Recent Food and Drug Administration draft guidance on use of electronic health records data when conducting clinical trials is useful, even if the nature of such guidance has limitations.

That’s the view of Jeff Smith, vice president of public policy at the American Medical Informatics Association. While the guidance is not binding, “you can see where FDA wants to go, but that’s where they start and stop,” Smith notes, adding that, most times, draft guidance does not result in some form of formal final guidance, even though a public comment period often accompanies a draft.

AMIA's Jeff Smith
AMIA's Jeff Smith

In some cases, guidance that’s issued is not followed by the industry. Sometimes, best practices are widely adopted, but with other types of guidance, organizations just ignore it, Smith adds. He believes the most recent guidance from the FDA shows its concern about variances in how EHR data is being used.

Depending on the importance of the issue to the agency that issues draft guidance, more regulatory pressure can be applied. In some cases, if guidance is not being adequately followed and the FDA’s expectations are not being met, that leaves the door open to issuing formal regulations, Smith says.

In relation to the most recent FDA guidance on EHR data, Smith believes that the agency is serious about having its directions followed. He characterizes the FDA document as rather bland and focusing heavily on the virtues of interoperability, but there likely are two or three levels of pressure it potentially could apply, he says. “If you can link EHR data with electronic data capture systems, it would facilitate (clinical research),” he says.

Smith believes tougher guidance could follow because there is no mention of standards supporting interoperability in the initial draft guidance, which is not a how-to document but rather raises issues related to having appropriate data integrity to validate clinical trial findings. At some point, Smith said he believes the clinical trials industry could see some expected level of harmonization on how data such be submitted.

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