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Vendors, providers mull effect of FDA mobile health regulations

Looming FDA regulations could turn smartphones into Class II medical devices. Early reaction from stakeholders suggests this could throw a wet blanket on innovation.

CAMBRIDGE, Mass. -- Proposed Food and Drug Administration (FDA) mobile health regulations showed up in the Federal Register in late July. A week later at the World Congress 3rd Annual Leadership Summit on mHealth, stakeholders debated if -- and how much -- they would stifle development.

While it is a detailed rule, the FDA is proposing, among other things, to regulate applications that port data between patient and provider on smartphones, tablets and personal digital assistants.

In a panel he shared with Jennifer Dyer, M.D., a mobile health software developer with Duet Health, and Partners Healthcare System's Center for Connected Health analyst Robert Havasy, attorney Brad Thompson said the regulation would cover several type of mHealth applications: 

  • those that aggregate information from home monitoring sensors and push data to health care providers (includes Dyer's Duet EndoGoddess, an iPhone app that aggregates a patient's home glucometer readings);
  • those where home sensor readings are manually input into the phone or tablet, and
  • those in which patients enter readings from devices manually and pass the data to providers.

The mHealth applications that fall under the rule as proposed would be considered Class II medical devices. These can include monitoring of safety issues and in some cases, special labeling. They do not require premarket approval, like prescription drugs.

Thompson stressed that, under one part of the FDA mobile health rule, the apps likely to get regulated are those marketed with claims beyond promoting general wellness. For example, the glucometer in the above example would probably come with the claim "helps manage diabetes," therefore making it a Class II medical device under the rule. Duet EndoGoddess would also be likely to be regulated under the "accessory rule" portion of the proposed regulation, Thompson said.

In theory, he added, everything connected to the regulated mHealth app could conceivably also be a Class II medical device. "Basically, when you plug in a medical device, it pollutes everything else that gets connected to it with that regulatory [coverage] -- potentially all the way to the cell tower, if you took FDA's literal interpretation to its natural conclusion," said Thompson, who serves as general counsel for the mHealth Regulatory Coalition vendor group.

The coalition, he said, seeks clarification from the FDA about how the accessory rule will be interpreted during the comment period and advocates that the FDA set limits on its reach.

What mHealth apps, powered wheelchairs have in common

According to FDA data, 43% of medical devices are Class II. This includes some pregnancy test kits and powered wheelchairs. Interestingly, distributors fall under this regulation, too. Although distributors are subject to fewer rules than the manufacturers, Thompson said the FDA mobile health rule could in theory affect Apple Inc. and its iTunes Store, which distributes some of the mHealth apps the rule would cover.

Dyer is a pediatric endocrinologist who designed her application to appeal to teen diabetics, who have the twin desires of wanting to fit in with non-diabetic peers and managing their condition without their parents bugging them. The app even offers iTunes store downloads as a reward for compliance.

Basically, when you plug in a medical device, it pollutes everything else that gets connected to it with that regulatory [coverage] -- potentially all the way to the cell tower.

Brad Thompson, general counsel, mHealth Regulatory Coalition

Dyer believes her app will help make it more appealing for her patients -- and those of other pediatric endocrinologists -- to manage their diabetes during a difficult time. While FDA mobile health regulation might complicate the development process, she will continue on the path of bringing Duet EndoGoddess to market, she hopes later this year.

"I'm just going to do whatever it takes," Dyer said. "[Patients] want this, they need it, and it will make their life better."

FDA mobile health regulations: Barrier or necessary safety check?

Despite his alignment with the vendor community -- and the knowledge that entrepreneurs in Silicon Valley and elsewhere prefer bare-knuckled market competition to weed out bad products over government intervention -- Thompson made the case that FDA regulation is a necessary barrier to market entry to protect patients from harm.

"That's not a bad thing. If [a product] is high risk, they ought to be regulating it," Thompson said. (He outlined the "regulation as benefit" argument in greater detail in FDA Regulation of Mobile Health, an e-book published earlier this year.)

In an earlier keynote, ONC special innovations assistant Wil Yu said the FDA was looking to regulate just a limited subset of mobile health applications, not mHealth in general.

"Even though the FDA recognizes the need to encourage as much free innovation as possible," Yu said, "it also has a dual responsibility to public health -- to oversee the safety and effectiveness of medical devices."

Let us know what you think about the story; email Don Fluckinger, Features Writer.

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