The Food and Drug Administration will soon launch a centralized digital health unit that will address the cybersecurity and interoperability of medical device software, says Bakul Patel, who is overseeing the effort.
The creation of the new unit was called for under the Medical Device User Fee Amendment Agreements of 2017, which are slated to be in place from Oct. 1, 2017, until Sept. 30, 2022.
Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act, the FDA explains in a statement.
Under the user fee system, medical device companies pay fees to the FDA when they register and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. The FDA says these fees are aimed at helping the agency increase the efficiency of regulatory processes, with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.
The user fee amendments, which get tweaked and renewed every five years, "is an agreement that the agency makes with industry on certain performance goals and activities ...including making sure that [product] submissions reviews [are] timely," Patel explains in an interview with Information Security Media Group.
"This time around ... emerging issues with digital health - that includes interoperability and cybersecurity - and 'software as a medical device' and 'software inside a medical device,' ... are some of the things that are of interest to the FDA ... and industry."
Oct. 1 Launch
The new unit, slated to formally launch Oct. 1, "is a central point to coordinate and be consistent as the emerging field [of digital health] evolves," Patel says.
In the interview (see audio link below photo), Patel also discusses:
- The types of products, including some mobile health applications, that potentially fall under the banner of "software as a medical device," as well as what the FDA means by "software inside medical devices";
- The FDA's increased attention to the cybersecurity of medical devices over the last several years - including the agency's release of pre-market and post-market guidance - and how those efforts will fit with the activities of the new digital health unit;
- The talent needs, including cybersecurity expertise, for the new digital health unit.
As associate director for digital health at the FDA Center for Devices and Radiological Health, Patel leads regulatory policy and scientific efforts in areas related to emerging and converging areas of medical devices, wireless and IT. This includes responsibilities for cybersecurity, mobile health, health information technology, medical device interoperability and medical device software. Patel is also the FDA's liaison with the Federal Communications Commission and Department of Health and Human Services' Office of the National Coordinator. Since its inception in 2013, Patel also has chaired the International Medical Device Regulators Forum's "software as a medical device" working group. Before joining the FDA, Patel held key leadership positions in the telecommunications, semiconductor capital equipment, wireless and IT industries.