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Federal Food Drug and Cosmetic Act (FFDCA) Artificial Intelligence Health Care Providers

Nelson Hardiman, LLP

The Limits of AI in Healthcare: Exploring Ethical and Practical Challenges

Nelson Hardiman, LLP on

Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

Jones Day

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

Jones Day on

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more

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