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Legal Challenges Regarding Telemedicine Services in the European Union

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eHealth: Legal, Ethical and Governance Challenges

Abstract

Telemedicine can help increase accessibility to healthcare for patients living in remote geographical areas, allow patients with chronic diseases to be monitored at home and involve patients in the management of their own healthcare. However, despite the potential benefits identified and the potential for growth of the telemedicine market, the use of telemedicine applications in everyday medicine is still relatively low. One of the reasons for this situation is the lack of legal clarity.

This chapter analyses several problematic legal aspects in the provision of cross-border telemedicine services in the European Union (EU). These include: licensing, accreditation and registration of health professionals providing telemedicine services; reimbursement of costs for telemedicine services; liability; personal data protection; conflict of jurisdictions and conflict of laws.

This chapter reflects solely the views of its author. The European Union institutions are not liable for any use that may be made of the information contained therein.

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Notes

  1. 1.

    EU Swedish Presidency Report: “eHealth for a Healthier Europe!”, available at http://www.sweden.gov.se/content/1/c6/12/98/15/5b63bacb.pdf

  2. 2.

    EC funded study: “eHealth is Worth it! The economic benefits of implemented eHealth solutions at 10 European sites”, available at http://ec.europa.eu/information_society/activities/health/docs/publications/ehealthimpactsept2006.pdf

  3. 3.

    EC funded study: “The socio-economic impact of interoperable electronic health record (EHR) and ePrescribing systems in Europe and beyond”, available at http://www.ehr-impact.eu/downloads/documents/EHRI_final_report_2009.pdf

  4. 4.

    e-Health—making healthcare better for European citizens: An action plan for a European e-Health Area, COM(2004) 356 final

  5. 5.

    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “A Digital Agenda for Europe”, COM(2010) 245 final/2

  6. 6.

    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “Telemedicine for the benefit of patients, healthcare systems and society”, COM(2008) 689 final, 4.11.2008. http://ec.europa.eu/information_society/activities/health/policy/telemedicine/index_en.htm

  7. 7.

    COM(2008) 689 final.

  8. 8.

    EC funded study: “Legally eHealth. Putting eHealth in its European legal context”, available at http://ec.europa.eu/information_society/activities/health/docs/studies/legally_ehealth/legally-ehealth-report.pdf

    EC funded study: “Legal Framework of Interoperable eHealth in Europe.” Country reports and final study report are available at: http://ec.europa.eu/information_society/activities/health/studies/published/index_en.htm#Legal_framework_of_Interoperable_eHealth_in_Europe

  9. 9.

    De Grove-Valdeyron (2011), pp. 299–327.

  10. 10.

    ECJ judgment, in case C-255/09, Commission vs Portugal, paragraph 48.

  11. 11.

    See Art. 114 TFEU on the approximation of laws for the establishment and functioning of the internal market.

  12. 12.

    ECJ judgment of 28 April 1998 in case C-158/96 Kohll; ECJ judgment of 27 October 2011 in case C-255/09, Commission v. Portugal; ECJ judgments of 12 July 2001 in cases C-368/98, Vanbraekel and C-157/99, Smits & Peerbooms; ECJ judgment of 13 May 2003 in case C-385/99, Müller-Fauré; ECJ judgment of 6 May 2006 in case C-372/04, Watts.

  13. 13.

    ECJ judgment of 25 July 1995 in case C-76/90 Sager, paragraph 15 et seq. See also ECJ cases on patient mobility: C-385/99, Müller-Fauré, paragraph 68 and C-157/99, Smits &Peerbooms, paragraph 75.

  14. 14.

    Driguez and Michel (2011), pp. 4–10.

  15. 15.

    Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market, OJ L 376/36.

  16. 16.

    Report of the European Parliament on the impact and consequences of the exclusion of health services from the Directive on services in the internal market, 10 May 2007, A6-0173/2007.

  17. 17.

    ECJ judgment of 28 April 1998 in case C-158/96 Kohll.

  18. 18.

    Art. 1(2) of the Directive 2011/24/EU.

  19. 19.

    Art. 4(d).

  20. 20.

    Art. 7(4).

  21. 21.

    Art. 7(7).

  22. 22.

    Art. 7(9).

  23. 23.

    Art. 4(1)(a) and (b).

  24. 24.

    Art. 2(q) and (e).

  25. 25.

    Art. 4(3) and Art. 4(4).

  26. 26.

    For example, Regulation 44/2001.

  27. 27.

    See Recital 19 of the Directive on patients’ rights in cross-border healthcare.

  28. 28.

    The “coordinated field” is defined in Art. 2(h) of the eCommerce Directive.

  29. 29.

    The concept of remuneration is interpreted in a non-restrictive manner by the Court.

    In Smits & Peerbooms(C-157/99) and other healthcare cases, the Court has (a) confirmed previous case law according to which remuneration may exist in triangular situations, i.e., where a third party (such as a fund) is paying to the benefit of the service recipient (patient) and, more importantly, (b) has accepted that remuneration may be found to exist even in situations where the correlation between services received and money paid is only indirect (for example, paid on a flat rate basis irrespective of the nature and cost of the service provided) if economically nonexistent.

  30. 30.

    Exception enacted in Annex V of the Directive 98/48/EC—services which are not provided via electronic processing/inventory systems: for example, telephone/telefax consultation of a doctor is not an information society service.

