Developers are working on new AI programs that enhance, support, or enable telemedicine. New uses include diagnostic tools and online tools that have legal compliance pitfalls
AI in the healthcare industry almost by definition, requires constant access to patient information. Developers and covered health providers need to understand when and how HIPAA applies to their [...]
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two
Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)
The FDA has a new proposal for approving AI and ML software that looks at the total product lifecycle from development to post-market uses and the adaptations the software learns
FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device
As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.
While I can't claim Marvin Minsky as a mentor I knew personally, his work did influence me--particularly his suggestion that the us v. them version of humans and robots (or AI) in the movies is [...]
Will artificial intelligence (AI) replace or augment professional human functions such as the analytical prowess and advisory skill of a talented attorney, as machine intelligence evolves, and [...]
Today a client asked me, "are you worried about the drought?" I said, "No, I'm worried about AI eating the world."