Lecture Masterclass Lviv Ukraine 2015

1. Regulating e-Health in
the European Union &
Country Experiences
André den Exter

2. Outline
• Background: EU and e-Health
• e-Health Legal Framework and MS Experiences
• Trends
• Unresolved issues
• Future Challenges

3. The e-Health Revolution
annual: 1-8 mln. CB prescr
G. Eysenbach, ehealthcare 2.0 (slideshare.netG.

4. Background
• Defining e-Health: the use of ICT in health products, services and
processes combined with organisational change in healthcare
systems and new skills’ (EC 2012)
• EU eHealth Action Plans 2004, 2012-2020
• To remove existing barriers to “a fully mature and interoperable
eHealth system in Europe”

5. Legal Framework E-Health: TFEU and Directive
2011/24/EU
• TFEU free movement, data protection, liability and the subsidiarity
principle
• EU Directive 2011/24 on Cross-border Health Care:
o Standards of care (art 4): country of treatment
o National Contact Points (art 6): bilingual website
o Reimbursement health services abroad (incl. telemedicine service,
art 7(7); covered MS affiliation; level reimbursement
MS: PA & Positive list & ‘related costs’
o Art. 11: Mutual Recognition Prescriptions & Interoperability ePs
Minimum data set Dir 2012/52/EU; Guidelines Interoperability
ePs 2014: integrated in EHR; exceptions

6. Legal Framework E-Health: Directive 2011/24/EU
(2)
• Art. 14: “fully mature and interoperable e-health system in Europe:
o e-Health network: Guidelines standardisation EHRs
o eID and authentication plan
MS: eHealth strategy; eHealth Act
Except for Scandinavia, and some regional experiments, CB
e-health experiences poorly developed, or absent

7. Trends:
Healthcare Services
via web and phone
- On-line advice
- Call centre advice
- Laboratory testing
- Electronic prescription
- ePharmacy
- Remote second opinion
L Eijpe, Skoop Solicitors 2009

8. Trends (2): ePharmacies, buying and selling
medicines online
• WHO: >50% internet medicines are counterfeit (2010)
• common EU logo (Directive 2011/62/EU)
o Registered pharmacies
o Prescription only medicines
o Mandatory logo website
MS Experiences: Exclusive competence MS
• EUCJ opened online market non-prescription medicines, medical
devices (DocMorris, Ker-Optika case) (eCommerce Directive)
• Towards online sale of all categories of medicines registered
pharmacies?
• Counterfeits outside EU regulated websites: Unregulated

9. Trends (3): mHealth apps
• A healthy woman wants to manage her wellness, and contacts
with Wellness Partners for remote monitoring and support. They
offer:
• A web based personal Health Record
• Integration with a physician held electronic health record
• biosignal collection
• Remote advice and consultation, incl. lab services, Prescription,
and ePharmacy
• Her GP supports Wellness Partners and himself makes use of a
remote second opinion service
Provided by: L. Eijpe Skoop sollicitors 2009

10. Trends (3): Regulating mHealth Apps
• Spread of lifestyle and health apps
• Regulating risks:
o Medical device? (MD Directives) safety requirements (CE)
o ‘intended for medical purposes’ rather vague
o Risk professional liability using ‘unregistered apps’
MS register health apps

11. e/m-Health: Data Protection
• Collecting large quantities of information, “health data”
• Privacy Directive (Dir 95/46/EC, Arts. 8-12); (draft) General Data
Protection Regulation
o Ban on processing sensitive data not absolute
o Conditions: informed consent, vital interest, obligation secrecy
o Processing & Data Protection Duties: Data controller
o Comply with different principles
o Rights of Data Subjects
MS General or EHR privacy legislation

12. Legal Framework: Professional Qualifications and
Licensing
• Recognition Professional Qualifications (2005/36/EC): Mutual
Recognition Diplomas
• CB telemedicine excluded
• eCommerce Directive (2001/31/EC): ‘country of origin principle’;
licensing
• MS: regulated by contract

13. Legal Framework: Liability rules and e-health
services
• General/specific liability regimes
• CB Liability rules:
o PM Dir.: rules of MS of treatment (art 4(1))
o Duty system of professional liability insurance or equivalent system
(art 4(2)(c)
MS : Fault/strict liability or no-fault system
o Transparent complaint procedures

14. Legal framework: Unresolved issues
• Subsidiarity Principle
• In-person examination ‘first encounter’ conditional for reimbursement:
barrier to free movement
o Justification
• Second e-Pinion: idem
• New inequalities digital illiterated persons
• Cross-border transfer data EHRs
• Third country e-health services (telemedicine consultations); liabilities

15. Future Challenges
• Implementation Dir 2011/24:
• diversity in quality standards; e-health network
• reimbursement (CB) eHealth services
• integrating EHRs and ePs
• e-Health: new dimension health care relationships; how does this
affect health law; patients’ rights?
• e-Public Health Information Systems:
• Data linkage advantages and accuracy results of public health
monitoring and surveillance;
• Facilitates immediate action (tailored for control of disease
outbreaks, eg Ebola), spread of epidemics, isolation & quarantine
Is privacy protection balanced with public health needs?

16. References
A. Den Exter, A. Santuari, T. Sokol, ‘One Year after the EU Patient
Mobility Directive: A Three Country Analysis’, E.L.R 2(2015) 278-292
Jean Monnet project:
http://www.bmg.eur.nl/english/research/eu_projects/jean_monnet_progra
mme/
Commission report on the operation of Directive 2011/24/EU on the
application of patients’ rights in cross-border healthcare: COM(2015)
421 final
European Commission Green Paper on mHealth COM(2014)219 final
Contact: denexter@bmg.eur.nl