Transcript P7 Draft High Level Recommendation-Sundgren-Wilson

Workshop on
Towards integration of clinical care & clinical
research for better health & high quality healthcare
Building high level statement
Mats Sundgren & Petra Wilson
EuroRec/Efpia/CDIR - Brussles
March 10-11, 2008
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Rationale
 The
Key Issues
 Health care costs
 Health
 EU
care quality
innovation
 Drug
development cost
 Pharma
research model
”EHR integration” is one common denominator
WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008
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Today’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
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How

Introduction


Overview of arguments, assumptions and
outcomes of the EHR task force
Breakout sessions
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Discuss & Identify how we are going to achieve
this



Key barriers
Momentum, key stakeholders, etc.
Consolidation

Build shared recommendations
WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008
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Building - High level statement
Arguments & building blocks
EuroRec/Efpia/CDIR - Brussles
March 10-11, 2008
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Today’s situation in EU



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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
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The transitional environment




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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 winwin-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
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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
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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
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Needs x 3

Build on three needs

Create the political will in EU member states

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Develop a sustainable interaction model for
interoperability of EHRs in EU


Awareness, governance, funding and key application
areas (e.g. drug safety monitoring, medical research)
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
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EHR levels x 3
 Primary

Identifiable EHRs
 Patient

& drug safety monitoring
Pseudonomyisation of EHRs
 Medical

care
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
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Reflections x 3
 Banking

industry
E.g the S.W.I.F.T project (1995)

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
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
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Reflections x 3
 Airline

industry
E.g. EDS and Amadeus systems (19952000)

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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
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Reflections x 3

ICH (the case of Good Clinical
Practice)

International Conference on
Harmonization (1990)

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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
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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
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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!

WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008
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Backup and redundant slides
EuroRec/Efpia/CDIR - Brussles
March 10-11, 2008
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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
WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008
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