On 1 April 2017, the implementing Decree of 26 December 2016 relating to the processing of personal data in the framework of the National System of Health Data (SNDS) entered into force. The decree lists the data that will be made available under the framework, establishes a list of public bodies that will have permanent access to SNDS data, and identifies the pathways for such access.
The SNDS, managed by the national health insurance fund CNAMTS, was created by the 2016 Law on the Modernisation of our Health Care System. It will incorporate most public registries of health data, such as health insurance data (SNIIRAM), hospital data (PMSI), data on the medical causes of deaths (CepiDC), data related to handicaps (CNSA), and a sample of data from complementary health insurance bodies. The first two databases became accessible on 1 April 2017 and the remainder will become available in due course. The SNDS will significantly increase access to health data in France, which will be made available in aggregated form or as individual pseudonymised data.
Certain public bodies (including public health insurance funds, the National Agency for Medicines and Health Products Safety, and the High Health Authority) are granted permanent access to SNDS data. Other actors, public or private, profit or non-profit, will only be able to access SNDS data upon prior authorisation from the Data Protection Authority (CNIL) and for the following purposes:
- Research, study or evaluation purposes for reasons of public interest.
- Perform tasks of governmental departments, public entities or bodies entrusted with a public service mission.
Health data accessed through the SNDS must not be used to:
- Promote health products (including medicines and cosmetics) to healthcare professionals.
- Exclude an individual or group of individuals presenting the same risk from their insurance contract guarantees or to modify their insurance premiums.
The use of the data is also subject to professional secrecy, confidentiality and integrity obligations.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2017 Issue (Thomson Reuters).