Top News
ONC HTI-1 Final Rule Effective Date Moved to March 11
The Office of the National Coordinator for Health Information Technology (ONC) changed the HTI-1 Final Rule or Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing, from January 9 to March 11, 2024. HTI-1 implements the EHR Reporting Program requirement of the 21st Century Cures Act by creating new conditions for health IT developers under the Health IT Certification Program.
The final rule requires certified health IT developers to update the United States Core Data for Interoperability (USCDI) Version 3, as of January 1, 2026. Additionally, HTI-1 establishes transparency requirements for AI and other predictive algorithms. Finally, the rule aims to enhance health information exchange under the information blocking regulations. AMIA is currently in contact with ONC regarding the rollout of HTI-1 and how the Final Rule could affect developers and providers.
Congress
Congressional Digital Health Caucus Established
House Representatives Troy Balderson (Rep. – Ohio District 12) and Robin Kelly (Dem. – Illinois District 2) announced the creation of the Digital Health Caucus, a bipartisan Congressional Caucus to inform policymakers about the innovations in the health care system especially on how AI is being used in health care today. The Caucus’s aim is to serve as a platform among experts from government, private sector, and the health care industry to partner and drive discussions to shape policies that support integrations of AI and emerging health technologies into health care. Key objectives include informing policymakers, ensuring accessibility for all Americans, promoting collaboration, addressing regulatory challenges, and advancing research and development.
Regulatory
FDA Comment Opportunity: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-regulated Medical Products Guidance
The FDA has released a new proposed guidance with recommendations on the use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and clinical studies for FDA-regulated medical products to promote consistency in submissions.
To ensure your comment will be considered on a draft guidance before it begins work on the final version, submit your comments by April 29.
See more about proposed draft guidance.
ICYMI
ONC Draft USCDI v5
The Office of the National Coordinator for Health Information Technology (ONC) Draft United States Core Data for Interoperability Version 5 (USCDI v5) is now available for public comment. The latest draft version includes 13 new data elements and two new data classes. The following AMIA recommendations were incorporated in Draft USCDI v5:
- Route data element to Medications data class
- Author and Author Role data elements to Provenance data class
- Test Kit Unique Device Identifier data element to Laboratory data class
- Orders data element and Orders data
ONC is accepting feedback until April 15.
Learn more about Draft USCDI v5.
AMIA’s Washington Download is your source for health informatics policy news and information from around the Beltway, covering action from the Hill, the Administration, and important AMIA collaborators.
About AMIA
AMIA, the leading professional association for informatics professionals, is the center of action for 5,500-plus informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.