The future European Health Data Space Act – a wealth of possibilities and risks
£45.00
The EHDS Act is coming – are you ready? Discover the regulatory implications, opportunities, and challenges that will affect the medical device industry
English
The European Health Data Space Act (EHDS Act) represents a pivotal legislative initiative aimed at reshaping the way health data are accessed, shared, and utilised across the European Economic Area. Although not yet published in the ‘Official Journal of the European Union’, and therefore not legally binding, the proposed Act has already sparked significant interest within the medical technology sector due to its potential to enhance healthcare innovation and research. At the same time, concerns persist about data privacy and regulatory compliance complexities stemming from overlapping legal frameworks. Broader access to relevant datasets – regardless of prior investments by a manufacturer – may also lead to intensified market competition. This article by Cécile van der Heijden explores the core elements of the EHDS Act to allow medical technology companies to gain an introductory understanding of the EHDS Act and its potential possibilities and repercussions.
Specification: 15 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the February 2025 issue of the Journal of Medical Device Regulation.
