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9th European Conference
on Rare Diseases and
Orphan Products
Vienna 10-12 May 2018
EU Strategy for Digital Transformation
in Cross-Border Healthcare
Tapani Piha
Head of Unit responsible for
European Reference Networks &
Digital Health
Health Systems, Medical Products
and Innovation
@EU_Health
@eHealth_EU
@tapani_piha
#digital transformation in
#healthcare #EU
#ECRDVienna
#ERNeu #RareDiseases
Commissioner Andriukaitis’s
message to ECRD 2018
“It is virtually impossible to help people with
rare diseases without collaboration. The
rare disease patients, caregivers and
researchers know it first-hand. This is why I
find it very worthy that it is in the centre of
the discussion at the ECRD 2018.”
Vytenis Andriukaitis, European Commissioner
for Health and Food Safety
Health Priorities in the Digital Single Market Strategy
Commission: Mid-Term Review of the
Digital Single Market Strategy, May 2017
Does Europe need a 5th freedom - free movement of data?
Read the latest speech by @Ansip_EU on #EUdataFF
http://bit.ly/2dJinIQ #digirev
DigitalSingleMarket
‫‏‬@DSMeu
tp 3.12.2016
Council Conclusions on Health in the Digital
Society, 8 December 2017
• Data-driven tools for healthcare services and sustainable health systems
• Implementation of existing EU legislation on the protection of personal
data, electronic identification and information security
• Building on initiatives under the Digital Single Market Strategy: European
Cloud Initiative, EuroHPC and European Open Science Cloud
• Improving access to larger European datasets, longitudinal data and
world-class high performance computing infrastructure
Commission Communication COM (2018) 233
• Digital transformation
of health and care
• in the Digital Single
Market
• empowering citizens
and building a healthier
society
1. Citizens' secure access to and
sharing of health data
eHealth DSI builds cross-border exchange
Clarify basis for the eHealth DSI and create
new services, such as exchange of electronic
health record
PROPOSED EU ACTION
Enable Citizen access and ability to use health data
securely across-borders through the European
electronic health record exchange format
PROPOSED EU ACTION
1610
3
Single national v. multiple EHR
Systems in place (N=29)
One national EHR system
Multiple EHR systems
No EHR systems
2. Better data to promote
research, disease prevention
and personalised health and
care
International Consortium
for Personalised Medicine
• 41 partners from 28 countries; 11 health
and 6 science ministries
• Policy orientation for PM research
• Paving the way for PM approaches to
reach health care systems and citizens
Clinical
decision
making
Regulatory
decision making:
clinical and
market access
development
plans
HTA: relative
effectiveness
HTA: health
economic
models for
PM
HTA: Health
Economic
Evaluation
Health
Data
Real World Data
Synthesis from H2020,
IMI1, IMI2 BD4BO, others
Commission. Modif tp 9.5.2018
Global Personalised Medicine Initiatives (Genomic data)
United States
1 milliongenomes
and € 3.8 billion
planned investment
China
100 milliongenomes
and € 7.9 billion
planned investment
France
235.000
genomes UK
100.000
genomes
Estonia
Planned
50.000
genomes Denmark Finland
1 million genomes by 2022
accessible through a
secure data infrastructure
privacy and security
by design
PROPOSED EU ACTION
Declaration on 1 million
sequenced genomes
• Signed by 16 Member States
• Agree to work together towards building a research cohort of
at least 1 million sequenced genomes accessible in the EU
• By 2022
• Access through a federated (non-centralised) network to
genomics data-sets created at national and regional levels
• Commission will support and facilitate, including funding form
Horizon 2020 and CEF programmes
3. Digital tools for citizen
empowerment and for person-
centred care
Cross-Border Possibilities to Help Patients
24 Networks
Full
Member
Affiliated
partner
26 Countries
tp 17/10/17
Conclusions
Conclusions
tp 2/3/2018
@EU_HEALTH
@EU_Commission @eHEALTH_EU
@V_Andriukaitis
DG Health and Food Safety
http://ec.europa.eu/health/ehealth/
policy/index_en.htm
DG Connect
http://ec.europa.eu/digital-
agenda/en/eu-policy-ehealth

