GoKawiilPatients who use mobile applications to manage medical conditions including depression and chronic pain might assume the apps have been evaluated by regulatory agencies to be safe and effective. But that isn’t necessarily the case.
Most of the more than 55,000 medical apps that claim to diagnose or treat a condition—or ones that provide clinical decision support, known as “therapeutic” apps—have never been assessed by any trusted neutral bodies or regulatory agencies to evaluate them for technical soundness, ethical design, or clinical benefit. The apps often don’t comply with regional data security and privacy laws to protect people’s sensitive health information.
Medical apps differ from traditional wellness apps, which provide users with insights into becoming healthier by, for example, tracking fitness activities, monitoring blood pressure, and analyzing sleep patterns.
There is no reliable way to verify that therapeutic apps deliver the results they indicate. To help ensure such apps are credible, the IEEE Standards Association (IEEE SA) recently launched the IEEE Global Medical Mobile App Assessment and Registry. The publicly searchable directory is designed to list apps that have been vetted by experts across several criteria including technical soundness, ethical design, compliance with data security and privacy regulations, and clinical efficacy, which is evidence of a clinical benefit for the patient.
“Patients, clinicians, payers, and health care systems often struggle to distinguish clinically meaningful therapeutic apps from those that are simply well-marketed,” says IEEE Senior Member Yuri Quintana, chair of the assessment and registry program. He is chief of the clinical informatics division at Beth Israel Deaconess Medical Center, in Boston. “Our goal is to establish a standardized review method using criteria developed by experts.”
Why regulation is lacking
Because the apps are intended for medical use without being part of a medical implement, they fall under the designation of software as a medical device (SaMD), according to the International Medical Device Regulators Forum. SaMD is supposed to be regulated by public health agencies such as the U.S. Food and Drug Administration, but the apps have developed and grown in popularity so quickly that regulators haven’t been able to keep up, Quintana says. Some companies have received approval, but most have not, he says.
Many users are unaware of the regulatory gap, he says.
“Seeing an app from a well-known company often creates the impression that it has been meaningfully vetted for safety and efficacy, even when that is not the case,” he says.
Some companies are using deceptive advertising to sell their product, he adds. Marketing materials might claim that all of a company’s health apps are certified, even though only one app has been approved by a regulatory body to treat a particular condition. Or the verbiage might imply the company has clinical evidence proving its application works, even though the app has never been tested independently.
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