Relationships between regulators and the regulated in the medical field could become increasingly contentions as the FDA moves to assume some authority of medical related apps that run on smart phones and tablets. Politicians, however, may be poised to offer relief, as Congress moved last month to consider curtailing the FDA's control over mobile device apps.
The concern originated over an FDA announcement last year that it was “…seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (“apps”) that are designed for use on smart phones and other mobile computing devices.” The FDA was prompted to make its move by a Research2Guidance prediction in 2010 that 500 million smart phone users worldwide would be using a health-care application by 2015.
The FDA has attempted to reassure the industry and potential customers that its goal is to encourage the development of mobile apps—it would not regulate the sale or consumer use of smart phones or tablets but would focus on a select group of applications. Those applications would fall into two categories. First, it would regulate applications and devices used as an accessory to medical device already regulated by the FDA—for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smart phone or a mobile tablet. And second, it would regulate applications and accessories that transform a mobile communications device into a regulated medical device by using attachments such as sensors—for example, an application that turns a smart phone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Nevertheless, reported Emily Ethridge of CQ Today Online News last month, the picture surrounding government regulation of health-related apps remains murky, and the FDA's draft guidance is causing “… consternation among software developers, many of whom have never had to work with the agency before and are used to the fast-paced, fairly unregulated world of the Internet.”
Consequently, she continued, “…the House and Senate have included provisions to slow the FDA’s regulation of the apps in legislation to reauthorize the agency’s ability to collect user fees to fund its review of drugs and devices.” The Senate would require the FDA to convene a working group of stakeholders and submit a report to Congress clarifying which apps might be regulated.
The House version would require that the Department of Health and Human Services (HHS) collaborate with the FDA, the National Coordinator for Health Information Technology, and the FCC and submit to Congress within 18 months recommendations about how to coordinate regulation.
Ethridge quoted Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, as saying it would take more than 18 months for the agency to meet the Senate requirements, so it looks like medical apps developers won't face a regulatory burden in the short term.
Tension between regulators and the regulated is unavoidable and probably even helpful. And an 18-month window can help medical apps and accessories makers demonstrate that they need minimal regulation, and the industry should be outspoken when making its case. It should also be transparent when inevitable problems occur.