A couple networks are live, and the Office of the National Coordinator for Health IT hopes the first group — among 12 entities that submitted letters of intent — will be officially designated qualified health information networks (QHINs) in early 2023.

Part of the Department of Health and Human Services, ONC published a framework in January for exchanging health information nationwide: the Trusted Exchange Framework and Common Agreement (TEFCA). Required by the 21st Century Cures Act, the framework provides non-binding principles and the agreement technical terms, and now it falls to ONC’s recognized coordinating entity, The Sequoia Project, to approve interoperable QHINs.

“What we’ve heard informally from a number of the prospective QHINs is that they are building in anticipation of getting approved,” Tripathi said, during eHealth Exchange’s annual meeting on Dec. 15. “They think that they would have a pretty good opportunity to do this in the 12-month window and hopefully shorter than that with some of them.”

QHINs will be added on a rolling basis to include electronic health record (EHR) vendors, ambulatory practices, hospitals, health centers, federal and public health agencies, and payers. Epic Systems became the first EHR vendor to announce it would seek QHIN status in August and was later joined by the likes of the eHealth Exchange network and trade association CommonWell Health Alliance.

How TEFCA coexists with other exchanges when it comes to benefits determinations, health care operations, treatment, payment and individual access remains to be seen. But scaling TEFCA will be the “real challenge” and one for which incorporating the Health Level Seven (HL7) Fast Healthcare Interoperability Resource (FHIR) data standard will be key, Tripathi said.

FHIR application programming interfaces streamline health information exchange by eliminating the need for separate data use agreements, and eventually they’ll enable questionnaires, scheduling, links, Clinical Decision Support hooks and subscriptions. That’s why there are already federal deadlines in place for their steady adoption across the public health ecosystem, but QHIN-to-QHIN brokered exchange remains years away.

By the end of 2022, certified EHR vendors must make a FHIR API available to customers.

HL7’s Helious FHIR Accelerator aims to improve the exchange of situational awareness information on hospital and intensive care unit beds available, ventilator counts, personal protective equipment counts, and vaccinations. The HHS Protect system launched during the height of the COVID-19 pandemic provides a lot of that information right now.

“But it’s done via spreadsheets,” Tripathi told FedScoop in July. “A lot of manual work is still done to populate that now.”

The government has spent about $40 billion on EHR infrastructure since the passage of the Health IT for Economic and Clinical Health (HITECH) Act in 2009. Yet clinical operations and health payment systems remain largely rooted in paper because states — most of which still don’t require electronic case reporting — have health authority in the U.S.

Jurisdictional issues and scarce resources are some reasons why about 30% of U.S. hospitals still don’t connect to a health information network, Tripathi said Dec. 15.

Naturally issues with case reports, lab and testing results, and vital records arose early in the pandemic, when they were often being shared by phone or fax.

For all these reasons the Centers for Disease Control and Prevention launched its Data Modernization Initiative (DMI) in 2020 to streamline sharing of electronic health information between care providers and state, local, tribal and territorial (SLTT) health departments. 

The DMI’s first phase has involved getting data from electronic sources into a Microsoft Azure cloud environment, called the Enterprise Data Analytics and Visualization (EDAV) platform, while providing SLTT health departments with automated forecasting analytics tools.

Data standardization is key to improving information sharing between these systems, which is why ONC is working closely with the CDC on its North Star Architecture. The U.S. Core Data for Interoperability (USCDI) Version 4 (v4) that ONC has planned for 2023 will become the de facto minimum set of health data classes and elements for nationwide, interoperable information exchange.

At the same time ONC is developing USCDI+, a nationwide public health data model, for release beyond 2023. Discussions with the CDC and Centers for Medicare and Medicaid Services revealed more than 20 data elements that overlapped, allowing the agencies to agree on a common approach.

ONC is now speaking with the White House Office of Science and Technology Policy and the National Institutes of Health about tailoring a USCDI+ program for President Biden’s Cancer Moonshot program.

