eurorec/efpia/cdir - brussles march 10-11, 20081 workshop on towards integration of clinical care...
TRANSCRIPT
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
WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 10
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
WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008 12
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