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The EU eHealth Strategy:
Connecting Member States
Tapani Piha
Head of Unit
eHealth and Health Technology Assessment
Health Systems and Products
2nd National eHealth Summit
Carton House, Kildare, 30 Sep 2015
#ehealthsummit15
•  Implementing disruptive
innovation schemes,
using any innovative
concept, product and
service that can create
new markets by applying
new sets of rules, values
and models which will
ultimately disrupt and
overtake existing markets
by displacing earlier
technologies and
alliances, …tp 27.9.2015
 
"The	
  physician's	
  role	
  is	
  changing	
  significantly,	
  
and	
  the	
  ways	
  how	
  pa7ents	
  use	
  the	
  know-­‐how	
  
of	
  the	
  doctor	
  will	
  diversify."	
  	
  
	
  
Dr	
  Heikki	
  Pälve,	
  CEO,	
  Finnish	
  Medical	
  Associa7on	
  
Finnish	
  Medical	
  Journal	
  	
  27	
  March	
  2015,	
  p.	
  849	
  
	
  
Consequences for
Patients & Doctors
•  Responsibility moves more to the patient
•  Role of the doctor changes substantially: guiding
treatment and coaching
FINNISH MEDICAL
JOURNAL
tp 10.05.2015
eHealth and the European Union
Benefits
Strategic Intent
Ireland
eHealth – why an EU co-operation?
•  eHealth has great cross-border potential, and is not bound to
local setting
•  Quality argument: Ensure continuity and quality of care across
borders provided in emergencies or on occasional basis
•  Research argument: enhance the quality of eHealth research,
more data →EU wide, better pilots →many MS; share experience
•  Shortage of resources: address the lack of funding and legal
expertise by pooling resources and expertise
•  Economic argument: strengthen the eHealth market by
promoting interoperability and addressing its fragmentation
jb / tp 27.9.2015
Connecting Member States for
health data exchange
MS
Hospitals
GPs
(…)
MS
MS
tp 27/09/2015
Developing EU policy & support measures
•  Research & Development activities (since 1989)
!  Research Projects, > 450 projects, > €1 billion
!  Cooperation with health services, industry, universities
•  Policy instruments (since 2004)
!  Communications, Recommendations, Directive(s)
!  Stakeholders'Group (users, industry)
!  Strategy studies, road maps, evidence
•  Support to deployment (since 2007)
!  Market validation and implementation
!  Competitiveness and Innovation
•  Work with national health systems (since 2011)
!  Collaboration of MS in the eHealth Network
!  Deployment of the results of projects
Adapted from From Flora Giorgio, 2010
3.9.2014
ICT for Health budget:
~ 75 Million €/year
eHealth Action Plan 2012-2020
•  eHealth Network ⇒
•  eHealth Interoperability Framework ⇒ Legal issues
•  Green Paper on mHealth ⇒
tp 27/9/2015
Policy Instruments
for eHealth in the EU
"  Directive on patients' rights in cross-border care
"  eHealth Network
"  2nd Joint Action on eHealth
"  Financing
"  Horizon 2020: research and innovation (since 1989)
"  Connecting Europe Facility: implementation (2015)
"  Strategy for the Digital Single Market
"  Adopted by the Commission 6 May 2015
HALF	
  of	
  EU	
  enterprises	
  	
  
provide	
  mobile	
  devices	
  for	
  
business	
  use	
  
276.5	
  million	
  EUR	
  
turnover	
  
of	
  EU	
  B2C	
  eCommerce	
  (2012)	
  
	
  
14%	
  of	
  EU	
  SMEs	
  	
  
selling	
  online	
  
	
  
29%	
  of	
  EU	
  
enterprises	
  	
  
use	
  e-­‐Invoices	
  
28%	
  EU	
  enterprises	
  	
  
use	
  Social	
  media	
  
38%	
  EU	
  venture	
  capital	
  
DIGITAL	
  
BUSINESS	
  
DIGITAL	
  ECONOMY	
  72%	
  of	
  EU	
  individuals	
  	
  
uses	
  INTERNET	
  	
  regularly	
  
900	
  000	
  estimated	
  demand/
supply	
  gap	
  by	
  2020	
  
150	
  Million	
  
subscriptions	
  
fixed	
  Broadband	
  
130	
  mobile	
  
subscriptions	
  	
  
per	
  100	
  people	
  
ICT	
  drives	
  1/3rd	
  	
  
EU	
  GDP	
  growth	
  	
  
1995-­‐2007	
  	
  
2.4%	
  	
  
of	
  workforce	
  
+	
  4.1%	
  	
  
yearly	
  employment	
  growth	
  
ICT	
  professionals	
  
55%	
  	
  
work	
  outside	
  ICT	
  sector	
  
7%	
  of	
  GDP	
  
	
  	
