2002, FDA, Licensing and Medicare - Health Care Compliance Brief

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2002

FDA

Licensing

Medicare

FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA

FDA Licensing Hospitals Medicaid

FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. 357 (2002); United States v. FDA , 119 F. Caronia , 703 F.3d

FDA

FDA Health Insurance Nurses Medicare

FDA Oversight of AI Software Developed by Health Care Providers

FDA and Off-Label Communication – Getting Closer to Truth

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