HIPAA compliance is built into the data architecture from Sprint 1 -- not a checklist applied during QA. The decisions that determine compliance (where PHI is stored, who can access it, how access is logged, how long data is retained) are made at schema design time, not retrofitted after the build. A system built without compliance in the architecture requires a partial rebuild to comply -- we do not build that way.
BAA established before development: we sign a Business Associate Agreement before any PHI is handled in design sessions, test environments, or integrations. We do not use production patient data for testing -- synthetic test data with structural fidelity to your patient population is generated during discovery for development and QA use.
Database schema design with access controls as first-class entities: every table containing PHI (patients, readings, alerts, audit_logs) is designed with a clinic_id foreign key and row-level security policies (PostgreSQL RLS) enforced at the database layer, not just the application layer. A compromised application credential cannot return cross-clinic patient data because the query itself is constrained by the database's RLS policy evaluating the JWT clinic_id claim. PHI field minimisation: the readings table stores device_id, patient_id, reading_type, value, and timestamp -- not patient name or contact details. Patient demographics are in a separate table with stricter access policies; joined only when the UI requires it, never in bulk exports.
Penetration testing performed by an independent security firm before launch -- included in the project cost, not an optional add-on. The pentest covers the patient app authentication flow, the care team dashboard API endpoints, the device data ingestion API (testing for injection via malformed device payloads), and the EHR integration OAuth token handling. Critical and high findings are resolved before go-live with documented remediation evidence for your compliance records.
Security deliverables provided as project outputs: HIPAA Security Risk Assessment documentation (required by the HIPAA Security Rule §164.308(a)(1)); data flow diagram showing every point where PHI is created, processed, stored, or transmitted; access control matrix showing which roles can access which PHI fields; and audit log retention policy documentation confirming 6-year retention with tamper-evident storage (AWS S3 with Object Lock in Compliance mode).