The Office of the National Coordinator for Health Information Technology (ONC) presented an overview of the proposed Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule at HIMSS23. The rule aims to improve interoperability, support trustworthy artificial intelligence, and address patient privacy concerns. The proposed rule would expand patient data points and requires developers of certified health IT to report every six months. ONC is offering webinars and sessions to help organizations prepare for the proposed rule and minimize info-blocking risks.
The Office of Policy team at the Office of the National Coordinator for Health Information Technology (ONC) recently presented an overview of the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) proposed rule at HIMSS23. The rule proposes data standards in development, guidelines for “trustworthy” artificial intelligence, reporting requirements for certified healthcare IT, and more.
During the live announcement of the notice of proposed rulemaking on April 11, National Coordinator for Health IT Micky Tripathi highlighted that the agency is working to improve interoperability with an eye towards health equity. The proposed rule connects to the 21st Century Cures Act and Biden-Harris executive orders, including Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats and orders advancing racial equity.
The proposed rule is in the best interest of patients, according to those who reached out to Healthcare IT News. Julie Nagy, Director of Clinical Product Design for EHR vendor CliniComp, noted that the information blocking provision of the proposed rule better supports the access and exchange of electronic health information, leading to a greater patient experience.
The proposed expectations of HTI-1 were presented by Elisabeth Meyers, Deputy Director of the Office of Policy Office of the National Coordinator for Health Information Technology, Jeffery Smith, Deputy Director of the Certification and Testing Division in ONC’s Policy Office, and Michael Lipinski, Director of the Office’s Regulatory and Policy Affairs Division. To encourage semantic interoperability, the recommended expectations call for increasing the number of patient data points, adding new interoperability standards, adopting revised policies, and revising language requirements.
The proposed rule also aims to address patient privacy and trust in AI. Smith said that HTI-1 helps enable a user of certified health IT to implement a process to restrict data from use in response to a patient request. The rule proposes criteria for patient-requested restrictions on what they perceive as sensitive data. The ONC policy team overview states that these baseline requirements for transparency aim to improve the trustworthiness of predictive algorithms and support their widespread use in healthcare.
ONC has had a clinical decision support requirement for ten years that EHR users are required to support, but they will now have to support criteria for what the agency now calls decision support interventions (DSI) with specific elements related to SDOH, race, ethnicity or language, gender identity, and sexual orientation. Because users of DSI will need to provide technical, performance, and real-world testing information, ONC also proposes that certified health IT developers “employ or engage in the risk management of predictive DSI.”
The Cures Act requires EHR reporting not only to measure the performance of certified health IT but also to address information gaps and help the agency understand the use of specific certified health IT functionalities. The proposed rule requires developers of certified health IT to report every six months if they meet specific criteria, and initial reporting of measures will be phased in over two years.
ONC is offering a series of webinars and sessions to help organizations lead readiness and minimize information-blocking risks. Additionally, the agency is soliciting comments on the proposed rule, which is referred to by RIN 0955-AA03 at Regulations.gov, and is also offering fact sheets and a webinar schedule on HealthIT.gov for more information on the proposed rule and the health IT certification program.