  	
  	
  	
  Size	
  of	
  the	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  digital	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  economy	
  
6%	
  of	
  
Gov't	
  
R&D	
  	
  
17%	
  of	
  
business	
  
R&D	
  
by	
  ICT	
  
sector	
  
ICT	
  
sector	
  
4.4%	
  
ICT	
  in	
  	
  
Other	
  Sectors	
  
17%	
  EU	
  patents	
  
All	
  sectors	
  
are	
  dependent	
  
on	
  ICT	
  
ICT	
  spending	
  by	
  category	
  of	
  
actors	
  (%	
  of	
  total	
  spending	
  on	
  
ICT	
  in	
  2012)	
  
Source:	
  OECD	
  
Consumer	
  
33%	
  
Financial	
  Services	
  
10%	
  
Telecom	
  
9%	
  
Government	
  
8%	
  
Services	
  
8%	
  
Manufacturing	
  
8%	
  
Transporta?on	
  
5%	
  
Healthcare	
  
4%	
  
Retail	
  Trade	
  
3%	
  
Wholesale	
  and	
  
Distribu?on	
  
3%	
  
Hospitality,	
  Hotels	
  
and	
  Leisure	
  
3%	
  
Energy	
  and	
  
U?li?es	
  
2%	
  
Construc?on	
  
2%	
  
Natural	
  
Resources	
  
1%	
  
Educa?onal	
  
Services	
  
1%	
  
SG/tp 16/6/2015
Healthcare
4%
•  Geoblocking
•  Copyright
•  E-commerce
•  Parcel delivery
•  Reducing VAT burden
Better access for
consumers and
businesses
•  Telecoms market
•  Media services
•  Platforms and intermediaries
•  Trust and security
Advanced digital
networks and
innovative
services
•  Data economy
•  Inclusive digital economy and society
•  Interoperability and standardisation
Enhance the
digital economy
Health →
telemedicine
+ mhealth
SG/tp 16/7/2015
Patients’ rights in Cross-border Healthcare
Directive 2011/24/EU
A major step towards a Europe for Health
eHealth Network
•  Article 14 of Directive
•  Leads cooperation of
Member States
•  Gives direction to eHealth developments
•  Adopts guidelines
•  Patient summary data
•  ePrescriptions
tp 10/05/2015
eHealth
Network
Political
body
Preparatory
body
eHealth
projects
The eHealth Network
– A Strategic Tool
tp 15/09/2015
Joint Action supporting
the eHealth Network
under the 3rd Health Programme
Ireland
•  Department of Health
•  Health Service Executive
tp 27.9.2015
Guidelines on ePrescriptions
dataset for electronic exchange
under the cross-border Directive
eHealth Network
Brussels
18 November 2014 Release 1
What do
the guidelines address?
22
Rules in
the guidelines
eHealth Digital Service Infrastructure
under the Connecting Europe Facility
tp 13.7.2015
2014-2015
Maintain and develop
interoperability assets,
handover to CEF
tp/mk 27/9/2015
2013-2015
Use common IT building
blocks in different public
policy areas
2008-2014
Pilot the service infrastructure
for cross-border health
eHDSI under CEF 2015 ->
Rely on the eHealth Network Guidelines
Implementation by Member States and Commission
eHealth Digital Service Infrastructure
the CEF funded project
Core services
Horizontal Building Blocks
eID, …
eHealth Building Blocks
terminology server, …
NCP
Hospitals
GPs
(…)
Member State's
connection to
the EU network
NCP: National
Contact PointNCP
tp 27/09/2015
NCP
T
E
C
H
N
I
C
A
L
Stork
epSOS eHDSI
Guidelines
eHealth NetworkP
O
L
I
C
Y
PILOTING DEPLOYMENT
CEF
gp/tp 27.9.2015
CEF WP 2015
AdoptedBudget of € 15 Million
(over 4 years)
CORE SERVICES
€ 7,5 Million
GENERIC SERVICES
€ 7,5 Million
Building Blocks
eID, eDelivery,…
eHealth-specific
Services
•  ICT infrastructure
•  Terminology svcs
•  NCP mngmt
•  …
Par?cipa?on	
  in	
  the	
  	
