Several subcommittees of the House Committee on Energy and Commerce held hearings this week regarding the regulation of Health Information Technology (Health IT), and in particular mobile medical apps. The series of hearings, beginning with testimony on Tuesday and Wednesday largely from industry representatives and patient advocacy groups, concluded on Thursday with testimony by the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC). These hearings came approximately 20 months after release of the July 2011 draft guidance from FDA regarding regulation of mobile medical apps (see Hogan Lovells' Medical Device Alert, July 25, 2011), as well as several months after a December 2012 proposed approach to improving safety for Health IT released by ONC (click here to view).
FDA update on regulation of mobile medical apps
On the third and final day of the hearings, Christy Foreman, the Director of the Office of Device Evaluation for FDA’s Center for Devices and Radiological Health (CDRH) joined Dr. Farzad Mostashari, the National Coordinator for Health Information Technology, in testifying before the Oversight and Investigations Subcommittee of the House Committee on Energy and Commerce.
Director Foreman was, in part, responding to a letter issued by the same subcommittee on 1 March 2013 (click here to view the letter). The letter requested that FDA provide an update on the status of the 2011 draft guidance on mobile medical apps and also clarify what actions the Agency has taken to date around those types of products. FDA delivered a written response to that letter during the hearing, although a copy is not yet publicly available. In her testimony, Director Foreman noted that the final guidance should be released in the coming months and, at the latest, by the end of the fiscal year. Director Foreman’s written testimony, as well as her summary comments during the hearing, outlined the key concepts from the draft guidance, suggesting that the approach in FDA’s final guidance likely will not deviate substantially from their draft proposal.
Director Foreman explained that FDA has been regulating mobile medical apps for over a decade. According to FDA analysis, over the last 3 years, the average FDA review time for a mobile medical app has been 67 days. Director Foreman further explained that FDA has reviewed approximately 100 apps. About 20 apps per year are submitted to the Agency, or approximately 0.5% of the total medical devices reviewed by the Agency. Director Foreman also confirmed that the Agency has not reviewed any apps to date that would be class III devices subject to premarket approval requirements.
In response to questions about FDA’s jurisdiction, Director Foreman explained that in order to be subject to the Agency’s oversight, an app would need to meet the definition of a medical device. Further, consistent with the approach outlined in the draft guidance, Director Foreman explained that the Agency only plans to regulate a subset of apps that meet the definition of a device. Defending the Agency’s approach in response to questions about regulatory overstep, Director Foreman noted that the Agency continues to believe that a large percentage of medical device apps would be subject to enforcement discretion and exempt from FDA requirements. Responding to a series of specific questions, Director Foreman stated that the Agency does not intend to regulate apps that count steps taken per day, serve as a patient health record or provide prescription reminders. Director Foreman also confirmed that the Agency has no plans to regulate smartphones or tablets generally.
Implications of the medical device excise tax
One of the key questions raised throughout the hearings was the potential application to mobile apps and Health IT generally of the medical device excise tax enacted as part of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA). Final regulations issued late in 2012 tie application of the tax to listing of a medical device with the FDA. Members of the committee raised concerns about whether the FDA’s proposed regulatory approach would subject mobile medical apps to the tax. After explaining that the FDA is a public health agency and not a taxing agency, Director Foreman stated her understanding that the tax would apply to any products listed as devices with the FDA, with some products potentially exempt due to status as consumer products (view Hogan Lovell's Medical Device Alert, 10 December 2012). When asked whether the FDA’s regulatory oversight would subject smartphones and tablets to the excise tax, Director Foreman explained that because FDA does not generally intend to regulate those products, they likely would not be subject to the tax.
ONC comments on interoperability and safety of Health IT
Dr. Farzad Mostashari, the National Coordinator for Health Information Technology, also testified during the same hearing. National Coordinator Mostashari noted that one of the challenges encountered in adoption and improvement of Health IT has been the lack of interoperability between individual Health IT systems, as well as between Health IT systems and medical devices. He explained that improvements in interoperability would greatly advance use of Health IT. When asked what ONC is doing to overcome this challenge, National Coordinator Mostashari noted that they are using every tool at their disposal to increase sharing of information. In the meantime, ONC is working with industry to establish standards that would improve interoperabilty. He noted that ONC’s 2014 certification standards for Electronic Health Records represent a step forward in solving these issues.
Members of the committee also questioned ONC regarding the data available supporting use of Health IT. National Coordinator Mostashari explained that there are many studies examining whether access to more information is ultimately helpful to patient care. Although there are a few negative studies that have received attention, the vast majority of the evidence demonstrates that Health IT improves outcomes. The National Coordinator also noted the safety guidelines proposed by ONC in December 2012 and explained that although steps can be taken to ensure patient safety, evidence suggests that the best thing that can be done for patient care is to move from paper to digital methods.
Webcasts of all of the committee hearings on Health IT and mobile medical apps are available on the website for the House Committee on Energy and Commerce, along with copies of the written testimony for each of the witnesses.