FDA Calls for Monitoring of AI as Tech Uses Widen in Healthcare

Hospitals are adopting AI assistants for patient care and Microsoft is rolling out medical imaging models, while the U.S. Food and Drug Administration (FDA) calls for vigilant monitoring of these rapidly evolving tools. The push toward AI integration promises to ease healthcare worker burnout and improve diagnostics, but regulators warn that these powerful new systems require continuous oversight to ensure patient safety.

FDA Calls for Monitoring of AI Medical Tools

According to a new FDA perspective published in JAMA, the Food and Drug Administration is pushing for continuous monitoring of artificial intelligence tools used in healthcare. The agency warns that unmonitored AI systems could pose risks to patient safety.

The agency, which has authorized nearly 1,000 AI-enabled medical devices to date, emphasizes that more than traditional one-time approvals may be needed for AI systems that can evolve and perform differently across various healthcare settings.

“Given the capacity for ‘unlocked’ models to evolve and AI’s sensitivity to contextual changes, it is becoming increasingly evident that AI performance should be monitored in the environment in which it is being used,” wrote Dr. Haider J. Warraich and colleagues from the FDA. “This need for postmarket performance monitoring of AI has profound implications for the management of information by health systems and clinical practices.”

The paper outlines several challenges, including balancing financial optimization with patient outcomes and evaluating large language models in clinical settings. The FDA also highlighted the importance of maintaining workforce expertise to review increasingly complex AI applications.

The agency advocates for a “total product life cycle” approach, requiring ongoing evaluation of AI tools’ safety and effectiveness after deployment, similar to monitoring patients in intensive care units.

Hospitals Turn to AI Agents to Streamline Patient Care

Hospitals are adopting AI-powered agents to assist with routine patient interactions and alleviate administrative workloads.

Virtual assistants developed by Deloitte and powered by Nvidia AI technology handle tasks such as scheduling appointments and answering common pre-surgery and post-care questions.

AI agents, which use natural language processing and machine learning to simulate human conversations, are increasingly being utilized in industries like healthcare for their ability to manage tasks that often overwhelm staff. As hospitals face staffing shortages and rising operational demands, these digital assistants are seen as a way to maintain efficient patient care while easing pressure on healthcare professionals.

”Avatar-based conversational AI agents offer an incredible opportunity to reduce the productivity paradox that our healthcare system faces with digitization,” Niraj Dalmia, a partner at Deloitte Canada, said in a news release. “It could possibly be the complimentary innovation that reduces administrative burden, complements our healthcare human resources to free up capacity, and helps solve for patient experience challenges.”

Hospitals aim to give patients around-the-clock access to healthcare information via AI assistants on their phones and computers, eliminating the need for constant staff supervision, according to Deloitte. More hospitals plan to adopt these systems by year’s end to cut paperwork and make healthcare more accessible for patients.

Microsoft Releases AI Models to Read Medical Scans

Microsoft says it is teaching artificial intelligence to interpret X-rays and medical scans, launching a suite of AI models Thursday that could help doctors diagnose diseases faster and more accurately.

The tech giant partnered with Providence and Paige.ai to develop the new medical imaging models available through its Azure AI Studio platform. The system can analyze everything from routine X-rays to complex genomic data, marking Microsoft’s latest push to transform healthcare with AI.

“We are at an inflection point where AI breakthroughs are fundamentally changing the way we work and live,” Joe Petro, Microsoft’s corporate vice president of Healthcare and Life Sciences Solutions, said in a news release. “These advancements are dramatically enhancing patient care and also rekindling the joy of practicing medicine for clinicians.”

The Redmond, Wash.-based company also announced new healthcare data solutions in Microsoft Fabric and a healthcare agent service in Copilot Studio for tasks like appointment scheduling and patient triaging. Additionally, Microsoft is developing an AI solution for nursing documentation in collaboration with Epic Systems Corp. and major healthcare organizations, including Duke Health and Stanford Health Care.

For all PYMNTS AI coverage, subscribe to the daily AI Newsletter.