France

French report on improving access to drug information published

Eveline Van Keymeulen

The French Minister of Healthcare recently announced the publication of a report  on improving access for patients and healthcare professionals to information on medicinal products. The report includes, in particular, recommendations on how to improve the information content (targets, quality, verification and so on) and evolution (especially during a health crisis), as well as access Read More

Telemedicine becomes a reality in France

Eveline Van Keymeulen

In September 2018, French Decree 2018-788, which sets out the conditions to provide telemedicine acts, entered into force. The Decree was adopted pursuant to Article 54 of the 2018 Social Security Financing Bill. It exempts health care professionals conducting a medical follow-up of patients over long distances (tele-monitoring) from obtaining, as required by Article R. 161-43 of the Read More

French ATU procedure simplified to ensure rapid patient access to innovations

Eveline Van Keymeulen

On 17 September 2018, the National Agency for Medicines and Health Products Safety (ANSM) introduced  a single portal for health care professionals to apply for individual temporary authorisations for use (ATUs) with the aim of increasing transparency and simplifying the processing of ATU applications to ensure earlier management of patients likely to benefit from new Read More

French Medical Council and data protection authority (CNIL) publish practical guide on implementation of the GDPR

Laurie-Anne Ancenys

In June 2018, the French Medical Council (Conseil national de l’ordre des médecins) and the French data protection authority (CNIL) published a practical guide for doctors in the context of the implementation of the general regulation on the protection of personal data (GDPR), which has been applicable since 25 May 2018. Physicians, and health care Read More

Processing of health data: first implementing decree on French Personal Data Protection Act

Laurie-Anne Ancenys

Decree 2018-687 implementing Act 2018-493 of 20 June 2018 on the Protection of Personal Data was recently published in the French Official Journal. The decree amends Decree 2005-1309, which implemented the 1978 French Data Protection Act. In particular, it amends the provisions concerning the processing of personal health data by including operating provisions on the processing of Read More