Congressional mHealth Hearings and the SOFTWARE Act Explained

11-22-2013 12-24-04 AM

During Congressional hearings within the House Energy and Commerce Committee this week, Jeffrey Shuren, MD, and FDA director over the Center for Devices and Radiological Health, was called to testify on the FDA’s recently published final guidance over the regulation of mobile medical apps.

During the hearing, it quickly became apparent that some members of congress, including Congressman Joe Pitts (PA) chairman of the subcommittee on Health,  viewed the guidance as both too restrictive and also too vague. Congressman Pitts opened the session saying:

In September of this year, the Food and Drug Administration (FDA) put forward a proposal, in the form of final guidance, indicating that software was a medical device for the purposes of regulation—except that software is not a medical device. To regulate it as such, the FDA has said it will use discretion to decide which software to regulate. Except that no matter what Dr. Shuren tells this committee here today, there is no guarantee that his successor won’t go back on this guidance tomorrow.

A short time later, representative Pitts questioned Dr. Shuren over the uncertainty of the final guidance on mobile medical apps and what it might one day include.

Pitts: Dr. Shuren, you have publically intimated in the past that the FDA could regulate electronic health records as medical devices.  Can the FDA Regulate electronic health records as medical devices? 
Shuren: Arguably yes, but we have stated on the record and put into formal policy that that is not what we are doing and that is now official policy of the agency.

Senator Pitts then goes on to ask whether the FDA had the authority to change its formal policy in the future, to include a regulatory position over EHRs or clinical decision support tools.  Shuren acknowledges that the FDA did retain the authority to expand its regulation to include EHRs and clinical decision support tools, but that in order to change a final policy, the FDA would need to follow a well defined and formal process that included both congressional oversight and solicitation of public comments.

At this point, the conversation moved directly to the recently proposed SOFTWARE Act. The SOFTWARE Act was written to formally name and define different types of software operating within the healthcare market. The bill then outlines the regulatory oversight the FDA would have over each. The bill aims to provide a long-term framework for medical software oversight within the FDA in a way that removes ambiguity or the potential for discretionary regulation in the future. Introduced by representative Martha Blackburn, the bill has won bi-partisan support.

Within the SOFTWARE Act, the authors have created definitions of medical software, clinical software, and health software. Medical software is essentially direct-to-consumer marketed mHealth apps that directly support self-administered clinical actions. The bill defines medical software as software that:

“is intended to be marketed for use by consumers and makes recommendations for clinical action that includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider.”

Clinical software, like EHRs and clinical decision support tools, are defined as systems that are marketed to healthcare providers, for use in healthcare settings that:

“captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body of man or other animals.”

Health software is defined as secondary software needed to either support or access clinical or medical software. Virtual environments like VMWare or Citrix would fall under the health software classification. The SOFTWARE act defines health software as software that:

“supports administrative or operational aspects of health care and is not used in the direct delivery of patient care; or whose primary purpose is to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.’’

Of the three, only software classified as medical software would be subject to FDA regulatory oversight. The bill does not drastically contradict the currently published final policy on mobile medical app regulation, but it takes away the ability of the FDA to apply discretionary regulatory oversight on certain apps, and it removes the authority of the FDA to ever attempt to regulate certain types of software in the future, such as EHRs.

Ultimately, the FDA’s final guidance on mobile medical apps is a first of its kind attempt to regulate software. Because it is an FDA policy, rather than a legislative framework, it is subject to changes in the future, and therefore is being criticized as potentially unstable. The proposed SOFTWARE Act attempts to take away some of that uncertainty by narrowing the potential scope of the FDA’s oversight.

Representative Gene Green, co-sponsor of the SOFTWARE Act explains that, “As new technologies emerge, it’s important that federal regulatory agencies like the FDA are properly equipped to provide a common sense level of oversight of medical software. This bill builds on the steps forward made by the FDA in their recently released guidance and focuses federal resources on the medical software that pose a risk to patients.”


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