Compliance & Security

Santé Relevance:

U.S. santé privacy and security requirements governing PHI handling by covered entities and business associates.

Key Requirements:

• Business Associate Agreements (BAAs)
• Role-based access and MFA
• Audit logging and surveillance
• Minimum necessary access
• Encryption in transit and at repos
• Breach notification procedures
• Periodic risque évaluations and workforce training

Santé Relevance:

EU/EEA framework for data protection, lawful processing, and data subject rights.

Key Requirements:

• Lawful basis and consent management
• Data subject rights (access, erasure, portability)
• Data Processing Agreements
• Data Protection by Design and Default
• Records of processing activities
• International transfer safeguards

Santé Relevance:

Singapore data protection obligations for consent, purpose limitation, notification, and access/correction.

Key Requirements:

• Consent and notification
• Purpose limitation
• Access and correction rights
• Protection and retention limits
• Data breach notification

Santé Relevance:

International standard for establishing, implementing, maintaining, and continuously improving an ISMS.

Key Requirements:

• Risque management program
• ISMS governance and documentation
• Security controls per Annex A
• Continuous improvement cycle

Santé Relevance:

Attestation of control effectiveness over a review period per AICPA Trust Services Criteria.

Key Requirements:

• Documented policies and procedures
• Security surveillance and alerting
• Change and incident management
• Vendor risque management

Santé Relevance:

Santé-focused certifiable framework harmonizing HIPAA, ISO, NIST, and other requirements.

Key Requirements:

• Risque-based control selection
• Policy/procedure implementation
• Validation and scoring
• External évaluation

Santé Relevance:

Regulatory guidance for médical device software and santé tech solutions in Singapore.

Key Requirements:

• Risque classification and documentation
• Quality management alignment
• Clinique and cybersecurity considerations

Santé Relevance:

U.S. breach notification and enforcement enhancements to HIPAA.

Key Requirements:

• Breach risque évaluation
• Timely notifications
• Media and HHS reporting thresholds

Santé Relevance:

Modern santé interoperability standard for structured clinique data exchange.

Key Requirements:

• FHIR resources and profiles
• RESTful APIs and conformance
• Security and authorization (SMART on FHIR)

Santé Relevance:

Legacy and current santé messaging standards widely used by EHRs and labs.

Key Requirements:

• Message formats and segments
• Ack/error handling
• Transport and security

Santé Relevance:

Quality management standard for organizations involved in médical device lifecycle.

Key Requirements:

• Documented QMS
• Design and development controls
• Risque management and traceability
• Post-market surveillance

Santé Relevance:

Framework for governing responsible AI systems across lifecycle.

Key Requirements:

• AI risque management and controls
• Data governance and transparency
• Surveillance and continuous improvement