New Horizons for ehealth and Active Ageing ALEC Paul Timmers Director European Commission - DG CONNECT Kiruna, 4 th February 2014

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New Horizons for ehealth and Active Ageing ALEC 2014 Paul Timmers Director European Commission - DG CONNECT Kiruna, 4 th February 2014

Summary: The ehealth Ladscape: Policy Policy Groups ehealth Network ehealth Stakeholder Group European Innovation Partnership on Active and Healthy Ageing Policy Papers ehealth Action Plan Draft Regulation on Data Protection eid/esignature legislative package Staff Working Paper on Telemedicine EU-US Memorandum of Understanding Green paper on mhealth Ongoing projects: European and regional dimensions ehealth and Horizon 2020 Future Goals Member States Involvement New strategic policies and projects Consolidated Integration of ehealth projects on Horizon 2020

The ehealth Ladscape: Policy Policy Groups: ehealth Network Resulting from Article 14 of the Directive 2011/24/EU on the application of patient's rights in cross border healthcare. Fourth meeting on 19 th November. - Adopted the guidelines on patient summaries. - Identifies semantic and technical interoperability as the major priority. ehealth Stakeholder Group Official "expert group" to contribute to the development of legislation and policy related to ehealth, including relevant actions of the Digital Agenda for Europe on ehealth and the ehealth Action Plan.

The ehealth Ladscape: Policy Policy Groups: European Innovation Partnership on Active and Healthy Ageing New stakeholder-driven approach to tackle challenges of an ageing population and turning it into a triple win: sustainability, better care and growth A Strategic Implementation Plan was launched in November 2011 with 6 ready to launch actions. A Commission Communication was launched on 29th February 2012, supporting the Plan. Invitations for Commitment and Invitations for expression of intent for candidate reference sites were launched 29th February Action Groups met for the second time in September 2013. A 2 nd Conference of Partners was held in November for further discussion on new actions, governance and monitoring of the actions implementation.

The ehealth Ladscape: Policy Policy Papers: ehealth Action Plan From end 2012 until 2020, mirroring the timeline of Europe 2020, the Digital Agenda for Europe and Innovation Union. Draft regulation on Data Protection The Commission presented in January 2012 a proposal to replace the current directive by a regulation. Changes related specifically to ehealth: A general article on sensitive data (Art. 9): banning principle with a list of exemptions (9.2.h) refers to health A specific article on the processing of data concerning health (Art. 81) A specific article on research (Art.83) Limitation of the "right to be forgotten" on the net (Art. 17) for health and research purposes.

The ehealth Ladscape: Policy Policy Papers: eid and esignature A forthcoming legislative package will propose to: Establish mutual recognition of electronic identification Achieve cross-border interoperability and ease of use of esignature. Cover related electronic trusted services Objective: improve businesses and administrations efficiency and lead to a massive reduction of paper-based processes. Staff Working Paper on Telemedicine Provides an analysis of the EU legal framework applicable to cross-border telemedicine and seeks to enhance legal clarity for all actors in the field. The document was published in December 2012.

The ehealth Ladscape: Policy Policy Papers: EU-US Memorandum of Understanding Signed in 2010 by the European Commission and the US Department of Health and Human Services. Aims to create market opportunities for companies and investors in the EU and US by fostering interoperability (in particular of electronic health records - EHR) Green paper on mhealth To open the debate on the most adequate actions to support mhealth deployment throughout the EU. A Staff Working Document (SWD), accompanying the green paper, will provide an overview of the EU legislation applicable to those apps, especially the data protection Directive and the Medical Devices Directives. It is expected to be adopted in the first Quarter of 2014.

Ongoing projects: European and regional dimensions EpSOS RENEWING HEALTH SUSTAINS PALLANTE MOMENTUM CAMEI Chain of Trust Trillium Bridge

Ongoing projects: European and regional dimensions Renewing Health Aims at: implementing large-scale real-life test beds for the validation and evaluation of telemedicine services using a patient-centred approach and an assessment technology. giving patients a central role in the management of their own diseases while helping detect early signs of worsening of pathologies. http://www.renewinghealth.eu/en/

Ongoing projects: European and regional dimensions Chain of Trust Aims at: assessing the views, needs, benefits and barriers related to telemedicine from the perspective of patients and health professionals increasing awareness of users' perspective on telehealth amongst patients' and health professionals' organisations and health authorities at EU and national level. http://www.chainoftrust.eu/

Ongoing projects: European and regional dimensions Momentum The Momentum Thematic Network is a platform of key players sharing knowledge and experience in deploying telemedicine services into routine care to build a body of good practice and: assist countries and telemedicine practitioners in their telemedicine implementations propose a set of policy recommendations to create the enabling environments to accelerate overall telemedicine deployment in Europe. http://www.telemedicine-momentum.eu/

