Should artificial intelligence or machine learning (AI/ML) be allowed to alter FDA approved software in medical devices? If so, where should the guardrails be set? The discussions and debates surrounding AI/ML are heated; some believe the technology may destroy humanity, while others look forward to the speed of advancement it will allow. The FDA is getting out ahead on this debate. This week the agency drafted a list of “guiding principles” intended to begin developing best practices for machine learning within medical devices. A new framework envisioned by the FDA includes a “predetermined change control plan” in premarket submissions. This plan would include the types of anticipated modifications, referred to as “Software as a Medical Device Pre-Specifications”. The associated methodology used to implement those changes in a measured and controlled approach that manages risk the FDA calls the “Algorithm Change Protocol.”

ChatGPT and the underlying AI technology are, as near as anyone can tell, the next-level toolkit for research, communication, idea generation, and a million other uses. If you haven’t introduced yourself to it yet, leave plenty of time – getting started is easy, but getting yourself to stop may not be. Those of us that were around pre-internet may liken the first-time experience to the first time we gained access to the world wide web. The Sudden, much easier access to a world of information, puts one in a place where you don’t know what to try first.ChatGPT is the AI natural language program that is disrupting major technology companies. We explore how investors, businesses, and households can benefit from the efficiencies it creates.