HHS’s Office of the National Coordinator for Health Information Technology (ONC), which released the draft Wednesday, establishes the following four goals: “promote health and wellness, enhance the delivery and experience of care, accelerate research and innovation and connect the health system with health data.” ONC said in a press release that it collaborated on the plan with 25 federal agencies that interact with health IT through purchasing, developing and regulating in order to improve health outcomes.

Among the overarching goals, the agency emphasized the need for a focus on “the policy and technology components needed to support” health IT users in connecting the system with data. 

Significantly, ONC states that the federal government plans to encourage “education, outreach and transparency” about artificial intelligence use so that both individuals and health care providers are informed about the performance and privacy practices of the technology. 

“The role of health IT and readily available access to health data have become increasingly essential to the administration of public health activities,” Jim Jirjis, director of the Centers for Disease Control and Prevention’s data policy and standards division, said in the release. “CDC appreciates how the draft 2024-2030 Federal Health IT Strategic Plan addresses the need to continue to advance the nation’s public health data infrastructure, while making sure that it is benefiting the communities that need it most.”

Additionally, Meg Marshall, director of informatics regulatory affairs at the Veterans Health Administration, said in the release that the VA is also seeking comments “so that veterans too can benefit from the goals of a coordinated federal health IT strategy.”

Marshall’s  statement follows a litany of problems with the VA’s Oracle Cerner-run electronic health record, including patient safety issues with EHR pharmacy software and a watchdog report about a veteran’s death tied to a scheduling error. The system was originally launched in 2020, in an effort to “establish interoperability of records between the VA and [Department of Defense] health care systems”.” EHR was later suspended in 2023 as part of a reset, and the department noted that it was working toward holding Oracle Cerner accountable for delivering high-quality services.

Marshall said in the statement that as the VA works to modernize its EHR system, ONC’s draft plan “provides direction towards a seamless health care experience” for patients and providers. 

“Not only that, the draft Federal Health IT Strategic Plan serves as an actionable roadmap for the federal government to align and coordinate health IT efforts in a transparent and accountable manner,” Marshall said.

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While the final rule from HHS’s Office of the National Coordinator for Health Information Technology extended deadlines for other requirements between the proposed and final versions — such as requirements related to a new baseline standard for the health IT certification program — it maintained the end-of-next-year deadline for the AI and algorithms portion, underscoring the Biden administration’s focus on regulating the nascent and growing technology.

Under the rule — called Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing, or HTI-1 — developers will need to update health IT currently certified under ONC’s old requirements by Dec. 31, 2024. Those new requirements mandate that tools used to aid decision-making that use AI and algorithms must share information about how the technology works as part of the agency’s certification process.

“I think it will be very interesting, you know, with that deadline coming a year out to see how the vendor community responds, and … can they make these new requirements work?” Jonathan French, senior director of public policy and content development at the Healthcare Information and Management Systems Society (HIMSS), said in an interview. 

In July, HIMSS recommended the agency delay the deadline to 2026. 

ONC Deputy National Coordinator Steven Posnack acknowledged the change in several deadlines in a call with reporters after the final rule was released last week, saying the agency “sought to space and pace many of the different requirements over time” to give industry time to make incremental adjustments. 

But Posnack added that “the algorithm-related transparency was a high priority for our office, the secretary, and administration. That’s one of the ones that we required straight out of the gate within a one-year time period.”

The algorithmic and AI requirements for decision support interventions (DSI) in the final rule come as the Biden administration has intensified its focus on regulating the technology. For example, the administration last week also announced voluntary commitments from health care companies to harness AI while managing its risks.

Generally, the algorithm requirements in the rule are aimed at promoting transparency and responsible AI use in health IT, such as electronic health records systems. In an interview with FedScoop in June, Micky Tripathi, the national coordinator for health IT, described the requirements as a “nutrition label” for algorithms.

In addition to the new AI and algorithm certification requirements, the rule also makes data interoperability updates to its health IT certification process and implements provisions under the 21st Century Cures Act.

