mHealth settlement raises concerns about future state-based enforcement

phone apps
Yesterday's settlement with three mobile health apps could signal a new wave of enforcement for the digital health industry.

A settlement between three mobile health app developers and the New York Attorney General’s Office signals the state’s intent to wade into regulatory waters typically reserved for federal agencies and raises concerns about how the digital health industry will contend with inconsistent state-based enforcement.

The settlement ends a year-long investigation of three mobile health apps accused of offering misleading claims about their product, according to an announcement from the New York Attorney General’s Office. Two of the apps—Cardiio and Runtastic—claimed their apps accurately measured heart rate but offered no evidence to support those claims, according to the Attorney General’s Office. A third app, called My Baby’s Beat, manufactured by Matis, claimed it could turn a smartphone into a fetal heart monitor.

All told, the companies paid just $30,000 in penalties, but Attorney General Eric Schneiderman offered a warning shot to other mHealth developers.

“Mobile health apps can benefit consumers if they function as advertised, do not make misleading claims and protect sensitive user information,” Schneiderman said. “However, my office will not hesitate to take action against developers that disseminate unfounded information that is both deceptive and potentially harmful to everyday consumers.”

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Although consumer-based health apps absorb the brunt of this enforcement, the announcement raises concerns that yet another agency is willing to regulate digital health. In addition to oversight from the Food and Drug Administration (FDA) and the Office of Civil Rights, the Federal Trade Commission (FTC) has shown a willingness to pursue digital health apps for misleading claims.  

If states decide to pursue potentially misleading advertising claims made by digital health apps, it could create confusion within the industry, Bradley Merrill Thompson, an attorney with Epstein Becker Green in the District of Columbia, told FierceHealthcare.

“If all 50 states were to get active in this, it would be highly likely that each state would look at claims a little bit differently,” he said in an email. “As a result, in effect, developers would have to comply with whatever the most demanding state requires.”

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Even if the FDA and the FTC loosen oversight of digital health—a shift that is expected under the leadership of Scott Gottlieb, who was nominated by President Donald Trump last week to lead the FDA—digital health companies could face various levels of enforcement from different states. With thousands of mHealth apps flooding the market, states like New York could opt to make digital health oversight a priority.

“The New York Attorney General clearly wants to make a name for himself in this domain,” Thompson said. “This step certainly establishes that office as a force to be reckoned with.”