FDA and two other federal agencies are reviewing applications for outside participation in a working group to help establish a government framework for overseeing health information technology.

FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology are required to establish the group, with participation from health IT stakeholders and experts, and to develop the framework under a provision in the FDA Safety and Innovation Act passed last summer. (See Also see "FDA Subject To More Oversight Following User Fee Bill Passage" - Medtech Insight, 2 July, 2012..)

Applications were due March 8 to ONC’s website. The agencies will oversee the working group, and will set the number of representatives to ensure it is diverse, including consumers, patients, health care providers, startup companies, health plans or third-party payers, venture capital investors, information technology vendors, small businesses and employers.

The House Energy and Commerce Committee sent a letter to FDA Commissioner Margaret Hamburg March 4 calling for more clarity on mobile app regulation and the release of a final guidance.

Applicants were required to fill out their top five areas of expertise from a list of nearly 60 subject areas, including health IT software, accountable care organizations and consumer health data.

The FDASIA law requires FDA, ONC and FCC (with help from the work group) to issue a report online by April 2014 containing recommendations for a risk-based regulatory framework pertaining to health IT, including mobile medical apps. The recommendations are intended to promote innovation, protect patient safety and avoid regulatory duplication. (See Also see "Final FDA Bill: Device Provisions" - Medtech Insight, 25 June, 2012..)

Health IT is defined by ONC as “hardware, software, integrated technologies or related licenses, intellectual property, upgrades or packaged solutions sold as services that are designed for or support the use of health care entities or patients for the electronic creation, maintenance, access or exchange of health information.”

Health IT is a framework that enables the management of health IT across multiple electronic systems, such as wireless medical devices, hospital information systems, communications infrastructure and electronic health record systems, according to FDA’s Health IT framework website.

The Bipartisan Policy Center released a framework for health IT patient safety regulation Feb. 13 with the goal of influencing the agencies’ recommendations. (See [A#01130225008].)

Call For Mobile Apps Guidance

FDA is engaged in broader health IT policy-setting in parallel with efforts to establish regulatory guidance specifically for mobile medical apps.

The agency issued its draft guidance describing how and to what extent it will regulate mobile medical apps in July 2011, but it has yet to finalize the document. Specifically, the draft details that FDA oversight should be applied to apps that either are used as an accessory to a medical device already regulated by FDA or transform a mobile communications device into a regulated medical device based on the intended use of the app. (See Also see "Industry Applauds FDA Draft Guidance On Mobile Medical Apps" - Medtech Insight, 25 July, 2011..)

The Republican leadership of the House Energy and Commerce Committee sent a letter to FDA Commissioner Margaret Hamburg March 4 calling for more clarity on mobile app regulation and the release of a final guidance.

The law makers say that although FDA has highlighted the app manufacturer’s “intended use” as the determining factor for whether FDA regulation is required, they are concerned that the policy could evolve into the app’s “actual use,” regardless of labeling, guiding policy.

This has implications for app makers, not just with regard to whether they may need to undergo pre-market and post-market oversight from FDA, but also whether they will be subject to the 2.3 percent medical device excise tax, since the Internal Revenue Service has defined the tax as applicable to devices registered and listed with FDA.

The House members say they want answers from FDA on several specific questions by March 15 “in order to clarify the uncertainty surrounding mobile medical applications, and how they will be regulated by FDA.”

Lawmakers asked Hamburg when FDA plans to issue the final guidance, whether FDA has analyzed the effect of the medical device tax on smartphones or the distributors of applications for those products, and whether the actual use of the app will factor into whether FDA regulates it.

The letter also requests information on the number of medical apps that have sought FDA approval, the processing time for the approvals, the number of apps that have been subject to FDA oversight after market introduction, and the number that have been changed or removed from the market due to FDA oversight.

Government Agencies Form Work Group To Develop Health IT Framework

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