The Food and Drug Administration is giving further latitude to health IT under its jurisdiction with a pair of now-final guidances, which industry observers feel are friendly to innovation.
The new guidance applies to two types of software: medical-device-data systems that draw data from an FDA-regulated device and either display it or send it to an electronic health record; and medical applications that run on smartphones or tablets. Developers of those technologies will no longer have to register their products with the FDA or ensure that they are FDA-compliant.
Lawmakers in both houses of Congress, meanwhile, have expressed interest in legislation that would formally exempt many categories of health IT from FDA supervision. Language to that effect has been incorporated into the 21st Century Cures initiative from Rep. Fred Upton (R-Mich.), as well as the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act from Sen. Orrin Hatch (R-Utah) and Sen. Michael Bennet (D-Colo.).
But some supporters of the legislation view the FDA's new hands-off approach as an attempt to suck momentum out of the bills. “We are witnessing a jurisdictional tug-of-war between the branches,” said Dan Haley, vice president of government and regulatory affairs at Athenahealth.
The final FDA documents are similar to drafts issued in June, but industry observers are pleased with a few changes. For example, the guidelines on medical-device-data systems have been expanded to include image-based data, noted Bradley Merrill Thompson, an attorney with Epstein Becker Green.
Robert Jarrin, senior director of government affairs at Qualcomm, said the agency also made important clarifications in its footnotes.
For instance, the FDA has more explicitly defined when a device is considered to be “actively” monitoring a patient's condition, which raises it from a “lighter-touch” regulatory category to a higher-risk category of medical-data-device systems. The FDA says that means “any device that is intended to be relied upon in deciding to take immediate clinical action.” Examples of higher-risk devices include telemetry and alarms for urgent medical conditions, the FDA stated.
Another guidance footnote broadens regulation exemptions. The FDA previously said it would still scrutinize products intended to manage certain disease categories, such as diabetes and cardiovascular disease, but now says that any app or medical-device-data system that provides simple treatment recommendations, such as those related to logging or tracking data, will be exempt.
Thompson noted that four years ago medical-data-device systems were subject to the highest category of FDA supervision and now they are exempt. He says that's illustrative of the agency's current approach to the broader health IT sector.
“The implications are profound,” he said. “The FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.”
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