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2024 outlook: Advancing AI innovations in patient care

Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety....

News

FTC calls out consumer protection and competition intersections in Copyright Office AI proceeding

The U.S. Federal Trade Commission (FTC) staked out its role in policing the potential competition and consumer protection implications of generative AI technologies’ use of...

News

U.S. AI policy heats up with new executive order and legislative activity

President Joe Biden signed a sweeping executive order on artificial intelligence (AI) spurring broad U.S. government action on AI safety, security, and trust and reinforcing Congressional...

Media Mention

Congress faces learning curve on AI in health care AXIOS

Congress isn’t moving any legislation on AI in health care yet – but lawmakers are definitely interested in the topic. New generative AI technologies are already being...

News

Technology policy’s next big challenge: Divergent approaches to regulating AI

The rapid growth of AI and its ramifications for nearly all aspects of society and the economy is placing increasing pressure on the U.S. and European governments to proactively set...

News

HHS ONC proposes new AI / ML requirements for certified Health IT

On April 11, the U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, and...

News

FDA promotes pre-approval for changes to AI devices via Predetermined Change Control Plans

On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change ...

News

CMS AppliedVR decision shows innovative tech can secure payment pathway under Medicare’s rigid statute

While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when...

News

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently...

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