On 3rd May 2022, the European Commission proposed a Regulation to set up the European Health Data Space, furthering its pursuits for a single market for digital health services and products. It is one of a number of laws that have been introduced in recent years under the European Commission's Data Strategy initiative, but the first common data space to be introduced.

The Health Data Space is set to be a health specific ecosystem comprised of rules, common standards and practices, infrastructure and a governance framework. Key themes from the proposed Regulation include:

1. increasing individuals' digital access to and control over their electronic personal health data, nationally and across the EU, including the ability to share these data with healthcare professionals in and across the EU to ensure consistent healthcare delivery (this is being termed "the primary use of data"); and

2. providing a consistent, trustworthy and efficient set-up for the use of health data for research purposes, which will involve the researcher applying for a permit before being allowed to use such data (this is being termed "the secondary use of data").

Look out for further updates from us as we track this Regulation through the legislative procedure.

Today, the European Commission launched the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union.

 ec.europa.eu/...