Governance & Program Info
Genomics & Precision Medicine Inference — Governance
Cross-builder institution context and per-item ownership, due dates, status, and next actions for the governance-relevant checklist items in this builder.
Institution context
Program info
Applies across every builder in the app. Stored locally; nothing leaves the browser.
Checklist governance
Items (0 of 18 marked complete)
Annotate ownership, due date, status, and next action. Items on the left come from the builder's governance / compliance phases.
05 · Governance & Compliance
Map HIPAA Privacy and Security Rules to the genomic AI stack
Document how 45 CFR 160 and 164 apply to training data, inference runtime, audit logs, and downstream reporting.
05 · Governance & Compliance
Document GINA compliance for genetic information use
Map the Genetic Information Nondiscrimination Act constraints on use in health insurance and employment decisions.
05 · Governance & Compliance
Enforce minimum-necessary and purpose limitation
Inference jobs should only access the minimum genomic data necessary for the task, with purpose-of-use tagged in the audit log.
05 · Governance & Compliance
Track the FDA LDT final rule phase-in schedule
The 2024 LDT final rule phases in IVD requirements for laboratory-developed tests over several years — monitor milestones against the launch plan.
05 · Governance & Compliance
Maintain 510(k) / PMA / De Novo submission artifacts
Keep a live evidence package aligned to the chosen pathway rather than reconstructing it at submission time.
05 · Governance & Compliance
Operate the PCCP change-control envelope
Define which updates are inside the pre-authorized envelope and which require a supplement, per FDA Sep 2025 PCCP guidance.
05 · Governance & Compliance
Build and maintain the EU AI Act technical file
Annex IV technical documentation, risk management, data governance, logging, human oversight, accuracy / robustness, cybersecurity.
05 · Governance & Compliance
Align with EU IVDR (Regulation 2017/746)
Document the IVDR risk class, notified body path, and post-market performance follow-up.
05 · Governance & Compliance
Plan post-market monitoring and incident reporting
Post-market surveillance, performance monitoring, and serious incident reporting under EU AI Act Article 72 and IVDR Article 80+.
05 · Governance & Compliance
Maintain CLIA high-complexity compliance
Personnel competency, proficiency testing, validation, and quality control under 42 CFR 493 for the full bioinformatics pipeline.
05 · Governance & Compliance
Maintain CAP accreditation including bioinformatics checklist
CAP laboratory accreditation with specific attention to the NGS bioinformatics checklist items.
05 · Governance & Compliance
Align medical-lab operations to ISO 15189
ISO 15189 quality management and competence for medical laboratories — required in the EU and increasingly expected globally.
05 · Governance & Compliance
Comply with 21 CFR Part 11 electronic records / signatures
Audit trails, electronic signatures, and record retention for any FDA-submitted evidence.
05 · Governance & Compliance
Align interoperability to ONC HTI-2
Where the system exchanges data with certified EHRs, align with ONC HTI-2 interoperability and transparency requirements.
05 · Governance & Compliance
Operate an AI risk management program aligned to NIST AI RMF 1.0
Govern, Map, Measure, Manage — across the full AI lifecycle for the genomic inference stack.
05 · Governance & Compliance
Maintain IRB approvals and data-use agreements
IRB protocols for research use, data-use agreements for cross-institutional cohorts, and clear clinical-vs-research separation.
05 · Governance & Compliance
Document consent, withdrawal, and re-contact workflows
Operational processes for consent scope changes, withdrawal, return of results, and incidental findings under ACMG recommendations.
05 · Governance & Compliance
Board-level AI governance reporting
Diagnostic yield, equity metrics, adverse events, and regulatory posture should reach institutional leadership, not only the lab.