European Parliament formally adopts the European Health Data Space (EHDS) Regulation

On 24 April 2024, the European Parliament adopted the provisional agreement on the European Health Data Space (EHDS) Regulation. The compromise text was already endorsed by COREPER on 22 March, but still requires formal adoption by the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO). After both Institutions have completed the legislative procedure, the new Regulation will be formally adopted.

The EHDS aims at allowing individuals faster and easier access to and control over their personal electronic health data (primary use). It will also allow certain health data to be reused for research and innovation reasons (secondary use). Both are crucial for the development of innovative and personalised medicines.

Small and medium sized innovators

Smaller and mid-sized companies that promote innovation can especially benefit from an EU-wide single market for health data. Increased numbers of high-quality data sets will be able to be made available for research and innovation purposes which are crucial for the development of innovative therapeutics, personalised medicines and improve diagnosis.

Use and reuse of health data

Under safe and trustworthy conditions, the EHDS will allow researchers, innovators and industry access to large and high-quality data sets. Access requires a permit from a health data access body (HDAB), which will be a national body with the ability to grant access to requested data for specific purposes. Enabling the reuse of data will ultimately help to encourage crucial R&D of life-saving treatments.

Rare diseases

It is difficult to share data across Member States borders, due to a combination of varying levels of digitalisation from one Member State to the other and diverging interpretations of how health data can be lawfully shared. The EHDS will ensure interoperability via the European electronic health record exchange format and ensure a unique single market and a common access point for data on rare diseases that is essential to foster research.

The text also encourages the uptake of real-world evidence (RWE), allowing for the ability to easily link different sources of health data from smaller patient populations, which are essential for the development of RWE, that is in turn crucial for the development of innovative medicines.

Opt-out

The text empowers Member States to allow patients to opt-out on the use of their health data for further use, except for the purposes of research and policy making in the public interest. Member States can also introduce additional safeguards and measures at national level for data categories.

EUCOPE encourages consistent implementation of opt-out mechanisms. Member States must work together to ensure a harmonised approach to opt-outs to reduce barriers to cross-border health research.

Intellectual property (IP) and trade secret safeguards

Although EUCOPE welcomes the improved IP protections and trade secret safeguards, the protection of IP rights and trade secrets by HDABs, will require sound guidelines are provided to all national HDABs to ensure predictable interpretations and management of commercially sensitive information.