Will policy and regulatory issues stifle AI advances in healthcare?

The recent AIMed Global Summit painted a positive picture for the technology to address healthcare’s biggest pain points, but a race to govern and regulate AI could make things tricky.

While healthcare organizations are scrambling to figure out how and where AI can best fit, there’s also a mad rush to figure out policies and regulations.

During the recent AIMed Global Summit in San Diego, Alya Sulaiman, a partner at digital health law firm McDermott Will & Emery, described an active landscape in which federal agencies such as the Health and Human Services Department’s Office of the National Coordinator of Health IT (ONC), the US Food and Drug Administration, and the Federal Trade Commission were competing with the likes of state attorneys general to regulate the technology.

[See also: AIMed Global Summit Puts Augmented Intelligence in the Spotlight.]

The ONC, for example, recently launched a proposal to create new transparency and risk management expectations for artificial intelligence and machine learning technology that aid in decision-making in healthcare, including any technology that integrates with electronic health records.

Meanwhile, she said, there are dozens of pieces of state-level legislation setting guidelines on technologies like chatbots, AI that helps nurses, and AI that helps in behavioral health treatment.

“There is an increase [number] of very specific health AI [bills]he said, which would add regulation and chains of approval to any healthcare system that uses the technology within a specific state’s borders.

Sulaiman also noted that AI could soon be cited in lawsuits where a healthcare system could be held liable if it doesn’t use available AI technology.

“This is a real example that we are starting to see [potential] litigation,” he said. “Artificial intelligence is being pushed into the standard of care.”

In this rapidly changing landscape, the three-day conference provided an opportunity to highlight how the healthcare sector is embracing AI, sometimes called augmented intelligence, rather than artificial intelligence, to focus on the idea of ​​the technology that assists doctors and other healthcare personnel rather than replacing or acting on their behalf.

The conference featured a series of keynotes and panel discussions on the challenges and benefits of using AI in healthcare, which is still in its infancy. It included a “Shark Tank”-style main stage event where several start-ups seeking investment finance presented their business plans to a board of investors. The start-ups encompassed a wide range of AI ideas in healthcare, including wound care analytics, drug discovery trials, consumer-facing search engines, identifying and managing the risk of a patient falling in hospital, heart health, oxygen therapy, and identifying and addressing mental health issues in high school students.

David Higginson, executive vice president and chief innovation officer at Phoenix Children’s Hospital and participant on more than one panel at the event, said healthcare organizations are slowly but steadily advancing with AI. They’re rolling out small programs that address gaps in support or “low-hanging fruit” to score easy wins, then scale up and down to address bigger problems.

“It’s good to know we’re getting there,” he said. “We have to take these risks.”

At the same time, healthcare leaders need to be aware of the changing policy and regulatory landscape.

Statewide, 23 attorneys general have sent a letter to the National Telecommunications and Information Administration (NTIA), a part of the US Department of Commerce, demanding transparency and accountability with AI technology. They also argued that MAs “should have concurrent enforcement authority in any federal regulatory regime governing AI.”

Artificial intelligence is increasingly part of our lives, influencing transactions and decisions large and small,” California Attorney General Rob Bonta said in a June 14 press release announcing he had joined the coalition. policies that govern this technology that prioritize transparency, audit and accountability, and that put consumer protection at the center.

At the same time, the American Medical Association, whose president-elect, Jesse Ehrenfeld, MD, MPH, addressed the AIMed conference, addressed AI at its recent annual meeting. The organization’s House of Delegates announced plans to “develop principles and recommendations on the benefits and unintended consequences of relying on AI-generated medical advice and content that may or may not be validated, accurate or appropriate.”

AI holds the promise of transforming medicine,” said Alexander Ding, MD, MS, MBA, AMA trustee, practicing physician and assistant professor at the University of Louisville School of Medicine, in a news release. released by the AMA.” We don’t want to chase technology. Rather, as scientists, we want to use our experience to design guidelines and guardrails to prevent unintended consequences, such as the accumulation of prejudices and widening disparities, the spread of incorrect medical advice, or the spread of misinformation or disinformation.

We are trying to look around the corner for our patients to understand the promises and limitations of AI,” he added. “There is a lot of uncertainty about the direction and regulatory framework for this use of AI that has made its way into the day – today’s practice of medicine.

The AMA also adopted a policy on the use of AI in one of the most controversial topics in healthcare: pre-approvals. This follows a report from ProPublica that said Cigna denied more than 300,000 complaints in two months through a process that used artificial intelligence, allowing doctors to spend an average of 1.2 seconds on a complaint.

“Using AI in pre-authorization can be a positive step toward reducing the use of valuable hands-on resources to conduct these manual and time-consuming processes,” said Marilyn Heine, MD, board member AMA board of directors and Pennsylvania physician, in an AMA press release. “But AI is not a silver bullet. As health insurance companies increasingly rely on AI as a more cost-effective way to conduct prior authorization reviews, the sheer volume of prior authorization requirements continues to place a huge burden on physicians and create significant barriers to care The bottom line remains the same: we need to reduce the number of things subject to prior authorization.

Regardless of the regulatory and policy challenges, the mood at the AIMed conference was that healthcare is well placed to benefit from technology as long as researchers and providers more slowly and steadily and don’t rush expecting to solve all health care problems within a few months, or even years.

Healthcare is “a complex system,” Robert Groves, MD, executive vice president and chief medical officer of Banner | Aetna said in a keynote on the final day of the event. “There are so many boxes to check, so many things to do [but] complexity is the nature of progress.”

The key, said Groves and many others, is to understand that AI can help as long as it’s used as a tool and not a substitute. Ultimately it’s important, Groves said, “to value nurturing over caring.”