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Regulatory Oversight › Machine Learning › Healthcare

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Foley & Lardner LLP

Artificial Intelligence in Health Care: Key Considerations for Oncology

Foley & Lardner LLP on

Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more

Health Care Compliance Association (HCCA)

Federation of State Medical Boards weighs in on ethical use of AI in clinical practice

Health Care Compliance Association (HCCA) on

Though responsible and ethical use of artificial intelligence (AI) has been a hot topic for the past few years, there has not yet been significant adoption of laws or regulations aimed specifically at regulating the use of AI...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Health Care Compliance Association (HCCA) on

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Foley Hoag LLP

Public Health Agencies Release “Guiding Principles” for Good Machine Learning Practice

Foley Hoag LLP on

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more

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