Certification/Adoption Workgroup 3-29

The Certification/Adoption Workgroup met on March 29, 2010. Following up on the previousMarch 12, 2010 meeting and the February 25, 2010 meeting, the committee reviewed the revised set of recommendations to the ONC, and discussed concerns expressed about the potential for increased FDA regulation of EHR systems and possible ways that the ONC and FDA could possibly collaborate.

They considered a draft proposal today that outlined best practices for electronic reporting of patient safety hazards. The practices are expected to be included in the second phase of meaningful use starting in 2013. “Most unsafe conditions are not the result of a single software error. Instead, multiple factors are involved, including challenges with usability, processes, and interoperability,” says the draft proposal.

One of the concerns of increased FDA regulation expressed is that the FDA focuses on vendors who market their products. As a result, the FDA’s efforts do not cover open-source software and might not cover some self developed EHR modules. This “uneven playing field” is a significant concern because a patient centered approach to safety should not depend on the source of the software involved.

They identified a couple ways that the ONC and the FDA might collaborate. They recommended that the two agencies collaborate on certification criteria that improve patient safety and also that they focus on health IT areas that are creating safety risks for EHR implementations. One example of such a safety risk is retail pharmacies which do not process electronic order cancellations, which can result in over-medication of patients.

They also recommended that ONC commission a formal study to thoroughly evaluate health IT patient safety concerns and audit trails for health information exchange activities.

The audio from the meeting is posted with the agenda and meeting materials below:

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Agenda

Patient Safety Working Document

FDA Recommendation Working Document