ONC’s certification program is voluntary, but it’s incentivized by requirements that hospitals and physicians use certified systems when participating in certain Centers for Medicare and Medicaid Services payment programs. In a press release about the rule last week, ONC said health IT that it has certified “supports the care delivered by more than 96% of hospitals and 78% of office-based physicians around the country.”

While the deadline remains, industry experts analyzing the 916-page document said the final rule so far appears to address other concerns around the algorithm transparency portion. French, for example, pointed to more detailed information on the “source attribution” requirements and more detail on testing information. 

During the public comment period, the ONC received responses that said the rule’s AI and algorithmic requirements went too far, and others that said they didn’t go far enough. The American College of Cardiology called the proposal “overly broad,” whereas Ron Wyatt, the chief scientist and medical officer at the Society to Improve Diagnosis in Medicine, argued that the rule should go further, requiring information provided about the algorithms to be made publicly available. 

The final rule does include changes, according to ONC. “In response to public comments, the final DSI criterion includes clearer [and] more precisely scoped requirements for health IT developers,” ONC said in a fact sheet accompanying the rule. “In particular, the final criterion requires that health IT developers are responsible for only the predictive DSIs that they supply as part of their certified health IT.”

Joseph Cody, associate director for health IT and digital health policy at the American College of Cardiology, said ONC “made steps in the right direction” with some of the changes. 

In particular, he said “they did a much better job of delineating the difference between” evidence-based and predictive DSIs. Though he said some of the definitions are “still overly broad.”

“If you’re expecting clinicians to spend a lot of time to go through and look at all the different components that are required to be publicly transparent and available to them, it becomes very hard for that clinician to be able to spend that time,” Cody said. He added that ACC is looking forward to having conversations with federal agencies about additional steps.

The final rule also includes ongoing maintenance and risk management requirements for health IT developers to keep “source attributable” information in the DSIs up-to-date, according to ONC. Health IT will be required to comply with the maintenance certification starting January 2025.

Rebecca Heilweil contributed to this article.

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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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In the new role, Oliva is responsible for identifying, developing and managing collaborations with external partners that improve the health care experience for veterans and clinical staff.

Initially Oliva will target professional and trade associations, standards development organizations, health systems, and Department of Health and Human Services agencies.

“Projects are focused on sharing management approaches and intellectual property, promoting competency of and access to a highly skilled clinical informatics workforce, advocacy of policies that improve the effectiveness of clinical informatics, and improving the science of clinical informatics,” a VA spokesperson told FedScoop.

Specific projects include the American Medical Informatics Association’s Health System Council, Object Management Group’s BPM+ for Health initiative, and the Office of the National Coordinator for Health IT and Health Level Seven’s Fast Healthcare Interoperability Resources (FHIR) Accelerator.

Oliva started in the role June 6, having previously served as director of strategic and clinical project management to the hospital director and six other roles at VA. Before that she was a business owner and healthcare management supervisor with the Air Force Reserve.

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Speaking during the National Center for Health Statistics Board of Scientific Counselors meeting Thursday, Dan Jernigan said the Enterprise Data Analytics and Visualization (EDAV) platform lets CDC scientists catalog, analyze and publish findings faster.

The COVID-19 pandemic revealed the CDC has a data-sharing problem due to its many one-off, proprietary systems tracking individual diseases, but EDAV allows for reuse of forecasting solutions.

“This is an important way that we are trying to have systems that are not unique to the pathogen but are pathogen and program agnostic,” Jernigan said.

Next, the agency’s Data Modernization Initiative (DMI) will connect EDAV core services with its Microsoft Azure cloud environment to rearchitect siloed systems like ArboNET, used to share arbovirus case information.

While Azure is the primary EDAV environment, the CDC sees itself as a multi-cloud environment, and future building blocks and applications will be cloud agnostic “as much as possible,” Jernigan said. The agency brought in architects familiar with different environments and is working with other cloud providers to develop tools that work in multiple environments for the public health benefits.

