Loi 78-17 Articles 65, 66, 73 and 76, Health-Data Processing Through CNIL Référentiels and a Declaration of Conformity (as Amended by the Simplification Law of 26 May 2026)

Article 66 II of Loi 78-17, as rewritten by Article 54 of the Loi de simplification de la vie économique of 26 May 2026 (the simplification law), provides that référentiels adopted by the CNIL set out how processing is to be carried out, balancing data protection against the public-interest purposes of Article 66 I, notably the development of research in the field of health.

Under Article 66 III, processing must conform to one of those référentiels, and before the processing starts its controller sends the CNIL a declaration attesting that conformity. One declaration of conformity is enough where a controller runs several processing operations under the same référentiel. Under Article 66 IV, processing that does not conform to a référentiel may still be carried out, as an exception to Article 66 III, after the CNIL's authorization.

Article 66 VI, which Article 54 adds, provides that where a controller has a CNIL authorization or has committed to conform to a référentiel, the controller holding the data in question must make them available within three months, renewable once, except data whose communication would harm national defense interests. Article 66 VI takes effect 18 months after the promulgation of the simplification law.

Article 66 VI does not apply to research using health data of the Ministry of Defense where making them available could harm the fundamental interests of the Nation. Article 73 now provides that, for the référentiels of Article 66 II, the CNIL adopts reference methodologies. In the first paragraph of Article 65, the simplification law inserts the words "in the field of health" after "processing".

Article 76 now lets authorization requests for studies, evaluations and research not involving the human person that have a favorable opinion from a local scientific and ethical committee be exempted from the prior opinion of the national ethics and scientific committee for health research, studies and evaluations, on conditions set by a decree of the Conseil d'État.

Article 54 is not among the provisions of the simplification law that the Conseil constitutionnel declared contrary to the Constitution in decision 2026-903 DC of 21 May 2026. The simplification law was promulgated on 26 May 2026 and published in the Journal officiel of 27 May 2026. Article 54 sets a start date only for Article 66 VI.

Under Article 1 of the Code civil a law takes effect on the date it sets or, failing that, the day after its publication, and a provision whose execution needs implementing measures takes effect when those measures do.