Acceptance Criteria Checklist for Healthcare Products
Healthcare acceptance criteria must validate patient safety, HIPAA compliance, and clinical accuracy. A healthcare feature is not done until it is clinically safe, privacy-compliant, and validated by a clinical stakeholder.
Use this template to ensure every healthcare story addresses the regulatory and safety requirements that govern health technology.
Template sections
4 sections covering the complete acceptance criteria workflow.
Patient Safety Criteria
Stories with Medium or higher patient safety impact include: Clinical outputs are clearly labeled (advisory vs diagnostic), Critical values trigger alerts that require acknowledgment, System failures degrade gracefully with clear messaging (never silently fail), and Clinical workflows have been validated by a clinical user.
HIPAA Privacy Criteria
Stories touching PHI include: Minimum necessary data is accessed (no over-fetching), Access is logged with user identity and timestamp, Data is encrypted in transit (TLS 1.2+) and at rest (AES-256), Unauthorized access returns a generic error (no data leakage in error messages), and Users can only access data within their authorized scope.
Clinical Accuracy Criteria
Stories involving clinical calculations, drug interactions, or medical reference data include: Calculations match validated clinical reference sources, Drug interaction checking uses a certified database (First Databank, Lexicomp), and Lab value ranges match current clinical standards.
Accessibility Criteria
Healthcare interfaces must be accessible: WCAG 2.1 AA compliance, keyboard navigation for all clinical workflows, screen reader support for critical information, and color-independent status indicators (do not rely solely on color to convey clinical status).
Copy-paste template
## Healthcare Acceptance Criteria ### Patient Safety - [ ] Clinical outputs labeled as advisory - [ ] Critical value alerts require acknowledgment - [ ] Graceful degradation on system failure - [ ] Clinical workflow validated by [role] ### HIPAA Privacy - [ ] Minimum necessary PHI accessed - [ ] Access logged (user, timestamp, resource) - [ ] Encrypted: TLS 1.2+ (transit), AES-256 (rest) - [ ] Generic error on unauthorized access ### Clinical Accuracy - [ ] Calculations match reference source - [ ] Data sources are clinically certified ### Accessibility - [ ] WCAG 2.1 AA compliant - [ ] Keyboard navigable - [ ] Screen reader compatible
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