TL/DR –
The health care industry’s use of generative artificial intelligence (AI) models is prompting discussions about regulation. Some states have begun implementing laws to regulate the use of generative AI in healthcare; for example, a new California law requires health care facilities that use generative AI to provide a disclaimer to patients when such technology is used in their care. This move aligns with trends and guidance from industry organizations, like the Federation of State Medical Boards, which emphasize the need for transparency, informed consent, and monitoring of potential equity and bias issues, along with allowing for more automated workflows for providers.
Regulating Generative AI in Healthcare
The healthcare industry’s use of artificial intelligence (AI) has expanded into generative AI models, increasing concerns about regulation of the technology. Unlike traditional AI, generative AI can theoretically make clinical decisions, identify health risks and develop patient-specific treatments.
Several states are implementing measures to regulate healthcare-specific generative AI, attempting to balance the benefits of innovation against the risks inherent to AI’s limitations.
Regulation Through Disclosure
One emerging trend in AI regulation involves mandatory patient disclosures whenever generative AI is used for communication. As an example, California Gov. Gavin Newsom recently enacted a law on AI creating synthetic content, including patient communications.
This law requires healthcare institutions using generative AI to:
- Disclose to patients when generative AI has been used.
- Guide patients on how to connect with a human provider.
These disclaimers should:
- Appear prominently at the beginning of each written communication.
- Be prominently displayed throughout continuous written online interactions.
- Be verbally provided at the start and end of audio communications.
- Be prominently displayed throughout video interactions.
Comparative Regulations
The California law echoes the 2024 Utah law on generative AI disclosures. This law similarly demands providers disclose when a patient engages with generative AI, necessitating disclosures at the start of any interaction. However, it does not specify content for these disclosures.
Industry Trends and Guidelines
The recent regulations align with trends and guidelines from industry organizations such as the Federation of State Medical Boards. Their report “Navigating the Responsible and Ethical Incorporation of Artificial Intelligence into Clinical Practice,” underlines the need for transparency and patient consent, while promoting automated operational workflows for healthcare providers.
The report also highlights other considerations such as physician accountability, equity issues, and bias in healthcare AI. As regulatory focus sharpens on AI in healthcare, stakeholders should closely observe these trends and guidelines to ensure full compliance.
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