Changes to health IT certification process

The Office of the National Coordinator (ONC) is proposing some major changes to the Health IT Certification Program for electronic health records, including the establishment of the EHR Reporting Program as directed by the 21st Century Cures Act.  

The proposed rule is called “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing,” but ONC officials have already shorted the cumbersome title to “HTI-1.”  

Major provisions of the rule address everything from interoperability to algorithm transparency while taking a stab at clarifying the concepts around information blocking and how to enforce the appropriate flow of information across disparate systems. 

Highlights from the proposed HTI-1 rule 

The document starts off by introducing the EHR Reporting Program, as a new condition of certification for health IT.   

“The Cures Act specified requirements in section 4002(c) to establish an Electronic Health Record (EHR) Reporting Program to provide transparent reporting on certified health IT in the categories of interoperability, usability and user-centered design, security, conformance to certification testing, and other categories, as appropriate to measure the performance of EHR technology,” the rule explains. “Data collected and reported would address information gaps in the health IT marketplace and provide insights on the use of certified health IT.” 

ONC will be referring to the program as the “Insights Condition,” as it is intended to provide clarity and transparency around four key areas:

• individuals’ access to electronic health information
• public health information exchange
• clinical care information exchange
• standards adoption and conformance

 Health IT stakeholders are invited to review the metrics proposed for each area of focus and provide comment to the ONC before the provisions are finalized. 

According to an ONC fact sheet, other notable features of the rule include: 

• Proposing adoption of United States Core Data for Interoperability (USCDI) Version 3 to replace USCDI Version 1 as the standard by January 1, 2025 
• Updating requirements for standardized application programming interfaces (APIs), including adoption of the Smart App Launch Implementation Guide v2 
• Requiring electronic case reporting using HL7 CDA- and HL7 FHIR-based specifications
• Clinical decision support (CDS) with several new transparency requirements for Health IT Modules that leverage predictive models or algorithms to provide decision support to users  
• New functionality to assist with flagging whether specific pieces of a patient’s USCDI data should be restricted from subsequent use or disclosure 

“In addition to fulfilling important statutory obligations of the 21st Century Cures Act, implementing these provisions is critical to advancing interoperability, promoting health equity, and supporting expansion of appropriate access, exchange, and use of electronic health information,” said Micky Tripathi, PhD, national coordinator for health information technology. 

ONC is also interested in eliminating the year-based labels for updates to the Health IT Certification Criteria.  Repeated timeline adjustments and delays have left the naming scheme out of step with the actual calendar, causing unnecessary confusion. 

Defining key issues around information blocking 

The rule also takes a look at the challenging task of defining what constitutes information blocking. ONC is proposing more concrete parameters for what it means to “offer” health IT, what type of health IT developers are subject to information blocking regulations, as well as outlining potential changes to infeasibility exceptions. 

For example, under the new guidelines, health care providers who “self-develop” certified health IT for their own use, but do not offer any certified health IT products or capabilities to other parties, would continue to be excluded from the “Health IT Developer of Certified Health IT” category. 

Implementing these semantic guardrails will help ONC and its partners ensure that all stakeholders are aware of how to avoid instances of information blocking and collaborate to continually improve interoperability across the healthcare industry. 

Providing feedback to ONC about the proposed changes 

ONC is eager to receive industry feedback about the rule. The public comment period is open from April 18 to June 20, 2023, at 11:59 PM ET.  Interested parties can submit their commentary using the form at the top of the Federal Register publication page. 

Jennifer Bresnick is a journalist and freelance content creator with a decade of experience in the health IT industry.  Her work has focused on leveraging innovative technology tools to create value, improve health equity, and achieve the promises of the learning health system.  She can be reached at jennifer@inklesscreative.com.