The document discusses data protection, ownership and portability in mHealth apps and whether current rules and regulations are fit for purpose. It provides an orientation on changing care models from hierarchical to integrated and from group-based to personalized. It reviews the history of mHealth and how technology is helping to achieve more affordable and personalized care. It then gives a status report on existing EU laws regarding medical devices, data protection and consumer rights as they apply to mHealth apps. It outlines member state actions and goals regarding mHealth as well as ongoing EU activities like a code of conduct and quality standards. Finally, it concludes that citizens must drive innovation, the digital divide must be avoided, and the legal framework works best with appropriate technology and governance.

1. Data protection, ownership and portability:
are current rules and regulations fit for purpose?
A code of conduct for mHealth apps.
Ain Aaviksoo, MD MPH
Deputy Secretary General for E-services & Innovation, Ministry of Social Affairs of Estonia
Chair of mHealth subgroup of the eHealth Network, European Commission
13. October 2016 | European Parliament, Brussels
„Towards an mHealth framework for Europe“

2. Topics
1. Orientation
2. The history
3. Status report
4. Conclusions
mHealth framework for Europe (Aaviksoo) 13 Oct 2016

3. Orientation

4. Changing care: integration vs hierarchy
mHealth framework for Europe (Aaviksoo) 13 Oct 2016

5. Generalized average
risk factors
Organ- and disease
specific
Disease-specific
diagnostics & treatment
Risk-group based
& molecular
Person-specific
predicition & prevention
Person-specific
diagnostics & treatment
To help every individual as precisely and effectively as possible
To find the most efficient solution for as many as possible
Changing care: individual vs group efficiency

6. Changing world – innovation is here and spreading
>2 Billion investments into digital
health in 2016 (6 months)
mHealth framework for Europe (Aaviksoo)
>66 EU project in eHealth

7. The history

8. How to achieve affordable,
less intrusive and
more personalised care?
1. My data, my decisions
2. Liberate the data
3. Connect up everything
4. Revolutionise health
5. Include everyone
mHealth framework for Europe (Aaviksoo) 13 Oct 2016
© European Union, 2012

9. Status report

10. Existing law at the EU level
• EU SAFETY AND PERFORMANCE REQUIREMENTS
• Medical Devices Directive & In vitro Diagnostic Medical Devices Directive
• ? General Products Safety Directive
• ? Directive on liability for defective products
• APP USER’S RIGHTS TO PRIVACY AND DATA PROTECTION
• Data protection directive / General Data Protection Regulation*
• ePrivacy Directive
• OTHER APP USERS’ RIGTHS
• Consumers' Rights Directive
• eCommerce Rights Directive
• Unfair Commercial Practices Directive
mHealth framework for Europe (Aaviksoo) 13 Oct 2016
Source: Commission staff working document „on the existing EU legal framework applicable to lifestyle
and wellbeing apps“ (Accompanying the document GREEN PAPER on mobile Health ("mHealth"))

11. Situation and actions in the Member States
• Goals and ambitions related to mHealth
• Patient-orientation of health systems
• Increased mobility of services and citizens/patients
• Improvement of quality and cost savings
• Market development of healthcare industry
• Legal situation and governance relating to mHealth
• Application of general law related to digital health data (if any)
• Authentication and authorisation of data use are critical
• Certification/Endorsement of mHealth solutios as main public responsbility
• Training and Education of Health Professionals and/or General Public
mHealth framework for Europe (Aaviksoo) 13 Oct 2016

12. Ongoing activities at the EU level
• Code of Conduct on privacy for mobile health applications
• Public consultation on the safety of apps and other non-embedded
software
• Guidelines on the assessment of data validity and reliability of mHealth
apps
• EU quality standards for mHealth apps
mHealth framework for Europe (Aaviksoo) 13 Oct 2016

13. Conclusions

14. Conclusions
• Citizens drive the society
• Digital divide is to be avoided
• Authentication and authorisation is critical in digital society
• Innovation comes from action
• Legal framework functions in combination with appropriate
technology and governance
mHealth framework for Europe (Aaviksoo) 13 Oct 2016

15. Everything should be made as simple as possible,
but not simpler.
- Albert Einstein -
mHealth framework for Europe (Aaviksoo) 13 Oct 2016
Intelligence means goal-oriented adaptive behaviour
- Sternberg & Salter-