Iceland's Ministry of Health (Heilbrigðisráðuneytið) opened public consultation on August 4, 2026 on a draft bill establishing Stafræn heilsa (Digital Health), a central unit that would build, operate and coordinate the country's shared digital health infrastructure. The consultation, case S-147/2026 on the Samráðsgátt government portal, runs from August 3 to 18, 2026, leaving stakeholders roughly two weeks to respond.
The bill is the legislative follow-through of the ministry's 2025 assessment of the healthcare system's digital development. That review found responsibility for shared digital infrastructure scattered across multiple actors, with no clear accountability, no standardized technical requirements and no central coordination, and it recommended exactly the central unit the draft now creates. If adopted, the law would also amend three existing statutes, the Health Services Act, the Medical Records Act and the Director of Health Act, to align them with the new architecture.
What would the new Digital Health unit actually do?
Under the draft, Stafræn heilsa would operate under the overall direction of the Minister of Health and take charge of building, operating, developing and coordinating the shared digital infrastructure of the healthcare system. That covers the backbone systems providers rely on to exchange information, rather than individual clinical applications.
The bill strengthens the legal basis for four operational pillars: interoperability between systems, technical standards, information security, and the processing of personal data necessary to run the infrastructure. For vendors and integrators, that signals where binding technical requirements will land: data exchange interfaces, security baselines and the data-processing conditions under which shared health infrastructure can operate.
Who is impacted, and what should they do now?
The development matters for health IT and healthtech vendors, electronic health record (EHR) integrators, health data processors and cloud providers operating in Iceland's healthcare market. The bill sets the rules of the road for the shared infrastructure these actors plug into, and the consultation is the window to shape technical and data-processing requirements before they harden into law.
Because the bill also amends the Health Services Act, the Medical Records Act and the Director of Health Act, obligations tied to health service delivery, medical record handling and the Directorate of Health's remit will move in step. Affected vendors should map their current Icelandic deployments against the four pillars, identify where their interoperability, security and data-processing arrangements would need to change, and file a consultation response by August 18, 2026.
How does this fit Iceland's wider digital health direction?
The draft implements the Health Policy to 2030 and the government's digital health service strategy, and it is explicitly designed to support Iceland's participation in international digital health cooperation. The ministry frames the unit as the foundation for safer, more continuous health services, better use of public funds, and a stable base for innovation by both public and private actors.
The direction is consistent with Iceland's broader digital regulatory pipeline. Several EU instruments with health-data relevance, the AI Act, the Data Act, the Data Governance Act, NIS2 and the Cyber Resilience Act, remain pending EEA incorporation and have not yet been transposed into Icelandic law. The Digital Health unit would be a natural home for the operational obligations those instruments create once they bind Iceland, which is why healthtech vendors tracking the EEA pipeline should treat this consultation as early grounding.
| Item | Detail |
|---|---|
| Consultation case | S-147/2026 |
| Lead ministry | Ministry of Health (Heilbrigðisráðuneytið) |
| Consultation window | August 3 to 18, 2026 |
| Instrument | Draft bill on Digital Health (Stafræn heilsa) |
| Statutes amended | Health Services Act, Medical Records Act, Director of Health Act |
| Source | Samráðsgátt, case S-147/2026 |
Take advantage of this real-time watch
Next steps for affected teams: confirm whether your products or services touch Iceland's shared health infrastructure, review the draft's four pillars against your interoperability, security and data-processing setup, and submit a consultation response before the August 18, 2026 deadline. Obsidian tracks this bill and the wider EEA digital-health pipeline as it moves from consultation to binding law.
