Healthcare leaders have begun to digest the Office of the National Coordinator for Health IT's recently proposed HTI-2 interoperability rule, and many have offered their reaction to its various components.

While most see the proposed rule as a conduit for improving health information exchange between providers, public health agencies and payers through standards-based APIs, others still see significant work to be done on issues such as documentation requirements and data sharing via the Trusted Exchange Framework and Common Agreement, or TEFCA.

Patient-centered goals

To further interoperability and drive nationwide health information sharing, ONC published the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing and Public Health Interoperability proposed rule for public comment on July 10.

The HTI-2 proposed rule is a set of standards and guidelines that could tackle key interoperability obstacles, including standardization, data quality, security issues and accessibility, according to Tim Price, chief product officer at Infermedica, a global digital health company.

"While the HTI-2 proposed rule addresses some gaps in public health infrastructure related to interoperability and streamlining data exchange, work remains in these areas," he said in a statement to Healthcare IT News. "Overcoming the challenges of seamlessly exchanging health data involves tackling obstacles such as standardization, data quality, security issues, and accessibility.

"The potential of interoperability to streamline patient care, spur innovation and advance medical research is clear," he added. "Addressing these challenges is essential for achieving a healthcare system that is truly patient-centered and efficient."

Kulwant Gill, senior vice president and management consulting leader for Pivot Point Consulting, agreed in his own statement that HTI-2 aims to address gaps in public health infrastructure related to data exchange.

But, he said, items critical in a value-based care environment will continue to expand – "allowing health systems to better predict financial and operational implications."

What will it do, and when?

The proposed regulation lays necessary groundwork for health information exchange and public health, said Jay Anders, chief medical officer at Medicomp Systems, by email, shortly after the proposed rule was announced.

"It also defines how healthcare information will be exchanged with payers and patients, streamlining the prior authorization process and addressing the patient's ability to get real-time prescription benefit information so that they can make better decisions about their care," he added last week by email.

While some like Anders feel the timeline sets a pace "that the HIT community can easily comply with," others do not share that POV.

The Electronic Health Records Association, a partner of Healthcare IT News parent company HIMSS, said that it has some concerns on the proposed compliance time lines, "given the scope of proposed requirements and alignment with [U.S Centers for Medicare & Medicaid Services] interoperability rule."

The EHR Association, an organization of 28 member companies, said in a statement that while the new rule was proposed, "significant efforts" toward HTI-1 compliance were already underway.

A spokesperson from Epic, an EHR giant and member of EHRA, said by email last week that it is reviewing HTI-2 and is likely to provide feedback "on proposals around patient engagement, information sharing and public health interoperability."

Other EHR vendors said they share the optimism and called the HTI-2 proposal a major step toward enhancing nationwide information sharing because it specifies certification criteria through standards-based APIs exchange. 

"What is required for data exchange success is technology designed to seamlessly integrate and present data from disparate sources, ensuring a holistic view of patient health," Aparna Bala, director of product development at CliniComp, said by email. 

Alignment and documentation 

HTI-2 offers long-awaited federal alignment on interoperability standards, most notably. CMS and ONC will now require the same e-prescribing standards for EHRs and prescribers. In 2020, the agencies had divergent requirements. 

With HTI-2, all new prescriptions, refills, change requests, fill notifications, cancellations and medication history need to be upgraded to NCPDP SCRIPT version 2023011 by January 1, 2028, under the CMS final rule, while ONC considers requiring electronic prior authorization in e-prescribing workflows with the proposed rule.

While a compliance date for this particular requirement will be determined by ONC when HTI-2 is finalized later this year, healthcare systems and IT vendors can start using the new standards as soon as they are ready.

A transition period for most requirements – ONC proposes several compliance dates in 2028 – could help organizations upgrade functionality. 

EHRA also said it will look closely at how HTI-2 governs other standards for moving targets.

