rate 1-5

The organisation using or mandating the use of the eHealth service has a formal system

of evaluation and testing for usability

There is a high level of uptake by users, particularly professional staff



65

1.3 Patient Access to Data

Definition: Patient access refers to the right and ability of individual patients to access their medical

records ether held as a summary record or as a full record held within a health system. Such access

may be enabled through the provision of a paper transcript or copy or through electronic access to

the record. The purpose of such access is to engender trust in the accuracy and completeness of the

record and implies the provision of some mechanism or process whereby the patient may request

changes to the record.

The following criteria suggest requirements for the successful implementation of patient access to

their personal medical data. Please indicate how successful you think the project has been in this

area (1 = Very Low Level of Success, 5 = Very High Level of Success.

(1-3) Patient Access to Data Tick or

rate 1-5

As part of the eHealth service, patients are able to access their personal medical re-

cords including both clinical and administrative data

There is more than a 50% uptake by patients of facilities to access their personal medi-

cal records either in full or summary form

A document management strategy exists defining, amongst other things, who can mod-

ify information within the personal health record and how such changes are recorded.

Patient surveys have been undertaken and indicate a high degree of satisfaction with

the access arrangements



66

1.4 Training

Definition: In order for the benefits of eHealth to be fully realised and for its full potential to be re-

leased, the meaningful involvement of patients is essential. Such involvement only becomes possible

if eHealth developments and implementation meet the needs and expectations of professionals and

patients who will ultimately use them. The European Commission in its report, “European Countries

on Their Journeys Towards National eHealth Infrastructures: Final Progress Report” published in

2011, recognises that education, training and continuous professional development for all, including

for those citizens and patients which are capable and motivated to become engaged in their own

care, must be strongly promoted: “There is a strong felt need to improve eHealth training and educa-

tion for professionals, but also to focus on reducing the asymmetry in capabilities, information and

knowledge between health professionals and patients, and thereby strengthen stakeholder engage-

ment”. They further acknowledge that skills of healthcare staff and ICT suppliers staff also need to be

expanded.

The following criteria suggested requirements for the demonstration of a positive training pro-

gramme for all stakeholders of eHealth. Please indicate how successful you think the project has

been in this area (1 = Very Low Level of Success, 5 = Very High Level of Success.

(1-4) Training Tick or

rate 1-5

The medical and bio-engineering curricula for the country/Region contain a formal and

approved module covering eHealth applications and their use

Patients using eHealth systems including telemedicine, telemonitoring and personal

health records receive or have access to training material and help desks

What other factors do you think have also contributed to the success of the project in this area ?


67

1.5 Mobility

Definition: Mobility can be viewed in two ways. Firstly, there is the possibility of information to fol-

low the patient as he or she travels either within their country of residence or anywhere else within

the European Union. Secondly, mobility can be taken to mean the use of mobile devices to improve

professional efficiency and patient convenience. In the first case much work has been carried out at

the legal level to preserve the rights of patients as they travel across borders and projects such as

CALLIOPE1 and epSOS2 have addressed or are addressing many of the issues associated with the in-

teroperability of systems with, perhaps, the ultimate goal of all stakeholders knowing that the pa-

tient’s medical record/information can follow them and be accessed (within privacy guidelines) freely

as they move around. This is a relatively mature area of investigation with both major projects having

considered the many technological legal and ethical issues associated with cross-border mobility.

The following criteria represent issues to be addressed in the area of mobility . Please indicate how

successful you think the project has been in this area (1 = Very Low Level of Success, 5 = Very High

Level of Success.

(1-5) Mobility Tick or

rate 1-5

The eHealth service supports policies and associated strategies for the provision of

cross-border care for its own and others patients treatment

The eHealth service involves the use of mobile devices encapsulating good practice

including training and support for users

What other factors do you think have also contributed to the success of the project in this area ?

1 http://www.calliope-network.eu/

2 http://www.epsos.eu/


68

1.6 Balanced Clinical Information Expression

Definition: The ability to convey and access clinical information in a way which offers a balanced ap-

proach to the use of coded/structured information and the freedom of textual expression. This cov-

ers as well the capture of such clinical facts (easy to select coded values, small number of clicks and

screen/list scrolls, relevant clinical terms, flexibility and conciseness of textual expression, etc.).

The following criteria represent issues to be addressed in the area of balanced clinical information

expression . Please indicate how successful you think the project has been in this area (1 = Very Low

Level of Success, 5 = Very High Level of Success.

