mHealth

1
mHealth EC Policies

• Claude Agnès Henrioul
• Health and Well-Being, European Commission
• Directorate General Connections Networks,
  Content Technologies 
• Geneva, ITU, 25 September 2012

2
Agenda

• EC Policies and Strategies in mHealth
• Definition of the e/mHealth Market
• Digital Agenda for Europe 2010-2020
• Draft eHealth Action Plan 2012-2020
• FP6 FP7 Projects

3
Definition of the eHealth/mHealth Market

• The eHealth market can be defined as comprising
  the following four interrelated major categories
  of applications
• 1. Clinical information systems
• a) Specialised tools for health professionals
  within care institutions (e.g., hospitals).
  Examples are Radiology Information Systems,
  Nursing Information Systems, Medical Imaging,
  Computer Assisted Diagnosis, Surgery Training and
  Planning Systems.
• b) Tools for primary care and/or for outside the
  care institutions such as general practitioner
  and pharmacy information systems.
• 2. Telemedicine and homecare, personalised health
  systems and services, such as disease management
  services, remote patient monitoring (e.g. at
  home), tele-consultation, tele-care,
  tele-medicine, and tele-radiology.
• 3. Integrated regional/national health
  information networks and distributed electronic
  health record systems and associated services
  such as e-prescriptions or e-referrals (cross
  border EHRePrescription)
• 4. Secondary usage non-clinical systems
• a) Systems for health education and health
  promotion of patients/citizens such as health
  portals or online health information services.
• b) Specialised systems for researchers and public
  health data collection and analysis such as
  bio-statistical programs for infectious diseases,
  drug development, and outcomes analysis.
• c) Support systems such as supply chain
  management, scheduling systems, billing systems
  administrative and management systems, which
  support clinical processes but are not used
  directly by patients or healthcare
  professionals.
• Lead Market Initiative - eHealth Taskforce report
  2007 eHealthhttp//ec.europa.eu/information_societ
  y/activities/health/policy/lmi_ehealth/index_en.ht
  m

mHealth in all market segments
4
Relevant Policy Hooks

• European Innovation Partnership on Active and
  Healthy Ageing (EIP AHA)
• Digital Agenda for Europe 2010-2020, Key Actions
  13 14
• eHealth Action Plan 2012-2020 - Innovative
  Healthcare for the 21st Century (under
  preparation)
• Adoption October 2012
• Guidelines on the qualification and
  classification of standalone software used in
  healthcare within the regulatory framework of
  medical devices (DG SANCO, Medical Devices Unit)
• January 2012
• Implicit classification of mHealth apps,
  telemedicine and web based systems
• Revision of the regulatory framework for medical
  devices
• new and emerging technologies have challenged the
  current framework
• consolidation and simplification
• College debate 26 September 2012
• Commission Staff Working Paper on the
  applicability of existing EU legal framework to
  telemedicine services
• Licensing conditions for processing health data
  issue of reimbursement new Directive 2011/24 on
  the patients rights in cross-border healthcare
  liability
• Adoption October 2012
• Privacy, security related directives

5
Digital Agenda for Europe 2010-2020

• 7 Pillars
• 101 Actions (eHealth 75 76)
• 16 Key Actions (eHealth13 14)

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The 7 Pillars of the DAE

• Vibrant Single Market
• Interoperability and Standards
• Trust and Security
• Fast and Ultra Fast Internet Access
• Research Innovation
• Digital Literacy, skills and Inclusion
• ICT for Societal challenges (including eHealth)

7
DAE Actions on eHealth

• Action 75 - Key Action 13 - Give Europeans secure
  online access to their medical health data by
  2015 and achieve wider deployment of telemedicine
  services by 2020 (leading to empowerment)
• 3 pilots funded, one project in negotiation
• Staff working paper on legal framework for
  telemedicine planned for Autumn 2012
• Action 76 - Key Action 14 - Recommendation to
  define minimum common set of patient data
• eHealth Network to adopt guidelines in first half
  of 2013

8
Draft eHealth Action Plan

• Innovative Healthcare for the 21st Century
• Duration 2012-2020
• Adoption October 2012
• Policy Context
• Proposed Objectives / Actions

