- Three companies marketing mHealth apps for cardiac care have been sanctioned for “misleading claims and irresponsible privacy practices.”
New York Attorney General Eric G. Schneiderman announced settlements with the three companies after a year-long investigation. Two marketed apps that claimed to enable users to measure heartrate after vigorous exercise through a smartphone camera and sensors; the third claimed to enable parents to monitor fetal heart rate.
“Mobile health apps can benefit consumers if they function as advertised, do not make misleading claims and protect sensitive user information,” Schneiderman said in a press release. “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.”
Schneiderman’s action highlights a national effort to bring consumer-facing mHealth apps – which number more than 165,000 at last count – under control. Because most do not fit the U.S. Food and Drug Administration’s designation of a medical device, the job of governing them is unclear. The Federal Trade Commission and state attorneys general have gone after some app developers who falsely advertise what those apps can do or claim to measure vital signs or other physiological data.
In this case, Schneiderman targeted:
- Matis, an Israel-based company whose My Baby’s Beat app “claimed [to] turn any smartphone into a fetal heart monitor,” though the app was never approved by the FDA. “Although Matis exhorted consumers to use My Baby’s Beat rather than a fetal heart monitor or Doppler, it never conducted, for example, a comparison to a fetal heart monitor, Doppler, or any other device that had been scientifically proven to amplify the sound of a fetal heartbeat,” Schneiderman said.
- Runtastic, an Austria-based company, and Cardio, an American company, both of whose same-named apps claimed to measure heart rate and performance during stressful situations. Neither tested the apps’ accuracy despite marketing the app for that purpose, Schneiderman said. In Cardio’s case, he added, the company “misleadingly implied that the app was endorsed by MIT,” in whose lab the app had been developed.
Under terms of the settlement, the three app developers agreed to amend their advertising to remove misleading claims and to pay a combined $30,000 in fines. All three are now required to post disclaimers that their apps are not medical devices nor approved by the FDA.
While evidence exists that mHealth apps can improve care management for patients and close the collaboration loop with their caregivers, doctors have been slow to embrace or recommend them because of concerns about quality, as well as privacy and security.
Aside from going after mHealth app developers who knowingly mislead users, the healthcare industry is looking to create a system where apps can be certified, so that providers can then recommend them to their patients.
The latest to target mHealth app certification is a partnership comprised of the Healthcare Information and Management Systems Society (HIMSS), the American Medical Association, the American Heart Association and the DHX Group. Late last year, the four launched Xcertia, described as a partnership to “advance the body of knowledge around clinical content, usability, privacy and security, interoperability and evidence of efficacy” for mHealth apps.
Just one month earlier, the AMA had signaled its concern with apps in adopting a new set of mHealth policies.
“While some mobile apps and devices are subject to FDA regulation, others are not, and do not undergo rigorous evaluation before deployment for general use, which raises quality and patient safety concerns,” the AMA’s Council on Medical Service said in a report first presented at the 2015 interim meeting. “Without ensuring that there is strong and sufficient evidence that provides clinical validation to mHealth apps and associated devices, trackers and sensors, physicians will not fully integrate mHealth apps into their practices. More investment is needed in expanding the evidence base necessary to show the accuracy, effectiveness, safety and security of mHealth apps.”