Monday, December 23, 2024

Governing health care AI

The ideas and innovators shaping health care
Dec 23, 2024 View in browser
 
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By Daniel Payne, Carmen Paun and Erin Schumaker

TECH MAZE

Donald Trump

President-elect Donald Trump's administration will set the tone for artificial intelligence regulation. | Rick Scuteri/AP Photo

Leaders across health sectors want the incoming Trump administration to take the lead on rules to govern artificial intelligence.

President-elect Donald Trump started that effort on Sunday, naming Sriram Krishnan, former general partner at venture capital firm Andreessen Horowitz, as senior policy adviser for artificial intelligence at the White House Office of Science and Technology Policy.

Health systems are looking to the federal government to step up its AI regulation in the coming years — including some that want the FDA to review AI to the same standard it reviews drugs: proving they’re safe and effective before entering the market.

“My hope is that products that come to market are well vetted,” said Dr. Dave Newman, chief medical officer for virtual care at Sanford Health, a South Dakota-based health system with hundreds of locations across the upper Midwest.

But providers aren’t the only ones in the health care sector who want the government to boost its regulation of the technology.

Members of the Healthcare Leadership Council, a coalition of health care industry executives, sent a letter to the co-chairs of Trump’s transition team asking it to build safeguards around the technology to bolster its use in American health care.

“We believe that, without federal leadership, the quickly forming patchwork of state requirements will hinder this innovation,” the group wrote, noting that data protection and privacy were top concerns for the technology’s rise.

Health organizations want more certainty about guiding principles as they increasingly invest in AI and try to make sense of its impacts on care.

Even so: Some groups are pushing for a softer touch from the government, including some Republicans in Congress. They worry that more rules will stifle the AI industry in the U.S. — just as demand for the technology is booming internationally.

The change in leadership across the government has increased the uncertainty of the rules that could be ahead.

Why it matters: The incoming administration’s approach could set the tone for how the U.S. government regulates the technology for decades to come. Lawmakers, agency leaders and the president-elect have shown interest in shaping the country’s approach in the coming years.

The rules governing AI could determine the standards that health care tools must meet before being used in patient care — which could affect all kinds of care nationwide.

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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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SAFETY CHECK

One-ounce bags of medicinal marijuana are displayed.

A new study warns of adverse health effects associated with legalizing medical cannabis use. | Justin Sullivan/Getty Images

States legalizing cannabis for medical or recreational use should establish treatment services for people who experience health-related adverse effects from the substance, according to a new study in JAMA Psychiatry. University of Kentucky researchers found an association between states where medical cannabis is legal and diagnoses of cannabis use disorder and cannabis poisonings among adults.

— Diagnoses of cannabis use disorder — defined as continued use despite impairment — increased by nearly 43 percent after states legalized it for medical use.

— Cannabis poisonings increased by nearly 89 percent after its medical use was legalized and rose by nearly 32 percent in states that legalized the drug for recreational use, the study shows.

Female enrollees and those between ages 35 and 44 had even higher increases in cannabis use disorder than the overall group, according to the study.

The research team analyzed data from more than 110 million enrollees in employer-sponsored health insurance between 2011 and 2021, between ages 18 and 64.

Why it matters: While most states have enacted medical cannabis laws, researchers are only beginning to understand its risk for adverse health effects.

As of June, 39 states and Washington had laws allowing the drug for medical use, while 24 states and Washington had recreational cannabis laws.

Increased cases of cannabis use disorder — which has no licensed treatment — and cannabis poisonings can burden health care systems, researchers say.

 

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WASHINGTON WATCH

Female white rats stand in a basin at an animal laboratory of a medical school on February 16, 2008 in Chongqing Municipality, China.

A government watchdog wants the National Institutes of Health to better track its animal studies. | China Photos/Getty Images

A government watchdog wants the National Institutes of Health to better track the $5.5 billion it spends on animal research each year.

For a report released by the Government Accountability Office last week, officials reviewed NIH data and documents and interviewed agency officials and stakeholders about NIH policies and animal research. While animal research has led to new treatments, including Covid-19 vaccines, the officials note, animal welfare advocates are concerned about animals’ living conditions and pain they might experience.

Two other concerns: whether animal trial results can be consistently reproduced and whether animal research reliably translates to humans.

“Results that cannot be reproduced or translated to humans can slow medical progress, waste resources, and decrease public trust in scientific research,” the report says.

Why’s that? Biological differences between humans and animals mean humans don’t necessarily respond the same way to experimental treatments that animals do.

But researchers could do some things differently, too, the report says.

Researchers don’t always publish sufficient details about their study designs and animal use, making their work more difficult to reproduce.

What’s next: The GAO made two recommendations to the NIH director:

— Set short-term, measurable goals for reproducing animal trial results and ensuring those trials translate into similar results for humans

— Evaluate whether the agency is meeting goals, potentially through analyzing attempts to reproduce NIH-funded studies or collecting information from projects that attempt to reproduce significant research

The report notes that the NIH agreed with both recommendations.

 

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