  
OpenNCP	
  Community	
  
Deployment	
  of	
  Na?onal	
  
Infrastructure	
  for	
  cross-­‐
border	
  exchange	
  of	
  data	
  
INEA
manages
Member
States
Call for
Proposals
75% EU
financing
Connecting Europe Facility CEF
- supports building of the connections
December 2014
The 2015 Work Plan
allocates € 15 mill.
to eHealth
November 2015
Call for proposals
to Member States
March 2016
Member States sent
proposals
2016-2018
Implementation
tp 14/09/2015
Examples of policies and actions
supporting eHealth data exchange
Regulation on eIdentification
•  Creates an EU legal framework for mutual recognition
and acceptance of eID and eSignature
•  The Regulation supports a cross-sectorial use of the
notified eIdentifciation systems
23 July 2014
Published in
OJ L 257/73
Legal Study on
Electronic Health Records:
Overview of national laws
•  Every country and region is in the process of progressively adapting legal
rules to enable EHR sharing
•  Each national and regional legal framework is different, and needs to be
read in its specific context
•  Typologies or classifications of these frameworks are difficult to make and
not very useful
•  Question: is diversity of national and regional legal frameworks an obstacle
for cross-border sharing?
mHealth
Trends in mHealth
Health and fitness apps are among the fastest
growing apps categories in terms of use, with
time spent in health and fitness apps growing
51% over the year to August 2014.
Localytics,
September 2014
Apps + Wearable Devices =
Future of Mobile Health
mHealth potential – "triple win"
•  Potential for citizens
→ More empowered patients, self-management, engagement
→ More accurate diagnosis and treatment
→ Earlier detection, increased prevention
→ Quality of life
→ Access
•  Potential for healthcare
•  Market potential
Green Paper on mHealth
•  Public consultation to stakeholders on how to overcome
the main challenges to mHealth deployment:
•  data protection
-  big data
•  legal framework
-  liability
-  safety and transparency
•  mHealth’s role in healthcare systems
-  reimbursement models
•  interoperability
•  international cooperation
•  web entrepreneurs' market access
Next steps in mHealth
!  Processes with stakeholders
!  Code of Conduct on privacy and security - (DPD Art 27)
!  Guidelines for assessing validity of data for the purposes of
linking apps to the electronic health records
!  Revision of medical devices guidelines - after adoption of
medical devices regulation
!  mHealth deployment under Horizon 2020
!  Use of big data in healthcare, security, health literacy
!  Commission-WHO-ITU initiative on evidence-gathering
and exchange of best practices – innovation hub
Summary - priorities
Priorities for healthcare
"  Enabling all actors to benefit from telemedicine
and mHealth through measures in the context of
Digital Single Market
"  Creating European infrastructure to exchange data
"  Legal and technical arrangements for exchange
"  European Reference Networks
"  Align EU standardisation activities in ehealth
"  Electronic patient access to health records
"  Secondary use of health data (Big Data)
tp 27.9.2015
DG Health and Food Safety site
http://ec.europa.eu/health/ehealth/policy/index_en.htm
DG Connect site
http://ec.europa.eu/digital-agenda/en/eu-policy-ehealth
@EU_HEALTH
@EU_Commission @EU_eHEALTH
@V_Andriukaitis
eHealth adoption by General Practitioners 2013
Source: Benchmarking Deployment of
eHealth among General Practitioners (2013)
Composite index
tp 27/9/2015
Health Objectives
for the EU cooperation on eHealth
"  Patients empowerment
"  Access to healthcare
"  Quality and safety of healthcare
"  Sustainability of health systems
tp 3.9.2014 43
Barriers

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eHealth Summit: "EU Address: The EU eHealth Strategy: Connecting Member States" by Dr Tapani Phia

