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 Database index

Legislation

France, Loi relative à la bioéthique

Full reference
LOI n° 2021-1017 du 2 août 2021 relative à la bioéthique
Legislator/regulator
French Parliament
Institutional level
National level
Number
2021-1017
Date
Type of Source
National legislation
Source national detail
Primary legislation
Stage of drafting
Approved
Territorial scope
National
Project area
AI and health
Law area
Privacy / data protection
Medical devices

Summary of the law

It introduces the notion of  “algorithmic data processing, the learning of which has been carried out on the basis of massive data” used for an act of prevention, diagnosis or treatment, a medical device. In this case the person concerned has to be informed of the use and of the resulting interpretation. 
The patient's data used in this processing and the results obtained are accessible to them and the designers of the algorithmic processing must ensure that users can understand how it works.

Specific provision(s) regarding AI and health
Health public code, Article L. 4001-3:
Any healthcare professional who decides to use, for an act of prevention, diagnosis or treatment, a medical device involving algorithmic data processing learned from massive data must ensure that the person concerned has been informed and, where appropriate, warned of the resulting interpretation. The professionals concerned are informed of the use of this data processing, and they have access to the patient data used in the algorithmic processing and to the results obtained. It is also the responsibility of the designers of algorithmic processing to ensure that it can be explained to professional users.
After receiving the opinion of the Haute autorité de la Santé (Health High Authority) and the CNIL (French data protection authority), a ministerial decree will establish the nature of the medical devices concerned by these requirements and their conditions of use.
Personal scope of the instrument
Public Authorities, Individuals, Legal Persons
Material scope of the instrument

Development of AI in Health. Principle of information; Principle of  transparency

AI system(s) involved
  • Machine learning
  • Deep learning
Initiative
  • Government
Fundamental rights involved
  • Right to data protection
  • Right to informed consent
Principles expressly applied
  • Explainability
  • Transparency

Case author
Fabienne Jault-Seseke
Professor
University of Versailles Saint Quentin-en-Yvelines