But the FDA's action alone does not establish which kinds of apps could be regulated, noted Bradley Thompson, an attorney with the Washington-based law firm Becker, Epstein and Green who is an expert on mobile health regulations. In fact, even the FDA's final guidance on mobile health apps, which is due this fall, will not settle some of the most important issues in this area, Thompson told InformationWeek Healthcare.
The FDA's letter was sent to Biosense Technologies Private Ltd., an Indian firm with a U.S. address in Mountain View, Calif. Biosense (which is not related to a U.S. company with the same name) makes an app called uChek, which is designed for use with commercially available urinalysis test pads, also known as dipsticks. When soaked in urine, these dipsticks turn different colors. A uCheck user takes photos of the test strips with an iPhone camera, and the app identifies the concentrations of certain substances in those strips. The developer claims that uChek produces test results equivalent to those of "semi-automated urine analyzer machines."
The FDA letter said that uChek appears to meet the definition of a medical device that requires FDA approval. Although the commercial dipsticks are cleared, the agency noted, any automated strip reader must receive separate clearance as a medical device. But it left the door open for the company to argue that uChek did not have to be regulated. Thompson said this kind of letter is rare and is generally reserved for neophytes who don't understand FDA rules.
[ Mobile health apps are one way to get patients better involved in their own care. See 5 Healthcare Tools To Boost Patient Involvement. ]
On the other hand, he noted, one of the FAQs on Biosense's website indicates that the company is very aware of FDA regulations. Using the exact language specified by FDA, that section states that uChek is a class I medical device, which doesn't require FDA clearance. Curiously, he added, the company had earlier stated that its app was not a medical device; but after Thompson testified about this issue and named uChek in front of a Congressional committee, it added this FAQ to its site.
Is there evidence that uChek doesn't do what it claims to do and therefore might be a threat to patient safety? Thompson responded that Gray Sheet, a medical device trade publication, had interviewed experts who said that Biosense had not done sufficient research to show that the app was reliable under FDA standards.
Thompson's firm recently did a survey of 100 randomly chosen mobile health apps on iTunes, reading the descriptions of each one. What the researchers discovered, he said, is that eight of the apps "clearly required FDA clearance or approval, and to our knowledge didn't have it," he said. "Another 30% could have gone either way. There wasn't enough information on iTunes to make a judgment about it."
The FDA's final guidance on mobile health, when it comes, is unlikely to resolve all of the regulatory issues, because two of the biggest ones will not even be part of that rule, Thompson said. They won't be in the final guidance because they weren't included in the draft rules that were released in 2011, he noted.
One of the areas that FDA failed to address is the difference between disease-related and wellness-related apps. A diet app that includes a calorie tracker and a pedometer, for example, doesn't need to be regulated if it's promoted for general wellness and fitness. "But if you take that same app and market it to people who have diabetes as a way to manage their diabetes, it's a medical device," Thompson said.
While uChek clearly has features of a mechanical device, in that it uses test strips and a camera, he said, other mobile health apps can be regarded as a device even if they only involve software. "Standalone software that does no more than use the computing power of a cellphone can be a medical device, if it's basically for managing a disease," he said, citing dosage calculators and imaging apps.
The other issue that FDA has not addressed -- but has said that it will deal with in a separate guidance -- is the definition of accessories, Thompson observed. Currently, anything used with a medical device to help it operate is defined as an accessory to that device and must be regulated. For example, he noted, software that connects a glucose meter to a cellphone could be defined as an accessory. Getting that definition updated to fit modern reality is a big priority for the industry, he said.