IS FDA’S NEW SAMD DESIGNATION A BREAKTHROUGH FOR AI/ML/HEALTH IOT OR JUST A DIFFERENT KIND OF INVESTIGATION?

The medical device, and Health IoT, sector is seeking to match the recent pace of innovation driven by digital health vendors. Unlike traditional digital health solutions, which aren’t subject to much regulation beyond HIPAA, Health IoT devices and software are subject to FDA’s MDDS, Class I, Class II, and Class III designations. To help move from an “inspection oriented” regime to “operational excellence” (OE) driven regulations, the FDA is spearheading a new Software as a Medical Device (SaMD) designation.   Machine Learning (ML) and Artificial Intelligence (AI) solutions, which seek to eliminate or augment clinical decision making, are good test cases for SaMD. Join Shahid Shah, an award-winning and internationally recognized Health IoT Business Modeler and Systems Architect, as he explains what SaMD is, what the OE focus is, and why it matters to next generation software platforms seeking to help patients make medical decisions via educational and diagnostic algorithms.
Shahid Shah, Chairman, Netspective