Amazon Web Services is used for the National Syndromic Surveillance Program, and Amazon provides the platform for the CDC’s biggest data-sharing intermediary, the AIMS Platform used by the Association of Public Health Laboratories.

The DMI is also reimagining data flow into the CDC through a consortium, including the Office of the National Coordinator for Health Information (ONC), developing a North Star Architecture. The future-state public health ecosystem will ensure federal, state and local health department information systems are connected and interoperable.

ONC is developing new data standards, in accordance with 21st Century Cures Act requirements, that the North Star Architecture will use to decrease the reporting burden on health care providers and hospitals, eliminate the need for phone calls, and improve national disease forecasting and mitigations.

The CDC further established a Consortium for Data Modernization, with public health partners and industry associations, that meets biweekly to identify issues and decide who will address them. The agency will also reestablish the Data and Surveillance Workgroup under the Advisory Committee for the Director this summer.

Lastly, the CDC is holding listening sessions with potential private sector partners on the development of prototypes that will further the DMI.

“We don’t have all the funding that we need to do it,” Jernigan said. “But we are going to be targeting that funding to get critical efforts underway.”

The CDC is budgeting for the DMI based on five priorities: building the right foundation, accelerating data to action, workforce, partnerships, and change management.

Building the right foundation involves getting data from the appropriate sources. For instance, the National Center for Health Statistics (NCHS) is part of a $200 million grant that will fund states standardizing vital statistics, immunization, and laboratory case reporting data from electronic health records and other sources.

From there the CDC will ensure there’s a secure, accessible cloud environment for the data to land and that there are tools available to state and local health departments to analyze the information available.

“We want to be able to have rapid outbreak responses and develop common operating pictures,” Jernigan said.

The DMI is integrating data from nontraditional sources, and the CDC received $3 billion through the American Rescue Plan Act for a five-year program grant that will help hire data scientists and other personnel.

Each of the five DMI priorities has an implementation team associated with it that are standing up communities of practice for developing definitions, identifying barriers and risks, and setting objectives and desired results.

“Our ultimate goal is to move from siloed and brittle public health data systems to connected, resilient, adaptable and sustainable. And that sustainable piece is going to be important as we move forward, thinking about how we’re going to keep these efforts going — response-ready systems that can help us solve problems before they happen and reduce the harm caused by the problems that do happen,” Jernigan said. “So essentially better, faster, actionable intelligence for decision-making at all levels of public health.”

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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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The fiscal 2022 spending legislation passed by the House this week doesn’t include any money for the Technology Modernization Fund and would slash or maintain funding for two other federal IT modernization vehicles.

Should the $1.5 trillion bill become law, the Office of Management and Budget’s IT Oversight and Reform Fund would receive $8 million, down $4.5 million from fiscal 2021, and the Federal Citizen Services Fund (FCSF) would receive the same $55 million as last year.

Congress’ decision not to add money to the TMF comes after a major infusion last year. The Biden administration requested $500 million for the TMF this fiscal year. It had received a $1 billion under the American Rescue Plan Act, on top of a regular appropriation of $25 million for fiscal 2021.

“The federal government must maximize the impact of these funds by developing a strategic plan for use of the funds that will prevent duplication of efforts, direct the funds to their highest use and guarantee coordination among agencies,” reads the joint explanatory statement of the bill. “OMB is directed to provide the committees with a detailed strategic plan for use of the funds no later than 60 days after the enactment of this act.”

The TMF Board continues to hand out money in the meantime. It awarded $9 million for two projects at smaller agencies that often lack the budgets and technical staff to sustain initiatives addressing urgent network or cybersecurity challenges.

The White House also asked for an additional $4.2 million for the FCSF. The fund supports interagency projects digitalizing processes and using IT in innovative ways, and the bill allows up to $5 million to be put toward functions and hiring in support of the Foundations for Evidence-Based Policymaking Act.

