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eHealth from a Dutch Perspective

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Part of the book series: Information Technology and Law Series ((ITLS,volume 20))

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Abstract

In this chapter, we will focus on the legal issues that relate to the eHealth developments in Europe and in the Netherlands. We will analyze these legal issues after setting out the European legal framework for eHealth. But before that, we will describe the eHealth policy developments at the EU level and we will give a few examples of eHealth services in The Netherlands. Our conclusion will focus on the importance of eHealth services and of the legal framework for the quality of healthcare and the quality of life.

Contribution received in 2010.

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Notes

  1. 1.

    Seehttp://ec.europa.eu/information_society/activities/health/whatis_ehealth/index_en.htm. Accessed 21 December 2009.

  2. 2.

    Seehttp://www.nveh.nl/index.php?option=com_content&view=article&id=67&Itemid=41. Accessed 21 December 2009.

  3. 3.

    Commission of the European Communities 2008c.

  4. 4.

    Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee, and the Committee of the Regions, e-Health—making healthcare better for European citizens: An action plan for a European e-Health Area. Brussels, 30.04.2004. COM (2004) 356 final.

  5. 5.

    European Commission 2008b.

  6. 6.

    Source: http://ec.europa.eu/information_society/eeurope/i2010/strategy/index_en.htm. Accessed 20 July 2009.

  7. 7.

    Source: http://ec.europa.eu/enterprise/policies/innovation/policy/lead-market-initiative/index_en.htm#h2-a-lead-market-initiative-for-europe. Accessed 20 July 2009.

  8. 8.

    Commission of the European Communities 2008b.

  9. 9.

    Commission of the European Communities 2007b.

  10. 10.

    Source: http://ec.europa.eu/information_society/activities/health/policy/targets/index_en.htm. Accessed 20 July 2009.

  11. 11.

    Commission of the European Communities 2008a.

  12. 12.

    Source: epSOS 2008.

  13. 13.

    Source: CALLIOPE 2009.

  14. 14.

    The Prague Declaration 2009.

  15. 15.

    Swedish Presidency of the European Union, Healthcare Division 2009.

  16. 16.

    The English summary of this advisory report is available at: http://www.rvz.net/cgi-bin/rvz_p.pl?id=68. Accessed 21 December 2009.

  17. 17.

    Seehttp://www.nveh.nl/index.php?option=com_content&view=article&id=86&Itemid=100. Accessed 21 December 2009.

  18. 18.

    Seehttp://www.tno.nl/downloads/Manifest_eHealth_v4a.pdf. Accessed 21 December 2009.

  19. 19.

    Seehttp://www.courtofaudit.com/english/News/Audits/Introductions/2009/06/E_health_an_innovation_in_long_term_care. Accessed 21 December 2009. On 11 June 2009, this report was submitted to the House of Representatives.

  20. 20.

    Seehttp://www.tno.nl/downloads/Manifest_eHealth_v4a.pdf (Manifest TNO). Accessed 21 December 2009.

  21. 21.

    Seehttp://www.teleconsultatie.nl/. Accessed 21 December 2009.

  22. 22.

    Seehttp://www.virtueletrombosedienst.nl/vtdfront. Accessed 21 December 2009.

  23. 23.

    See https://www.zorgdomein.nl/zorgdomein/opencms/www/home/english.html (see also Good eHealth Practice in EU> NL, p. 37). Accessed 21 December 2009.

  24. 24.

    Sources: European Commission 2009. European Commission, Information Society and Media, Good eHealth. Exchange of Good Practices on eHealth—Knowledge Base http://www.good-ehealth.org

  25. 25.

    See, e.g., UMC St. Radboud, Digitale IVF-poli 'Case of the month' http://kb.good-ehealth.org/browseContent_alt.do?contentId=49&action=v3. Accessed 21 December 2009.

  26. 26.

    See http://www.icom.trimbos.nl. Accessed 21 December 2009.

  27. 27.

    I.COM Innovation Centre of Mental Health and Technology.

  28. 28.

    Ministry of Health, Welfare and Sport 2006.

  29. 29.

    See also European Commission 2008a.

  30. 30.

    Commission of the European Communities 2008c.

  31. 31.

    European Commission 2008a.

  32. 32.

    Art. 3 consolidated version of the Treaty of the functioning of the European Union. OJ C115 of 9 May 2008 (hereafter TFEU).

  33. 33.

    Art. 4, paragraph 2, sub k, TFEU.

  34. 34.

    Art. 6, sub a, TFEU.

  35. 35.

    Art. 3, consolidated version of the Treaty on the European Union. OJ C115 of 9 May 2008 (hereafter TEU).

  36. 36.

    See also European Commission 2008a, pp. 14 et seq.

  37. 37.

    Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. OJ L 281, 23.11.1995.

  38. 38.

    European Commission 2008a.

  39. 39.

    Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. OJ L 11, 15.1.2002, pp. 4–17.

  40. 40.

    Directive 1999/34/EC of the European Parliament and of the Council of 10 May 1999 amending Council Directive 85/374/EEC on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products. OJ L 141, 4.6.1999, pp. 20–21.

  41. 41.

    Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees. OJ L 171, 7.7.1999, pp. 12–16.

  42. 42.

    Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts—Statement by the Council and the Parliament re Article 6(1)—Statement by the Commission re Article 3(1), first indent. OJ L 144, 4.6.1997, pp. 19–27.

  43. 43.

    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. OJ L 210, 7.8.1985, pp. 29–33.

  44. 44.

