Walter-Benjamin-Platz 6 | 10629 Berlin | Telefon + 49.30.327 787 - 0 | E-Mail office@db-law.de | www.db-law.d

1. Walter-Benjamin-Platz 6 | 10629 Berlin | Telefon + 49.30.327 787 - 0 | E-Mail office@db-law.de | www.db-law.de

2. License, registration and authorisation of telemedicine professionalsWorkshop on legal aspects of telemedicine2nd of March 2010European Commission, Brussels • Christian Dierks, Berlin • Attorney at Law • www.db-law.de

3. D+B internal Review • 15 years legal advice in telemedicine • Focus so far on • data protection • reimbursement • contracts • Cross boarder licencing issues: 3 • telemonitoring • navigation • teleradiology to former USSR states

4. License • Personal permission to practice as a physician 1. Member-State regulations/authorities (i.e.): - British Medical Council (UK) - Bundesärztekammer (Germany) - Conseil National de l‘Ordre des Médicins (Belgium) - Koninklijke Nederlandsche Maatschappij tot Bevordering der Geneeskunst (NL) 2. Directive 2005/36/EC on the recognition of qualifications

5. Registration • Local requirement to practice as a qualified professional • Differentiation: • - Mobility of the service provider • - Mobility of the service • Spirit and purpose of registration? • - Patient/Consumer security • - Quality management • - Control

6. Mobility of the physician • Registration with Medical Council (Member-State provisions) • Worst Case: Registration with 26 other Member-State authorities (plus potential national split-up) • In Germany: 17 Medical Councils (Ärztekammern) • Preconditions: EU-Member-state inhabitant, knowledge of language, proof of medical education

7. Authorisation • Regarding the scope of activities • Depending on the qualification of the physician (special fields: MRI, remote radiology, a.o.) • Is there a need for special regulations regarding Telemedicine? • Telematic services do not broaden the scope of the underlying medical service • They may add new risks (five senses rule)

8. Applicable framework • Art. 9 directive 2005/36/EC (recognition) • Information to the service recipient • Art. 4, 5 directive 2000/31/EC(e-commerce) • Country of origin principle • Principle excluding prior authorization (Art. 4) • Information to be provided (Art. 5 1f): • Professional body with which service provider is registered • Reference to the applicable professional rules in the Member State of Establishment and the means to access them

9. e-Commerce Directive • Art. 3 para. 2 directive 2000/31/EC: • „Member-states may not, for reasons falling within the coordinated field, restrict the freedom to provide information society services from another Member State“ • General Exemption: Necessity for the protection of public health (Art. 3 para. 4 a i)

10. e-Commerce Directive II • Special Exclusion: Consumer contracts (Art. 3 para. 3 /Annex) • Differentiation is required: • Professional to professional services (e.g. teleradiology) • Business-to-consumer activities (e.g. telemonitoring) – No country of origin principle in this case • But: what is the practical experience?

11. Recognition-Directive • Directive 2005/36/EC refers to the non-telematic case as a basis (simultaneous presence of physician and patient) • It does not provide special regulations regarding cross-border telemedicine services

12. Case I • Portuguese physician provides Teleradiology services from Portugal (website-offer) • Second opinion – for e.g. German physician • License and Registration in Portugal • Particular authorisation? – local law • Local professional law must allow telematic services • Information Art 5 1f • Prices, VAT etc. • German license – no • German registration - no

13. Annex: Professional Law • Germany Sec 7 para III BO: • Physician must not solely telematic advice or treatment if supplied • What does „solely“ mean? • For all patients? • For all services? • Can it be defied by cooperation with other doctors? • Lack of security

14. Case II • Portuguese physician provides Teleradiology services from Portugal (german website-offer) • Second opinion – for German patient • License and Registration in Portugal • Particular authorisation? – local law • Local professional law must allow telematic services • Information Art 5 1f? • German license/registration? • § 3 TMG: no restriction, but legal barrier admissible: § 10b „supplying services in Germany after changing into the territory“:German Law!

15. Case III • German pharmacist from Aachen commutes to Belgium • Services (e.g. in a pharmacy`s call center) for • a) Patient in Belgium • b) Patient in the UK • a+b: A license/registration in Belgium is required by the respective medical council (as well as German) • a+b: Information about the regulating authority in charge for the pharmacist (from Germany)? • b: Also the UK-council might require license or registration • Three licenses for the pharmacist?

16. Gaps in regulation? • Is the security of patients at risk? • Standard of care guaranteed? • Control-gaps? • Information requirements sufficient for the purposes of security, quality and control? • Action for the purpose of legal clarity – develop a single legal framework on Telemedicine?

17. Goals • Freedom of services • Protection of public health • 3. Access to justice (No denial of justice – does legal framework in Member-states provide sufficient court control? – Stefaan Callens)

18. Final Questions • An efficient Qualification (consistent license level within EU) is reached. • What about the Quality of services (regarding modes of service – „level of scientific acceptance“) within the EU? • Control –„state of treatment-principle“? • Art 5 of Draft Cross border directive focusses on the travelling patient. What else wo we need?

19. „You don‘t need a license for your pet fish!“

20. The presentation may be requested via E-Mail Christian Dierks, MD, JD, Professor Walter-Benjamin-Platz 6 , D - 10629 Berlin Tel: 030 - 327 787 22 | Fax: 030 - 327 787 77 office@db-law.de www.db-law.de Thank you for your attention