(1-5) Balanced Clinical Information Expression Tick or

rate 1-5

The eHealth service uses a formal coding system for clinical information that is bal-

anced and easy to use

There is a high degree of acceptance by clinical staff of the usability of the sys-

tem(s)/service in terms of quick access, flexibility and other factors



69

2 Ethical Aspects

2.1 Privacy

The right to privacy is fundamental. Indeed, within Article 8, the European Convention on Human

Rights states that, “Everyone has the right to respect for his private and family life, his home and his

correspondence”. The recently completed 7th Framework Programme, ETHICAL took as its definition

of privacy the following:

“…The right of individuals to be left alone and to be protected against physical or psycho-

logical invasion or the misuse of their property. It includes freedom from intrusion or ob-

servation into one’s private affairs, the right to maintain control over certain personal in-

formation, and the freedom to act without outside interference…”

It is important to understand that privacy, whilst linked, is different from confidentiality. An individ-

ual is private in that they hold information about themselves and choose what and how much of that

information they wish to impart to another person or individual. Having released that information

they may or may not place a duty of confidentiality upon that third party expecting them to protect it

and not to share it. It is this duty of confidentiality that makes the patient/professional relationship

work in real terms: the doctor needs to know and the patient needs to trust.

The following criteria suggested requirements for a robust environment for the understanding and

management of privacy . Please indicate how successful you think the project has been in this area

(1 = Very Low Level of Success, 5 = Very High Level of Success.

(2-1) Privacy Tick or

rate 1-5

The patient’s right to privacy is fully understood by all professional and administrative

staff across the organisation

Issues of privacy and confidentiality are included as part of the formal induction pro-

gramme for all new members of staff

The organisation has a defined process for dealing with breaches of privacy



70

2.2 Data Sharing and Informed Consent

The treatment of patients and the way in which information is shared for that purpose has become

increasingly more complex. Treatment is now undertaken on a multi-institutional basis involving the

sharing of personal and often sensitive information regarding the patient’s condition in order for the

individual to receive comprehensive and safe treatment. However, most Western countries now

have data protection legislation in place that contains provision for the data subjects (encompassing

individuals as patients) to provide their consent for information about them to be processed which

might include sharing.

Consent can be either implied or specific/explicit. Consent for treatment is rather well understood

and needs to be clearly distinguished from consent for accessing or sharing information. The policies

controlling the need for either implicit or explicit consent for sharing and accessing health informa-

tion varies among the European countries. . A typical example of implied consent would be where a

patient presents herself for treatment with a family practitioner. Here it would be reasonable for

information to be recorded and shared with other healthcare professionals within the family practi-

tioner’s office for the purpose of that treatment and possibly with other providers to which the pa-

tient may be referred in an environment which can be reasonably assumed to be secure with profes-

sional duties of confidentiality operating correctly.

Explicit consent is required in situations where information is to be obtained and used for research

purposes by public, academic or private organisation. It may also be re required where information is

to be shared between a health organisation and industry e.g. a drug company. Given the require-

ment for explicit consent, it may be required for certain types of telemonitoring. It means that the

individual has to actively agree to participate in a such a telemonitoring procedure, experiment or

research project. By definition, explicit consent requires to be informed consent.

The following criteria suggested requirements for an environment for the management of data shar-

ing and consent. Please indicate how successful you think the project has been in this area (1 = Very

Low Level of Success, 5 = Very High Level of Success.

(2-2) Data Sharing and Informed Consent Tick or

rate 1-5

Formal guidelines exist to inform staff regarding the legal and ethical boundaries sur-

rounding the correct application of implied and explicit consent for health information

sharing and access.

The eHealth service has an ethics committee to approve procedures for operational

healthcare and research purposes and to resolve issues where necessary.

Researchers are aware of the requirement to inform patients that their data is to be

used for research purposes and to obtain their explicit, informed consent.

Patient have access to an independent third party who can explain the objectives of the

research, the methods to be used and the rights of the data subject in this process


71



72

3 Organisational Issues

3.1 User Driven/Collaborative Design

Collaborative design in the area of trust and acceptability implies the existence of a formal methods

of engaging stakeholders with the ongoing development of eHealth applications in order to ensure

consensus in areas such as usability, safety or indeed any area where agreement is required to en-

sure the successful introduction of such systems

The following criteria suggested requirements for an environment for the management of data shar-

ing and consent. Please indicate how successful you think the project has been in this area (1 = Very

Low Level of Success, 5 = Very High Level of Success.

(3-1) Collaborative Design Tick or

rate 1-5

The eHealth system works with established groups of clinical and administrative expert

users that support the development, testing and customisation of eHealth applications

and services.

