European Health Data Space Regulation sets requirements for electronic health record systems

As we have previously reported, the Regulation is intended to enhance the accessibility, interoperability and security of electronic health data in the EU. It aims to give individuals access to their health records and allow healthcare professionals across the EU to access a patient’s personal health data to facilitate treatment. Others, such as public health authorities, researchers and industry (known as ‘health data users’) will also be able to use health data made available by so-called data holders in anonymised or pseudonymised forms for certain secondary uses.

The Regulation lists both permitted and prohibited secondary use purposes for electronic health data. Permitted purposes include: 

• Activities in the public interest in public or occupational health;
• Policy making and regulatory activities;
• Official statistics; 
• Education at vocational and higher education levels; 
• Scientific research (which covers the development of new products and medicines), training, testing and evaluating algorithms (including in medical devices), AI systems and digital applications; and 
• The improvement of delivery of care. 

Prohibited purposes include using electronic health data to: 

• Take decisions detrimental to a person or group of people; 
• Take discriminatory decisions, for example relating to an insurance premium or conditions or to a job offer; 
• Conduct marketing or advertising activities; 
• Develop harmful products; or 
• Conduct activities which conflict with ethical provisions in national laws. 

Health data users will be able to apply for a permit from a health data access body to obtain access to health data, which must be granted if the health data access body concludes that relevant requirements are satisfied. These include that the data will be used for a permitted purpose, the requested data is necessary, adequate and proportionate for the intended purpose, the applicant has a legal basis and satisfactory qualifications and expertise for the intended purpose, among others. However, the application can be denied if there are risks for national defence, security, public security, and public order, or confidentiality of governmental databases which are not sufficiently mitigated.

Fines for breaches of the Regulation can reach up to €20 million or 4% of annual worldwide turnover. 

The Regulation entered into force on March 26, 2025. It will apply from March 26, 2027, with different commencement dates applicable to certain obligations. For example, Chapter III, which sets out the provisions on secondary use of electronic health data, will apply only from March 26, 2029. For certain data (including medical imaging studies and related imaging reports, medical test results and discharge reports), data holders’ sharing obligations will only apply from March 26, 2031. 

The European Commission has also published a document of frequently asked questions (FAQs) on the Regulation.

The Regulation is available here and the FAQs here.