SWEDEN Law and Practice Contributed by: Anna Fernqvist Svensson, Karl-Fredrik Björklund and Jakob Westling, Hellström Advokatbyrå KB
Companies providing healthcare products or services may anonymise patient data for product development and scientific research under specific conditions, as true anonymisation removes data from the GDPR’s scope. European Health Data Space Regulation Impact The aim of the EHDS Regulation is: • to improve access to and control over electronic health data for individuals to enable health data to be shared within and between EU countries so that it is available to healthcare professionals and pharmacies when needed for the best possible care and treatment of patients; and • to enable health data to be reused throughout the EU for purposes such as research, innovation and preparedness for and response to health threats. For secondary use, the EHDS creates Health Data Access Bodies in each member state to facilitate access to electronic health data for research and innovation. The regulation aims to enable life scienc - es companies to apply for access to pseudonymised health data across EU member states through stand - ardised procedures. This is done partly by specifying specific exemptions in Article 9 GDPR to which healthcare data covered by the regulation can apply. It aims to add specific rules for healthcare data to complement the existing rule set in the GDPR. Aside from this regulation, there have been no national (Swedish) guidelines put in place, or any other laws that regulate the health data space. 1.5 Processing of Personal Data in the Context of Artificial Intelligence Providers and deployers must comply with the GDPR where personal data is processed. Controllers must establish lawful bases for data collection and process - ing. There are so far (February 2026) no national guidelines or national AI Act in Sweden. The rules governing AI and automated decisions all stem from the AI Act and the GDPR.
The AI Act regime is risk-based, with prohibited AI uses including manipulative techniques causing sig - nificant harm, social scoring, and real-time remote biometric identification for law enforcement (except in narrow cases), as well as certain emotion recogni - tion and biometric categorisation systems. High-risk AI includes classification for specific areas including biometrics, critical infrastructure, education, employment, essential services (credit/insurance), law enforcement, migration/asylum, justice, and demo - cratic processes. Transparency and accountability serve as founda - tional principles across both regulatory frameworks. Within the GDPR framework, organisations must fulfil specific information duties when collecting personal data (for example Article 13 GDPR). The AI Act simi - larly prioritises transparency, though it implements this principle differently. High-risk AI system providers bear responsibility for equipping deployers with com - prehensive usage documentation, enabling them to properly understand and apply the system’s outputs (Article 13 AI Act). Under the EU AI Act (Article 14), “human oversight” refers to the requirement that high-risk AI systems must be designed and developed in such a way that they can be effectively overseen by natural persons during the period in which they are in use, with the aim of preventing or minimising risks to health, safety, or fundamental rights. In practice, this means that per - sons assigned to oversight must be able to under - stand the system’s capabilities and limitations, detect anomalies, avoid over-reliance on AI outputs (automa - tion bias), correctly interpret results, and crucially, be able to override, disregard, or shut down the system entirely. In Sweden, IMY has published a guideline which aims to create conditions for combining the development and use of AI with strong data protection, thereby promoting innovation and digitalisation in a privacy- friendly manner. The guidance stipulates that any processing of per - sonal data in the context of AI development or use must comply with GDPR.
458 CHAMBERS.COM
Powered by FlippingBook