It’s official: AI rules are coming in 2024

The ideas and innovators shaping health care
Dec 13, 2023 View in browser
 
Future Pulse

By Daniel Payne, Ruth Reader, Erin Schumaker and Evan Peng

THE REGULATORS

Micky Tripathi

National Coordinator for Health IT Micky Tripathi has overseen development of the new AI rules.

The Department of Health and Human Services has struck first in regulating the new artificial intelligence tools in health care

The agency announced today it will require more transparency about artificial intelligence used in clinical settings, with the goal of helping providers understand algorithms’ potential risk, POLITICO’s Ben Leonard reports.

Why? The final rule will fill a void in regulation, aiming to help providers, like hospitals and physician groups, choose safer artificial intelligence that avoids bias. As it stands, AI in health care is loosely regulated and little is known about how the algorithms work.

It also fulfills requirements under President Joe Biden’s recent executive order on artificial intelligence.

How? The regulations will require software developers to provide more data to customers with the aim of allowing providers to determine whether AI is “fair, appropriate, valid, effective and safe.”

They will cover models analyzing medical imaging, generating clinical notes, and alerting clinicians to potential risks to patients.

AI tool makers will have to disclose information on how the software works and was developed. That includes who funded the technology, what its intended decision-making role is and when clinicians should be cautious about using it.

Software developers will also have to tell their customers how representative the AI’s training data is, how they attempted to mitigate bias and how the software was externally validated. Additionally, they’ll have to reveal performance measures, explain how they monitor performance over time and describe how often they update algorithms.

The agency said the rule has a broad scope, covering models not directly involved in clinical decision-making that can impact care delivery, like those aiding supply chains.

When? The regulations from the Office of the National Coordinator for Health IT within HHS will apply to clinicians using HHS-certified decision support software by the end of 2024.

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TECH MAZE

BARCELONA, SPAIN - NOVEMBER 11: A nurse works with the computer in the ICU on November 11, 2020 in Barcelona, Spain. Clinic Hospital's ICU Unit has a capacity for 48 beds and half of it is occupied by patients with coronavirus. Also, 30% of the total capacity of the hospital is occupied with patients with coronavirus. The activity in the Hospital is at 90%, with a 10% left for visits and delayed surgeries.   (Photo by Cesc Maymo/Getty Images)

The new year will be big for AI, a new survey of health care executives found. | Getty Images

Health providers say 2024 will be the year they take the plunge into advanced AI — despite potential pitfalls.

In a new report from KLAS Research that surveyed 66 health executives, 58 percent said they’ll likely purchase or implement the new technology in their organizations next year.

That’s especially true for large providers — hospitals with more than 500 beds — which are most likely to have already implemented or plan to implement the technology next year.

Where the bots will go: The leaders seemed to agree on where the tools could be most useful in the immediate future — more than two-thirds said they would use them to boost operational efficiency.

They’re looking for AI solutions for documentation, patient communication, workflow automation and coding, they said.

But concerns remain: Health leaders don’t fully trust the technology for some uses, and accuracy remains, by far, the biggest challenge for using the tech, according to the analysis — though cost, security and privacy are also concerns across the sector.

INNOVATORS

The Cleveland Clinic is pictured in Cleveland, Ohio on March 10, 2020. - Just days before, on March 9, 2020, 3 positive cases of the virus were confirmed in the Cleveland area. Democratic presidential hopefuls Bernie Sanders and Joe Biden both cancelled their election night rallies in Cleveland, Ohio Tuesday as fears of the coronavirus took hold in their taut primary battle. (Photo by Megan JELINGER / AFP) (Photo   by MEGAN JELINGER/AFP via Getty Images)

The best use cases for AI in the hospital are becoming clearer. | AFP via Getty Images

Health providers are diving into AI — but where they use the tech varies.

Advanced AI has potential in nearly every part of a clinic or hospital, from research to record-keeping and coding to clinical workflow.

Providers are shepherding resources around the applications likely to have the biggest impact.

The Cleveland Clinic, positioning itself as a leader among its peers in AI by partnering with tech companies in a new alliance to advance the tech’s development, has made its decision.

Dr. Lara Jehi, Cleveland Clinic’s chief research information officer, said she sees two priorities emerging:

  1. Disease and drug research. AI holds promise in helping researchers discover new biomarkers for diseases and simulating molecules that could lead to breakthroughs in drug development.
  2. Patient care. AI has the potential to help streamline workflows, easing the navigation of electronic health records and making communication with patients more efficient.

Even within the same system, those priorities require different resources.
The processes and data requirements can change based on the project, as can the required expertise.

The clinic’s work with tech companies aims to pool resources to accelerate those efforts.

“It’s a much more efficient way of doing research and generating knowledge," Jehi said.

 

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