PRD Template: Jira + Confluence for Healthcare
Healthcare PRDs must address a regulatory landscape that can halt your product entirely if mishandled. HIPAA privacy and security rules, FDA software classification (especially for SaMD), and clinical workflow integration requirements all constrain what you can build and how you test it.
This template layers healthcare-specific compliance sections onto the Jira + Confluence workflow so your engineering team gets clear stories with compliance acceptance criteria built in from the start.
Template sections
5 sections covering the complete prd workflow.
HIPAA Compliance Scope and PHI Classification
Identify every data element your feature touches and classify it as PHI, de-identified data, or non-health data. HIPAA defines 18 identifiers that make data PHI when combined with health information. Your PRD must specify how each PHI element is collected, stored, transmitted, and disposed of. Use the Confluence table macro to create a data inventory that maps each field to its HIPAA classification and protection requirements.
Patient portal messaging feature handles: patient name (PHI), date of birth (PHI), medical record number (PHI), message content discussing symptoms (PHI), and provider name (not PHI alone). All PHI encrypted at rest with AES-256 and in transit with TLS 1.3. Access restricted to treating provider and patient via role-based access control verified against the care team roster.
Tips
- Create a Jira custom field for PHI Classification on every story (None/Contains PHI/Accesses PHI)
- Use Confluence to maintain a living data inventory linked from every healthcare PRD
- Add HIPAA Security Rule reference numbers to Jira story acceptance criteria
- Set up a Jira workflow rule requiring security review before any PHI-touching story moves to Done
Clinical Workflow Integration
Healthcare products must fit into existing clinical workflows without disrupting patient care. Document the current workflow (observe clinicians, do not assume), the proposed change, and the impact on clinical time. Every additional click or screen transition in a clinical workflow has a measurable cost: studies show each EHR click adds 0.5-2 seconds, and clinicians already spend 50% of their time on documentation. Your feature must reduce this burden, not add to it.
Current medication reconciliation workflow: nurse opens EHR (2 min), pulls paper list from patient (1 min), manually enters each medication (8 min for avg 12 medications), flags discrepancies for pharmacist review (3 min). Proposed: patient completes medication list on portal pre-visit, auto-matched against drug database, nurse reviews pre-populated list and confirms (3 min total). Net savings: 11 minutes per patient encounter.
Tips
- Shadow clinicians for at least 4 hours before writing the PRD to understand real workflows
- Measure the feature impact in clinical time saved per patient encounter
- Include a Workflow Impact section in every Jira epic description
- Create Confluence diagrams showing before and after clinical workflows with time annotations
FDA Software Classification (SaMD)
Determine whether your feature qualifies as Software as a Medical Device under FDA guidance. The FDA uses a risk framework based on the seriousness of the condition and the significance of the information provided. If your software informs clinical decisions, it may require FDA clearance. Document your classification rationale in Confluence and link it to the feature epic in Jira. Even if your feature does not require FDA clearance, document why to create an audit trail.
AI-powered symptom checker classified as SaMD Class II under FDA guidance: provides information to inform clinical management decisions (not just administrative), targets non-serious conditions (common cold, allergies), and significance of information is moderate (suggests when to see a doctor). Required: 510(k) premarket notification, quality management system per 21 CFR 820, and post-market surveillance plan.
Tips
- Create a Confluence decision page documenting the FDA classification rationale before development starts
- If classified as SaMD, add FDA submission milestones to the Jira roadmap
- Include a Design Controls section in the PRD if FDA-regulated (design input, output, verification, validation)
- Consult with a regulatory affairs specialist for any feature that interprets clinical data
Interoperability and Data Standards
Healthcare data exchange requires adherence to standards: HL7 FHIR for modern APIs, HL7 v2 for legacy system integration, DICOM for imaging, and X12 for claims. Your PRD must specify which standards apply, which FHIR resources your feature uses, and how you handle the inevitable gaps where real-world clinical systems deviate from the standard. The 21st Century Cures Act requires FHIR-based APIs for patient access, making this a legal requirement for many features.
Patient data export uses FHIR R4 resources: Patient, Condition, MedicationRequest, Observation, and AllergyIntolerance. Integration with Epic EHR via SMART on FHIR for OAuth 2.0 authorization. Legacy lab system sends HL7 v2 ORU messages converted to FHIR DiagnosticReport via Mirth Connect interface engine. Data mapping validated against US Core Implementation Guide profiles.
Tips
- Specify the exact FHIR resource types and profiles in Jira story descriptions
- Create integration test stories for each external system connection
- Document data mapping tables in Confluence showing source fields to FHIR elements
- Include a fallback plan for when external systems are unavailable or return non-standard data
Access Control and Minimum Necessary Standard
HIPAA requires that access to PHI be limited to the minimum necessary for each user role. Your PRD must define role-based access controls that map to clinical roles: attending physician sees full record, consulting specialist sees only relevant sections, billing staff sees only administrative and billing codes, and researchers see only de-identified data. Document these access rules in Confluence and translate them into Jira stories with specific acceptance criteria for each role.
Role matrix for patient portal: Patient sees own records only. Primary care physician sees full record including notes from specialists. Specialist sees referral reason, relevant history, and own notes only. Nurse sees vitals, medications, allergies, and care plan. Front desk sees demographics, insurance, and appointment schedule only. Audit log captures every access with role, timestamp, and records viewed.
Tips
- Create a RACI matrix in Confluence mapping each data element to clinical roles
- Write separate Jira stories for each role access level with role-specific test cases
- Include break-the-glass procedures for emergency access that bypasses normal restrictions
- Test access controls with clinician personas, not just generic user accounts
Copy-paste template
# [Feature] PRD — Healthcare (Jira + Confluence) ## HIPAA Scope | Data Element | PHI? | Protection | Storage | |---|---|---|---| | [Field] | [Yes/No] | [Encryption/Access Control] | [Location] | ## FDA Classification - **SaMD Class:** [I/II/III/Not SaMD] - **Rationale:** [Why this classification] - **Regulatory Path:** [510(k)/De Novo/PMA/Exempt] ## Clinical Workflow - **Current flow:** [Description with timing] - **Proposed flow:** [Description with timing] - **Net impact:** [Time saved per encounter] ## Interoperability | Standard | Version | Resources/Messages | External System | |---|---|---|---| | [FHIR/HL7v2/DICOM] | [Version] | [Resources] | [System] | ## Access Control Matrix | Role | Data Access | Restrictions | |---|---|---| | [Role] | [What they see] | [What is hidden] |
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