Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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Stephen Browning, FDA assistant director for hemodynamic and heart failure diagnostics, explains the FDA perspectives and regulatory pathways for AI-enabled cardiovascular devices at TCT 2024.

FDA regulator examines AI's growing influence in cardiology

Stephen Browning, the FDA's assistant director of hemodynamics and heart failure diagnostics, spoke with Cardiovascular Business about the agency's perspective on AI-enabled cardiovascular devices and many other topics.

Artificial intelligence AI

Industry Watcher’s Digest

HHS isn’t waiting to see what its incoming secretary does before filling some key leadership positions. 

circuit board

Industry Watcher’s Digest

Having released the latest version of Llama in December, Meta is telling the world that open-source AI is the future of AI in healthcare. 

4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

glass and steel skyscraper

Industry Watcher’s Digest

Is AI adoption a marathon or a sprint? 

artificial intelligence AI infrastructure

Industry Watcher’s Digest

New Year’s Day brought the go-live for California’s new law forbidding the use of AI to deny health insurance claims. 

FDA AI enabled medical devices approval clearance

FDA to hopeful marketers of AI-equipped medical devices: Think beyond your initial approval

Some FDA-approved medical devices age more safely than others. That’s no less true of AI-enabled technologies than of any others. The agency spells out the ramifications in draft guidance issued this week. 

AI emerging technologies 3D printing

Industry Watcher’s Digest

Hospital boards of trustees should be grilling their CEOs about AI. 

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Around the web

Health Exec
These health systems have the biggest digital health portfolios

U.S. health systems are increasingly leveraging digital health to conduct their operations, but how health systems are using digital health in their strategies can vary widely.

Health Exec
Toylike robot pleases counseling clients where humanoid counterpart struggles to connect

When human counselors are unavailable to provide work-based wellness coaching, robots can substitute—as long as the workers are comfortable with emerging technologies and the machines aren’t overly humanlike.

Health Exec
Medsender, Patagonia Health team up to aid public health efforts against COVID-19

A vendor that supplies EHR software to public health agencies is partnering with a health-tech startup in the cloud-communications space to equip state and local governments for managing their response to the COVID-19 crisis.