Bradley Merrill Thompson ,a Member of the firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article titled "Mobile Apps: Proposed FDA Rule Will Disrupt Industry."
Following is an excerpt:
The Food and Drug Administration's recent guidance on how it might regulate mobile health applications used by physicians and consumers will affect only a small portion of the apps on the market. "The majority of the folks who I've been dealing with do fall within the scope of that guidance document," said Thompson.
"If you're just managing your fitness, it's not regulated," he pointed out. "But if you use it to help manage your diabetes and to coordinate with your physician so the physician can help manage your diabetes, suddenly you're in a different territory. It's not connected to a medical device, but you've made it a medical device because it's decision support software."
The guidance also extends to home monitoring devices, some of which are already regulated. "If you connect directly to a home monitoring device, it's a [regulated] accessory to the device," Thompson said. "If the patient puts the data in manually, depending on how it's used and whether the patient shares the data with a physician to help manage his or her health, the app might be FDA-regulated."
If a mobile app is regarded as an "accessory" to a medical device, the guidance says, it will be regulated in the same category as the device itself. But the FDA also opened the door to certain applications being regulated at a lower level if they are accessories, Thompson noted. Device makers, he said, believe it's "overkill" to classify mobile accessories to Class III devices such as pacemakers and defibrillators in class III. The FDA is soliciting comments on this issue.
Manufacturers of mobile apps that come under FDA regulation may be required to show that their apps work as well as non-mobile software already being used in healthcare settings. But Thompson doesn't think that will drive many firms out of business.
"I'd hope that anyone entering this market would realize that, just because you're operating in a home setting doesn't mean that safety and effectiveness isn't equally important," he said. "I don't think that will surprise a lot of folks." On the other hand, he pointed out, when FDA issues regulations on mobile health apps, investors will be more likely to support mobile apps, because they will have more certainty about what's required and what their rate of return might be.
