In overseeing patient safety problems, which role is NOT performed by the FDA?

• A. Monitor patient safety problems
• B. Verify that a healthcare organization is using an EHR correctly
• C. Collaborate about certification criteria
• D. Focus on areas of EHR implementation that have safety risks

Answer: (B)

Regulatory oversight for patient safety in health IT centers on signals of harm, safety standards, and risk reduction, not on auditing how a hospital uses their EHR day to day. The FDA keeps watch over safety problems related to medical devices and software, conducts post-market surveillance, and issues alerts or recalls when needed. It also contributes to shaping safety-related criteria and standards in collaboration with other bodies, including those that define how EHRs should meet certification criteria. It also focuses on areas of risk within EHR implementations where faulty design or software behavior could lead to patient harm.

Verifying that a healthcare organization is using an EHR correctly falls outside the FDA’s remit. That kind of verification is handled by other entities involved in certification, accreditation, and implementation governance, not by the FDA.