Monday, October 28, 2024

HHS’ AI plans come into view

The ideas and innovators shaping health care
Oct 28, 2024 View in browser
 
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By Ruth Reader, Erin Schumaker and Daniel Payne

TECH MAZE

Robert Califf testifies before the House Oversight and Accountability committee.

Califf sees a big challenge in ensuring AI tools do what they say they'll do. | Anna Moneymaker/Getty Images

At HLTH's health care industry conference in Las Vegas, HHS officials said they’re developing a cross-agency strategic plan to regulate artificial intelligence in health care, aiming to balance its benefits and potential risks.

Key to that effort will be hiring a chief technology officer, a chief data officer and a chief AI officer.

“We’re entering an era where we have to rethink everything we do,” Dr. Robert Califf, commissioner of the HHS’ Food and Drug Administration, said at the conference last week.

The backstory: The Department of Health and Human Services and its agencies regulate AI when it’s embedded in medical devices and when it poses a risk to privacy or the potential for discrimination. In December, the agency’s assistant secretary for technology policy finalized rules requiring AI developers who want federal certification to reveal additional data about their algorithms.

The FDA is also starting to use AI internally for compliance monitoring and thinking about how hospital systems can regularly validate AI, Califf said.

But so far, HHS and its agencies have taken a flexible approach to AI regulation, issuing more guidance than rules and working with the health tech industry to build safe products.

Officials restated that approach in Las Vegas.

“A lot of my cases you don’t read about in the news, you don’t read about them in POLITICO, because they’re handled with technical assistance, voluntary compliance,” said Melanie Fontes Rainer, acting director of HHS’ Office for Civil Rights.

Why it matters: Industry wants guidance on how regulators will handle artificial intelligence so they can build compliance systems early.

Several industry groups, most prominently the Coalition for Health AI, which counts Microsoft, the Mayo Clinic, Johns Hopkins and Duke among its members, have formed to pursue private sector-led vetting of AI tools.

What’s next? HHS officials have said private sector-led compliance labs can be part of the answer.

Califf has repeatedly said the FDA doesn’t have the resources or personnel to vet all advanced AI tools. In Las Vegas, he said the health care industry doesn’t, either.

“I don’t know of a single health system in the U.S. which is capable of doing the validation,” he said. “We need a major change.”

Fontes Rainer said her agency is considering asking health systems and payers to submit to voluntary audits to ensure compliance with her anti-discrimination rule. “We’re thinking about doing that because AI is so different when it comes to regulation and it comes to enforcement,” said Fontes Rainer.

She said her office is working on additional guidance and hopes to share more of its thinking on AI before the end of the year.

Even so: Everything could change with a new administration.

Former President Donald Trump has promised that if he wins he would revoke the executive order President Joe Biden issued a year ago, tasking federal agencies with launching AI rules.

WELCOME TO FUTURE PULSE

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This is where we explore the ideas and innovators shaping health care. 

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Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com, or Erin Schumaker at eschumaker@politico.com.

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THE NEXT CURES

SAN FRANCISCO - AUGUST 18:  Eighteen-year-old cancer patient Patrick McGill lies in his hospital bed while receiving IV chemotherapy treatment for a rare form of cancer at the UCSF Comprehensive Cancer Center Childrens Hospital August 18, 2005 in San Francisco, California. The UCSF Comprehensive Cancer Center continues to use the latest research and technology to battle cancer and was recently   rated 16th best cancer center in the nation by US News and World Report.  (Photo by Justin Sullivan/Getty Images)

ARPA-H wants to see more sharing of pediatric cancer data. | Getty Images

Pediatric cancer researchers are building a tool to share real-time cancer and rare disease data worldwide with $10 million from the Advanced Research Projects Agency for Health.

How so? The project, called Real-time Analysis and Discovery in Integrated And Networked Technologies, or RADIANT, aims to process millions of cancer data points and make the findings available to doctors everywhere.

The effort builds on years of research by the Center for Data-Driven Discovery in Biomedicine at the Children’s Hospital of Philadelphia. It will act as a data coordination hub for RADIANT, integrating patient electronic health records and genomic and imaging data from participating hospitals nationwide. Partner institutions include more than 35 hospitals in the Children’s Brain Tumor Network and the Pediatric Neuro-Oncology Consortium.

The upshot: Doctors should initially be able to use the tool to offer precision cancer care to their patients. Over time, researchers hope the framework will inform new clinical trial models and improve patient access to them.

“Many pediatric brain tumor patients have no curative standard of care , it’s only through advancing new models of care empowered by these technologies that as clinicians we’ll be able to enhance options for our patients and their participation in clinical trials,” Dr. Sabine Mueller, pediatric neuro-oncologist, co-executive chair of the Children’s Brain Tumor Network and co-leader of the Pediatric Neuro-Oncology Consortium, said in a press release.

FORWARD THINKING

Dr. Laurie Margolies demonstrates the Koios DS Smart Ultrasound software, Wednesday, May 8, 2024, at Mount Sinai hospital in New York. The breast imaging AI is used to get a second opinion on mammography ultrasounds. “I will tell patients, ‘I looked at it, and the computer looked at it, and we both agree,’” Margolies said. “Hearing me say that we both agree, I think that gives the patient an even greater level   of confidence.” (AP Photo/Mary Altaffer)

Doctors can help build the algorithms, one health tech company believes. | AP

Health AI developers are trying to empower doctors to create diagnostic algorithms themselves.

Regard, a health tech company that boasts nearly 4 million diagnoses made through its artificial intelligence system, is rolling out a way to increase the number of maladies its AI can detect.

Doctors partnering with Regard can help train AI to detect diseases or disorders without needing expertise in coding.

The process puts clinicians at the center of the early development of diagnostic AI modules for each new ailment. Each module will be tested against the company’s data and, if sufficiently accurate, beta tested by doctors.

Why it matters: “Engineers and doctors don’t know how to speak the same language to each other,” Eli Ben-Joseph, co-founder and CEO of Regard, told Daniel. “That back-and-forth just caused a lot of delay.”

The new process aims to roll out diagnostic modules much faster.

Ben-Joseph said the company looks to release 20 new diagnostic modules this quarter, which previously took about a year to do. Regard expects to launch 100 new diagnoses in the next 12 months, he said, more than doubling its current abilities.

 

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