Healthcare stakeholders are largely optimistic about HTI-2

Healthcare leaders have begun studying the HTI-2 interoperability rule recently proposed by the Office of the National Coordinator for Health IT, and many have offered their reactions to various components of the rule.

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

Patient-centered goals

To enhance interoperability and promote the sharing of health information nationwide, ONC released its proposed rule on Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability for public comment on July 10.

The HTI-2 proposed rule is a set of standards and guidance that can address key interoperability hurdles, including standardization, data quality, security issues, and accessibility, according to Tim Price, chief product officer at Infermedica, a global digital healthcare company.

“While the proposed HTI-2 rule addresses some gaps in public health infrastructure related to interoperability and streamlining data exchange, there is still much work to be done in these areas,” he said in a statement to the Healthcare IT News. “To overcome the challenges of seamless health data exchange, obstacles such as standardization, data quality, security issues, and accessibility need to be addressed.

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

Kulwant Gill, senior vice president and managing director of Pivot Point Consulting, agreed in his statement that HTI-2 aims to address gaps in public health infrastructure related to data exchange.

But he said key items in the value-based care environment will continue to expand – “allowing health systems to better predict the financial and operational impacts.”

What will it do and when?

Jay Anders, chief medical officer at Medicomp Systems, said in an email shortly after the proposed rule was released that the proposed rule lays the necessary foundation for the exchange of medical and public health information.

“It also defines how health care information will be shared with payers and patients, streamlines the pre-approval process, and addresses patients’ ability to receive real-time prescription drug benefit information so they can make better decisions about their care,” he added via email last week.

While some like Anders feel the timeline sets a pace “that the HIT community can easily adhere to,” others don’t share that view.

The Electronic Health Records Consortium, a partner of Healthcare IT News HIMSS parent company said it has some concerns about the proposed compliance timeline, “given the scope of the proposed requirements and the consistency with [U.S Centers for Medicare & Medicaid Services] rules of interaction.”

The EHR Association, an organization of 28 member companies, said in a statement that while the new regulation has been proposed, “significant efforts” toward HTI-1 compliance are already underway.

A spokesperson for Epic, a major EHR company and member of the EHRA, said via email last week that it is reviewing HTI-2 and will likely provide feedback “on recommendations related to patient engagement, information sharing, and interoperability in public health.”

Other EHR vendors said they share the optimism and called the HTI-2 proposal a big step toward increased information sharing across the country because it specifies certification criteria through a standards-based API exchange.

“Essential to successful data exchange is technology designed to seamlessly integrate and present data from multiple sources, ensuring a holistic view of a patient’s health,” Aparna Bala, director of product development at CliniComp, said via email.

Alignment and documentation

HTI-2 provides 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 different requirements.

With HTI-2, all new prescriptions, refills, change requests, refill notifications, canceled prescriptions, and medication histories need to be upgraded to NCPDP SCRIPT version 2023011 by January 1, 2028, according to CMS’s final rule, while ONC is considering requiring electronic prior authorization in the e-prescribing process under the proposed rule.

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

Transition times for most requirements – ONC proposes some compliance dates in 2028 – can help organizations upgrade functionality.

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

“Other areas of particular 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 related to ePrior Authorization, certification changes and TEFCA,” the EHRA statement said.

“Some of the previous validation work, public health extensions were not clearly defined, and extending USCDI to v.4 will likely require significant effort on the part of HIT providers,” Don Rucker, chief strategy officer at 1upHealth, explained via email on Friday.

“However, the core FHIR APIs should be easy to implement because they are basic modern RESTful JSON APIs and easy to program,” he said. “Workflows will have to change along with the new standards,” Anders admitted.

However, he notes that “Change has always been seen as worrisome, meaningful use has been resisted, but EHR vendors have been able to comply.”

Additional requirements may also increase the supplier’s paperwork.

“ONC’s proposal to add race and ethnicity to every prescription has the potential to create a huge workload for prescribers,” Rucker added.

Unstructured Data, TEFCA and AI

National Coordinator Micky Tripathi said when announcing the HTI-2 proposal that the new version of TEFCA, which takes effect July 1, will position eligible participating Health Information Networks to move towards FHIR-based exchanges.

Automation could allow FHIR APIs to connect to EHR systems, allowing more applications to request EHR data and “eliminating the critical friction point that we have today,” he said.

Rucker said he still sees ONC stuck in the health care industry’s siloed past with certifications governed under TEFCA, and two key challenges remain, despite the updated proposals.

“HTI2 is still based on legacy EHR concepts and does not enable the modern digital healthcare economy,” he said.

“TEFCA continues to use a 1990s-era document-only protocol. TEFCA’s ‘trust me’ authentication model for privacy is fundamentally insecure,” according to the former national health IT coordinator.

“While ONC and [The Sequoia Project] “While TEFCA has attempted to add more ‘trust me’ authentication to make permissible uses, particularly HIPAA’s ‘treatment exceptions’ more granular, TEFCA still relies on user authentication rather than the public-key and untrusted cryptography used by the modern Internet,” he said.

“With all the cybersecurity issues surrounding medical records, this is really concerning,” he added.

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

“HTI-2 does not specify a RESTful API, which allows efficient access to individual FHIR Resources,” said Rucker.

ONC, he said, “needs to demonstrate why continuing to anchor the toll collector using a 1990s web view architecture is in the public interest.”

“What is perhaps less obvious is that modern protocols also eliminate the need to build an entire TEFCA broker architecture.”

Still, Anders said he’s seen some changes to how health care regulations have historically locked away important data in unstructured document files.

“ONC and CMS are very serious about sharing useful health information,” he said.

“One of the issues will be how usable the information shared is. My understanding is that this rule would not be acceptable if sending a multi-page PDF that would have to be decrypted,” Anders explained.

“Discrete data will have to be integrated into the receiving system so that it can be easily accessed and used.”

Sharing actionable data is key to realizing 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 agrees that most healthcare data is in unstructured formats and that only when this “last hurdle in the clinical data pipeline” is addressed will the healthcare industry “realize a return on 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 the usability of healthcare data,” she said.

Ultimately, Gary Hamilton, CEO of patient advocacy company InteliChart, said the proposed HTI-2 rule would represent “a major step toward digital interoperability and integration” across the entire healthcare ecosystem.

“Establishing clear standards for data sharing can help streamline administrative processes, reduce provider burnout, and significantly reduce the likelihood of medical errors,” he explains. “It also highlights the need for better integration between public health agencies and the broader healthcare system, which is critical to enabling advanced clinical decision-making and predictive analytics tools that can transform patient care.”