Data protection

EDPB opinion on GDPR and Clinical Trials Regulation clarifies the basis for processing personal data in a clinical trial context

Emma Keeling

On 23 January 2019, the European Data Protection Board (the EDPB) adopted an opinion on the interplay between the EU Clinical Trials Regulation (536/2014) (the CTR) and the General Data Protection Regulation (2016/679) (the GDPR) (the Opinion). The Opinion aims to provide greater certainty for those conducting clinical trials, clarifying: the distinction between consent requirements Read More

China – Data compliance in the life sciences sector

David Shen

China’s Ministry of Science and Technology (MOST) recently announced administrative sanctions against six entities for breach of the Provisional Measures for the Administration of Human Genetic Resources (Measure). In the 20 years since the Measure was implemented, this is the first time that MOST has announced any enforcement action. A closer look at the MOST Read More

Belgium: Mobile health apps can now be published on mhealthbelgium.be

Kaat Van Delm

From the end of October 2018 onwards, companies can apply for publication of their mobile health-applications (mhealth apps) on the governmental website “mhealthbelgium.be“. The website aims to encourage mobile health and make mhealth patient care an integrated pillar of the healthcare sector. It has been created through cooperation among Belgian authorities for food, medicines and 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

UK Department for Health and Social Care publishes an initial code of conduct for use of digital technology

Emma Keeling

As big data continues to be big news and data protection law continues to evolve, it is timely that the Department for Health and Social Care (the Department) has published a code of conduct relating to the use of data-driven health and care technology (the Code). Published in its initial form on Wednesday, the code Read More