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FDA Treatment of AI, Machine Learning Software as a Medical Devic

FDA Treatment of AI, Machine Learning Software as a Medical Devic
natlawreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from natlawreview.com Daily Mail and Mail on Sunday newspapers.

Rob-califf , Digital-health-center , Us-congress , Software-precertification-pilot-program , National-evaluation-system , Drug-administration , Machine-learning , Medical-devices-workshop , Current-medical-device , Federal-food , Cosmetic-act , Different-regulatory-pathway

FDA Needs a New Approach to AI/ML-Enabled Medical Devices | Mintz - Health Care Viewpoints

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital...

Rob-califf , Digital-health-center , Health-care-viewpoints , Us-congress , National-evaluation-system , Drug-administration , Software-precertification-pilot-program , Machine-learning , Medical-devices-workshop , Current-medical-device , Federal-food , Cosmetic-act

Medicare drug price negotiation's day in court

Medicare drug price negotiation's day in court
statnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from statnews.com Daily Mail and Mail on Sunday newspapers.

Delaware , United-states , Rob-califf , John-wilkerson , Robert-gracia , Melanie-egorin , Colm-connolly , Janet-woodcock , Brad-wenstrupr-ohio , Bob-herman , Novo-nordisk , Novartis

FDA seeks greater LDT oversight and enforcement discretion phaseout by 2028

In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic…

Hogan-lovells , Rob-califf , Drug-administration , Clinical-laboratory-improvement-amendments , Us-supreme-court , Federal-food , Cosmetic-act , Verifying-accurate-leading-edge , Verifying-accurate , Leukocyte-antigen , Quality-system , Bill-cassidy

FDA seeks greater LDT oversight and enforcement discretion phaseout by 2028 | Hogan Lovells

In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases...

Rob-califf , Hogan-lovells , Us-supreme-court , Clinical-laboratory-improvement-amendments , Verifying-accurate , Leukocyte-antigen , Quality-system , Bill-cassidy , Administrative-procedure-act ,

The FDA's Dueling Narratives: Protector Versus Obstacle

The FDA's Dueling Narratives: Protector Versus Obstacle
healthaffairs.org - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healthaffairs.org Daily Mail and Mail on Sunday newspapers.

Dallas , Texas , United-states , Alma-hayden , George-annas , Richard-epstein , Rob-califf , Frances-oldham-kelsey , Advisory-panel , Lorenzo-oil , Sarepta-therapeutics-inc , Dallas-buyer-club

Rogue Faculty and Academic Freedom in the Age of Misinformation

Should our nation's academic institutions rein in faculty who amplify conspiracy theories and spread potentially harmful falsehoods?

Florida , United-states , University-of-florida , Robert-harrington , Ericj-topol , Kellyanne-conway , Bob-wachter , Roberta-harrington , Rob-califf , Eric-topol , Clyde-yancy , Jay-bhattacharya

Dr. Loh: Science, misinformation and health

Addressing two key issues — disparities in healthcare and misinformation, both of which adversely impact the health of Americans.

United-states , Chicago , Illinois , Americans , American , Irving-kent-loh , Rob-califf , Google , American-heart-association , Earth-society , Drug-administration , Annual-american-heart-association

MM+M Podcast 11.2.22: Industry's drug-price fixes, payers' birth-control restrictions, and Rob Califf's thoughts on Alzheimer's coverage

We recap last week's Galien Forum, which touched on DTC in a price-sensitive era, and Lecia reports on how payers are restricting access to birth control.

Rob-califf , Galien-forum ,

The Critical Link Between Health Care Cybersecurity And Health Disinformation

The Critical Link Between Health Care Cybersecurity And Health Disinformation
healthaffairs.org - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healthaffairs.org Daily Mail and Mail on Sunday newspapers.

United-states , Denmark , Russia , Ukraine , Russian , American , Danish , Rob-califf , Technology-modernization , Human-services , Drug-administration , American-medical-association

Live Breaking News & Updates on Rob califf

We recap last week's Galien Forum, which touched on DTC in a price-sensitive era, and Lecia reports on how payers are restricting access to birth control.Rob-califf , Galien-forum ,

We recap last week's Galien Forum, which touched on DTC in a price-sensitive era, and Lecia reports on how payers are restricting access to birth control.

Rob-califf , Galien-forum ,