FDA’s regulation of Health IT under its medical device authorities can be seen as proceeding on two separate tracks during the last year.

Track one is FDA’s ongoing policymaking.  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for regulating products within these Health IT categories.  FDA has stated that it intends to finalize the mobile medical apps draft guidance by the end of this fiscal year, and the agency has indicated that it intends to develop guidance regarding its regulation of clinical decision support software.

Track two is an assignment from Congress.  Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to issue a report to Congress by January of 2014 setting forth a “risk-based regulatory framework pertaining to health information technology, including mobile medical applications.” Section 618 also directed FDA to create a diverse working group of Health IT experts to assist it in this task.  That group held its final meeting last month, discussing a set of draft recommendations for regulation of Health IT.  The group will provide a final set of recommendations to FDA in September.  FDA will review the recommendations, along with public comments, when drafting its report to Congress.
Continue Reading FDASIA Workgroup Releases Draft Recommendations for Regulation of Health IT