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California’s “Physicians Make Decisions Act,” effective January 1, 2025, requires human oversight of the use of artificial intelligence in medical treatments and decisions.

Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.

ChatGPT will help doctors and medical practices keep better records, review medications, track diseases, and monitor patients. Healthcare providers need to understand the legal rules that govern [...]

Regulatory compliance and business transactional review of digital health companies and practices including telemedicine, medical software, health hardware, and the IoT.

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 [...]

Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning

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

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 [...]