"mHealth: Should we regulate?" Presentation by Peteris Zilgalvis, Head of Unit for eHealth & Wellbeing, DG Connect at European Commission

1. Health & Wellness@Mobile
World Congress 2016
Pēteris Zilgalvis, J.D.,
Head of Unit, Health and Well-
Being,
DG CONNECT
MHEALTH: SHOULD WE REGULATE?

2. TABLE OF CONTENTS
i. Context – Green Paper on mHealth
ii. Privacy and security
a) consultation results
b) actions
iii. Quality and transparency
a) consultation
b) actions
iv. Legal framework
a) consultation results
b) actions

3. GREEN PAPER ON MHEALTH
The Green Paper asked stakeholders for their
inputs on how to overcome the main challenges
to mHealth deployment, e.g.:
data protection
the legal framework
patient safety
mHealth’s role in healthcare systems
international cooperation and web entrepreneurs'
market access

4. Privacy and
security
Quality and
transparency
Legal framework

5. Privacy and
security

6. RESULTS OF THE CONSULTATION -
PRIVACY AND SECURITY
Strong privacy and security tools are needed to
build users' trust
Data encryption both "in transit" and "at rest"
Authentication mechanisms, e.g. digital
certificates, biometric parameters, tokens etc.
User's consent and access controls are crucial
Importance of secured networks settings to
prevent data interception

7. CURRENT LACK OF TRUST
Source: Mobiquity, The Appification of Health and Fitness,
April 2014

8. ACTIONS: PRIVACY AND
SECURITY
Action: Code of conduct on mobile health apps
covering data protection and security principles;
voluntary instrument;
to be signed by mHealth app developers and possibly
to be approved by the Article 29 Working Party;
Legal basis: Article 27 of the Data Protection Directive;
Objectives: Increased trust; Raising awareness and
facilitating compliance with data protection rules at
EU level; Competitive advantage.

9. ACTIONS: PRIVACY AND
SECURITY
• ... Code of conduct on mobile health apps
Process and next steps:
Industry drafting team with the EC as facilitator;
Meeting on 7 December – presentation of 1st draft;
Update of the draft and integration of comments;
Submission to Article 29 Working Party
Security Actions:
ENISA report on Security and Resilience in eHealth – Security
Challenges and Risks
Research & Innovation action under WP 2016/17 "Increasing digital
security of health related data on a systemic level"

10. Quality and
transparency

11. RESULTS OF THE CONSULTATION –
QUALITY AND TRANSPARENCY
Need for certification schemes to assess
mHealth apps
Sharing and transferring best practices
Importance of standards for patient safety
Setting-up of (national) bodies to review
mHealth apps

12. ACTIONS: QUALITY AND
TRANSPARENCY
Action: Facilitate the development of a European standard on
quality criteria for health and wellness apps
providing guidance and principles for health and wellness app
developers to follow throughout the app project life cycle (including
development, testing, releasing and updating of an app)
Action: mHealth sub-group within the eHealth Network to
facilitate exchange of information and best practices
to produce a report on national mHealth strategies with
recommendations for further collaboration on mHealth at European
level by autumn 2016

13. ACTIONS: QUALITY AND
TRANSPARENCY
Action: Guidelines for assessing validity and
reliability of mHealth app data to be linked with
electronic health records
The guidelines could be used by public authorities, health
care providers, professional and patients associations and
others;
A working group of 20 organisations, representing civil
society, academia, industry, public authorities;
Process open to all interested stakeholders via online
consultations and open stakeholder meetings.

14. Legal framework

15. RESULTS OF THE CONSULTATION –
LEGAL FRAMEWORK
Safety and performance requirements of
lifestyle and wellbeing apps should be covered
by legislation, soft law or quality
labelling/certification
Need to clarify the borderline between
"medical" and "lifestyle and wellbeing" apps
Need for strengthened enforcement of medical
device and data protection legislation

16. ACTIONS: LEGAL FRAMEWORK
Unclear application of EU rules on medical
devices
Action: Revision of manual on borderline and
classification and MEDDEV guidance (finalization after
MD regulations adoption)
Lack of protection in case of unsafe or defective
digital products (e.g. lifestyle and wellbeing
apps)
Action: Making consumer protection and eCommerce
legislation fit for new technologies

17. peteris.zilgalvis@ec.europa.eu
THANK YOU FOR YOUR
ATTENTION!