The health care organisation responsible for the service continuously analyses the

change management needs implied by eHealth services and applications and has estab-

lished and organisation-wide concept of service orchestration that considers the needs

and requirements of all users including patients.



73

3.2 Change and Benefits Management

The introduction of eHealth into any health management environment implies change. Change im-

plies unfamiliarity that in turn can build significant resistance to the introduction of new ways of

working and the deployment of new technology. Thus, before any change is made it should be prop-

erly planned and be subject to a change management process. Change Management is complex and

often requires specific and specialist expertise to achieve well. However, there are key principles that

can be considered and applied by eHealth projects.

Closely linked to the management of change is benefits management. Benefits Management is an

important component of change management but needs some separate consideration because it is a

powerful tool, if used properly, for gaining acceptance within eHealth developments. Many eHealth

projects fail or fail to achieve large scale deployment because they are technology driven with a lack

a focus on the business or strategic objectives of the organisation whether at national, regional or

local level.

The following criteria suggested requirements for a well defined approach to the management of

change and benefits. Please indicate how successful you think the project has been in this area (1 =

Very Low Level of Success, 5 = Very High Level of Success.

(3-2) Change and Benefits Management Tick or

rate 1-5

Change management is a mandated component of all proposed eHealth projects

Project approval is subject to a formal sign-off of the benefits to be achieved by a par-

ticular project or initiative within the eHealth service/system with appropriate account-

ability being defined



74

3.3 Buy-In Strategies

Buy in or enrolment strategies can be seen as operating at two levels: either convincing policy-

makers, managers or the workforce in general of the benefits associated with eHealth or in engaging

patients through the use of strategies to elicit their participation in new but unfamiliar healthcare

processes. The free movement of patients across borders is one example of the new arrangements

raising new demands for interoperability between systems. However, technology is only one issue

with any number of cultural, philosophical and historical barriers to overcome.

Buy-in strategies can come in any number of forms including legal protection for patient safety, pri-

vacy and consent, communication programmes to increase transparency and thus trust, patient em-

powerment by providing access to their personal health records or providing the right to opt-out of

certain processes such as data sharing.

The following criteria suggested requirements for successful buy-in strategies. Please indicate how


Level of Success.

(3-3) Buy-In Strategies Tick or

rate 1-5

The State, Region or organisation has a planned and documented strategy for patient

buy-in for the eHealth system

The State, Region or organisation has a documented evaluation of the success of its

buy-in strategy



75

4 Economic and Financial Aspects

4.1 Meaningful Use

The HITECH Act that forms part of the American Recovery and Reinvestment Act of 2009* specifies

three main components of Meaningful Use:

4 The use of a certified EHR in a meaningful manner, such as e-prescribing.

5 The use of certified EHR technology for electronic exchange of health information to improve quality of health care.

6 The use of certified EHR technology to submit clinical quality and other measures.

Simply put, "meaningful use" means providers need to show they are using certified EHR technology

in ways that can be measured significantly in quality and in quantity.

The following criteria suggested requirements meaningful use of eHealth. Please indicate how suc-

cessful you think the project has been in this area (1 = Very Low Level of Success, 5 = Very High Level

of Success.

(4-1) Meaningful Use Tick or

rate 1-5

A strategy for meaningful use has been designed, published or mandated at national,

regional or local level to which the eHealth service is expected to adhere

Meaningful use criteria are reviewed annually

Meaningful use covers at least one area for quality measures , clinical outcomes and

medication management

Meaningful use processes include certification of products against basic functionality

standards.



76

4.2 Funding and Incentives

A major issue supporting the acceptability of eHealth systems is the provision of incentives to stimu-

late their adoption. These include the development of sustainable financial models for eHealth im-

plementation as well as social and regulatory incentives.

In 2010, the Organisation for Economic Cooperation and Development (OECD) published a detailed

report analysing , “Improving Health Sector Efficiency: The Role of Information and Communication

Technologies”3. While not focussed specifically on eHealth it offered some detailed insights into

funding issues and incentive models for encouraging the introduction of ICT in healthcare. These

insights offer some potential solutions for stimulating the adoption of eHealth technologies outside

of the traditional ICT solutions and including telemedicine, telecare and telemonitoring.

OECD identified three ways in which national governments could stimulate the introduction of ICT

into healthcare, namely:

direct regulation: enforcing compliance by determining expected outcomes,

economic instruments: persuasion through economic incentive and market stimuli, and

persuasive measures: often combined with economic instruments and might encompass train-

ing and education, peer pressure and recognition of achievement.

