Data protection

EU: On the Origin of Big Data is D.A.R.W.I.N the future?

Benjamin Scrace

A joint task force of the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) has proposed a new approach to the use of “big data” in EU medicines regulation. The report, from the Big Data Task Force (BDTF) (accessed here), contributes to the EMA and HMA’s “EU Network Strategy” to 2025 and shows Read More

Big data in healthcare: key recommendations of the French National Ethical Consultative Committee for Life Sciences

Laurie-Anne Ancenys

On 29 May 2019, the French National Ethical Consultative Committee for Life Sciences and Health (CCNE) delivered its Opinion (n°130) on ethical issues in connection with big data in the health sector (the Opinion). The Opinion aims at identifying the ethical challenges raised by the exploitation of large set of data in healthcare and provide Read More

AI in health: the launch of the French Health Data Hub

Laurie-Anne Ancenys

The French Office parlementaire d’évaluation des choix scientifiques (the Office) has published a report on artificial intelligence and health data following the public hearing organised in February 2019, in the form of two round tables on artificial intelligence and health data. The hearing, attended by AI researchers, entrepreneurs, public and private stakeholders of the health Read More

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