Context
Drawn from a healthcare technology product where regulatory compliance and integration requirements demanded exceptional documentation rigor.
Intent
Illustrate the depth and structure expected in enterprise PRDs, particularly for regulated industries or complex procurement environments.
1. Problem Statement
Care coordinators in [REDACTED] health systems currently spend 22–34 minutes per patient reconciling medication lists across three or more source systems. The reconciliation error rate is 4.1%, of which 0.6% result in a clinically significant discrepancy. Existing workflows do not produce a defensible audit trail sufficient for CMS documentation requirements.
2. Users and Jobs
- Care coordinator — reconciling medications during transitions of care.
- Attending physician — reviewing reconciled list before order entry.
- Compliance officer — auditing reconciliation events post hoc.
- Health system CIO — approving integrations and data-flow authorizations.
3. Success Criteria
- Median reconciliation time reduced to under 8 minutes.
- Reconciliation error rate reduced to below 1.0%; clinically significant discrepancies below 0.1%.
- 100% of reconciliation events produce an audit-defensible record within 60 seconds of completion.
- Zero PHI exposure events across the pilot deployment.
4. Constraints
- HIPAA and applicable state privacy law compliance.
- HL7 FHIR R4 conformance for all inbound and outbound data.
- SOC 2 Type II controls maintained across the reconciliation pipeline.
- No dependency on internet egress from within the customer network boundary.
- Model-assisted reconciliation, if introduced, must operate under Tier 2 (Supervised Action) per our Agent Autonomy Standard.
5. Out of Scope
- Order entry — remains the exclusive responsibility of the EHR of record.
- Insurance eligibility verification.
- Patient-facing communication of reconciled lists.
6. Evidence and Sign-Off
Requires written sign-off from Engineering Lead, Security Officer, Compliance Officer, and the designated Clinical Advisor. Attach discovery evidence pack, security review record, and DPIA to the ADR.