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. 

artificial intelligence AI in healthcare

4 points crucial to the nimble regulation of GenAI

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

HeartLung Technologies, a Houston-based artificial intelligence (AI) company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new software that assesses chest CT scans for signs of coronary artery disease (CAD) and other potentially fatal heart conditions. The newly cleared offering, AutoChamber, was designed with opportunistic heart evaluations in mind.

FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

AI governance meeting

Good AI governance can spell the difference between smashing success and mere learning experience

Discussions of AI governance may cause many an eye to glass over, but the discipline is as crucial to the ascent of AI in healthcare as big training datasets drawn from diverse patient populations.

artificial intelligence AI in healthcare

Industry Watcher’s Digest

Payers are still running ahead of providers in the AI arms race. 

Code AI artificial intelligence

Industry Watcher’s Digest

Ransomware attacks even hurt hospitals that aren’t hit. 

artificial intelligence partnership on AI global cooperation

Partnership on AI valiantly trying to wrap arms around the world

It’s going to take a multinational effort for the global AI community—such as it is—to avoid the emergence of a “fragmented AI landscape.” 

HeartFlow Plaque Analysis Example

New Category I CPT code issued for AI-enabled coronary plaque analysis software

The news comes just days after CMS confirmed these technologies would start receiving expanded Medicare coverage in November. HeartFlow and other AI vendors have already shared their excitement over the decision. 

doctors nurses ai in healthcare fda oversight

How the FDA sees its role vis-à-vis AI in healthcare

The U.S. Food and Drug Administration has its hands full making sure medical AI products are safe, efficacious and trustworthy before they hit the market. The rise of ever-more-innovative iterations of the technology—not least generative AI—is only adding to the burden. 

Around the web

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.

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.

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.

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