On the other hand, the administration requested $10.4 million for the IT Oversight and Reform Fund, a modest $2.1 million cut compared to the current bill, which would allow OMB’s director to transfer the money to agencies’ projects.

The Senate is expected to pass the legislation later this month.

Rep. Gerry Connolly, D-Va., who chairs the House Subcommittee on Government Operations, expressed his “perennial disappointment” with IT underinvestment in the annual appropriations bill but also pointed out the “transformative” $1 billion for the TMF in the American Rescue Plan Act was the equivalent of 40 years of annual appropriations.

“New TMF projects were announced just this week,” Connolly said. “While I wish more robust funding for IT was in this package, we will continue to advocate for additional IT funding in future packages and help educate Congress about the power of IT investment.”

Familiar numbers for VA, IRS

Agencies struggling with their IT modernization efforts would continue to receive funding to right their respective ships.

Of the $4.8 billion allocated to the Department of Veterans Affairs for its IT systems, $2.5 billion would go toward its Electronic Health Record Modernization (EHRM) initiative — $127 million less than fiscal 2021. That money would be contingent upon the department secretary providing quarterly reports to Congress, and 25% of the funding would by withheld until July 1, provided the department presents a plan with benchmarks and metrics for deployment and all infrastructure upgrades 30 days prior.

“While the committees remain supportive of the EHRM initiative and the secretary’s
comprehensive strategic review, as with any acquisition of this size and magnitude, there
continue to be implementation concerns,” reads the joint explanatory statement of the bill. “The funding level and contingency requirement recognize the implementation delays and challenges to date, as well as the need to communicate a clear plan to address infrastructure needs, deploy the new system, monitor progress and demonstrate success.”

The IRS finds itself in a similar situation concerning its Business Systems Modernization initiative, which would receive $275 million — up from $222.7 million in fiscal 2021. That number includes funding for a Customer Account Data Engine 2, enterprise case management system, web applications, taxpayer assistance systems, cybersecurity and data protection.

But the IRS is expected to report to Congress and the U.S. comptroller quarterly on IT investments in its Integrated Modernization Business Plan portfolio including on costs, results, risks and mitigations. That’s in addition to an annual Government Accountability Office audit.

The IRS would also have to include in its fiscal 2023 budget justification a summary of cost and schedule performance information for its major IT systems.

Elsewhere the bill would increase the Office of the National Coordinator for Health IT‘s budget for developing interoperable health IT, and the Fast Healthcare Interoperability Resource standard in particular, by $1.8 million to $64.2 million.

The legislation would require the heads of agencies it funds to ensure their chief information officers are part of their budget planning processes.

On the cyber side, the bill would provide the Cybersecurity and Infrastructure Security Agency with $2.6 billion, an additional $568.7 million compared to fiscal 2021 and $460 million more than the White House sought. The legislation would also require agencies that receive a cyber incident report, including those concerning ransomware, to share it with CISA within 24 hours.

Of the $125 million the bill makes available to the State Department for its diplomatic programs to respond to Russia‘s military invasion of Ukraine, $50 million could be transferred to its capital investment fund for cybersecurity and $15 million used for emergencies in the diplomatic and consular service. The money could also be used to identify the assets of Russian oligarchs and freeze them in coordination with the Treasury Department.

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The FDA recognized early in the pandemic it would need to get better at aggregating and analyzing data at scale to handle the large volume coming in from COVID-19 tests being widely distributed said Sara Brenner, speaking at an AFCEA Bethesda Health IT event panel Feb. 15.

“COVID-19 is tip of the spear for what will hopefully be a sea change in terms of patients having the ability to have data from diagnostic tests that are widely distributed and powering our country’s ability to utilize diagnostic testing data at scale for diseases beyond COVID,” Brenner said.

Test data used to improve decision-making requires the creation of regulations for the standardization of data at source. Medical devices developed by the health industry for home and over-the-counter use increasingly permit such standardization.