EHR vendors support TEFCA and the DMI because they’ll be able to maintain just one customer interface, rather than hundreds to meet the various jurisdictional requirements of SLTT health departments, Tripathi said in July.

Phase I of the DMI is also improving the CDC’s situational awareness, which is based on the Data Collation and Integration for Public Health Event Response (DCIPHER) platform — originally intended to track food-borne diseases. DCIPHER gave rise to HHS Protect and has since had hospital capacity, social vulnerability, mobility, race and ethnicity, social determinants of health, economic, two-on-one, and climate data layered atop it as part of the new Center for Forecasting and Outbreak Analytics’ work, Dr. Dan Jernigan, deputy director for public health science and surveillance, told FedScoop in August.

The center can already do weekly influenza and some Mpox forecasting and has visibility into emerging problems at about 70% of emergency departments.

“To see a fully formed prediction center, it’s going to be a couple years,” Jernigan said. “The numbers of staff that are in the Center for Forecasting right now are in the tens to thirties, but it is anticipated to be a much larger group.”

As part of DMI Phase I, 128 reportable diseases now automatically trigger EHR electronic case reporting, which is routed to the Association of Public Health Laboratories-APHL Informatics Messaging Services (APHL-AIMS) cloud platform and then SLTT health departments. Electronic case reporting increased from 187 facilities pre-pandemic to more than 14,000, more than 30 of which turned on Monkeypox reporting.

While the effort highlights the CDC’s move toward pathogen- and program-agnostic systems through its DMI, electronic case reporting continues to fall short.

“It’s not nearly the volume that we need it to be,” Tripathi said in July. “But at least we’re starting to set up those pathways.”

At the same time the DMI has seen “dramatic improvements” in COVID-19 reporting across immunization information systems (IISs), he added.

IISs were slow to take adult COVID-19 vaccination information, but now they accept line-listed records using privacy-preserving record linkage — even for Monkeypox.

The CDC recently revised its DMI implementation plan, and Phase 2 will focus on improving state health departments’ cloud infrastructure and update the National Electronic Disease Surveillance System (NEDSS) Base System (NBS) that 26 states use for case management.

Cloud migration allows doctors like Phil Huang, director of Dallas Health and Human Services, to match immunization, lab and death records to know if a patient who passed away tested positive for COVID-19 and was vaccinated. 

“That ability to put that data together and integrate it with other kinds of information, even down to the neighborhood level, helps him do his prevention work and his mitigation work in a much more targeted way,” Jernigan. 

CDC proposed the DMI receive about $200 million in fiscal 2023 to continue its “incremental” progress, but the Healthcare Information and Management Systems Society estimated the initiative needs $33 billion over the next 10 years to be successful, he added.

Meanwhile ONC, unable to enforce TEFCA, is working with federal partners to highlight the need for network-to-network interoperability and hoping its rollout leads outside providers to question why they’re still faxing records.

“We were given no dollars and no new authorities to do this,” Tripathi said.

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Becerra tasked the Office of the National Coordinator for Health IT with the research given its work with vendors of electronic health records, which are increasingly the source of data used to train and develop algorithms.

ONC has found algorithms developed by, say, the Mayo Clinic in Rochester, Minnesota, might not apply to hospitals in San Juan, Puerto Rico, as the Biden administration prioritizes more equitable health outcomes nationally, according to the HHS secretary.

“As part of the effort, I’ve asked ONC to take a deep look at algorithmic bias and its implications for health equity to ensure that all Americans get the benefits that modern analytic technologies can provide,” Becerra said, during the ONC 2022 Annual Meeting on Wednesday.

ONC has also begun working with the Centers for Disease Control and Prevention on what’s being informally called its “north star architecture,” a more cloud-oriented environment to support the federated public health infrastructure across the U.S. The north star architecture is part of the CDC’s Public Health Data Modernization Initiative and includes a collaborative governance model co-chaired by both agencies and including state, local, tribal and territorial public health agencies.

