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Socialstyrelsens föreskrifter (HSLF FS 2016:40)

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The Swedish regulations on patient records and personal data processing (HSLF-FS 2016:40) is intended for use in conjunction with the Patient Data Act (2008:355). The regulation introduces stricter information security requirements in the healthcare sector for authentication and logging. It was amended in 2025 with HSLF 205:57 to include mandates for multi-factor authentication for system access, systematic and recurring sample checks of access logs and a requirement to save logs for at least five years.

This regulation amends the existing framework HSLF-FS 2016:40, which governs patient records and the processing of personal data within the Swedish healthcare system. Issued by the Swedish National Board of Health and Welfare (Socialstyrelsen), HSLF-FS 2025:57 introduces updated requirements for information security. It reinforces the need for continuous risk assessments to prevent unauthorized access and ensure the integrity, confidentiality, and availability of personal data. The regulation is part of Sweden's broader effort to enhance cybersecurity and data protection in the health and social care sectors.
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Socialstyrelsens föreskrifter (HSLF FS 2016:40)
compliance?
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Socialstyrelsens föreskrifter (HSLF FS 2016:40)
requires and how to comply.

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Requirements
4 §: Åtkomst till ospärrade patientuppgifter
7 §: Åtkomst till uppgift om spärrade uppgifter vid sammanhållen vård-och omsorgsdokumentation
8 §: Nödöppning vid sammanhållen vård- och omsorgsdokumentation
9 §: Dokumentation och kontroll av åtkomst till uppgifter
10 §: Information till en patient om åtkomst
11 §: Flerfaktorsautentisering för enskildas elektroniska åtkomst till uppgifter
12 §: Information till enskilda om begränsad elektronisk åtkomst till uppgifter
1-2 §: Tillgänglighet och tydlighet i patientjournaler
3 §: Krav på innehåll i patientjournal
4 §: Patientjournal utan standardiserad patientidentifiering
5 §: Medicinska uppgifter i patientjournal
6 §: Granskning av dokumentation
1 §: Skydd av autentiserings verktyg och obevakade enheter
2 §: Entreprenörers skyldighet att skydda patientuppgifter
3 §: Upplysning om spärrade uppgifter
4–5 §: Signering av journalanteckningar
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Socialstyrelsens föreskrifter (HSLF FS 2016:40)

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What are frameworks?

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The ISMS component hierachy

When building an ISMS, it's important to understand the different levels of information hierarchy. Here's how Cyberday is structured.

Framework

Sets the overall compliance standard or regulation your organization needs to follow.

Requirements

Break down the framework into specific obligations that must be met.

Tasks

Concrete actions and activities your team carries out to satisfy each requirement.

Policies

Documented rules and practices that are created and maintained as a result of completing tasks.

Never duplicate effort. Do it once - improve compliance across frameworks.

Reach multi-framework compliance in the simplest possible way
Security frameworks tend to share the same core requirements - like risk management, backup, malware, personnel awareness or access management.
Cyberday maps all frameworks’ requirements into shared tasks - one single plan that improves all frameworks’ compliance.
Do it once - we automatically apply it to all current and future frameworks.