Developers: Get Your Medical Mobile App Verified By IEEE

Patients using mobile apps to manage medical conditions like depression and chronic pain may assume these apps have been evaluated by regulatory agencies to be safe and effective. However, this is often not the case. Out of over 55,000 medical apps that claim to diagnose or treat a condition, most have not been assessed by trusted neutral bodies or regulatory agencies for technical soundness, ethical design, or clinical benefit.

The IEEE Standards Association (IEEE SA) has recently launched the IEEE Global Medical Mobile App Assessment and Registry to address this issue. This publicly searchable directory lists apps vetted by experts across several criteria, including technical soundness, ethical design, compliance with data security and privacy regulations, and clinical efficacy. "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.

The need for such a registry arises because medical apps, classified as software as a medical device (SaMD), have not been adequately regulated by public health agencies like the U.S. Food and Drug Administration. The rapid development and popularity of these apps have outpaced regulatory efforts, leaving users unaware of the regulatory gap.

Some companies use deceptive advertising, claiming their apps are certified or clinically proven, when in fact, they have not undergone rigorous evaluation. The IEEE registry aims to fill this gap by providing a standardized review method using criteria developed by experts. The assessment framework was developed by a multidisciplinary group of 35 volunteer experts from 10 countries.

The registry will evaluate apps against about 150 consensus-based criteria across three major areas: clinical efficacy, technical soundness, and ethical design. The submission of apps is voluntary, and developers can expect the review process to take six to eight weeks. The IEEE charges a nonrefundable submission fee that covers the cost of the assessment plus the registry's annual subscription for the first year.

Approved apps receive an IEEE certification badge and submission identifier, which can be displayed on the company's website, app store listings, and marketing materials. The registry will be publicly available at no cost, providing patients, payers, and insurers with a valuable resource for identifying safe and trustworthy medical apps.