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MEDx.Care : EU Strategy for Digital Transformation in Cross-Border Healthcare

  • 1. 9th European Conference on Rare Diseases and Orphan Products Vienna 10-12 May 2018 EU Strategy for Digital Transformation in Cross-Border Healthcare Tapani Piha Head of Unit responsible for European Reference Networks & Digital Health Health Systems, Medical Products and Innovation @EU_Health @eHealth_EU @tapani_piha #digital transformation in #healthcare #EU #ECRDVienna #ERNeu #RareDiseases
  • 2. Commissioner Andriukaitis’s message to ECRD 2018 “It is virtually impossible to help people with rare diseases without collaboration. The rare disease patients, caregivers and researchers know it first-hand. This is why I find it very worthy that it is in the centre of the discussion at the ECRD 2018.” Vytenis Andriukaitis, European Commissioner for Health and Food Safety
  • 3. Health Priorities in the Digital Single Market Strategy Commission: Mid-Term Review of the Digital Single Market Strategy, May 2017
  • 4. Does Europe need a 5th freedom - free movement of data? Read the latest speech by @Ansip_EU on #EUdataFF http://bit.ly/2dJinIQ #digirev DigitalSingleMarket ‫‏‬@DSMeu tp 3.12.2016
  • 5. Council Conclusions on Health in the Digital Society, 8 December 2017 • Data-driven tools for healthcare services and sustainable health systems • Implementation of existing EU legislation on the protection of personal data, electronic identification and information security • Building on initiatives under the Digital Single Market Strategy: European Cloud Initiative, EuroHPC and European Open Science Cloud • Improving access to larger European datasets, longitudinal data and world-class high performance computing infrastructure
  • 6. Commission Communication COM (2018) 233 • Digital transformation of health and care • in the Digital Single Market • empowering citizens and building a healthier society
  • 7. 1. Citizens' secure access to and sharing of health data
  • 8. eHealth DSI builds cross-border exchange Clarify basis for the eHealth DSI and create new services, such as exchange of electronic health record PROPOSED EU ACTION
  • 9. Enable Citizen access and ability to use health data securely across-borders through the European electronic health record exchange format PROPOSED EU ACTION 1610 3 Single national v. multiple EHR Systems in place (N=29) One national EHR system Multiple EHR systems No EHR systems
  • 10. 2. Better data to promote research, disease prevention and personalised health and care
  • 11. International Consortium for Personalised Medicine • 41 partners from 28 countries; 11 health and 6 science ministries • Policy orientation for PM research • Paving the way for PM approaches to reach health care systems and citizens
  • 12. Clinical decision making Regulatory decision making: clinical and market access development plans HTA: relative effectiveness HTA: health economic models for PM HTA: Health Economic Evaluation Health Data Real World Data Synthesis from H2020, IMI1, IMI2 BD4BO, others Commission. Modif tp 9.5.2018
  • 13. Global Personalised Medicine Initiatives (Genomic data) United States 1 milliongenomes and € 3.8 billion planned investment China 100 milliongenomes and € 7.9 billion planned investment France 235.000 genomes UK 100.000 genomes Estonia Planned 50.000 genomes Denmark Finland 1 million genomes by 2022 accessible through a secure data infrastructure privacy and security by design PROPOSED EU ACTION
  • 14. Declaration on 1 million sequenced genomes • Signed by 16 Member States • Agree to work together towards building a research cohort of at least 1 million sequenced genomes accessible in the EU • By 2022 • Access through a federated (non-centralised) network to genomics data-sets created at national and regional levels • Commission will support and facilitate, including funding form Horizon 2020 and CEF programmes
  • 15. 3. Digital tools for citizen empowerment and for person- centred care
  • 20. Conclusions tp 2/3/2018 @EU_HEALTH @EU_Commission @eHEALTH_EU @V_Andriukaitis DG Health and Food Safety http://ec.europa.eu/health/ehealth/ policy/index_en.htm DG Connect http://ec.europa.eu/digital- agenda/en/eu-policy-ehealth