Legislative developments

The assignment within the Ministry of Health and Social Affair includes submitting proposals on how the national collection of data on children’s and young people’s health can be improved. The remit includes, among other things, analysing which data should be collected at national level from school health services’ medical interventions, which data on children and young people should be recorded in the dental health registry, and whether a new health data registry should be established or whether existing registries can be used.

Name of the assignment: Uppdrag om att utreda bättre förutsättningar för att följa upp barns och ungas hälsa och hälsoutveckling (S 2025:D).

The inquiry involves submitting proposals for legislative measures aimed at increasing the number of clinical trials and certain research initiatives in Sweden (Dir. 2025:76).

Name of the inquiry: Utredningen om beslutsoförmögna forskningspersoner (S 2025:09).

The assignment within the Ministry of Health and Social Affair concerns enabling a national digital infrastructure for health data and includes, among other things, submitting legislative proposals to adapt Swedish law to the EU Regulation on the European Health Data Space (EHDS).

Name of the assignment: Uppdrag att möjliggöra en nationell digital infrastruktur för hälsodata (S 2024:A).

In its report, ‘Vidareanvändning av hälsodata för vård och klinisk forskning’ (SOU 2023:76), the inquiry has proposed a new law on certain secondary uses of personal data for clinical research.

The proposal entails, amongst other things, that regional authorities or higher education institutions conducting clinical research may be granted access to personal data, provided that the data subject has consented to participate in the research and to the data being made available via direct access or other electronic disclosure.

The proposals are being prepared within the Government Offices of Sweden.

In the referral to the Council on Legislation ‘Nytt regelverk för hälsodataregister‘, the Government proposes a new Health Data Registries Act. The proposals include, among other things, broader possibilities for the National Board of Health and Welfare to process personal data in national health data registries.

The European Parliament and the Council have adopted a Regulation on the European Health Data Space (EHDS), which, amongst other things, regulates the secondary use of health data for purposes such as scientific research.

The Regulation enables researchers to access anonymised or pseudonymised health data from multiple health data holders in secure processing environments after obtaining a data permit from a health data access body.

The Regulation will enter into force in March 2027. The provisions on the secondary use of health data will apply from March 2029.

On 17 June 2026, the Swedish Parliament adopted amendments to the Ethical Review Act in accordance with the Government’s proposal. The amendments will enter into force on 1 July 2027.

On 20 May 2026, the Swedish Parliament adopted the Social Data Register Act in accordance with the Government’s proposal. The Act entered into force on 1 August 2026.