Ongoing projects: European and regional dimensions epsos A pilot of cross-border interoperability 36 million, 5 years project partially funded by the European Commission (2008-2013) 47 partner organizations across 23 different European countries National and regional ministries of health National / regional competence centers An industry team composed of more than 30 companies Developed An interoperability framework and common architecture Open source software components, Profiles (Interoperability specifications at the technical level) A mini ontology for interoperability at semantic level Governance and operational processes (organizational level) Used existing testing methodology and tools (projectathon) EXPAND will ensure the sustainability of the epsos infostructure in view of CEF deployments www.epsos.eu

Ongoing projects: European and regional dimensions Sustains Aims at: giving citizens online access to their Electronic Health Records (EHR) 11 pilots in 9 EU countries Contributes to empowerment of patients; Quality of care; Efficiency and economy and supporting widespread deployment of telemedicine services http://ec.europa.eu/information_society/apps/pr ojects/factsheet/index.cfm?project_ref=297206

Ongoing projects: European and regional dimensions Pallante Aims at: Patient empowerment to reduce healthcare costs and improve efficiency of the health systems Based on the concept of secure and user friendly online access by citizens to their medical/health data. Globally, the project mobilizes 21 partners in 10 different countries, and 69.550 new users. Considers 7 new pilots in 6 countries (7 regions) and 2 additional ongoing pilots in 2 other countries. 5 of these pilots deal with integrated chronic disease management support, including comprehensive self-learning, education and monitoring systems that will be validated for diabetes, chronic heart failure, severe arthritis and respiratory diseases. http://ec.europa.eu/information_society/apps/projects/factsheet/index.c fm?project_ref=297260

Ongoing projects: European and regional dimensions Trillium Bridge Aims at: international interoperability of EHRs (Building the Transatlantic bridge for patient summaries) Coordinated by HL7 Europe Three MS are engaged: Portugal, Spain and Italy Other EU partners: HL7 Europe, Eurorec, IHE, Phast, CEN US organisations involved: Kaiser permanente, Mayo Clinic, Atrius Health, etc http://www.epractice.eu/files/trillium%20bridge%20- %20Catherine%20Cronaki.pdf

Ongoing projects: European and regional dimensions CAMEI Aims at: addressing digital skills for the healthcare workforce Coordinated by Northern Research Institute Other partners: Aristotle University of Thessaloniki (EL), Karolinska Institute (SE), Universitat Politecnica de Valencia (ES) Empower the evidence-based clinical practice guidelines for telemedicine services Covering digital gap of healthcare workforce in ehealth/health IT http://www.epractice.eu/files/camei%20- %20Stathis%20Konstantinidis.pdf

Examples of mhealth related R&D&I projects in healthcare settings AP@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 (diabetes, clinical-guidelinebased guidance for professionals and patients) MONARCA (mental health, bipolar disease) MovingLife (roadmapping for mhealth, primary focus for clinicalmedical use) Nephron+ (renal care) REACTION (diabetes) Renewing Health (large CIP covers three most prevalent chronic diseases, includes mobile element) SENSORART (cvd) SmartPersonalHealth (roadmapping, Continua Health Alliance) SmartHEALTH (point of care diagnostics) StrokeBack (stroke) Pre-Commercial Procurement (PCP) actions led by health procurers, last calls of FP7, mhealth in central role in some of them DECIPHER, PCP, mhealth solutions applied in public healthcare; Pan- European access to prescription and emergency data UNWIRED Health, PCP, a mobile care path for consumers, patient-centric, converging interoperable platforms, improve vaccination coverage and adherence to coach patients with heart failure NYMPHA-MD, PCP, mhealth solutions applied in public healthcare, mental health treatment

ehealth and Horizon 2020 What's new? A single programme bringing together three separate programmes/initiatives* Three Priorities: Excellence of science; Industrial leadership and Societal Challenges Coupling research to innovation all forms of innovation Focus on societal challenges facing European society e.g. health and ageing, clean energy and transport Simplified access, for all companies, universities, institutes in all EU countries and beyond The 7 th Research Framework Programme (FP7), innovation aspects of Competitiveness and Innovation Framework Programme (CIP), EU contribution to the European Institute of Innovation and Technology (EIT)

ehealth and Horizon 2020 Topic area: 'Health, demographic change and wellbeing' is the 1 st topic of Societal Challenges 7 Sub-topics: Understanding health, ageing and disease; Effective health promotion, disease prevention, preparedness and screening; Improving diagnosis; Innovative treatments and technologies; Advancing active and healthy ageing; Integrated, sustainable and citizen centred care; Improving health information, data exploitation, and providing regulation. ICT