  31. 31.

    Art. 3(1) of the eCommerce Directive.

  32. 32.

    On the relationship between Regulation 883/2004 and Directive on patients’ rights, please see Recitals 30 and 31 of the Directive on patients’ rights.

  33. 33.

    Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems.

  34. 34.

    Recital 26 of the Directive on patients’ rights.

  35. 35.

    Recital 13 of Directive on patients’ rights.

  36. 36.

    Art. 8(7).

  37. 37.

    See Study on the Legal Framework for Interoperable eHealth in Europe http://ec.europa.eu/information_society/activities/health/docs/studies/legal-fw-interop/ehealth-legal-fmwk-final-report.pdf

  38. 38.

    For example, Regulation 44/2001.

  39. 39.

    Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products [Official Journal L 210 of 07.08.1985].

  40. 40.

    Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council [OJ L 304/64].

  41. 41.

    Further clarifications and examples can be found in “Opinion 4/2007 (WP 136) of the Article 29 Working Party on Data Protection on the concept of personal data” (http://ec.europa.eu/justice/policies/privacy/docs/wpdocs/2007/wp136_en.pdf).

  42. 42.

    ECJ Judgment of 6 November 2003, Case C-101/01—Bodil Lindqvist, paragraphs 50 and 51.

  43. 43.

    A useful general guidance on the general legal data protection framework for health data, and for EHR systems in particular can be found in the Article 29 Working Party Working Document on the processing of personal data relating to health in electronic health records (EHR) (http://ec.europa.eu/justice/policies/privacy/docs/wpdocs/2007/wp131_en.pdf).

  44. 44.

    Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications), OJ L 201, 31.7.2002, pp. 37–47.

  45. 45.

    See Art. 4 of Directive 2009/136/EC of the European Parliament and of the Council of 25 November 2009 amending Directive 2002/22/EC on universal service and users’ rights relating to electronic communications networks and services, Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector and Regulation (EC) No 2006/2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (Text with EEA relevance) OJ L 337, 18.12.2009, pp. 11–36.

  46. 46.

    An electronic health record (EHR) is defined as “A comprehensive medical record or similar documentation of the past and present physical and mental state of health of an individual in electronic form and providing for ready availability of these data for medical treatment and other closely related purposes.” See Commission Recommendation of 2 July 2008 on cross-border interoperability of electronic health record systems C(2008) 3282.

  47. 47.

    Working Document on the processing of personal data relating to health in electronic health records (EHR), WP 131/2007

    http://ec.europa.eu/justice/policies/privacy/docs/wpdocs/2007/wp131_en.pdf

  48. 48.

    Communication from the Commission to the European Parliament and the Council on “Promoting Data Protection by Privacy Enhancing Technologies (PETs)”, COM (2007) 228 final, 2.05.2007.

  49. 49.

    Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions on “A comprehensive approach on personal data protection in the European Union”, (COM(2010) 609 final), 4.11.2010. See especially Sect. 2.2. “Enhancing the internal market dimension”. http://ec.europa.eu/justice/news/consulting_public/0006/com_2010_609_en.pdf; http://ec.europa.eu/justice/newsroom/data-protection/news/120125_en.htm

  50. 50.

    Regulation 44/2001 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters.

  51. 51.

    Convention on jurisdiction and the enforcement of judgments in civil and commercial matters, concluded at Brussels on 27 September 1968.

    Regulation 44/2001 shall, as between the Member States, supersede the Brussels Convention, except as regards the territories of the Member States which fall within the territorial scope of that Convention and which are excluded from this Regulation pursuant to Article 299 of the Treaty.

    In so far as Regulation 44/2001 replaces the provisions of the Brussels Convention between Member States, any reference to the Convention shall be understood as a reference to this Regulation (68 of Regulation 44/2001).

  52. 52.

    ECJ judgment of 30 November 1976 in case 21/76, Minnes de potasse d’Alsace, paragraphs 24 and 25.

  53. 53.

    ECJ judgment of 19 September 1995 in case C-364/93 Marinari, paragraph 14; ECJ judgment of 11 January 1990 in case C-220/88 Dumez France, paragraphs 20 et seq; ECJ judgment of 7 March 1995 in case C-68/93 Shevill, paragraphs 30 et seq.

  54. 54.

    Blobel (2004), pp. 187–191.

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Authors and Affiliations

  1. Lawyer Administrator, European Parliament, Brussels, Belgium

    Catalina Ionescu-Dima

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  1. Catalina Ionescu-Dima
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Correspondence to Catalina Ionescu-Dima .

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Editors and Affiliations

  1. , School of Science and Technology, Middlesex University, The Burroughs, London, NW4 4BT, United Kingdom

    Carlisle George

  2. The Castlegate Consultancy, 27, Castlegate, Malton, North Yorkshire, YO17 7DP, United Kingdom

    Diane Whitehouse

  3. , School of Science and Technology, Middlesex University, The Burroughs, London, NW4 4BT, United Kingdom

    Penny Duquenoy

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Ionescu-Dima, C. (2013). Legal Challenges Regarding Telemedicine Services in the European Union. In: George, C., Whitehouse, D., Duquenoy, P. (eds) eHealth: Legal, Ethical and Governance Challenges. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-22474-4_5

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