Regulating e-Health in

the European Union &

Country Experiences

André den Exter

Outline

• Background: EU and e-Health

• e-Health Legal Framework and MS Experiences

• Trends

• Unresolved issues

• Future Challenges

The e-Health Revolution

annual: 1-8 mln. CB prescr

G. Eysenbach, ehealthcare 2.0 (slideshare.netG.

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”

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

MS: barriers MR remain; ePs operational several MS

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

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

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

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

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

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

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

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

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

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?

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