  • 1. The EU eHealth Strategy: Connecting Member States Tapani Piha Head of Unit eHealth and Health Technology Assessment Health Systems and Products 2nd National eHealth Summit Carton House, Kildare, 30 Sep 2015 #ehealthsummit15
  • 2.
  • 3. •  Implementing disruptive innovation schemes, using any innovative concept, product and service that can create new markets by applying new sets of rules, values and models which will ultimately disrupt and overtake existing markets by displacing earlier technologies and alliances, …tp 27.9.2015
  • 4.   "The  physician's  role  is  changing  significantly,   and  the  ways  how  pa7ents  use  the  know-­‐how   of  the  doctor  will  diversify."       Dr  Heikki  Pälve,  CEO,  Finnish  Medical  Associa7on   Finnish  Medical  Journal    27  March  2015,  p.  849    
  • 5. Consequences for Patients & Doctors •  Responsibility moves more to the patient •  Role of the doctor changes substantially: guiding treatment and coaching FINNISH MEDICAL JOURNAL tp 10.05.2015
  • 6. eHealth and the European Union
  • 8. eHealth – why an EU co-operation? •  eHealth has great cross-border potential, and is not bound to local setting •  Quality argument: Ensure continuity and quality of care across borders provided in emergencies or on occasional basis •  Research argument: enhance the quality of eHealth research, more data →EU wide, better pilots →many MS; share experience •  Shortage of resources: address the lack of funding and legal expertise by pooling resources and expertise •  Economic argument: strengthen the eHealth market by promoting interoperability and addressing its fragmentation jb / tp 27.9.2015
  • 9. Connecting Member States for health data exchange MS Hospitals GPs (…) MS MS tp 27/09/2015
  • 10.
  • 11. Developing EU policy & support measures •  Research & Development activities (since 1989) !  Research Projects, > 450 projects, > €1 billion !  Cooperation with health services, industry, universities •  Policy instruments (since 2004) !  Communications, Recommendations, Directive(s) !  Stakeholders'Group (users, industry) !  Strategy studies, road maps, evidence •  Support to deployment (since 2007) !  Market validation and implementation !  Competitiveness and Innovation •  Work with national health systems (since 2011) !  Collaboration of MS in the eHealth Network !  Deployment of the results of projects Adapted from From Flora Giorgio, 2010 3.9.2014 ICT for Health budget: ~ 75 Million €/year
  • 12. eHealth Action Plan 2012-2020 •  eHealth Network ⇒ •  eHealth Interoperability Framework ⇒ Legal issues •  Green Paper on mHealth ⇒ tp 27/9/2015
  • 13. Policy Instruments for eHealth in the EU "  Directive on patients' rights in cross-border care "  eHealth Network "  2nd Joint Action on eHealth "  Financing "  Horizon 2020: research and innovation (since 1989) "  Connecting Europe Facility: implementation (2015) "  Strategy for the Digital Single Market "  Adopted by the Commission 6 May 2015
  • 14. HALF  of  EU  enterprises     provide  mobile  devices  for   business  use   276.5  million  EUR   turnover   of  EU  B2C  eCommerce  (2012)     14%  of  EU  SMEs     selling  online     29%  of  EU   enterprises     use  e-­‐Invoices   28%  EU  enterprises     use  Social  media   38%  EU  venture  capital   DIGITAL   BUSINESS   DIGITAL  ECONOMY  72%  of  EU  individuals     uses  INTERNET    regularly   900  000  estimated  demand/ supply  gap  by  2020   150  Million   subscriptions   fixed  Broadband   130  mobile   subscriptions     per  100  people   ICT  drives  1/3rd     EU  GDP  growth     1995-­‐2007     2.4%     of  workforce   +  4.1%     yearly  employment  growth   ICT  professionals   55%     work  outside  ICT  sector   7%  of  GDP            Size  of  the                        digital                            economy   6%  of   Gov't   R&D     17%  of   business   R&D   by  ICT   sector   ICT   sector   4.4%   ICT  in     Other  Sectors   17%  EU  patents  
  • 15. All  sectors   are  dependent   on  ICT   ICT  spending  by  category  of   actors  (%  of  total  spending  on   ICT  in  2012)   Source:  OECD   Consumer   33%   Financial  Services   10%   Telecom   9%   Government   8%   Services   8%   Manufacturing   8%   Transporta?on   5%   Healthcare   4%   Retail  Trade   3%   Wholesale  and   Distribu?on   3%   Hospitality,  Hotels   and  Leisure   3%   Energy  and   U?li?es   2%   Construc?on   2%   Natural   Resources   1%   Educa?onal   Services   1%   SG/tp 16/6/2015 Healthcare 4%
  • 16. •  Geoblocking •  Copyright •  E-commerce •  Parcel delivery •  Reducing VAT burden Better access for consumers and businesses •  Telecoms market •  Media services •  Platforms and intermediaries •  Trust and security Advanced digital networks and innovative services •  Data economy •  Inclusive digital economy and society •  Interoperability and standardisation Enhance the digital economy Health → telemedicine + mhealth SG/tp 16/7/2015
  • 17. Patients’ rights in Cross-border Healthcare Directive 2011/24/EU A major step towards a Europe for Health
  • 18. eHealth Network •  Article 14 of Directive •  Leads cooperation of Member States •  Gives direction to eHealth developments •  Adopts guidelines •  Patient summary data •  ePrescriptions tp 10/05/2015
