The Office of the National Coordinator for Health IT announced a proposed new rule on Tuesday that includes new statutory language for further implementation and the certification criteria of the Healing Act. 21.
The Code – Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing, or HTI-1 – will be published next week in the Register federal sign.
WHY IT IMPORTANT
Health IT National Coordinator Micky Tripathi, speaking at an online news conference announcing the new rule, said it was an exciting day for the ONC to announce work on the rules around certification of medical records. electronic health records and interoperability.
The new rule, he said, will address fundamental aspects of ONC’s four key priorities: building a digital foundation of health record information; make interoperability easy; promote information sharing and ensure proper use of digital health tools.
According to the ONC, some of the key recommendations in the NPRM include:
- Making the Electronic Health Record Reporting Program a new certification requirement for certified medical IT developers.
- Expand and amend exceptions to information suppression regulations to support broader information sharing.
- Revised several certification criteria – including rules around clinical decision support, patient demographics and observations, electronic case reports, and APIs for patient and population services .
- Adoption of version 3 of U.S. Interoperability Core Data as a standard in the ONC Certification Program – and set an expiration date for USCDI Version 1 as the certification standard for the program.
- Update some of the implementation standards and specifications adopted under the certification program to improve interoperability, support health-enhanced IT functionality, and reduce burden and costs.
Tripathi also said ONC has been very focused on algorithmic transparency, working to help ensure trust in the clinical algorithms available in commercial EHR products.
“As evidence-based and predictive decision support interventions include patient observations and demographic data, social factors determine health data and data,” says Tripathi. health assessment data, health IT modules allow users to review these data as part of existing source attribute requirements”. .
He said the ONC has been working with HHS’s Office of Civil Rights on incorporating rules against algorithmic bias in Section 1557 of the Affordable Care Act, which would make any provider Any health care provider that receives funding from the federal government refuses to treat an individual, based on the algorithm’s consistent definition.
Regarding health equity considerations in HTI-1, the definition allows users to “operate” their understanding of the algorithm, he said – adding that conforming to the OCR definition can help users find out where there could be a problem leading to a potential hazard. discriminatory output.
Tripathi also noted that there may be the possibility of future rule-making around the adoption of the HT-1 standard and certification. That could include changes around discouraging healthcare providers who don’t comply with information blocking rules.
“We anticipate that healthcare providers will express concern about the potential complexity of this approach,” HHS officials said in 2022 regarding the proposed rules. that output.
In addition to the ONC, the new proposed rule was developed in partnership with several HHS departments, including the Health Research and Quality Administration, the Food and Drug Administration, the U.S. Department of Veterans Affairs, and the Department of Veterans Affairs. Federal Trade Commission.
The public comment period for HTI-1 began on April 18 and ended on June 20.
TREND TO BIGGER WOMAN
Elise Sweeney Anthony, executive director of policy at ONC, in an extensive blog post about today’s announcement.
Like many other ONC policy announcements in recent years, the publication of HTI-1 in the federal register on April 18 appears to coincide with the 2023 Annual Global Health Expo & Conference. of HIMSS next week, where more HHS officials will appear.
That Tuesday, Tripathi is scheduled to speak with HHS Deputy Secretary Andrea Palm in a keynote session that promises to “discuss the health department’s IT priorities and continue efforts to enable future digital healthcare system with information sharing as a standard of care and business.”
ON PROFILE
“In addition to fulfilling the important statutory obligations of the 21st Century Cures Act, implementing these provisions is critical to enhancing interoperability, promoting health equity, and supporting expand access, exchange and use of appropriate electronic health information,” Tripathi said in a statement today about HTI-1.
Tina Manoharan will provide more details during the HIMSS23 session “AI and Data Interoperability: A Symbiotic Relationship for Healthcare.” Scheduled for Tuesday, April 18 at 4:15pm – 5:15pm CT at South Building, 4th Floor, room S401.
