Healthcare Compliance

HIPAA establishes national standards for protecting patient health information in the United States. This guide covers the Privacy Rule, Security Rule, Breach Notification, BAAs, and practical compliance strategies.

HITRUST CSF is the most widely adopted security framework in US healthcare. This guide covers the e1, i1, and r2 assessment types, certification process, costs, and why health systems require it.

FDA 21 CFR Part 11 establishes requirements for electronic records and signatures in FDA-regulated industries. This guide covers validation, audit trails, e-signatures, and compliance for pharma and medical devices.

GDPR imposes heightened requirements on health data as a special category. This guide covers lawful bases for health data processing, DPIAs, patient rights, cross-border transfers, and healthcare-specific compliance.

The HITECH Act strengthened HIPAA enforcement, extended requirements to business associates, and mandated breach notification. This guide covers HITECH's impact on healthcare data security and compliance.

MEHARI is a comprehensive risk analysis method widely used in French healthcare. This guide covers the methodology, risk assessment approach, healthcare applications, and integration with ISO 27001.

The NHS DSPT is the UK's self-assessment tool for health and social care organizations to measure data security and protection. This guide covers the 10 standards, submission process, and achieving compliance.

PIPEDA governs health data privacy in Canada's private sector. This guide covers consent requirements, provincial health privacy laws, breach notification, and compliance strategies for health organizations.