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Healthcare Domain Testing

Healthcare software testing is governed by stringent regulatory requirements (FDA, HIPAA, CE marking) and carries the highest possible consequence of failure — patient safety. Testing in this domain requires formal validation processes, extensive documentation, and deep domain knowledge.

◈Key Points

HIPAA compliance: patient health information (PHI) must be protected — encrypt, audit-log, access-control all PHI.
FDA 21 CFR Part 11: electronic records and signatures in regulated environments must meet strict validation standards.
IEC 62304: the standard for software lifecycle processes in medical devices.
Validation vs Verification: verification checks 'did we build it right?'; validation checks 'did we build the right thing?'.
Traceability is mandatory: every test must trace back to a requirement and forward to evidence of execution.

⚡ Expert Pro Tip

Never use real patient data for testing — not even anonymised data in lower environments unless contractually permitted. Synthetic clinical data generators exist for this purpose.