What was one of the recommendations from the 1996 FDA workshop on regulating clinical software?

• A. Software quality audits
• B. Competent human intervention as a guiding principle
• C. FDA regulation of EHRs
• D. Establishment of a certification process for EHRs

Answer: (A)

Ensuring safety in clinical software hinges on solid quality processes rather than broad, blanket regulation. The 1996 FDA workshop on regulating clinical software emphasized building reliable software through disciplined development and verification activities, and one concrete way to verify those processes is through software quality audits. These audits provide independent checks that the software was developed under established procedures, that requirements were traced through design and testing, that changes were controlled, and that risks were appropriately identified and mitigated. By validating the quality of the development and maintenance processes themselves, audits help catch issues before they can impact patient care, making them a practical and effective recommendation from that workshop.

The other ideas—regulating EHRs directly, creating a certification process for EHRs, or framing safety around “competent human intervention”—reflect broader or different approaches to governance and safety that were not the specific recommendation highlighted by the workshop.