European Health Data Space Regulation Passes European Parliament

Following the final vote in the European Parliament on 24 April, the final steps will be taken toward adopting the European Health Data Space (EHDS) Regulation, which aims to facilitate the access, use and re-use of health data both within and across EU borders.

The EHDS is one of the several EU legislative initiatives concerning data (Data Governance Act, Data Act, AI Act, Cyber Resilience Act) and the first sectoral legislation of the proposed data spaces.

“We applaud the regulations for their goals of efficient and timely sharing of medical records across borders.  This is vital to improving patient outcomes and saving lives,” said HIMSS President & CEO Hal Wolf. “Significant to the global health ecosystem is how the EHDS regulates patient data to help foster innovation through its secondary use, including research.  Europe’s lead in this area will be studied by all.” 

European Health Data Space Regulation looks to foster a genuine single market for digital health services and products by setting up a governance structure for the use of health data for research, innovation, policy-making and regulatory activities (i.e., secondary use of data), as well as testing and certification process to ensure that such data are Findable, Accessible, Interoperable and Reusable (FAIR).

Over the past two years, various points and topics of the Regulation have been debated, among which the key points were: 

• Patients will have the right to opt out of their anonymized or pseudonymized health data being made accessible for secondary use. 
• Member States may allow patients to opt out of data being made available for primary use by a healthcare professional other than the one(s) who collected it.
• Where one organization holds a significant volume of data that may be of interest for secondary use, they may be designated as trusted data holders by a Member State to assist with data access request administration and reduce the burden on Health Data Access Bodies.

In terms of the next steps, the Regulation will enter 20 days after publication in the Official Journal of the EU, which is expected in the next month. This will mark the start of the implementation timeline, which requires Member States to gradually implement the law, starting with the creation of the Health Data Access Bodies and Digital Health Authorities by mid-2026, allowing primary use of patient summaries, ePrescription and eDispensation by mid-2028, and secondary use of such data by 2030.

Additional non-EU countries, such as the United States, may participate in EHDS starting in 2030. 

HIMSS will continue to be a resource for the EU health community and members on this and other EU Regulations, which will be widely discussed in the many policy-focused sessions at HIMSS24 European Health Conference and Exhibition, taking place from 29-31 May 2024, in Rome.