The following criteria suggested indicators of incentives for the introduction of eHealth Please indi-

cate how successful you think the project has been in this area (1 = Very Low Level of Success, 5 =

Very High Level of Success.

(4-2) Funding and Incentives Tick or

rate 1-5

The organisation responsible for the eHealth service can demonstrate the use of sus-

tainable financial incentives to encourage its take-up

The organisation can demonstrate the use of regulatory incentives to encourage the

take-up of the eHealth service

The organisation can demonstrate the use of managed social incentives to encourage

the take-up of the eHealth service.


3 http://ec.europa.eu/health/eu_world/docs/oecd_ict_en.pdf


77

5 Legal Aspects

5.1 Legal Certainty

Legal certainty is provided by the legal system to those subject to the law. As such the legal system

needs to permit those subject to the law to regulate their conduct with certainty and to protect

those subject to the law from arbitrary use of state power. As such legal certainty entails a require-

ment for decisions to be made according to legal rules, i.e. be lawful. The concept of legal certainty

may be strongly linked to that of individual autonomy in national jurisprudence. The degree to which

the concept of legal certainty is incorporated into law varies depending on national jurisprudence.

However, legal certainty frequently serves as the central principle for the development of legal

methods by which law is made, interpreted and applied.

Legal certainty is now recognised as one of the general principles of European community law and

"requires that all law be sufficiently precise to allow the person - if need be, with appropriate advice -

to foresee, to a degree that is reasonable in the circumstances, the consequences which a given ac-

tion may entail". The principle of legal certainty, and as such the rule of law, requires that:

laws and decisions must be made public

laws and decisions must be definite and clear

the decisions of courts must be regarded as binding

the retroactivity of laws and decisions must be limited

legitimate interests and expectations must be protected.

The following criteria suggested indicators of legal certainty within eHealth. Please indicate how


Level of Success.

(5-1) Legal Certainty Tick or

rate 1-5

Open and transparent approaches to legal certainty can be seen operating at national,

regional and local level


http://en.wikipedia.org/wiki/Individual_autonomy

http://en.wikipedia.org/wiki/European_community_law

http://en.wikipedia.org/wiki/Retroactivity


78

5.2 Liability

The emergence of eHealth products and services raises many issues regarding legal liability whether

in relation to the healthcare professional product manufacturer or information provider. One of the

definitive pieces of work in this area is the publication “Legally eHealth” published by the European

Commission in 20084. This report considers the complex issues of eHealth delivery and considers

what legislation applies in terms of legal liability.

The report sums up the present position relating to potential damage arising from eHealth very con-

cisely as,

“An eHealth service might be passive, such as delivering general medical information

through a Website, or might be active in giving medical advice or specific decision sup-

port to clinicians, or might involve the collection of biomedical data for remote monitor-

ing by a clinician. Such a service might conceivably cause damage to someone relying on

the service. A citizen might follow bad advice and fall ill, or even die; a clinician might fol-

low the recommended procedure after using a decision support tool and might harm a

patient; or a remote monitoring service might fail to transmit relevant data, thereby put-

ting a patient’s life at risk.

In many such cases, a causal link will exist between the harm suffered and a defective

product. Thus, if an error exists in decision-support software, the doctor who relied on

the software would have a claim based in Council Directive 85/374/EEC, …..”.

One of its primary findings is that “There currently is no general European harmonisation of liability

rules for services in which no defect can be found in a device. Therefore, liability for services is gov-

erned by ordinary rules of law applicable in the Member States”. This can be considered to be a seri-

ous gap that has implications for legal certainty and thus impacts upon both trust and acceptability if

it is not clear which organisation or individual can be held responsible should any harm result from

the use of the goods or services concerned.

The following criteria suggested indicators of legal liability within eHealth. Please indicate how suc-

cessful you think the project has been in this area (1 = Very Low Level of Success, 5 = Very High Level

of Success.

(5-2) Liability Tick or

rate 1-5

Evidence exists that there are suitable legal liability arrangements associated with the

eHealth service

A formal legal framework for liability within eHealth can be described and accessed

within a Member State

4 http://www.epsos.eu/uploads/tx_epsosfileshare/Legally-eHealth-Report_01.pdf


79



80

5.3 Accountability

As eHealth information networks become more diverse and personal records are managed and

stored in a number of, often, remote locations, the application of effective data security becomes

more difficult. In such circumstances, the need for an effective accountability framework becomes

more necessary.

One definition of information accountability holds that, “the use of information should be transpar-

ent so it is possible to determine whether a particular use is appropriate under a given set of rules

and that the system enables individuals and institutions to be held accountable for misuse.”5.

