Dive Brief:
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Mhealth app developers Cardiio, Runtastic, and Matis have agreed to settle, pay a combined $30,000 to the New York Attorney General following a year-long investigation into deceptive marketing practices.
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As part of the settlement, the app developers have also agreed to change language in marketing material to make clear that the apps are not medical devices nor approved by the FDA and to clarify privacy policies.
- Cardiio and Runtastic were accused of claiming that their apps could accurately measure certain vital signs while Matis advertised the ability to turn a smartphone into a fetal heart monitor. The FDA had not evaluated these claims.
Dive Insight:
There are more than 165,000 health-related apps available to smartphone users, but they are loosely regulated. Mobile apps can be useful tools, but are associated with risks as summed up by New York Attorney General Eric T. Schneiderman, saying, “Mobile health apps can benefit consumers if they function as advertised, do not make misleading claims, and protect sensitive user information.”
All three app developers agreed to alter their marketing language and to disclose that apps would collect and share personally identifying information.
The FDA announced in guidance issued last August that it would not subject health-related apps to stringent regulations. Many applauded the move, which was intended to promote the development of apps that “empower individuals to take a more active role in their health.” However, enthusiasm for apps in healthcare has been tempered by calls for a cautious approach.
Last, November, the American Medical Association issued a broad set of policies for physicians to follow when incorporating apps into their practices, noting that there was little evidence to support clinical validation. A Health Affairs study published December 2016 determined there are relatively few apps available that deliver clinical utility to patients and physicians. Outside a lack of evidence to support their usefulness, apps also come with privacy concerns. HHS warned last summer it had little ability to enforce existing privacy protections when it came to apps.
Like other health IT products, there can be a lot of excitement surrounding health-related apps. While it is likely that some can be incorporated into clinical practice to encourage health behavior and to improve outcomes, patients and physicians should be wary of promises made by app developers.