Sweden Moves to Untangle the Legal Knots Around Health Data

Key Takeaways

• Healthcare Actors Still Face Legal Friction: Uncertainty persists around how data protection, administrative law, and health regulations interact in practice.
• AI and Cloud Services Raise the Stakes: Emerging technologies are intensifying governance and compliance challenges around health data.
• New Guidance Has Been Launched: Authorities have released high-level legal guidance and an initial digital legal search service.

Deep Dive

Swedish authorities have recently delivered a long-awaited attempt at clarity on  how health data can be used, shared, and governed. A government assignment launched in June 2025 asked the Swedish eHealth Agency and the Swedish Data Protection Authority to do something healthcare actors have been asking for repeatedly i.e., explain how the law actually works in practice when it comes to health data. That work is now complete, with the authorities submitting their final report this week to the Ministry of Health and Welfare.

The assignment focused on mapping the legal grey zones that continue to slow digitalization in healthcare. According to the report, organizations working with health data routinely struggle to interpret how different legal frameworks fit together, particularly data protection rules, administrative law, and sector-specific health legislation. As digital tools become more sophisticated, those challenges are being amplified by the use of AI, cloud services, and data-driven analytics.

Gunilla Nordlöf, Director General of the Swedish eHealth Agency, said the aim was to move beyond abstract legal principles and toward guidance that actually helps people make decisions.

“The legal guidance in the area of health data needs to be developed and scaled up to ensure that support for healthcare actors is effective and appropriate,” she said. “By developing such guidance, clearer and safer conditions are created for the handling of health data.”

The Swedish Data Protection Authority struck a similar note, pointing to the delicate balance between protecting individuals and enabling progress. Health data remains among the most sensitive categories of personal information, yet it is also essential for patient care, research, and innovation.

“Health data is sensitive information,” said Director General Eric Leijonram. “At the same time, health data needs to be able to be shared so that patients receive the right care and to enable research and new treatment methods. Healthcare actors must be able to safely implement digitalization initiatives without risking the rights of individuals.”

As part of the assignment, the two authorities produced new high-level legal guidance and rolled out an initial version of a legal search service on the eHealth Agency’s website. The tool is designed to help healthcare organizations navigate relevant laws and interpretations in one place. Both agencies acknowledge that the guidance remains general in nature, shaped by the tight timeframe of the project, but say it lays the groundwork for something more robust.

That future vision features prominently in the report’s recommendations. The authorities propose that the eHealth Agency be given a long-term mandate to lead legal guidance on health data sharing, supported by a national council focused on legal issues in the health data ecosystem. They also call for further development of digital tools to coordinate guidance across authorities and reduce fragmentation.

The GRC Report is your premier destination for the latest in governance, risk, and compliance news. As your reliable source for comprehensive coverage, we ensure you stay informed and ready to navigate the dynamic landscape of GRC. Beyond being a news source, the GRC Report represents a thriving community of professionals who, like you, are dedicated to GRC excellence. Explore our insightful articles and breaking news, and actively participate in the conversation to enhance your GRC journey.