ehealth and Horizon 2020 The Work Programme 2014/15 is online http://ec.europa.eu/programmes/horizon2020/

ehealth and Horizon 2020 Funding opportunities in Horizon 2020, Calls 2014 and 2015 SC1: Health, Demographic Change and Well-Being PHC 19 2014: Advancing Active and Healthy Ageing with ICT: Service Robotics within Assisted Living Environments PHC 20-2014: Advancing Active and Healthy Ageing with ICT: ICT Solutions for Independent Living with Cognitive Impairment PHC 21 2015: Advancing Active and Healthy Ageing with ICT: Early Risk Detection and Intervention PHC 25-2015: Advanced ICT Systems and Services for Integrated Care PHC 26 2014: Self-Management of Health and Disease: Citizen engagement and mhealth PHC 27-2015: Self-management of Health and Disease and Patient Empowerment Supported by ICT PHC 28-2015: Self-management of Health and Disease and Decision Support Systems Based on Predictive Computer Modelling Used by the Patient Him or Herself

ehealth and Horizon 2020 Funding opportunities in Horizon 2020, Calls 2014 and 2015 SC1: Health, Demographic Change and Well-Being Cont PHC 29 2015: Public Procurement of Innovative e-health Services PHC 30-2015: Digital Representation of Health Data to Improve Disease Diagnosis and Treatment PHC 34 2014: ehealth Interoperability HCO 1 2014: Innovation Partnership: Support for the European Innovation Partnership on Active and Healthy Ageing HCO 2 2014: Coordination Action for JPI "More Years, Better Lives - the Challenges and Opportunities of Demographic Change"

ehealth and Horizon 2020 Understanding the call topics: example 'PHC 2 2015' 'Specific challenge' 'Scope' 'Expected impact' 'Type of action'

ehealth and Horizon 2020 Applying for funding your one-stop shop http://ec.europa.eu/research/participants/portal

ehealth and Horizon 2020 More opportunities for SMEs Some 20% of the total budget for societal challenges/leits to go to SMEs Simplification a great benefit to SMEs 'Access to risk finance' with strong SME focus (debt and equity facility) A new SME instrument

ehealth and Horizon 2020 SME instrument Idea Phase 1 Phase 2 Phase 3 Concept & Feasibility Assessment Innovation R&D activities Commercialisation Market Feasibility of concept Risk assessment IP regime Partner search Design study Lump sum: ~ 50.000 ~ 6 months Development, prototype, testing Miniaturisation/design Clinical trials Etc. Output-based payments: 1 to 5 M 12 to 36 months Facilitate access to private finance Support via networking, training, coaching, knowledge sharing, dissemination No direct funding

ehealth and Horizon 2020 Pre-Commercial Procurement (PCP) and Public Procurement for Innovative solutions (PPI) co-fund actions - complementarity PCP to steer the development of solutions towards concrete public sector needs, whilst comparing/validating alternative solution approaches from various vendors PPI to act as launching customer / early adopter / first buyer of innovative commercial endsolutions newly arriving on the market Applied R&D / Pre-commercial Procurement (PCP) Phase 0 Curiosity Driven Research Phase 1 Solution design Supplier A Supplier B Supplier C Supplier D Phase 2 Prototype development Supplier B Supplier C Supplier D Phase 3 Original development of limited volume of first test products / services Supplier B Supplier D Objectives: Price/quality products that better fit public sector needs Earlier customer feedback for companies developing solutions Better take-up/wider commercialisation of R&D results Phase 4 Deployment of commercial volumes of end-products Wide diffusion of newly developed solutions Supplier(s) A,B,C,D and/or X Also normally multiple sourcing here to keep competition going

ehealth and Horizon 2020 Horizon 2020: Between 2014 and 2020 7.472 billion in Societal Challenge 1 (whole Health programme) Horizon 2020: Between 2014 and 2015 1.200 billion in Societal Challenge 1 from which about 15% ICT related R&D&I

ehealth and Horizon 2020 Applying for funding the process in brief Publication of the calls Time to prepare the proposal Submission of proposals Evaluation Signature grant agreement Preparation of the grant Information on the outcome of the evaluator

Future Goals: Involvement of the Member States Stronger commitment of the Member States in all working groups and relevant projects related to ehealth deployment Stronger Advocacy among and outside the stakeholders fora New Strategic policies and projects Creation of working groups and renewal of relevant projects in the area of ehealth development and implementation Consolidated Integration of ehealth projects on Horizon 2020 Combine the research and innovation funding Programmes to address the ehealth related issues and the societal challenge of an ageing population.

Thank you!