eurorec/efpia/cdir - brussles march 10-11, 20081 workshop on towards integration of clinical care...

EuroRec/Efpia/CDIR - Brussles March 10-11, 2008 1

Workshop onWorkshop onTowards integration of clinical care & clinical Towards integration of clinical care & clinical

research for better health & high quality healthcareresearch for better health & high quality healthcare

Mats Sundgren & Petra WilsonMats Sundgren & Petra Wilson

Building high level statementBuilding high level statement

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 2

RationaleRationaleThe Key Issues

Health care costsHealth care qualityEU innovation Drug development costPharma research model

””EHR integration” is one common denominatorEHR integration” is one common denominator

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 3

Today’s ObjectivesToday’s Objectives Use the outcomes of the three workstreams,

(technical, interaction model, and legal), to develope a joint consolidated and integrated

recommendation on which all can agree – a High Level Statement ”High level statement” will not only be reflected in the white

paper but also, be used to enhance the ”political will” to promote the more

engagement to understand and support integration of EHR

to support medical research among EU member states

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 4

HowHow Introduction

Overview of arguments, assumptions and outcomes of the EHR task force

Breakout sessions Discuss & Identify how we are going to achieve

this Key barriers Momentum, key stakeholders, etc.

Consolidation Build shared recommendations

EuroRec/Efpia/CDIR - Brussles March 10-11, 2008 5

Building - High level statementBuilding - High level statement

Arguments & building blocksArguments & building blocks

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 6

Today’s situation in EUToday’s situation in EU In the case of EHR implementation & interoperability

aspects, Health Care, Life Science industry and other actors are living in separate worlds

Lack of transparency & cooperation across EU member states to support harmonization on interpretation of data protection in respect to EHR implementations

Need for further guidance on current legal framework on EHRs

There is a need for enhanced political engagement to support integration and a wider use of EHR information for other medical purposes

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 7

The transitional environmentThe transitional environment EHR technology is becoming more mature Pace of standardisations & nomenclature models are

moving forward Adoption of EHR in both hospitals & private practice is

on a steady incline Increasing engagement (in EU & US) to leverage

eHealth issues Integration of EHR have a large potential to create a win-

win-win situation for health care, patients & industry

Trends have created a transitional environment (Health care, Governmental, Patients, Vendors, and Bio-pharma), which bring different opportunities & challenges

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 8

Assumptions x 3

Build on three assumptions Time is ripe to lay the platform in EU

for enable large benefits to Patients, Health care & Industry

Technology & standardisation Becoming mature

Implementation and usage Is in steady incline

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 9

Benefits x 3 Build on three benefits

Support mobility of EU citizens (EHR utilisation across member states)

Strengthen innovation capability in EU

by providing an improved interaction and utilisation of patient information in the life science industry

Safer & efficient Health care in EU

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Needs x 3 Build on three needs

Create the political will in EU member states Awareness, governance, funding and key application

areas (e.g. drug safety monitoring, medical research) Develop a sustainable interaction model for

interoperability of EHRs in EU Information broker (third party), Need of accreditation,

standards, Sustainable business models, accreditation mechanisms, and for clinical care & clinical research

Secure legal guidance that encompasses medical research aiming for harmonized interpretation across EU

Establish certification mechanisms and “model contract terms” for interoperability of EHRs to meet secrecy obligations across EU member states

Inclusive with consistent interpretations across EU

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 11

EHR levels x 3EHR levels x 3

Primary care Identifiable EHRs

Patient & drug safety monitoring Pseudonomyisation of EHRs

Medical research purposes Anonymisation of EHRs

NB: requires different levels and methods of data protection

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Reflections x 3Reflections x 3Banking industry

E.g the S.W.I.F.T project (1995) Society for Worldwide Interbank Financial

Telecommunication Supplying secure messaging services and

interface software to more than 5,500 financial institutions in 150 countries

S.W.I.F.T.'s wide range of products and services help customers reduce costs, raise productivity, control risk, and strengthen the security of global financial communications

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 13

Reflections x 3Reflections x 3Airline industry

E.g. EDS and Amadeus systems (1995-2000)

Keeping an airline operating during a migration involves moving millions of electronic passenger name records (PNRs) and electronic tickets, while continuing to process passengers and move airplanes

It also involves aligning those migrated PNRs with travel agencies and industry partners, such as hotel booking alliance code share partners, and coordinating countless details

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 14

Reflections x 3Reflections x 3 ICH (the case of Good Clinical

Practice) International Conference on

Harmonization (1990) Process to harmonize the technical

requirements for registration of pharmaceuticals in human use

Involves regulatory authorities and industry experts from: Europe, US, and Japan

Make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 15

Comment - interoperability?Comment - interoperability?

Interoperability & health information (e.g. EHR) exchange are best understood as business concepts rather than technical concepts

Like in the banking industry, the technical feat of creating ATM networks and point-of-service credit cards improved its interoperability and the enivironment was right

Similarly, in healthcare it is easy to be overwhelmed by the technical complexity of healthcare standards, security, architecture, and other technical advances,

Healthcare is seen as next on the list of industries that canbecome interoperable and consumer-centric

Solving these issues can have an impressive effect on the structure and functioning of the healthcare marketplace

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 16

Breakout sessions Expectations

Go from a high level to a more practical level

Legal aspects are inbuilt to each breakout session

How can interoperability be achieved, Identify barriers & opportunities Ranking– primary and secondary What are the principal recommendations for

action!

EuroRec/Efpia/CDIR - Brussles March 10-11, 2008 17

Backup and redundant slides

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 18

EHR integration in EU – “one liner 1” The transitional environment in the area of EHRs

bring opportunities to support mobility, enhance safe & efficient health care for EU citizens, but also to strengthen and regain the innovation capability in EU

Time is ripe to secure synergies that will enable innovation in life science industry in EU