Last week, the EU Parliament and Council agreed on a draft regulation for the "European Health Data Space" (EHDS) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022PC0197.

EDHS is a health-specific ecosystem comprised of rules, common standards and practices, infrastructures, and a governance framework that aims at

• empowering individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide, and support to their free movement, as well as fostering a genuine single market for electronic health record systems, relevant medical devices and high risk AI systems (primary use of data)
• providing a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities (secondary use of data )

It enables the storage of health data of the EU's 450 million citizens.

The provisional agreement amends the Commission’s original proposal in a number of key areas, including:

• opt-out: member states can allow patients to opt-out on the use of their health data being accessed, whether by a healthcare professional (primary use) or for further use (secondary use, always under strict conditions), except for purposes of public interest, policy-making, statistics and research purposes in the public interest
• restricted information: if patients choose to restrict information, healthcare professionals will only be able to access restricted health data in situations of vital interest
• sensitive data: member states may put in place stricter measures governing access to certain kinds of sensitive data, such as genetic data, for research purposes
• trusted data holders: in order to reduce the administrative burden, member states may establish trusted data holders that can securely process requests for access to health data
• clinically significant findings by researchers: in instances where health data access bodies  are informed about findings that may impact the health of a patient whose data was used in the scientific research.

Pursuant to the new proposed EDHS , individuals will have better access and control over their health data, regardless of whether they are in their home country or another member state.

The EHDS will also provide researchers and policy-makers with access to specific kinds of secure health data, enabling them to tap into the EU’s health data and to be used for scientific research in the public interest. It also requires all electronic health record (EHR) systems to comply with the specifications of the European electronic health record exchange format, ensuring that they are interoperable at EU level.

EU countries pursuant to the draft Article 10, will also be required to set up a digital health authority to implement the new provisions and a new EDHS board will be set up at European level as well as a Stakeholders forum.

The EHDS regulation will subsist and interact with other applicable legal frameworks including GDPR, Data Governance Act, Data Act, Medical Devices Regulation. Entry into force will most likely occur for the majority of the provisions after two years from date of coming into force the EDHS.