This is Part 3 in a series of articles on the European Health Data Space (“EHDS“).  Part 1, which provides a general overview of the EHDS, is available here. Part 2, which deals with the requirements on the manufacturers of EHR-Systems under the EHDS, is available here.

This article provides an

Continue Reading EU: EHDS – Access to health data for secondary use under the European Health Data Space

Introduction

In its judgement of 04 October 2024 (C-21/23), the European Court of Justice (“ECJ”, “Court”) ruled, that the provisions of Chapter VIII of the GDPR, do not preclude national rules which grant undertakings the right to rely, on the basis of the prohibition of acts of unfair competition

Continue Reading EU: ECJ rules that competitors are entitled to bring an injunction claim based on an infringement of the GDPR.

This is Part 2 in a series of articles on the European Health Data Space (“EHDS“).  Part 1, which provides a general overview of the EHDS, is available here.

Alongside the better-known provisions of the EHDS dealing with secondary use of health data, the draft Regulation also sets out specific technical requirements

Continue Reading Requirements of EHR systems under the European Health Data Space

In March 2024, the Council of the European Union and the European Parliament reached a deal on a provisional agreement for the European Health Data Space (“EHDS”) regulation as part of the broader EU data strategy. The Council of the European Union published the compromise text of this agreement as a work-in-progress, providing

Continue Reading The European Health Data Space – What lies ahead?

Authors: Denise Lebeau-Marianna, Divya Shanmugathas and Lucie Dubecq-Princeteau

On 15 March 2023, the French Supervisory Authority (the “CNIL”) unveiled in a post its four key priorities regarding its upcoming investigations for 2023 targeting specific sectors (I), to which it added another topic related to DPO in line with the coordinated enforcement framework of

Continue Reading France: the CNIL has released its annual dawn raid Program for 2023: four national priorities and one priority coming from the EDPB!

Authors: Eliza Saunders, Sarah Birkett, James Clark, Senal Premarathna

Introduction

The benefits of using genetic information for research purposes are clear, especially as the technology underpinning medical research continues to advance at such a rapid pace. Outside of research and clinical development, the number of organisations which use blood and saliva samples
Continue Reading Genetic information – global privacy considerations – an Australian and UK perspective

Author: James Clark

The UK’s Department for Health and Social Care (“DHSC”) has published a major strategy document (‘Data saves lives: reshaping health and social care with data’) outlining the government’s plans for the regulation and use of data in healthcare.

In this post, we look at some of the most
Continue Reading UK: New National Strategy for Health Data