Those products have not been cleared by the feds, and offer little or no clinical evidence to back up their claims.
“Most of these (apps) carry minimal risks to patients and consumers. However, others can carry significant risks if they do not function properly,” an FDA spokeswoman said on Wednesday.
“FDA intends to exercise enforcement discretion for the majority of mobile apps that meet the definition of device.”
BETTER FLAGGING?
The FDA has cracked down on a small number of mobile medical apps in recent years. In 2013, the agency admonished Biosense Technologies, maker of the “uChek” urine analysis system, for failing to seek regulatory clearance.
Some say Apple and Google should give them a hand. Apple, for instance, has no qualms about banning apps with explicit or illegal content. Malay Gandhi, strategy officer at digital health venture firm Rock Health, recommends they use flags to better indicate which apps are certified, or provide a way to report dodgy apps to the FDA.
If these companies are not more proactive, “nothing will be remedied until bodies start piling up,” said Christopher Dolan, a personal injury lawyer with the Dolan Law Firm in San Francisco.
To avoid liability, developers typically include disclaimers in their terms of use. But these are often buried in the fine print, or may be missed by nonnative English speakers.
Dolan points to Cardiograph, an app from Macropinch that sells for $1.99 on the App Store. It claims to monitor people’s heart rate with “the same approach used by professional medical equipment.”
The app’s description contains anonymous reviews advising patients to ignore the disclaimer: “Warning: The instrument, although accurate, is not an actual medical equipment. Consult your physician.”
“Judging by the feedback we’ve received over the years, our users are well-informed about the purpose and limitations of the app,” said Vladimir Georgiev, a spokesman for Macropinch.
Thompson, who runs the mHealth Regulatory Coalition, an organization that counts Samsung and Qualcomm among its members, is pushing the FDA to distinguish between products it will not regulate and those it considers mobile medical devices.
In September 2013, the FDA said it would regulate products that transform smartphones into devices the agency currently regulates, such as electrocardiography machines, or that would be used as accessories to such devices.
“The FDA wasn’t designed for post-market surveillance,” said Jason Brooke, chief executive officer and general counsel at Vasoptic Medical, maker of a mobile diagnostic that competes with a number of unregulated apps. The FDA needs to act soon to ensure that developers will “comply on their own.” (Reuters)