Abstract
The European Commission has since 2004 declared its intention to drive greater legal certainty in the area of eHealth. Whilst some significant steps have been taken towards attaining this goal, the questions of liability for eHealth goods and services are still not fully addressed in EU level legislation. This chapter explores the extent to which current EU level legislation on consumer protection is applicable to eHealth and outlines where uncertainties still exist. It looks in particular at the applicability of eHealth product liability in the terms of Directive 2001/95 on General Product Safety and Directive 93/42 on Medical Devices and at liability for eHealth services within the scope of existing legislation on internal market services and the newer legislation on patients’ rights in cross-border care.
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- 1.
Please note that the present is chapter has been developed from work initially performed within the framework of the European Commission co-financed SHARE and Legally eHealth projects. For more details one this these, please see I. Andoulsi, J. Herveg, V. Stroetmann, K. Stroetmann, A. Dobrev, C. Van Doosselaere, P. Wilson, Bottlenecks & Challenges and RTD Responses for Legal, Ethical, Social and Economical Aspects of HealthGrids—Roadmap II, 2007, 38 p., to be found at http://eu-share.org/deliverables.html and; C. Van Doosselaere, J. Herveg, D. Silber and P. Wilson, Legally eHealth—Putting eHealth in its European Legal Context, 2008, European Commission, Information Society and Media.
- 2.
Case C-203/99 European Court of Justice.
- 3.
The Times, London, 14 March 1989.
- 4.
Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, OJ, L 11, 15 January 2002, pp. 4–17. A public consultation for the revision of the directive was launched in July 2010 and ended in August 2010 in order to adapt the system to the challenges of globalisation.
- 5.
Note here that Directive 2001/83/EC on the Community code relating to medicinal products for human pursues the same preventive purpose as the Medical Device Directive. It requires that no medicinal product is placed on the market, distributed, manufactured or imported unless a marketing authorisation is issued by the competent national authorities of the relevant Member State. The Directive on medicinal products sets out a detailed framework for the safe provision of medicinal products in the European Union. The analysis shows that almost all aspects of the General Product Safety Directive are covered by specific provisions of the Directive on medicinal products. In addition, the General Product Safety Directive provisions apply to the medicinal products which are not covered by the medicinal product directive and which are supplied to consumers. For instance, these would include medicinal products neither prepared industrially nor manufactured by a method involving an industrial process.
- 6.
Article 2(a), Directive 2001/95/EC.
- 7.
These guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives and by the Competent Authorities charged with safeguarding Public Health. Nevertheless, they are not legally binding. However, due to the participation of the aforementioned interested parties and experts from the Competent Authorities, it is anticipated that they will be followed within the Member States and, therefore, ensure uniform application of relevant directives' provisions. For details and references see http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm.
- 8.
Note that current interpretations of the legislation do not generally include software used for the administration of general patient data, such as electronic health records, as medical devices. It should, however, be noted that some Member States are questioning whether such software also constitutes a medical device as it is increasingly used in some form of medical decision-making (e.g., the automated scheduling of appointments based on data feeds into record of laboratory test results).
- 9.
See: Section 13, Supply of Goods and Services Act 1982 http://www.legislation.gov.uk/ukpga/1982/29.
- 10.
Directive 2000/31 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, OJ, L 178, 17 July 2000, pp. 1–16. On 10 August 2010, the European Commission launched a public consultation on the electronic commerce Directive. This consultation aims at analysing the reasons why electronic commerce remains limited in the European Union. It seeks to identify obstacles to the development of e-commerce and to evaluate the impact of the electronic commerce Directive. On the basis of the responses received, as well as the input from discussions with Member States, and relevant reports from the European Parliament, the Commission will come forward, in early 2011, with a Communication on e-Commerce setting out lessons learned and possible next steps.
- 11.
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 August 1985, pp. 29–33.
- 12.
A spirometer is used to measure the volume of air inspired and expired by the lungs.
- 13.
The Single European Act introduced the notion of consumer into the European Community Treaty. With the Treaty of Maastricht, the consumers’ protection policy was introduced into the framework of the more general internal market policy. It then became the subject the article 153 of the European Community Treaty, which became the article 169 of the TFUE. For more information on this point see Dony, M., Droit de l’Union européenne, troisième edition, Editions de l’Université de Bruxelles, Bruxelles, 2010, pp. 571–575.
References
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Case C-203/99, Henning Veedfald vs. Arhus Regional Authority. ECJ judgment accessed on 12th march 2011 at http://eur-lex.europa.eu
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Andoulsi, I., Wilson, P. (2013). Understanding Liability in eHealth: Towards Greater Clarity at European Union Level. 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_7
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