    The proposed Directive on the application of patients’ rights in cross-border healthcare COM (2008) 414 final, does have a provision on the applicable law. See Sect. 16.3.2.4.

  45. 45.

    Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce). OJ L 178, 17.7.2000, pp. 1–16.

  46. 46.

    European Commission 2008a.

  47. 47.

    Case C-158/96 Kohl (1998) ECR I-1931 and Case C-120/95 Decker (1998) ECR I-1831.

  48. 48.

    Before the Treaty of Lisbon, the Arts. 81–89 Treaty of the EU (old) contained the competition rules.

  49. 49.

    FENIN v. Commission of the European Communities, 11 July 2006, Case C-205/03.

  50. 50.

    Communication from the commission, Consultation regarding Community action on health services, Brussels, 26 September 2006, SEC (2006) 1195/4.

  51. 51.

    Art. 35 Charter of Fundamental Rights of the European Union. OJ C 364, 18.12.2000, pp. 1–22.

  52. 52.

    See the rulings mentioned in note 47.

  53. 53.

    European Commission, COM (2006) 122.

  54. 54.

    COM (2008) 414 final. Proposal for a Directive of the European Parliament and of the Council on the Application of Patients' Rights in Cross-Border Healthcare, 2008/0142 (COD).

  55. 55.

    However in the most recent proposal, the Directive does not apply to long-term care whose purpose it is to support people in need of assistance, of every day routine tasks.

  56. 56.

    Art. 4 Proposed Directive on the application of patients’ rights in cross border healthcare.

  57. 57.

    Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169, 12.7.1993, pp. 1–3.

  58. 58.

    Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. OJ L 189, 20.7.1990, pp. 17–36.

  59. 59.

    Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. OJ L 331, 7.12.1998, pp. 1–37.

  60. 60.

    Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311, 28.11.2001, pp. 67–128.

  61. 61.

    Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. OJ L 247, 21.9.2007, pp. 21–55.

  62. 62.

    Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (Text with EEA relevance). OJ L 255, 30.9.2005, pp. 22–142.

  63. 63.

    Exceptional Medical Expense Act (AWBZ). See: http://www.minvws.nl/en/themes/exceptional-medical-expenses-act/default.asp. Last modified: 13 March 2007.

  64. 64.

    Amendment of the Act on the Use of the Citizen Service Number in Healthcare in the context of the Electronic Exchange of Information in Healthcare (‘Wijziging van de Wet gebruik burgerservicenummer in de zorg in verband met de elektronische informatieuitwisseling in de zorg’). Kamerstukken 31466.

  65. 65.

    Handelingen II, 56, p. 4488 (18 February 2009).

  66. 66.

    Art. 6:185 Civil Code.

  67. 67.

    Source: http://www.nza.nl/nza/#

  68. 68.

    Commission of the European Communities 2007a.

  69. 69.

    See the overview of legislation on: http://www.igz.nl/fabloket/fablok_medische_hulpmidd/med-hulpm_wetgeving. Latest update: 11 August 2009.

  70. 70.

    See: http://twitter.com/tweetspreekuur. Accessed 11 November 2009.

Abbreviations

BIG Act:

Wet Beroepen in de individuele gezondheidszorg (Individual Healthcare Act)

CVZ:

College voor Zorgverzekeringen (Health Care Insurance Board)

EHR:

Electronic Health Record

EPD:

Elektronisch Patienten Dossier (Electronic Health Record)

epSOS:

Smart Open Services for European Patients

GP:

General Practitioner

I.COM:

Innovation Centre of Mental Health and Technology

ICT:

Information and Communication Technologies

IGZ:

Health Care Inspectorate

Kwz:

Kwaliteitswet zorginstellingen (Quality of Healthcare Institutions Act)

LMI:

Lead Market Initiative

LSP:

National Switch Point

NVEH:

De Nederlandse Vereniging voor e-Health (Dutch Association of eHealth)

NZa:

Dutch Healthcare Authority

RVZ:

Council for Public Health and Health Care

SGEI:

Services of General Economic Interest

TCCN:

Stichting Teledermatologisch Consultatie Centrum (Teledermatological Consultation Centre Netherlands)

WGBO:

Wet geneeskundige behandelingsovereenkomst (Medical Treatment Contract Act)

WVP:

Wet Bescherming Persoonsgegevens (Personal Data Protection Act)

ZVW:

Zorgverzekeringswet (Health Care Insurance Act)

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Authors and Affiliations

  1. Royal Dutch Medical Association (KNMG), Utrecht, The Netherlands

    Hilde van der Meer & Sjaak Nouwt

Authors
  1. Hilde van der Meer
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  2. Sjaak Nouwt
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Correspondence to Sjaak Nouwt .

Editor information

Editors and Affiliations

  1. , Tilburg Institute for Law Technology and, Tilburg University, Warandelaan 2, Tilburg, 5037 AB, Netherlands

    Simone van der Hof

  2. , Faculty of Law, Department of Public Law, Leiden University, Faculty of Law, Depar, Kamerlingh Onnes Gebouw, Steenschuur 25, Leiden, 2311 ES, Netherlands

    Marga M. Groothuis

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© 2011 T.M.C. ASSER PRESS, The Hague, The Netherlands, and the authors 2011

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van der Meer, H., Nouwt, S. (2011). eHealth from a Dutch Perspective. In: van der Hof, S., Groothuis, M. (eds) Innovating Government. Information Technology and Law Series, vol 20. T.M.C. Asser Press. https://doi.org/10.1007/978-90-6704-731-9_16

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