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FDA calls for monitoring of AI as use of technology in healthcare increases


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

FDA calls for monitoring of AI medical devices

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

The agency, which has authorized nearly 1,000 AI-based medical devices to date, emphasizes that more than traditional one-time approvals may be needed for AI systems that may evolve and perform differently in different healthcare environments.

“Given the ability of ‘unlocked’ models to evolve and AI’s sensitivity to contextual changes, it is becoming increasingly clear that AI performance needs to be monitored in the environment in which it is used,” wrote Dr. Haider J. Warraich and colleagues at the FDA. “This need for post-market monitoring of AI performance has profound implications for information management by healthcare systems and clinical practices.”

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

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

Hospitals are turning to AI agents to streamline patient care

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

Virtual assistants developed by Deloitte and powered by Nvidia AI technology perform tasks such as scheduling appointments and answering common questions before surgery and after care.

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

“Avatar-based conversational AI agents offer an incredible opportunity to alleviate the productivity paradox facing our healthcare system with digitalization,” said Niraj Dalmia, a partner at Deloitte Canada, in a press release. “It could potentially be the complementary innovation that reduces administrative burdens, complements our human resources in healthcare to free up capacity, and helps solve patient experience challenges.”

Hospitals want to give patients 24-hour access to healthcare information through AI assistants on their phones and computers, eliminating the need for constant staff supervision, according to Deloitte. More hospitals plan to implement these systems by the end of the year to reduce paperwork and make healthcare more accessible to 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 range of AI models on Thursday that will 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 attempt to transform healthcare with AI.

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

The Redmond, Washington-based company also announced new healthcare data solutions in Microsoft Fabric and a healthcare agent service in Copilot Studio for tasks like scheduling appointments and assessing patients. In addition, 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.



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