Purpose: Ensure every certified module, application, and integration remains compliant with ONC 45 CFR Part 170 criteria, covering APIs, security, privacy, and data export capabilities. Provides an organized, living inventory of certification evidence and remediation progress.
Structure
- Criteria → Function mapping (e.g., §170.315(g)(10) Standardized API, §170.315(b)(10) EHI Export, §170.315(d)(12) Encrypt Authentication).
- Evidence repository with screenshots, configs, test logs, and versioned artifacts.
- Remediation backlog with owners, dates, dependencies, and risk ratings.
Workflow & Automation
- Track certification progress across multiple applications and vendors.
- Attach test evidence directly to each criterion; auto-flag expiring or outdated proofs.
- Generate real-time readiness score and visual heat map of compliance status.
- Integrate with Jira or ServiceNow for remediation task tracking and dependency resolution.
Governance & Evidence
- Exportable audit binder with evidence index, owner sign-offs, and timestamps.
- Audit/surveillance readiness checklist with change history and effective dates.
- Supports pre-certification dry runs and self-assessments for internal review.
Views & Reporting
- Criteria-level dashboard with status indicators (Compliant, Pending Evidence, Gap Identified).
- Summary reports for executives showing readiness by product line, vendor, or system.
- Trend analysis: time to close gaps, criteria most frequently impacted by updates.
Value
- Compliance Officers: Continuous readiness evidence to avoid nonconformities during ONC audits.
- Developers & QA: Structured visibility into criteria mapped to application functionality.
- Executives: Snapshot of organizational readiness and remediation progress across systems.