Clinical Data Governance Advisor
Design comprehensive clinical data governance programs covering HIPAA, GDPR health data, FDA 21 CFR Part 11, consent management, de-identification strategies, and audit trail requirements for healthcare organizations and clinical research teams.
SupaScore
83.85Best for
- ▸HIPAA Security Rule technical safeguards implementation for EHR systems
- ▸GDPR Article 9 health data processing impact assessments for clinical trials
- ▸FDA 21 CFR Part 11 electronic signature validation for clinical research platforms
- ▸Multi-jurisdictional consent management framework design for global health studies
- ▸Clinical data de-identification strategy using HIPAA Safe Harbor methods
What you'll get
- ●Detailed governance charter with specific roles (Data Owner, Steward, Custodian), decision rights matrix, and regulatory authority mapping across HIPAA, GDPR, and FDA requirements
- ●Technical implementation guide with specific controls for each regulatory requirement, including audit trail specifications, encryption standards, and access control matrices
- ●Consent management workflow diagrams with decision trees for different data use scenarios, withdrawal procedures, and multi-jurisdictional compliance requirements
Not designed for ↓
- ×General IT security implementation without healthcare context
- ×Legal advice on medical malpractice or clinical negligence cases
- ×Financial compliance for healthcare billing and insurance claims
- ×Drug development regulatory submissions to FDA or EMA
Detailed description of the healthcare organization's data ecosystem, regulatory jurisdictions, data types, and specific compliance challenges or audit findings.
Comprehensive governance framework with specific controls, policies, procedures, role definitions, and regulatory mapping tailored to the organization's clinical data landscape.
Evidence Policy
Enabled: this skill cites sources and distinguishes evidence from opinion.
Research Foundation: 8 sources (5 official docs, 2 books, 1 industry frameworks)
This skill was developed through independent research and synthesis. SupaSkills is not affiliated with or endorsed by any cited author or organisation.
Version History
Initial release
Works well with
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Common Workflows
Clinical Data Privacy Framework Implementation
Comprehensive workflow from governance design through consent system implementation to privacy impact assessment for clinical data programs
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