Sekundäranvändning av patientuppgifter för vårdändamål : En rättslig analys av svensk rätt och aktuella lagförslag för utvecklingen av precisionsmedicin i ljuset av det europeiska hälsodataområdet

Sammanfattning

This thesis examines the legal prerequisites for the secondary use of personal health data in order to enable the implementation of precision medicine within the Swedish public healthcare system. Precision medicine technologies are based on advances in genetic studies which involve tailoring prevention, diagnosis and treatment to individual patients. This new medical approach has the potential to shift the paradigm from an 'one size fits all' approach to treatment that is tailored to each patient's unique circumstances. However, the effective implementation of precision medicine requires the analysis and comparison of health data from a variety of individuals. The study focuses on the legislative proposal in the Swedish Government Official Report SOU 2023:76, examining its compatibility with the General Data Protection Regulation (GDPR) and the recently adopted European Health Data Space (EHDS) regulation. A combination of legal dogmatic and EU legal methods are employed to determine the applicable law, supplemented by elements of legal policy analysis to evaluate whether the proposed rules are appropriate and effective in light of current healthcare objectives. The study concludes that Article 6(1)(e) of the GDPR provides a justifiable legal basis for processing personal data for this purpose. However, considerable legal uncertainty remains as to whether the exception in Article 9(2)(h) GDPR, which is normally applicable to healthcare provided to the data subject, can be extended to permit processing for the care of another person, a central aspect of precision medicine. Furthermore, the thesis highlights structural ambiguities in the Swedish Patient Data Act (PDL), including the lack of distinction between the primary and secondary purposes of data use. This contrasts with the more harmonised model under the European Health Data Space (EHDS). The analysis suggests that future Swedish legislation should adopt a more modern categorisation of purposes that is aligned with EU developments. Additionally, the thesis evaluates the proposal to establish regional precision medicine databases. While this model is formally compatible with GDPR and EHDS, it poses a risks leading to fragmentation and inequality in access to health data. Ultimately, the thesis concludes that a national solution would better fulfil the overarching goals of data interoperability, equity and innovation in healthcare delivery.