United4Health session Regulatory Framework Trends & Updates. Nicole Denjoy COCIR Secretary General Wed. 7 May 2014, Berlin (Germany)

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1 United4Health session Regulatory Framework Trends & Updates Nicole Denjoy COCIR Secretary General Wed. 7 May 2014, Berlin (Germany)

2 Outline 1. What is COCIR? 2. COCIR s vision on ehealth 3. Overview on mhealth 4. Legal & Regulatory Trends

3 1. What is COCIR?

4 What is COCIR? COCIR is a non-profit trade association, founded in 1959, representing the medical technology industry in Europe COCIR covers 3 key industry sectors: Medical Imaging Electromedical Health ICT Our Industry leads in state-of-art advanced technology and provides integrated solutions covering the complete care cycle With offices in Brussels and in China, COCIR promotes the use of advanced medical and ICT technology towards seamless care delivery and shared knowledge to build a better world with improved access to affordable, quality and safe healthcare

5 COCIR Member Companies

6 COCIR National Trade Associations Members Belgium UK Germany Spain Netherlands Finland Netherlands France Germany Sweden Turkey Germany

7 COCIR at international level

8 2. COCIR s vision on ehealth

9 COCIR vision on ehealth Vision: Transform Healthcare towards seamless integrated care Mission: Act as a EU Hub & Support national and regional deployment

10 COCIR presence and influence on ehealth National level Cooperation with national trade associations Direct links with governments, competent authorites, national agencies Participation in national events European level COCIR sits in various fora: ehgi, ehealth stakeholder group, Strong relationship with EU insitutions Participates in EU funded projects Stakeholder federator: COCIR is the initiator of the Healthcare Coalition on Data Protection International level COCIR chairs the BIAC Healthcare Task Force COCIR contributes to EU-US cooperation on interoperability COCIR contributes to EU-China cooperation COCIR is a driving force behind the IMDRF COCIR is a member of DITTA

11 COCIR Toolkits Concept

12 3. Overview on mhealth

13 The mhealth value chain A multiplicity of actors

14 The mhealth market Growth perspectives Estimated mhealth revenue, Sources: Commonwealth Fund, 2009; CSC, PhRMA, ANA, AHA, 2011; Deloitte, CMS, 2012; GSMA 2012

15 Growth of mhealth apps between 2010 & % % Total number of mhealth apps Source: Research2Guidance, 2013

16 Benefits of mhealth Better access to healthcare Helps address demographic trends Improves efficiency of healthcare

17 mhealth - COCIR recommendations 7. Foster use of widely recognised standards 1. Integrate mhealth into care delivery structures 6. Provide clear regulatory guidance 5. Support mobile broadbacnd policies 2. Enable citizens access to their data 4. Establish a harmonised data protection regime that allows innovation 3. Develop appropriate reimbursement strategies

18 4. Legal and Regulatory Trends A Regulatory Trends on Medical Software B - Data protection C Standardisation initiatives

19 Global landscape Proliferation of initiatives, lack of harmonisation compared to the fast development of technologies FDA guidance on mobile medical apps - EU Medical Devices Directive -EU guidelines on standalone software (+ national initiatives) EU -EU data protection Directive -Under discussions: -EU Medical Device Regulation -EU General Data Protection Regulation -Green Paper on mhealth - consultation Towards Global Harmonisation

20 EU political agenda on ehealth

21

22 Green paper on mhealth 1. The Green Paper: Launched on 10 April 2014 is a wide public consultation to collect ideas to unlock mhealth potential in Europe. Consultation will close on 3 July This consultation is accompanied with a Staff Working Document which clarifies the current legal framework applicable to lifestyle and wellbeing apps

23 1. Contents of the Consultation 1. General information on respondents 2. Data protection including security of health data 3. Big data 4. State of play on the applicable EU legal framework 5. Patient safety and transparency of information 6. The role of mhealth in healthcare systems and equal access 7. Interoperability 8. Reimbursement models 9. Liability 10. Research and innovation in mhealth 11. International cooperation 12. Access of web entrepreneurs to the mhealth market 13. Concluding remarks & references

24 2. Staff Working Paper - Structure Introduction EU Safety and performance requirements App Users Rights Right to privacy and to data protection Other rights Consumers Rights Dirctive Rights enshrined in ecommerce Directive Rights enshrined in unfair commercial practice Directive Most Important One

25 2. Important References 1. Medical Device Directive 93/42 & 47/2007 If mhealth apps fall under the definition of a medical devices, or of an in-vitro diagnostic medical device: they have to comply with Dir. 93/42 & 47/2007.

26 A-Safety & performance requirements 2. MEDDEV 2012 EC guidance to determine whether an app qualifies as a medical device (decision tree).

27 A-Safety & performance requirements 3. General Products Safety Directive & Directive on Liability for Defective Products It is not clear whether these Directives apply to health apps.

28 A-Safety & performance requirements Other initiatives: IMDRF Canada Japan USA

29 A-Safety & performance requirements IMDRF work item «SaMD: Software As a medical Device» Objective to achieve global regulatory convergence on medical software by determining: 1. Common key criteria whether software is a MD or not, 2. Risk stratification framework for generic types of SaMD on their unique risks 3. Corresponding controls for the different SaMD types

30 B Privacy &Data Protection Data Protection Directive (95/46/EC) eprivacy Directive (2002/58/EC) Health data cannot be processed, with a few exceptions: Explicit consent of data subject Vital interest of data subject For purposes of preventive medicine, medical diagnosis, provision of care, or the management of HC services, where these data are managed by a HC professional with a professional obligation of secrecy Data controllers must notify dataprotection authorities before processing personal data.

31 B Privacy &Data Protection Article 29 Working Party opinion on apps on smart devices Article 29 Working Party opinion on cloud computing

32 B Privacy &Data Protection Timeline 1995 Directive 2012 EC adopted Draft Regulation 2013 Vote in EP committee 2014 Vote in EP plenary 2015 Adoption if Council reaches consensus

33 B- Privacy & Data Protection Draft regulation intends to regulate how to collect, store, process and share health data: Art 4: Any data related directy or indirectly to the patient will be considered medical data, incl. a device identifier Art 81: Only health professionals can access health data Art 33 : Important data protection impact assessment obligations Joint liability with data controller (healthcare provider) Can negatively impact the benefits of data driven healthcare

34 B Privacy & Data Protection Healthcare Coalition on Data protection informs decisionmakers on the health aspects in the Regulation.

35 C - Standardisation initiatives Standards play an important role, complementing the existing regulatory framework and brining consistency 3 Key International Committees: ISO TC 210 ISO TC 215 IEC TC 62 reference: IEC and

36 COCIR recommendations 1. Build a supportive, predictable, and cost efficient regulatory system, to consolidate the EU s leadership in MD innovation and maintain patients rapide acces to healthcare 2. Provide clear & simple guidance on what is a medical device 3. Promote the adoption of market-driven standards, while avoiding strict technology mandates 4. Adopt clear, workable data protection regime that allows data sharing in healthcare 5. Integrate health data from consumer/personal apps in EPRs and healthcare system 6. Strengthen IT skills in healthcare workforce

37 Thank you for your attention!

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