The U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) on April 11 released a Notice of Proposed Rulemaking for public comment on its proposed rule, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1).”

The proposals are related to the implementation of key provisions of the 21st Century Cures Act to establish an Electronic Health Record Reporting Program and to enhance the ONC Health IT Certification Program. The proposed regulations seek to protect patients and to reduce burdens on laboratories by establishing new data standards and modes of movement for electronic health information.

According to the College of American Pathologists, the HTI-1 proposals with implications for laboratory data include: increasing patient access to predictive Decision Support Interventions, which would include the underlying data used to generate recommendations for their care; increasing the interoperability of laboratory datasets for public health emergencies, as well as overall laboratory interoperability; and providing algorithm transparency to reduce the likelihood of “algorithmic discrimination.”

The proposed rule was published to the Federal Register on April 18 and will be open for public comment until June 20. ONC will host a series of information sessions about the proposed rule in the coming weeks, including an overview session on April 27. More information can be found at