Scope

The European Health Data Space (EHDS) primarily targets manufacturers and suppliers of EHR systems and wellness applications, and other controllers and processors of health data. The proposal seeks to empower individuals with greater control over their electronic health data and facilitate its use by researchers, innovators, and policymakers.

Relevance

The Regulation will allow Norwegian patients to benefit from improved cross-border healthcare services, as the EHDS facilitates easier access and transfer of health data across the EU/EEA. Norwegian researchers and innovators in the health sector could gain access to a broader pool of health data, fostering collaboration and accelerating developments in medical research and digital health solutions.

The proposed Regulation is likely to require amendments to Norwegian health legislation, such as the Patient Records Act (Nw. Pasientjournalloven) and the Personal Health Data Filing System Act (Nw. Helseregisterloven).

Key obligations

The proposal entails a right for individuals to access their own health data and enable them to share own health data with medical personnel across the EEA. The Regulation further establishes a common European format for patient journal and other medical documentation, which healthcare providers will have to adhere to.

The EHDS sets out conditions under which health data can be used for purposes beyond direct healthcare, such as research, innovation, public health, and policy-making. Entities wishing to access health data for these secondary purposes must comply with strict governance and privacy standards, ensuring data use is ethical and secure.

The negotiated compromise between the EU bodies include a right for patients to opt out of secondary use of their health data, except for public interest purposes, policy making, statistics and research purposes in the public interest.