In April of this year, the Department of Health and Human Services (HHS) published a proposed rule concerning data interoperability that is of significant importance to developers of health information technology (health IT).  

Having the title, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing,” it seeks to make changes to the ONC Health IT Certification Program (Program) by adding “Decision Support Interventions” (DSIs) certification criteria to “keep pace with advances in software that developers of certified health IT enable or interface with to aid decision-making in healthcare,” along with numerous other updates that are indicated below.  

A strong emphasis is also placed on advancing health equity, with the adoption of the United States Core Data for Interoperability Standard Version 3 (USCDI v3) being proposed, which would include data elements such as social determinants of health and would support “data users’ abilities to identify, assess, and analyze gaps in care.” 

ONC HEALTH IT CERTIFICATION PROGRAM UPDATES 

The proposed rule outlines the updates being sought to the ONC Health IT Certification Program, including the following: 

• The adoption of USCDI v3  
• Updates to the C-CDA Companion Guide
• The adoption of newer versions of “minimum standards” code sets 
• Revisions to the “transmission to public health agencies – electronic case reporting” criterion  
• A new certification criterion for decision support interventions  
• Proposals related to patient demographics and observations  
• Updates to transitions of care certification criterion
• Increased support relating to patient requested restrictions; and,  
• Requirements for health IT developers to update previously certified health IT Modules. 

Such updates aim to improve interoperability, facilitate effective transitions of care, improve decision-making in healthcare, and provide individuals with greater control over the collection, use, and disclosure of their electronic health information. 

USCDI v3 figures heavily into the updates, factoring into potential revisions as to the C-CDA Companion Guide, standardized API for patient and population services, patient demographics and observations certification criterion, and updates to transitions of care certification criterion, seeking to bring them into alignment with the new data classes and elements. The adoption of the Substitutable Medical Applications, Reusable Technologies (SMART) Application Launch Framework Implementation Guide Release 2.0.0 (SMART v2 Guide) is also being proposed as to standardized API for patient and population services, in order to include “new features and technical revisions based on industry consensus, including features that reflect security best practices.” Other updates and revisions to existing certification criteria include newer versions of “minimum standards” code sets that would serve as a baseline for certification, and the adoption of “consensus-based, industry developed electronic stands and implementation guides” as to electronic case reporting.  

Of special note is the proposal to include “decision support interventions (DSI)” as iterative and replacement criterion for the “clinical decision support (CDS) criterion found in section 170.315(a)(9) in order to improve assistance in guiding medical decisions. The new criterion is said to reflect “an array of contemporary functionalities, data elements, and software applications, including the use of predictive models or algorithms, that certified Health IT Module(s) enable or interface with to aid decision-making in healthcare.”  

In relation, a new definition as to “predictive decision support intervention,” is being proposed and developers would be subject to the following requirements in order to provide transparency as to predictive DSIs: 

• They must enable users to review predictive DSI “source attribute” information through the Health IT Modules 
• They must “employ or engage” in intervention risk management practices 
• They must make summary information as to these intervention risk management practices available via a publicly accessible hyperlink 
• They must enable users to provide feedback regarding DSI information displayed through the Health IT Module; and,
• Such Health IT Modules must make available such feedback data for export in a computable format. 

Proposed compliance for the new requirements is specified as being by the date of December 31, 2024.  

EHR REPORTING 

Pursuant to the 21^st Century Cures Act section 4002(c), the Department of Health and Human Services (HHS) is required to create an Electronic Health Record (EHR) Reporting Program to “measure the performance of EHR technology,” according to language found in the proposed rule. Specifically, this means requiring developers of health IT to provide relevant information by submitting responses as to reporting criteria under the ONC Health IT Certification Program. The proposed rule refers to the reporting requirements relating to EHR, as the Insights Condition and Maintenance of Certification, or Insights Condition, and signals a number of updates. 

The focus will initially be on reporting as to interoperability, across the following four areas:  

• individual’s access to electronic health records;  
• public health information exchange; 
• clinical care information exchange; and,  
• standards and conformance. 

Other reporting areas required by the Cures act will be addressed in “future years” and consist of security, usability and user-centered design, conformance to certification testing, and “other categories to measure the performance of EHR technology.”  

The proposed rule seeks to implement the Insights Condition and Maintenance of Certification requirements in two phases and describes its purpose as being, “to provide transparent reporting, address information gaps in the health IT marketplace, and provide insights on the use of health IT.”  

REAL WORLD TESTING REQUIREMENTS  

The proposed rule also seeks to require Health IT developers to include the newer versions of “those certified Health IT Module(s) that are updated using Inherited Certified Status after August 31 of the year in which the plan is submitted.” This would revise the Condition and Maintenance of Certification requirement for health IT developers to successfully test the real-world use of health IT interoperability in the ‘types of settings in which such technology would be marketed,’ under section 4002(a) of the Cures Act and would seek to ensure that certified Health IT Modules are not inadvertently excluded from real world testing reporting requirements.  

INFORMATION BLOCKING 

The proposed rule also seeks enhancements to the information blocking regulations found in 45 CFR part 171. Information blocking is defined by HealthIT.gov as practices that are “likely to interfere with the access, exchange, or use of electronic health information (EHI),” and such proposed enhancements include narrowing the definition of what it means to “offer health information technology” as to the “applicability of the health IT developer of certified health IT.” The Rule also seeks to revise the Infeasibility Exception found in 45 CFR 171.204(a) to “further clarify when an actor’s practice of not fulfilling a request for access, exchange, or use of EHI meets the condition.” 

The public comment period for the proposed rule ended recently on June 20, 2023, with the Regulations.gov site listing a total of 234 comments made. According to the site FedScoop.com, a spokesperson for the Office of the National Coordinator for Health Information Technology (ONC) has indicated the possibility of the final rule being published “as early as later this year.”

Categories: AI, DATA ACCESS & INTEROPERABILITY