Paper Calls for Patient-First Regulation of AI in Healthcare

Ever wonder if the latest and greatest artificial intelligence (AI) tool you read about in the morning paper is going to save your life? A new study published in JAMA led by John W. Ayers, Ph.D., of the Qualcomm Institute within the University of California San Diego, finds that question can be difficult to answer since AI products in healthcare do not universally undergo any externally evaluated approval process assessing how it might benefit patient outcomes before coming to market.

The research team evaluated the recent White House Executive Order that instructed the Department of Health and Human Services to develop new AI-specific regulatory strategies addressing equity, safety, privacy, and quality for AI in healthcare before April 27, 2024. However, team members were surprised to find the order did not once mention patient outcomes, the standard metric by which healthcare products are judged before being allowed to access the healthcare marketplace.

"The goal of medicine is to save lives," said Davey Smith, M.D., head of the Division of Infectious Disease and Global Public Health at UC San Diego School of Medicine, co-director of the university’s Altman Clinical and Translational Research Institute, and study senior author. "AI tools should prove clinically significant improvements in patient outcomes before they are widely adopted."

According to the team, AI-powered early warning systems for sepsis, a fatal acute illness among hospitalized patients that affects 1.7 million Americans each year, demonstrates the consequences of inadequate prioritization of patient outcomes in regulations. A third-party evaluation of the most widely adopted AI sepsis prediction model revealed 67% of patients who developed sepsis were not identified by the system. Would hospital administrators have chosen this sepsis prediction system if trials assessing patient outcomes data were mandated, the team wondered, considering the array of available early warning systems for sepsis?

"We are calling for a revision to the White House Executive Order that prioritizes patient outcomes when regulating AI products," added John W. Ayers, Ph.D., who is deputy director of informatics in Altman Clinical and Translational Research Institute in addition to his Qualcomm Institute affiliation. "Similar to pharmaceutical products, AI tools that impact patient care should be evaluated by federal agencies for how they improve patients' feeling, function, and survival."

The team points to its 2023 study in JAMA Internal Medicine on using AI-powered chatbots to respond to patient messages as an example of what patient outcome-centric regulations can achieve. "Theoretically, a study comparing standard care versus standard care enhanced by AI conversational agents might find differences in downstream care utilization in some patient populations, such as heart failure patients," said Nimit Desai, B.S., who is a research affiliate at the Qualcomm Institute, UC San Diego School of Medicine student, and study coauthor. "But studies like this don’t just happen unless regulators appropriately incentivize them. With a patient outcomes-centric approach, AI for patient messaging and all other clinical applications can truly enhance people’s lives."

The team recognizes that its proposed regulatory strategy can be a significant lift for AI and healthcare industry partners and may not be necessary for every flavor of AI use case in healthcare. However, the researchers say, excluding patient outcomes-centric rules in the White House Executive Order is a serious omission.

Ayers JW, Desai N, Smith DM.
Regulate Artificial Intelligence in Health Care by Prioritizing Patient Outcomes.
JAMA. 2024 Jan 29. doi: 10.1001/jama.2024.0549

Most Popular Now

AI in Personalized Cancer Medicine: New …

The application of AI in precision oncology has so far been largely confined to the development of new drugs and had only limited impact on the personalisation of therapies. New...

AI can Predict Brain Cancer Patients…

Artificial Intelligence (AI) can predict whether adult patients with brain cancer will survive more than eight months after receiving radiotherapy treatment. The use of the AI to successfully predict patient outcomes...

Max Planck Institute for Informatics and…

The Max Planck Institute for Informatics and Google deepen their strategic research partnership. With additional financial support from the U.S. IT company, the "Saarbrücken Research Center for Visual Computing, Interaction...

JMIR Medical Informatics Invites Submiss…

JMIR Publications has announced a new section titled, "AI Language Models in Health Care" in JMIR Medical Informatics. This leading peer-reviewed journal is indexed in PubMed and has a unique...

Paper Calls for Patient-First Regulation…

Ever wonder if the latest and greatest artificial intelligence (AI) tool you read about in the morning paper is going to save your life? A new study published in JAMA...

Could ChatGPT Help or Hurt Scientific Re…

Since its introduction to the public in November 2022, ChatGPT, an artificial intelligence system, has substantially grown in use, creating written stories, graphics, art and more with just a short...

Evaluating the Performance of AI-Based L…

A new study evaluates an artificial intelligence (AI)-based algorithm for autocontouring prior to radiotherapy in head and neck cancer. Manual contouring to pinpoint the area of treatment requires significant time...

Making AI a Partner in Neuroscientific D…

The past year has seen major advances in Large Language Models (LLMs) such as ChatGPT. The ability of these models to interpret and produce human text sources (and other sequence...

Chapman Scientists Code ChatGPT to Desig…

Generative artificial intelligence platforms, from ChatGPT to Midjourney, grabbed headlines in 2023. But GenAI can do more than create collaged images and help write emails - it can also design...

DMEA nova Award: Wanted - Visionary Solu…

9 - 11 April 2024, Berlin, Germany. The DMEA nova Award is being presented at DMEA 2024 for the first time. The award honours a digital health startup for an outstanding...

New Digital Therapy Reduces Anxiety and …

A therapist-guided digital cognitive behavioural therapy reduced distress in 89 per cent of participants living with long-term physical health conditions, a new King's College London study finds. Researchers at the Institute...

Europe's Digital Health Industry Me…

9 - 11 April 2024, Berlin, Germany. In just over two months, from 9 to 11 April 2024, DMEA, Europe's leading event for digitalisation of healthcare, will gather digital health experts...