9
European e-Health Action Plan Communication
COM(2004)356

• Asks commitment of MS to work together to
  implement eHealth
• Advocates the development of common
  interoperability approaches and standards for
  patient identifiers, medical data messaging,
  electronic health records
• Calls for legal clarity and leadership to
  implement eHealth

10
A New e-Health Action Plan Why?

• To reflect the progress made so far
• To ensure more coherence between health policy
  developments and eHealth deployment
• To scale up eHealth for empowerment, efficiency
  and innovation in healthcare
• To contribute to more jobs and growth
• Requested in Council Conclusions (December 2009)

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Addressing the issues that count

• New action plan will address the key issues
  considered to be important in public
  consultation
• Increase awareness of the benefits and
  opportunities of eHealth, and empower citizens,
  patients and healthcare professionals
• Address issues currently impeding eHealth
  interoperability
• Improve legal certainty for eHealth
• Support research and innovation in eHealth and
  development of a competitive European market
• over 90 agreed / partially agreed

12
eHealth Action Plan vision

• Tackle eHealth challenges related to
• Personal Health (improve Chronic Disease
  Management, prevention and health promotion)
• Health systems (unlocking innovation, enhancing
  patient-centric care, encouraging organisational
  changes)
• Legal / socio-economic aspects (cross-border
  healthcare, legal and market conditions)

13
eHealth Action Plan overall policy goals

• Improve quality of life and wellbeing of citizens
• Providing Europeans with equal access to high
  quality and sustainable healthcare services
• Enhancing competitiveness of EU industry

14
Operational objectives

• Setting up an eHealth Interoperability Framework
• ? Addressing technical / organisational / legal
  layers
• ? Legal layers telemedicine, data
  protection, mHealth
• Supporting Research, Development, Innovation
  Competitiveness in eHealth
• Ensuring wider deployment of eHealth
• Facilitating uptake of eHealth
• Promoting policy dialogue international
  cooperation on eHealth on global level

15
Addressing the legal layer

• Staff Working Paper on the applicability of the
  EU legal framework to cross-border telemedicine,
  adoption in October 2012
• Support for legal work linking eHealth and
  ICT-led innovation
• Guidance on how to apply EU data protection law
  in the area of health data (empowering citizens
  and patients following adoption of DP regulation)
• Tackle the lack of legal clarity around mHealth
  and Health Wellbeing apps Green Paper on
  Legal Framework applicable to Health Wellbeing
  Apps by 2014

16
eHealth Action Plan - Conclusions

• eHealth Action Plan responds to climate of
  budgetary constraints of health systems ageing
  population citizens expectations
• Promoting innovation for better health and care
  transparency and empowerment more skilled
  workforce more efficient and sustainable health
  and care systems new business opportunities in
  Europe and beyond
• Scheduled Adoption by the EC end of October 2012

17
Proposal for a Regulation on Medical Devices

• Scheduled for adoption by the EC 26 September
  2012
• mHealth and health and wellbeing apps not
  satisfactorily covered in the Proposed Regulation
  on MD
• Question to regulate or not addressed in a Green
  Paper on Health and Wellbeing Apps
• Green Paper scheduled for adoption by the EC end
  of 2014

18
EC funded eHealth Research (FP7) or Deployment
(CIP) Projects with mHealth Elements

• AP_at_home (diabetes)
• CAALYX (FP6, continuation in CIP)
• CD-MEDICS (point-of care diagnostics)
• HeartCycle (cvd, tailored drugs for patients)
• Help4Mood (depression recovery)
• ICT4DEPRESSION (depression recovery)
• INTERSTRESS (psychological stress)
• METABO (diabetes)
• Mobiguide (clinical-guideline-based guidance for
  professionals and patients)
• MONARCA (mental health, bipolar disease)
• MovingLife (road mapping for mHealth, primary
  focus for clinical-medical use)
• Nephron (renal care)
• REACTION (diabetes)
• Renewing Health (large CIP covers three most
  prevalent chronic diseases, includes mobile
  element)
• SENSORART (cvd)
• SmartPersonalHealth (road mapping, Continua
  health alliance, final report available)
• SmartHEALTH (point of care diagnostics, FP6)
• StrokeBack (stroke)

19
More information and contacts

• claude-agnes.henrioul_at_ec.europa.eu

• ec.europa.eu/ehealth

_at_EU_ehealth _at_EU_ehealthweek
EU.ehealth Ehealthweek.eu