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Category: Regulation

Home » News » Category: Regulation
Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers

Intended Use of Imaging Software for Intracranial Large Vessel Occlusion – Letter to Health Care Providers

(04/11/2022)
News / Regulation

The U.S. Food and Drug Administration (FDA) is reminding health care providers about the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO). …

FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

(10/27/2021)
International / News / Regulation / Trustworthy AI

Today, the U.S. Food and Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the “Good Machine Learning Practice for Medical Device …

FDA Artificial Intelligence and Machine Learning in Software as a Medical Device

FDA Artificial Intelligence and Machine Learning in Software as a Medical Device

(01/12/2021)
News / Regulation / Strategy

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of …

White House Guidance for Regulation of Artificial Intelligence Applications

White House Guidance for Regulation of Artificial Intelligence Applications

(11/17/2020)
Applications / News / Regulation

Executive Order 13859, “Maintaining American Leadership in Artificial Intelligence,” 1 requires the Director of the Office of Management and Budget (0MB), in coordination with the Director of the Office of …

HHS Launches First-of-its-Kind Regulatory Clean-Up Initiative Utilizing AI

HHS Launches First-of-its-Kind Regulatory Clean-Up Initiative Utilizing AI

(11/17/2020)
News / Regulation

The Department of Health and Human Services (HHS) has issued a final rule as part of a new department-wide regulatory clean-up initiative, the first of its kind utilizing artificial intelligence …

GSA Issues Award for Regulatory Workflow Modernization

GSA Issues Award for Regulatory Workflow Modernization

(09/16/2020)
Applications / News / Regulation

WASHINGTON – The U.S. General Services Administration today announced the award of its multiple year, $9.9 million contract to Deloitte Consulting LLP, and Esper, Inc., through GSA’s Commercial Solutions Opening …

CFPB Issues Policies to Facilitate Compliance and Promote Innovation

CFPB Issues Policies to Facilitate Compliance and Promote Innovation

(09/10/2019)
Applications / News / Regulation

WASHINGTON, D.C. – The Consumer Financial Protection Bureau (Bureau) today issued three new policies to promote innovation and facilitate compliance: the No-Action Letter (NAL) Policy, Trial Disclosure Program (TDP) Policy, and …

The Role of Machine Readability in an AI World

The Role of Machine Readability in an AI World

(05/03/2018)
Applications / Data / News / Regulation

… At the Commission we are currently applying machine learning methods to detect potential market misconduct. Many of the methods are open source and easy to implement for those trained …

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