Generative AI stormed onto the scene in late 2022 with the introduction of ChatGPT. Since that time, the technology has become increasingly prevalent, especially in marketing. Due to concerns such as inaccuracies and bias, healthcare has been a little slower to welcome AI, although its use in the industry is growing in use cases such as clinical decision support software and predictive tools. 

The US Department of Health and Human Services (HHS) recently rolled out a far-reaching rule to address healthcare AI concerns. The rule, which comes from the Office of the National Coordinator for Health Information Technology (ONC), will become effective in late 2024. The rule is referred to at HTI-1, or Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing.

The new rule is focused on data interoperability and patient access and includes establishment of transparency requirements for healthcare AI software. It includes an updated interoperability standard, which will go into effect in early 2026. Overall, it is intended to promote equity, reduce disparities and promote public health data collaboration.