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  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for regulating products within these Health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  FDA has stated that it intends to finalize the mobile medical apps draft guidance by the end of this fiscal year, and the agency has indicated that it intends to develop guidance regarding its regulation of clinical decision support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

Key Workgroup recommendations included:

  • Health IT should not be subject to FDA premarket requirements, except when used as medical device accessories, certain forms of high-risk clinical decision support, and certain high-risk uses of software.
  • FDA “should actively establish a policy of Enforcement Discretion for lowest-risk HIT, where enforcement of regulations is inappropriate.”
  • FDA should consider an exemption from GMP requirements for lower-risk HIT.
  • FDA “should in general expedite guidance and provide clarity on issues in this area.”
  • Additional funding might be needed to appropriately staff and build FDA expertise in Health IT and mobile medical apps.

The recommendations also noted that FDA’s regulatory policies toward Health IT were ambiguous on many important issues, including the border between wellness- and disease-related claims, the accessory rule, forms of clinical decision support software FDA intends to regulate, and the regulatory status of software modules incorporated into a medical device or accessed by a device.

Although the recommendations — and particularly the identified areas of ambiguity — do not critique specific aspects of FDA’s draft guidance on mobile medical apps, they reflect many key criticisms of the document.  As we noted in a previous post, industry coalitions have taken conflicting positions on whether FDA should delay releasing a final version of the mobile medical apps guidance document until it has had the opportunity to review and consider the Workgroup’s recommendations.  According to the Gray Sheet, the Workgroup’s recommendation that FDA “should in general expedite guidance” has reignited this debate.  Stakeholders should expect a busy close to 2013, as FDA grapples with pressure from industry and lawmakers to clarify its Health IT regulatory policies.