Abstract
Legislative and regulatory norms applicable to digital health vary from one country to another. These differences can be explained by the vision States have of the use of new technologies in the health sector. France, country of clinical traditions has opted for a practice-focused use of new technologies, making rise then a singular definition of telehealth whereas other countries opted for a larger vision and now consider the medical performance as a service delivery, far beyond the simple medical act. From these conceptions result different practices but all of them are based on the same legal basis. Same statement is made for the legal status of the connected objects and the DATA created from them. Therefore, it seems that, according to the norms, economic competitiveness within the health sector is different from one country to another. Liberal norms are seen as more conducive to projects development contrary to more restrictive ones, considered as more respectful to fundamental human rights. Solving the equation by making a choice between the economic development of States and their ability to make respected the Human Rights seems inconceivable. It is then essential to think the related norm through a single conception to guarantee the equality of rights and chances.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
This is the case in Germany. For example, see “L’e-santé en Allemagne” (www.science-allemagne.fr/fr/wp-content/uploads/2016/03/E-santé-en-Allemagne.pdf).
- 2.
This could be a “targets and resources” multi-year contract (contrat pluri annuel d’objectifs et de moyens [CPOM]) entered into by the director of a health establishment and a local health authority, or it could be a “health care coordination and quality-enhancement contract” (contrat d’amélioration de la qualité et de la coordination des soins [CAQCS]) between the project holder and the health insurer.
- 3.
This mainly pertains to civil liability resulting from injuries suffered by a patient when a standard is not complied with, or the liability of the individual health-care professional involved.
- 4.
The goal of this legislation was to create a legal framework overseeing the free circulation of services in the information society.
- 5.
Comparison made by Clive Humby at the 2006 Association of National Advertisers senior marketers summit, Kellogg School of Management: http://ana.blogs.com/maestros/2006/11/data_is_the_new.html.
- 6.
This regulation is directly applicable in the national legislation of the member countries and supersedes Directive 95/46/EC, which has now been ruled obsolete.
- 7.
On December 15, 1983, the Constitutional Court of Germany issued an order enshrining the principle of informational self-determination in law, that is, the ability of an individual to decide, in principle, on the communication and use of personal information belonging to them.
- 8.
See the MyData project, www.cil.cnrs.fr/CIL/spip.php?article1645.
- 9.
In particular, this is provided for under France’s 1978 law on computers and liberties. That law covered the following aspects: prior provision of accurate information; explicit consent; that the data must have a legitimate and predefined purpose, be relevant and up to date, and have a limited conservation time; and that appropriate security measures to protect the data be in place.
- 10.
Article 8 II of the law on computers and liberties specifies that the conditions for the collecting and processing of data are to be monitored by the Commission nationale de l’informatique et des libertés, particularly regarding: security and information; treatment required to safeguard human life; treatments carried out by physicians or biologists for preventive medical purposes, medical diagnostics, and administration of care and treatment; medical research; public interest; the processing of data that has been anonymized; and the handling of assessments of health-care practices.
- 11.
In France, this is the Commission nationale de l’informatique et des libertés (CNIL) (national commission on computers and liberties).
- 12.
Directive 90/385/EEC applies to active implantable medical devices, 93/42/EEC applies to medical devices, and 98/79/EEC applies to in-vitro diagnostic medical devices.
References
Chandra, A., C.E. Pettry, and D.P. Paul. “Telemedicine from a Macromarketing Viewpoint: A Critical Evaluation with Proposed Licensing Strategies,” In Government Policy and Program Impacts on Technology Development, Transfer and Commercialization, International Perspectives, ed. Kimball P. Marshall et al. (New York: Routledge, 2013), 111–136.
CNIL. “Le corps, nouvel objet connecté du ‘quantified self’ à la M-santé: les nouveaux territoires de la mise en données du monde,” Cahiers IP, Innovation & Prospective, no. 2 (May, 2014): 45–48.
Cons. “Const,” Official Journal, no. 95–352 DC (January 18, 1995). January 21, 1995.
Council of Europe Treaty Series no. 108. “Signed in Strasbourg, France,” January 28, 1981.
Crigger, B. “E-medicine: Policy to Shape the Future of Health Care,” Hastings Center Report 36, no. 1 (2006): 12–13. doi: 10.1353/hcr.2006.0006.
Croels, M., “Le droit des obligations à l’épreuve de la telemedicine,” Presses Universitaires d’Aix-Marseille (2006): 38, quoted in P. Simon, “La télémédecine ce n’est pas du e-commerce,” Association Nationale de Telemédecine and the Ordre national des médecins (November 22, 2013): www.automesure.com/library/pdf/telemedecine_e-commerce_2013.pdf.
European Union. “Charter of Fundamental Rights of the European Union,” December 18, 2000, C 364/1.
European Union Regulation 2016/679. Official Journal of the European Union, no. L119 (May 4, 2016): 1.
Gallois, F., and A. Rauly, “Télémédecine et comparaison des systèmes de santé: questionnements méthodologiques” (paper presented at Colloque international Recherche & Régulation, Paris, France, June 10–12, 2015).
Kerleau, M., and N. Pelletier-Fleury. “Restructuring of the Health Care System and the Diffusion of Telemedicine,” The European Journal of Health Economics 3, no. 3 (September 2002): 207–214, doi: 10.1007/s10198-002-0131-8.
Kirsch, G. “The Business of eHealth,” Journal of Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing 2, no. 2 (January 1, 2002): 106–110, doi: 10.1057/palgrave.jmm.5040062.
“Law no. 2004–801 of August 6, 2004 on the protection of individuals with regards to the processing of personal information, amending law no. 78–17 of January 6, 1978 on computers, files and liberties,” Journal officiel de la République française, no. 182 (August 7, 2004). 14063.
Loi no. 2010–1229 Official Journal, no. 0245 (October 21, 2010).
Serma Ingenierie, Study on Safety of Medical Devices Software (France, 2016). http://ansm.sante.fr/var/ansm_site/storage/original/application/1f3c81fac07d6e659075a332c5d00431.pdf.
Simon, P. “La télémédecine ce n’est pas du e-commerce,” Association Nationale de Telemédecine and the Ordre national des médecins (November 22, 2013): www.automesure.com/library/pdf/ telemedecine_e-commerce_2013.pdf.
“Treaty on European Union and the Treaty on the Functioning of the European Union,” Official Journal, no. C326 (October 26, 2012): 001–0390.
World Health Organization, “The Declaration on the Promotion of Patients’ Rights in Europe,” (presented at the WHO European Consultation on the Rights of Patients, Amsterdam, June 28, 1994).
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Copyright information
© 2017 The Author(s)
About this chapter
Cite this chapter
Williatte, L. (2017). Use of New Information and Communication Technologies in the Health Sector: The Legal Reason for Differences Between International and European Standards. In: Menvielle, L., Audrain-Pontevia, AF., Menvielle, W. (eds) The Digitization of Healthcare. Palgrave Macmillan, London. https://doi.org/10.1057/978-1-349-95173-4_21
Download citation
DOI: https://doi.org/10.1057/978-1-349-95173-4_21
Published:
Publisher Name: Palgrave Macmillan, London
Print ISBN: 978-1-349-95172-7
Online ISBN: 978-1-349-95173-4
eBook Packages: Business and ManagementBusiness and Management (R0)