IEEE Standards Association has launched the IEEE Global Medical Mobile App Assessment and Registry, a voluntary certification program for therapeutic mobile apps. Over 55,000 medical apps claim to diagnose or treat conditions, yet most have never been independently assessed for safety, efficacy, or regulatory compliance. The registry evaluates apps across ~150 criteria in three areas: clinical efficacy, technical soundness, and ethical design. Apps must achieve over 85% compliance in each category to be listed. The review process takes 6–8 weeks, costs a submission fee, and approved apps receive an IEEE certification badge. The program aims to fill regulatory gaps left by agencies like the FDA that haven't kept pace with the rapid growth of medical apps.

7m read timeFrom spectrum.ieee.org
Post cover image
Table of contents
Why regulation is lackingHow the registry works

Sort: