Results for “healthcare-compliance”

Provides HIPAA-specific decision gates and guardrails for healthcare software, directing users to implementation and review skills for PHI handling, audit logging, and compliance.

Orchestrates multi-framework compliance programs by selecting applicable frameworks, mapping control overlaps, simulating audits, and consolidating evidence checklists.

Applies the HIPAA framework to identify, assess, and mitigate security risks in systems, processes, and data handling.

Routes compliance requests to the appropriate regulatory and quality-management skill among 15 bundled options, covering ISO 13485, EU MDR, FDA submissions, ISO 14971, CAPA, document control, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2, and auditing.

Guides implementation of data protection and privacy controls for regulatory frameworks such as GDPR, HIPAA, SOC 2, and PCI-DSS, including audits, retention policies, and data subject requests.

Conduct HIPAA Security Rule risk analysis, implement administrative, physical, and technical safeguards, manage Business Associate Agreements, and establish breach-notification readiness for covered entities and business associates.

Reference for SOC 2, PCI-DSS, HIPAA, and GDPR compliance requirements, including control checklists, evidence collection, and audit preparation guidance.

Prepare ISO 13485:2016 certification documentation for medical device Quality Management Systems, including gap analysis, template-based document creation, and compliance checklists.

Pressure-tests any compliance program with six forcing questions before adopting a new framework, planning an audit cycle, or signing off on certification readiness.

Applies the Sarbanes-Oxley Act to assess financial-reporting integrity and IT general controls, mapping executive certification and internal-control areas to auditable evidence for public companies.

Provides ISO 13485 internal audit methodology for medical device quality management systems, covering audit planning, execution, nonconformity classification, and external audit preparation.

Applies the California Consumer Privacy Act framework to identify, assess, and mitigate security risks in systems, processes, and data handling.

Audits codebases against HIPAA Security Rule safeguards, mapping findings to 45 CFR sections and tracing PHI data flows.