New York Attorney General puts mHealth app developers on notice
Eric Schneiderman says vendors made deceptive claims and used irresponsible privacy practices, but some fear his approach could lead to fragmentation in regulating medical apps.
After a year-long investigation, New York Attorney General Eric Schneiderman has reached settlements with the developers of three popular health apps available online in Apple’s App Store and Google Play after they made misleading claims and implemented irresponsible privacy practices.
Under the settlements, the vendors were required to amend “deceptive” statements about their apps and to modify their privacy policies to better protect consumers, while also making clear that their apps are not medical devices and are not approved by the Food and Drug Administration, according to Schneiderman’s office.
Two of the app developers—U.S.-based Cardiio and Austria-based Runtastic—contended that their apps accurately measured heart rate after vigorous exercise using only a smartphone camera and sensors.
A third developer—Israel-based Matis—claimed that its app transformed a smartphone into a fetal heart monitor and therefore could be used to play an unborn baby’s heart rate, even though the app was not an FDA-approved fetal heart monitor.
Also See: Blood pressure app vendor settles with FTC
The three vendors were not immediately available for comment. However, Schneiderman noted that the companies have cooperated with his office and revised their advertising, consumer warnings and privacy practices. In particular, they now post clear and prominent disclaimers informing consumers that the apps are not medical devices and are not approved by the FDA, he said.
Further, under the terms of the settlements, the developers have agreed to provide additional information about testing of their apps; to change their ads to make them non-misleading; and to pay $30,000 in combined penalties. The vendors also made changes to protect consumers’ privacy by requiring affirmative consent to their privacy policies for these apps and disclose that they collect and share information that may be personally identifiable.
“Mobile health apps can benefit consumers if they function as advertised, do not make misleading claims, and protect sensitive user information,” said Schneiderman in a written statement. “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.”
Bradley Merrill Thompson, an attorney at the Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, says Schneiderman “clearly wants to make a name for himself” when it comes to mHealth apps. However, he warns that if other states follow the New York Attorney General’s example, it could become a serious problem for app developers nationwide.
“Most states have agencies that oversee advertising within their state, even though much of the advertising done is done broadly across the states,” observes Thompson. “This means software developers have to think about potentially all 50 states and whether an enforcer in any state might take offense at their claims.”
If states across the country become more active in looking at medical apps, he contends that it would have the potential to create confusion and conflicting legal standards.
“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,” warns Thompson. “As a result, in effect, developers would have to comply with whatever the most demanding state requires.”
According to Thompson, states like New York are not waiting for the federal government—either the FDA or the Federal Trade Commission—to take regulatory action. “Yet, again, we have an agency other than FDA weighing in on what it thinks is misleading advertising,” concludes Thompson. “Over the last several years, we’ve seen the FTC pursue mobile app companies on the basis of unsupported claims in the medical realm. Indeed, it has pursued claims that would likely fall under FDA regulation. But, the federal government doesn’t have a monopoly on regulating advertising, even for health-related products.”
Under the settlements, the vendors were required to amend “deceptive” statements about their apps and to modify their privacy policies to better protect consumers, while also making clear that their apps are not medical devices and are not approved by the Food and Drug Administration, according to Schneiderman’s office.
Two of the app developers—U.S.-based Cardiio and Austria-based Runtastic—contended that their apps accurately measured heart rate after vigorous exercise using only a smartphone camera and sensors. A third developer—Israel-based Matis—claimed that its app transformed a smartphone into a fetal heart monitor and therefore could be used to play an unborn baby’s heart rate, even though the app was not an FDA-approved fetal heart monitor.
Also See: Blood pressure app vendor settles with FTC
The three vendors were not immediately available for comment. However, Schneiderman noted that the companies have cooperated with his office and revised their advertising, consumer warnings and privacy practices. In particular, they now post clear and prominent disclaimers informing consumers that the apps are not medical devices and are not approved by the FDA, he said.
Further, under the terms of the settlements, the developers have agreed to provide additional information about testing of their apps; to change their ads to make them non-misleading; and to pay $30,000 in combined penalties. The vendors also made changes to protect consumers’ privacy by requiring affirmative consent to their privacy policies for these apps and disclose that they collect and share information that may be personally identifiable.
“Mobile health apps can benefit consumers if they function as advertised, do not make misleading claims, and protect sensitive user information,” said Schneiderman in a written statement. “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.”
Bradley Merrill Thompson, an attorney at the Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, says Schneiderman “clearly wants to make a name for himself” when it comes to mHealth apps. However, he warns that if other states follow the New York Attorney General’s example, it could become a serious problem for app developers nationwide.
“Most states have agencies that oversee advertising within their state, even though much of the advertising done is done broadly across the states,” observes Thompson. “This means software developers have to think about potentially all 50 states and whether an enforcer in any state might take offense at their claims.”
If states across the country become more active in looking at medical apps, he contends that it would have the potential to create confusion and conflicting legal standards.
“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,” warns Thompson. “As a result, in effect, developers would have to comply with whatever the most demanding state requires.”
According to Thompson, states like New York are not waiting for the federal government—either the FDA or the Federal Trade Commission—to take regulatory action. “Yet, again, we have an agency other than FDA weighing in on what it thinks is misleading advertising,” concludes Thompson. “Over the last several years, we’ve seen the FTC pursue mobile app companies on the basis of unsupported claims in the medical realm. Indeed, it has pursued claims that would likely fall under FDA regulation. But, the federal government doesn’t have a monopoly on regulating advertising, even for health-related products.”
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