CQ TODAY ONLINE NEWS
May 18, 2012 – 10:33 p.m.
Lawmakers Seek to Clarify FDA Medical App Role
By Emily Ethridge, CQ Staff
Congress is stepping into the murky area of government regulation of health-related applications on mobile devices, trying to help determine when an app is just a helpful item on a smartphone and when it qualifies as a medical device.
Most items in the rapidly expanding industry of medical mobile applications currently fall into a regulatory gray area. The apps can range from simple educational tools, such as those that enable consumers to monitor their caloric intake, to advanced programs such as smartphone-based ultrasounds.
The Food and Drug Administration (FDA), which has long regulated medical devices, is trying to determine which applications qualify for its review and oversight. But its draft guidance published in July 2011 caused consternation among software developers, many of whom have never had to work with the agency before and are used to the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.
Now 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 bills, which will be considered on the two floors this month, contain very different language on the apps — setting up a potential fight for the conference committee.
Senate Majority Leader
The Senate bill would set requirements that the FDA must meet before issuing a final guidance on regulating the apps. The agency would have to convene a working group of stakeholders, and then submit a report to Congress with a proposed framework for regulation, clarifying whether individual applications should be regulated.
The Senate bill language would result in a “de facto moratorium” on the agency’s ability to finalize its policy, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. Forcing the agency to meet with the working group and report requirements first could delay a final guidance by years, he said, and until that guidance is in place, companies will remain in the dark about which applications the agency will regulate.
The House version (
It would “certainly take more than 18 months” for the FDA to meet the Senate bill’s requirements, Shuren said at a congressional briefing May 18.
IT Support for Senate Bill
But the Senate bill has gotten support from some software and technology companies. Health IT Now, a coalition of 65 organizations, endorsed the provision, saying it would ensure a collaborative approach on regulating mobile medical applications.
In a May 17 letter, Joel C. White, the group’s executive director, said he did not believe the provision would serve as a moratorium on the FDA draft guidance.
Lawmakers Seek to Clarify FDA Medical App Role
“The speed with which HHS satisfies the reporting and consultation requirements will determine how quickly it may issue final guidance,” White said in a letter to the Senate Health, Education, Labor and Pensions Committee. “Further, nothing in the legislation precludes FDA from issuing additional guidance with respect to health information technologies, including mobile medical applications.”
Shuren said that delay would prevent software developers from getting what they are asking for: more clarification. Companies have voiced concerns that simple apps would need to meet traditional FDA device-approval requirements, which could lead to higher costs and slower production times. They also question whether they will need to submit marketing information and scientific data from clinical studies if their products are determined to be medical devices.
Shuren describes the 2011 draft guidance as a “pulling back” of the agency’s power. He said that the agency’s goal is to make it so that many applications that would be subject to FDA regulations under current standards no longer would have to be regulated.
He noted that most medical mobile applications are low-risk, and likely to serve only educational or organizational purposes.
“They’re subject to our regulations today — what we want to say is, you don’t have to worry about this anymore,” Shuren added.
At the same time, the FDA maintains that it has “a public health responsibility” to oversee any mobile medical apps that “present a potential risk to patients if they do not work as intended.” And it already has approved some applications, including one that allows providers to view X-rays and other medical images remotely.
Picking those apps out of the ever-growing universe of medical mobile applications could be difficult. By the end of last year, more than 9,000 mobile applications were designated as medical devices, and by 2015, 500 million smartphone users are expected to use a medical device application, according to the agency.
Under the draft guidance, the agency could review any applications that control a medical device, turn a mobile platform such as a phone into a device, or create alarms or recommendations based on data received from a medical device.
“These are essentially an app version of a device we’re already regulating,” Shuren said. When the agency makes a final guidance, he said it also would set up a website to be updated with examples of medical applications that do not need agency regulation.
But the timing of any final guidance may depend on which chamber’s language ends up in the final user fee reauthorization measure.