The EU AI Act in Sweden

Per Sweden - AI Ecosystem Roadmap (SOU 2025:12)

• Regeringskansliet (Government Offices of Sweden) — Policy coordination and potential host for central AI strategy and cross-ministerial unit
• Myndigheten för digital förvaltning (DIGG) — Operational guidance, public sector procurement templates, digitalisation support
• Integritetsskyddsmyndigheten (IMY) — Data protection oversight, GDPR guidance for AI in the public sector
• Finansdepartementet (Ministry of Finance) — Commissioning department for the AI Commission (SOU series) and budgetary oversight

Per Sweden - AI Regulation Adjustments (SOU 2025:101)

• Post- och telestyrelsen (PTS) — Designated coordinating market control authority and common contact point; leads national market surveillance and regulatory sandbox operations
• Integritetsskyddsmyndigheten (IMY) — Data protection oversight; approves certain tests and advises on GDPR alignment and documentation requirements
• Finansinspektionen (FI) — Sectoral approval and oversight for testing/approvals within finance sector; participates in approvals for tests under real-world conditions
• Styrelsen för ackreditering och teknisk kontroll (Swedac) — Accreditation and oversight of conformity assessment bodies (anmälande myndighet for accreditation purposes)
• Läkemedelsverket (Swedish Medical Products Agency) — Notifying authority for AI systems related to medical devices and health products; sectoral competence for medical device conformity
• Myndigheten för digital förvaltning (DIGG) — Coordination on digital infrastructure, interoperability and public-sector digitalisation matters related to AI deployment
• Kammarkollegiet — Collection point for sanction fees and administrative fee management for certain enforcement actions

Per Sweden - National AI Strategy

• Ministry of Enterprise and Innovation (Näringsdepartementet) — Lead policy owner and producer of the inriktning document
• Ministry of Finance (Finansdepartementet) — Budgetary coordination and information-material sponsor (document marked as information material from Finansdepartementet)
• Vinnova (Swedish Innovation Agency) — Primary implementing agency for research and innovation funding; produced background analysis informing the strategy
• AI Sweden (National centre for applied AI) — National competence and applied research/innovation hub supporting implementation and public–private collaboration

Per Sweden - AI Ecosystem Roadmap (SOU 2025:12)

• The Roadmap itself does not prescribe statutory penalties; it recommends that future regulatory and procurement instruments clarify administrative and contractual penalties for non-compliance, aligned with EU-level rules.
• Proposals include using contracting remedies, administrative oversight actions and alignment with GDPR enforcement mechanisms where data protection rules are breached.
• Potential civil liability allocation through contracts and existing liability frameworks for harms caused by high-impact systems.

Per Sweden - AI Regulation Adjustments (SOU 2025:101)

• Administrative sanction fees for infringements of national implementing provisions (fee collection via Kammarkollegiet)
• Orders to suspend or withdraw AI systems from the market or to block certain uses
• Mandatory corrective actions and compliance orders (remediation plans)
• Public disclosure of enforcement actions and non-compliance findings
• Potential civil liability claims under Swedish law where harm results from non-compliant AI systems

Per Sweden - National AI Strategy

• The 2018 inriktning is a strategic (non‑binding) document and does not establish specific legal penalties.
• Existing legal frameworks (e.g., liability rules, sectoral regulation and GDPR) continue to apply to AI applications where relevant.
• The Government indicated that regulatory follow-up may be proposed where needed; such future measures could include sanctions or enforcement mechanisms once enacted.
• Organizations are expected to comply with applicable procurement, data protection and sectoral safety regulations; non‑compliance may trigger existing administrative or legal remedies.