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Artificial Intelligence › Health Technology › Regulatory Oversight

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

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On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

Lathrop GPM

Fighting the Robots: Texas Attorney General Settles “First-of-its-Kind” Investigation of Healthcare AI Company

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In what it describes as a “First-of-its-Kind Healthcare Generative AI Investigation”, the Texas Attorney General (AGO) recently reached a settlement agreement with an artificial intelligence (AI) healthcare technology...more

Robinson+Cole Health Law Diagnosis

Forecasting the Integration of AI into Health Care Compliance Programs

Robinson+Cole Health Law Diagnosis on

Health care entities maintain compliance programs in order to comply with the myriad changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial...more

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

Arnall Golden Gregory LLP on

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Alston & Bird

AI Regulation in the U.S.: What’s Coming, and What Companies Need to Do in 2023

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Artificial intelligence (AI) is expanding into more industries (often in surprising ways) and has inevitably caught the attention of federal and state regulators. Our Privacy, Cyber & Data Strategy Team summarizes the...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

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Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

Akin Gump Strauss Hauer & Feld LLP

FDA’s AI White Paper: To Be or Not to Be, That is the Question

Akin Gump Strauss Hauer & Feld LLP on

• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more

Hogan Lovells

An intelligent approach for regulating medical device AI

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From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more

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