France

French data protection authority (CNIL) publishes reference methods for health data processing

Laurie-Anne Ancenys

On 16 July 2018, the French Data Protection Authority (CNIL) published revised and new reference methods (MRs) regarding data processing in health research to adapt the existing framework to the EU General Data Protection Regulation (GDPR) and the national health data system (SNDS). Specifically, the CNIL updated: MR-001 on interventional research. MR-003 on non-interventional research. It also Read More

French government meets with healthcare industry at eighth meeting of the Strategic Council for the Healthcare Industries

Eveline Van Keymeulen

The eighth meeting of the Strategic Council for the Healthcare Industries (CSIS), between the French government and representatives of the healthcare industry, took place on 10 July 2018. The CSIS agreed on certain measures as part of a long-term roadmap to help France regain its attractiveness as an international centre of health innovation and excellence. Read More

French Administrative Supreme Court quashes mandatory certification of medical prescription assistance software

Eveline Van Keymeulen

On 12 July 2018, the French Administrative Supreme Court (Conseil d’Etat) partially annulled Decree No. 2014-1359 insofar as it establishes a general certification obligation for medical prescription assistance software by the High Health Authority (HAS) regardless of its functionalities (Decision n. 387156). The decision follows a December 2017 preliminary ruling of the CJEU in response Read More

France debates measures to facilitate early access to medicines

Eveline Van Keymeulen

On 13 June 2018, the committee in charge of assessing social security financing laws at the French Senate submitted a report on early access to new medicines to the Senate Presidency. The report assesses the conditions applicable for making new treatments accessible at all stages (from clinical trial to authorisation and marketing) and provides recommendations that Read More

Revised French Personal Data Protection Act: Constitutional Court upholds health related provisions included in the bill

Laurie-Anne Ancenys

On 22 June 2018, a new law entered into force, after the French parliament amended the personal data protection bill to reflect a decision of the French Constitutional Court. The court had indeed earlier upheld the majority of the provisions of the French personal data protection bill, which amends Act n. 78-17 on Information Technology, Read More