For ONC’s part, it will release more use case-specific data as part of its U.S. Core Data for Interoperability+ (USCDI+) initiative to create a nationwide public health data model.

“The idea is to create an infrastructure that allows the benefits of what cloud-hosted architecture can provide and cloud-native solutions can provide but also still give the jurisdictions — the state, local, tribal and territorial public health agencies — the autonomy that they need and is a part of the Constitution,” said Micky Tripathi, national coordinator for health IT.

Tripathi called 2022 a “pivotal” year in the U.S.’s transition to “digitally native” health care while admitting faxing is still “hiding in plain sight” across the delivery system. He’s both encouraged by the commitment of health care providers, technology developers and health information networks to meeting the new Fast Healthcare Interoperability Resource (FHIR) data standard for health information sharing and concerned providers may not be aware of all the deadlines and requirements.

ONC plans to launch pilots of different patterns of support for FHIR in early 2023. Patterns include non-brokered or facilitated FHIR, which allows for the use of network infrastructure like endpoint directories, record-location services and security certificates to make it easier for applications to connect and the standard itself to scale.

The agency is additionally working with the CDC to launch the Helios FHIR Accelerator, a public-private initiative to streamline data sharing through new use cases and ultimately speed up modernization of public health technology.

Tripathi hopes to escape the cycle of industry doing the bare minimum, forcing agencies including ONC to issue more detailed regulations.

“I think one of the scourges of our industry is the minimum viable compliance problem,” Tripathi said. “That is doing just enough to meet the letter of a regulation and not embracing the spirit or the opportunity of what we can do together.”

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A draft Version 3 of the U.S. Core Data for Interoperability (USCDI v3) adds the health insurance information and health status classes and 20 elements between them and the laboratory, patient demographics and procedures classes.

Interoperable networks have been on the Office of the National Coordinator for Health IT’s wishlist since its creation in 2004 because they allow everything from federal agencies to health-care providers to share the data HHS is prioritizing in real-time to respond to disease outbreaks and prevent future pandemics.

ONC added classes and elements supporting exchange of social determinants of health and sexual orientation and gender identity data with USCDI v2 in July. More recently ONC released a technical specification for consistently formatting patient addresses in early January and a framework for securely sharing clinical data between health information networks Tuesday, on a path to establishing a nationwide exchange for public health and personal access purposes.

“The USCDI is also used to align interoperability requirements and national priorities for health IT and health care broadly across industry initiatives,” reads draft USCDI v3. “In fact, CMS and other federal, state, local, and tribal partners reference the USCDI for a range of health information exchange purposes.”

New data elements align with President Biden’s executive orders promoting a data-driven response to the COVID-19 pandemic and racial equity.

The addition of the health status data class along with its disability status, mental function, functional status and pregnancy status elements broadens the original health concerns class — now reclassified as an element along with smoking status — to improve patient care and address inequalities.

Health insurance information is the other new class and comes with seven elements — coverage status, relationship to subscriber, member, subscriber, group identifiers, coverage type, payer identifier — chosen to improve care, price transparency and coverage disparities.

The existing patient demographics class receives six new elements: related person’s name, related person’s relationship, date of death, occupation, occupation industry, and tribal affiliation. ONC added these elements to improve record linkages, patient matching and equitable public health reporting and research.

The third version of USCDI fine-tunes requirements for elements, including discharge dates and locations, instructions and reasons for hospitalization for the discharge summery note element.

Vocabulary standards will be updated in the final draft, and ONC is seeking additional feedback on the sex (assigned at birth) element, due to changes in the concept, and the gender identity element, which lacks terms for transgender people. ONC also wants to know if its tech spec for patient addresses should be the required USCDI standard.

The public has until April 30, 2022, to comment on draft USCDI v3, the final version of which will be published in July 2022.

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