Healthcare stakeholders are largely optimistic about HTI-2

Healthcare leaders have begun digesting the Office of the National Coordinator for Health IT’s recently proposed HTI-2 interoperability regulations, and many have responded to its various components.

While most see the proposed regulations as a way to improve the exchange of health information between providers, public health authorities, and payers through standards-based APIs, others believe much work remains to be done on issues such as documentation requirements and data sharing through the Trusted Exchange Framework and Common Agreement (TEFCA).

Patient-centered goals

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

According to Tim Price, Chief Product Officer at Infermedica, a global digital health company, the proposed HTI-2 regulation is a set of standards and guidelines that can address key barriers to interoperability, including standardization, data quality, security concerns and accessibility.

“While the proposed HTI-2 regulations address some of the gaps in the public health infrastructure related to interoperability and streamlining data sharing, there is still work to be done in these areas,” he said in a statement to Healthcare IT News“To overcome the challenges of seamlessly exchanging health data, we must address barriers such as standardization, data quality, security issues and accessibility.

“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 health care system that is truly patient-centric 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 the public health infrastructure related to data sharing.

But he said items that are critical in a value-based care environment will continue to expand — “allowing health systems to better predict the financial and operational implications.”

What will it do, and when?

The proposed regulations lay the necessary foundation for health information exchange and public health, Jay Anders, chief medical officer of Medicomp Systems, said in an email shortly after the proposed regulations were announced.

“It also defines how medical information is exchanged with payers and patients, streamlining the prior authorization process and improving patients’ ability to obtain real-time information about prescription reimbursements so they can make better decisions about their care,” he added by email last week.

While some, like Anders, feel the timeline sets a pace “that the HIT community can easily adhere to,” others disagree.

The Electronic Health Records Association, a partner of Healthcare IT News Parent company HIMSS said it has some concerns about the proposed compliance deadlines, “given the scope of the proposed requirements and the coordination 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” were already underway to comply with HTI-1.

A spokesperson for Epic, an EHR giant and EHRA member, said in an email last week that it is evaluating HTI-2 and will likely provide feedback “on proposals around patient engagement, information sharing, and interoperability in public health.”

Other EHR vendors expressed their shared optimism, calling the HTI-2 proposal an important step toward improving national information sharing as it specifies certification criteria through standards-based API exchange.

“Successful data exchange requires technology that seamlessly integrates and presents data from disparate sources to create a holistic picture of a patient’s health,” said Aparna Bala, director of product development at CliniComp, via email.

Alignment and documentation

HTI-2 provides long-awaited federal alignment on interoperability standards, specifically 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, refill notifications, cancellations, and medication histories must be upgraded to NCPDP SCRIPT version 2023011 by January 1, 2028, according to CMS’s final rule. ONC is considering requiring electronic prior authorization in e-prescribing workflows with the proposed rule.

The ONC will set a date for compliance with this specific requirement when HTI-2 is finalized later this year. However, health systems and IT vendors can begin using the new standards as soon as they are finalized.

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

EHRA also said it will closely examine how HTI-2 regulates other moving target standards.

“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, healthcare IT obligations related to ePrior authorization, certification changes, and TEFCA,” the EHRA statement said.

“Some of the previous authorization work, the poorly defined public health extensions, and the expansion of the USCDI to version 4 will likely require significant effort from HIT vendors,” Don Rucker, Chief Strategy Officer at 1upHealth, explained by email Friday.

“However, the core FHIR APIs should be easy to implement as they are simple modern RESTful JSON APIs and easy to program,” he said. “Workflows will need to change with the new standards,” Anders acknowledged.

“However, change is always seen as problematic, meaningful use was met with resistance, but EHR providers were still able to adhere to it,” he noted.

Additional requirements may also increase the provider’s documentation.

“The ONC’s proposal to add race and ethnicity to every prescription has the potential to create an extraordinary amount of work for 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 came into effect on July 1, allows participating Qualified Health Information Networks to continue with FHIR-based exchange.

Automation can enable FHIR APIs to connect to an EHR system, allowing many applications to query EHR data. “This will remove a serious bottleneck that we have now,” he said.

Rucker said ONC is still stuck in its siloed health care past, with attestations falling under TEFCA. Two major challenges remain, despite the proposed updates.

“HTI2 is based on old EHR concepts and does not contribute to a modern, digital healthcare economy,” he said.

“TEFCA is continuing with its 1990s document-only protocol. TEFCA’s ‘trust me’ attestation model of privacy is fundamentally insecure,” said the former national coordinator of health IT.

“While ONC and (The Sequoia Project) have attempted to add multiple ‘trust me’ attestations to more granularly define permitted uses, most notably HIPAA’s ‘treatment exception,’ TEFCA is still based on user attestations rather than the public key cryptography and zero trust used by the modern Internet,” he said.

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

The second issue is how TEFCA uses FHIR. According to him, FHIR is a data format and not an API protocol.

“HTI-2 does not specify RESTful APIs, which would enable efficient access to individual FHIR resources,” Rucker said.

According to him, the ONC must “show why further anchoring of toll collectors using the web page display architecture from the 1990s is a public good.”

“What may not be so obvious is that modern protocols also remove the need for the entire broker architecture on which TEFCA is based.”

However, Anders says he does see some change in the way healthcare regulations have historically captured key data in unstructured documentation files.

“The ONC and CMS take the sharing of useful medical information seriously,” he said.

“One of the issues will be how useful the shared information will be. As I read the regulations, it is not acceptable to send a multi-page PDF that needs to be decrypted,” Anders explained.

“The discrete data must be incorporated into the receiving system so that it is easily accessible and usable.”

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 software for natural language processing.

She admitted that most healthcare data is in unstructured formats and that healthcare will not see a return on its investment in digital health technology until this “last barrier in the clinical data pipeline” is addressed.

“In addition to driving greater interoperability, we need to modernize the industry’s data processing pipelines and leverage AI (NLP) and large language models to improve the usability of medical data,” she said.

Ultimately, the proposed HTI-2 regulation should represent a “significant step toward interoperability and digital integration” across the healthcare ecosystem, according to Gary Hamilton, CEO of patient engagement company InteliChart.

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