Standardization empowering AI-enabled systems in healthcare – workshop report
Abstract
The importance and growth of autonomous and artificial intelligence (AI) systems has led to a strong consensus that ANSI should identify needs for the coordination of standardization for AI in healthcare, using a collaborative community approach. Current events and an explosion of AI in healthcare led to an initial broad stakeholder survey, a virtual workshop, and this report. Survey responses identified wide-ranging uses of AI in consumer wellness, medical care, hospital operations, analytics, research, financing, cybersecurity, and administration. In many organizations and applications, AI is pervasive, oftentimes with apparent limited consumer awareness. Because AI is embedded in other technologies, AI powers and supports many things, and can help to enhance quality, manage complexity, and lower costs—high-level drivers in all healthcare sectors. Much of AI standards development is sector agnostic, but healthcare has specific standards-related needs. Standard Development Organizations (SDOs) have an opportunity to be more nimble with AI technologies through partnerships with industry leadership, related regulatory agencies, and stakeholders. These communities strongly support ANSI principles and open consensus standards development processes. Healthcare has unique considerations including sensitive health data, patient safety, and potential for disparate impact of AI. More standardization is needed to promote safety, effectiveness, and trustworthiness of healthcare-based AI and to support informed regulatory measures. Some states are enacting legislation focused on privacy, or automated decisions, that could set de facto national standards affecting healthcare AI. Survey responses and workshop discussions recommended and encouraged some foundational principles and potential next steps that could be supported, coordinated, and developed by collaborations of ANSI with SDOs, NIST, and other government agencies. ANSI presently is working with stakeholders to develop plans for a future workshop to explore these needs, principles, and next steps for coordination of healthcare AI standardization.
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Key Information
Country of publication: USA
Date published: 10 Jan 2026