  • 20. Joint Action supporting the eHealth Network under the 3rd Health Programme Ireland •  Department of Health •  Health Service Executive tp 27.9.2015
  • 21. Guidelines on ePrescriptions dataset for electronic exchange under the cross-border Directive eHealth Network Brussels 18 November 2014 Release 1
  • 22. What do the guidelines address? 22 Rules in the guidelines
  • 23.
  • 24. eHealth Digital Service Infrastructure under the Connecting Europe Facility tp 13.7.2015
  • 25. 2014-2015 Maintain and develop interoperability assets, handover to CEF tp/mk 27/9/2015 2013-2015 Use common IT building blocks in different public policy areas 2008-2014 Pilot the service infrastructure for cross-border health eHDSI under CEF 2015 -> Rely on the eHealth Network Guidelines Implementation by Member States and Commission
  • 26. eHealth Digital Service Infrastructure the CEF funded project Core services Horizontal Building Blocks eID, … eHealth Building Blocks terminology server, … NCP Hospitals GPs (…) Member State's connection to the EU network NCP: National Contact PointNCP tp 27/09/2015 NCP
  • 28. CEF WP 2015 AdoptedBudget of € 15 Million (over 4 years) CORE SERVICES € 7,5 Million GENERIC SERVICES € 7,5 Million Building Blocks eID, eDelivery,… eHealth-specific Services •  ICT infrastructure •  Terminology svcs •  NCP mngmt •  … Par?cipa?on  in  the     OpenNCP  Community   Deployment  of  Na?onal   Infrastructure  for  cross-­‐ border  exchange  of  data   INEA manages Member States Call for Proposals 75% EU financing
  • 29. Connecting Europe Facility CEF - supports building of the connections December 2014 The 2015 Work Plan allocates € 15 mill. to eHealth November 2015 Call for proposals to Member States March 2016 Member States sent proposals 2016-2018 Implementation tp 14/09/2015
  • 30. Examples of policies and actions supporting eHealth data exchange
  • 31. Regulation on eIdentification •  Creates an EU legal framework for mutual recognition and acceptance of eID and eSignature •  The Regulation supports a cross-sectorial use of the notified eIdentifciation systems 23 July 2014 Published in OJ L 257/73
  • 32. Legal Study on Electronic Health Records: Overview of national laws •  Every country and region is in the process of progressively adapting legal rules to enable EHR sharing •  Each national and regional legal framework is different, and needs to be read in its specific context •  Typologies or classifications of these frameworks are difficult to make and not very useful •  Question: is diversity of national and regional legal frameworks an obstacle for cross-border sharing?
  • 34. Trends in mHealth Health and fitness apps are among the fastest growing apps categories in terms of use, with time spent in health and fitness apps growing 51% over the year to August 2014. Localytics, September 2014 Apps + Wearable Devices = Future of Mobile Health
  • 35. mHealth potential – "triple win" •  Potential for citizens → More empowered patients, self-management, engagement → More accurate diagnosis and treatment → Earlier detection, increased prevention → Quality of life → Access •  Potential for healthcare •  Market potential
  • 36. Green Paper on mHealth •  Public consultation to stakeholders on how to overcome the main challenges to mHealth deployment: •  data protection -  big data •  legal framework -  liability -  safety and transparency •  mHealth’s role in healthcare systems -  reimbursement models •  interoperability •  international cooperation •  web entrepreneurs' market access
  • 37. Next steps in mHealth !  Processes with stakeholders !  Code of Conduct on privacy and security - (DPD Art 27) !  Guidelines for assessing validity of data for the purposes of linking apps to the electronic health records !  Revision of medical devices guidelines - after adoption of medical devices regulation !  mHealth deployment under Horizon 2020 !  Use of big data in healthcare, security, health literacy !  Commission-WHO-ITU initiative on evidence-gathering and exchange of best practices – innovation hub
  • 39.
  • 40. Priorities for healthcare "  Enabling all actors to benefit from telemedicine and mHealth through measures in the context of Digital Single Market "  Creating European infrastructure to exchange data "  Legal and technical arrangements for exchange "  European Reference Networks "  Align EU standardisation activities in ehealth "  Electronic patient access to health records "  Secondary use of health data (Big Data) tp 27.9.2015
  • 41. DG Health and Food Safety site http://ec.europa.eu/health/ehealth/policy/index_en.htm DG Connect site http://ec.europa.eu/digital-agenda/en/eu-policy-ehealth @EU_HEALTH @EU_Commission @EU_eHEALTH @V_Andriukaitis
  • 42. eHealth adoption by General Practitioners 2013 Source: Benchmarking Deployment of eHealth among General Practitioners (2013) Composite index tp 27/9/2015
  • 43. Health Objectives for the EU cooperation on eHealth "  Patients empowerment "  Access to healthcare "  Quality and safety of healthcare "  Sustainability of health systems tp 3.9.2014 43