In the Abstract to their paper, “What is accountability in Healthcare?”, the Emmanuels6 provide a

useful overview: ,“The concept of accountability contains three essential components:

1) the loci of accountability—health care consists of at least 11 different parties that can be held

accountable or hold others accountable;

2) the domains of accountability—in health care, parties can be held accountable for as many as six

activities: professional competence, legal and ethical conduct, financial performance, adequacy of

access, public health promotion, and community benefit; and

3) the procedures of accountability, including formal and informal procedures for evaluating compli-

ance with domains and for disseminating the evaluation and responses by the accountable parties.”

The following criteria suggested indicators of accountability within eHealth. Please indicate how


Level of Success.

(5-3) Accountability Tick or

rate 1-5

The following domains of accountability can be identified within the eHealth service:

professional competence, legal and ethical conduct, financial performance, adequacy of

access, public health promotion, and community benefit

Do formal and informal procedures for evaluating compliance exist?


5 http://groups.csail.mit.edu/mac/users/hal/misc/cacm-late-draft.pdf

6 http://www.annals.org/content/124/2/229.abstract


81

6 Technical Issues

6.1 Clarity and transparency of Interoperability Specifications

As the interoperability through eHealth information networks require evolution of point of care de-

livery IT systems and devices so they support new standardized interfaces, it is import that software

and systems developers have access to clear eHealth interoperability specifications for evaluation,

and implementation within their software. Acceptability is increased if these eHealth interoperability

specifications rely on widely accepted standards and profiles across the EU market. The ability to

validate the conformance of their implementation need to be transparently available at an accept-

able costs and effort.

The following criteria represent issues to be addressed in the area of interoperability specification

clarity . Please indicate how successful you think the project has been in this area (1 = Very Low


(6-1) Clarity and Transparency of Interoperability Specifications Tick or

rate 1-5

The organisation responsible for the eHealth service provides clear and unambiguous

technical and interoperability specifications when working with system developers

All interoperability specifications adhere to accepted standards and profiles across the

EU market.

The eHealth service is subject to conformance testing at transparent and acceptable

costs to all involved in the process.



82

6.2 Availability and choice of point of delivery systems

Organisations that deploy point of delivery IT systems and devices need to be offered eHealth inter-

operable systems that conform to the eHealth specifications and are compatible with the eHealth

information exchange infrastructure so that that configuration and connection requires minimal ef-

forts. For eHealth interoperability to be acceptable to these organisations, it should not overly limit

their choice in the market of the best IT system or device that fit the specifics of their practice, and

meet their performance criteria.

The following criteria represent issues to be addressed in the area of availability and choice of point

of delivery systems Please indicate how successful you think the project has been in this area (1 =

Very Low Level of Success, 5 = Very High Level of Success.

(6-2) Availability and Choice of Point of Delivery Systems Tick or

rate 1-5

The eHealth project utilises interoperable systems that conform to and are compatible

with the eHealth information exchange infrastructure

In terms of selecting systems there is a process of engagement between clinical, techni-

cal and system supplier personnel



83

6.3 Reliable and available eHealth services

When connected the IT systems and devices should offer a reliable access to the eHealth services

through the information exchange infrastructure to which they are connected.

The following criteria represent issues to be addressed in the area of reliable and available health

services . Please indicate how successful you think the project has been in this area (1 = Very Low


(6-3) Reliable and available eHealth services Tick or

rate 1-5

The eHealth service uses systems that offer reliable access to eHealth services through

the information exchange infrastructure

There is a high degree of acceptability from all users of the eHealth systems and ser-

vices including clinical and administrative staff



84

Annex: Full List of Criteria (19)

0 Name of the eHealth project/service

1 Service Characteristics and Safety

1.1 Security

1.2 Usability

1.3 Patient Access to Data

1.4 Training

1.5 Mobility

1.6 Balanced Clinical Information Expression

2 Ethical Aspects

2.1 Privacy

2.2 Data Sharing and Informed Consent

3 Organisational Issues

3.1 User Driven/Collaborative Design

3.2 Change and Benefits Management

3.3 Buy-In Strategies

4 Economic and Financial Aspects

4.1 Meaningful Use

4.2 Funding and Incentives

5 Legal Aspects

5.1 Legal Certainty

5.2 Liability

5.3 Accountability

6 Technical Issues

6.1 Clarity and transparency of Interoperability Specifications

6.2 Availability and choice of point of delivery systems

6.3 Reliable and available eHealth services

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