"Other areas of specific interest to our member organizations include those related to [United States Core Data for Interoperability], expanded API use cases, new and revised information blocking exceptions, health IT obligations regarding ePrior Authorization, certification changes and TEFCA," the EHRA statement said.

"Some of the prior auth work, the under-defined public health extensions and expansion of the USCDI to v.4 will likely require significant effort on the part of HIT vendors," Don Rucker, chief strategy officer at 1upHealth, explained by email Friday.  

"However the core FHIR APIs should be straightforward to implement as these are basic modern RESTful JSON APIs and easily programmed," he said. "Workflows will have to change along with the new standards," Anders acknowledged.

However, "Change is always seen as troubling, meaningful use had pushback, yet EHR providers were able to comply," he noted.

Additional requirements could also increase provider documentation.

The "ONC proposal to add race and ethnicity to every prescription will potentially generate extraordinary work by prescribers," Rucker added.

Unstructured data, TEFCA and AI

National Coordinator Micky Tripathi said in announcing the HTI-2 proposal that the new version of TEFCA, which became effective July 1, positions participating Qualified Health Information Networks to move forward on FHIR-based exchange. 

Automation can enable FHIR APIs to connect to an EHR system, enabling many applications to request EHR data and "will eliminate a serious friction point that we have right now," he said.

Rucker said that he still sees ONC stuck in healthcare's siloed past with attestations governed under TEFCA, and two main challenges remain, despite the proposed updates.

"HTI2 is anchored on legacy EHR concepts and does not facilitate a modern digital healthcare economy," he said. 

"TEFCA continues with its 1990s document-only protocol. TEFCA’s 'trust me' attestation model of privacy is fundamentally insecure," according to the former national health IT coordinator. 

"While ONC and [The Sequoia Project] have attempted to add multiple further 'trust me' attestations to make permitted uses, in particular, HIPAA’s 'treatment exception' more granular, TEFCA is still based on user attestations rather than the public key cryptography and zero trust used by the modern Internet," he said.  

"With all of the cybersecurity issues around medical records, this is concerning," he added.

The second issue is how TEFCA leverages FHIR, which he noted is a data format and not an API protocol. 

"HTI-2 does not specify RESTful APIs, which would allow efficient access at individual FHIR Resources," Rucker said.

ONC "needs to show why further anchoring on toll-takers using 1990’s webpage view architecture is a public good," he said.

"Maybe not so obvious is that modern protocols also eliminate the need the entire broker architecture TEFCA is built on."   

However, Anders said he does see some movement on how healthcare regulations have historically locked key data up in unstructured documentation files.

"The ONC and CMS are serious about sharing usable medical information," he said.

"One of the issues will be how usable the shared information will be. The way I read the regulation is that it will not be acceptable to send a multipage PDF that will have to be deciphered," Anders explained. 

"The discrete data will have to be incorporated in the receiving system, such that it is easily accessible and usable."

Sharing actionable data is the key to fulfilling the vision of value-based care, according to Kim Perry, chief growth officer at emtelligent, a company that develops clinical-grade natural language processing software. 

She agreed that most healthcare data is in unstructured formats, and only when this "final barrier in the clinical data pipeline" is addressed will healthcare "realize the return on its investment in digital health technology."

"In addition to pursuing greater interoperability, we must modernize the industry’s data processing pipelines and leverage AI, [NLP] and large language models to improve healthcare data usability," she said.

Ultimately, said Gary Hamilton, CEO of patient engagement company InteliChart, the HTI-2 proposed rule should represent a "significant step towards interoperability and the digital integration" across the healthcare ecosystem.

"Setting clear standards for data sharing can help streamline administrative processes, reduce provider burnout, and significantly decrease the likelihood of medical errors," he explained. "It also underscores the need for better integration between public health agencies and the broader healthcare system, which is crucial for enabling advanced clinical decision-making and predictive analytics tools that can transform patient care."