AI in healthcare increases need for guidance to protect patients

Several studies have raised potential problems with using AI in healthcare settings over the past few years.

A 2019 analysis published in the journal Science found a commercial algorithm from Optum used by health systems to select patients for a care management program that designated less healthy Black patients. have the same level of risk as white patients, meaning that Black patients are less likely to be identified as needing further care.

An Optum spokesperson said in a statement that the algorithm was not racially biased, and that the researchers misrepresented the cost prediction algorithm based on using the company’s incorrect, unrecommended tool. a health system.

“The algorithm is designed to predict future costs an individual patient may incur based on past healthcare experience and does not result in racism when used,” the spokesperson said. used for that purpose—a fact agreed upon by the study authors.”

In 2021, researchers at the University of Michigan School of Medicine published a peer-reviewed study showing a widely used sepsis prediction model from the massive electronic health record system. Epic Systems failed to identify 67% of people with sepsis. It also raised sepsis alerts by 43%, even though the hospital’s total patient count fell by 35% in the early days of the pandemic. Epic did not provide the AI ​​sepsis model working group for interviews.

The White House Office of Science and Technology Policy included both cases, without naming the companies, in a report accompanying the blueprint “Artificial Intelligence Bill of Rights.” , which is intended as a guide for many industries.

Although the framework has no enforcement mechanism, it includes five rights that the public should enjoy: Algorithms should be secure and efficient, non-discriminatory, completely transparent, protect privacy of the people they influence and allows for alternatives, choices- outs and feedback.

Jeff Cutler, commercial director of Ada Health, a healthcare AI company that provides symptom check-ups to patients, says his organization follows five principles when it comes to developing and implementing algorithms. maths.

“It’s really important that the industry takes the ‘Declaration of Human Rights’ very seriously,” Cutler said. “It is important that users and businesses using these platforms are asking the right questions about clinical efficacy, accuracy, quality, and safety. And it’s important that we’re transparent with our users.”

But experts say real regulation is needed to make a difference. Although the Food and Drug Administration is tasked with overseeing software as a medical device, including AI, experts say the agency has difficulty responding to the number of days An increasing number of algorithms are developed for clinical use. Congress could step in to define AI in healthcare and outline mandatory standards for health systems, developers, and users.

“There will be enforcement and oversight to ensure that the algorithms being developed take into account discrimination, bias, and bias,” said Linda Malek, president of healthcare practice at law firm Moses & Singer. taste and privacy.

John Halamka, president of the Mayo Clinic Platform, a Rochester, Minnesota-based portfolio of healthcare businesses focused on integrating new technologies, including AI, into healthcare health, said more policies may be on the way.

The Office of the National Coordinator is expected to coordinate much of regulatory guidance from various government agencies including the FDA, the Centers for Disease Control and Prevention, said Halamka, who advised. , the National Institutes of Health, and other federal agencies outside of HHS. ONC and the federal government on many healthcare technology initiatives, but are not directly involved in oversight.

Halamka expects significant regulatory and sub-regulation guidance within the next two years.

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