When it comes to tether emerging technologies to existing data standards, it’s the Office of the National Coordinator for Health IT within the Department of Health and Human Services that has to play “bad cop,” added Ryan Argentieri, deputy director of ONC’s Office of Technology.

ONC has been pushing the use of open application programming interfaces and recently added new data classes and elements for electronic exchange in draft Version 3 of the U.S. Core Data for Interoperability.

Once the quality of health data is assured, HHS can push faster adoption of its preferred Fast Healthcare Interoperability Resource data standard by government and industry.

For that reason FDA and ONC are a part of three interagency working groups created by President Biden’s January 2021 Executive Order on Ensuring a Data-Driven Response to COVID-⁠19 and Future High-Consequence Public Health Threats: Enhancing Data Collection and Collaboration Capabilities, Public Health Data Systems, and Innovation in Data and Analysis.

The FDA further leads the Diagnostic Data effort for the HHS Data Strategy and Execution Workgroup, one of several related to the national COVID-19 pandemic response that also include the Centers for Disease Control and Prevention, National Institutes of Health, and HHS.

“These include technical, policy and implementation efforts in data standardization, harmonization and reporting for SARS-CoV-2 diagnostic tests; supporting data analytics; building data transmission and ingestion pipelines for high quality, high volume data in real time; and supporting the stakeholder community in adoption and implementation of data standards, capture and reporting,” an FDA spokesperson told FedScoop.

The FDA’s Digital Health Center of Excellence is chiefly responsible for tailoring medical device regulations for digital technologies, and the agency is also staffing up its programs for digital diagnostics outside of laboratories and Semantic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD).

Both of those efforts involve interagency collaboration with ONC.

“It’s a very concrete way in which we’re already utilizing lessons learned from COVID with future health technologies and how this will benefit patients beyond SARS-COV2 into all different areas of medicine,” Brenner said.

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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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Together the Trusted Exchange Framework and Common Agreement (TEFCA) provide rules for securely sharing clinical data between health information networks. The former provides non-binding principles, and the latter establishes technical terms.

HHS‘s Office of the National Coordinator for Health IT was created in 2004 with a goal of establishing a nationwide health information network, and soon entities will be able to apply for a qualified health information network (QHIN) designation.

“We want to be able to create a uniform floor of interoperability so that every authorized [network broker] and authorized user, including individuals, have a baseline expectation of being able to get basic health care medical record information securely and reliably across the network — regardless of where they are geographically or which vendor they’re using, which technology they’re using,” Micky Tripathi, national coordinator for health IT, told reporters on a call Tuesday afternoon. “We also want to be able to greatly simplify connectivity.”

QHINs will sign the Common Agreement with recognized coordinating entity (RCE) The Sequoia Project, which will likely begin accepting applications on a rolling basis within 90 days, said CEO Mariann Yeagar.

The Sequoia Project will verify applicants meet QHIN requirements before admitting them to the exchange production environment in late 2022 or early 2023.

“The fact that this framework is really multipurpose is huge,” Yeagar said. “Everytime we want to enable a nationwide network of network capabilities or use cases, we don’t have to go and create a separate thing dedicated to that purpose.”

The exchange can be used for purposes including public health, benefits determinations, health-care operations, treatment, payment, and individual access. Of those QHIN applicants will be expected to address treatment and individual access, with additional eligibility criteria around the others. 

The Sequoia Project hasn’t quantified how many health information networks, ambulatory practices, hospitals, health centers, federal agencies, public health agencies, and payers intend to seek QHIN status.

The agency also released the TEFCA Health Level Seven (HL7) Fast Healthcare Interoperability Resource (FHIR) Roadmap, outlining how the FHIR data standard will be incorporated into the exchange over time.

Tripathi encouraged the departments of Veterans Affairs and Defense in June to accelerate health-care interoperability efforts by adopting FHIR Release 4 (R4) on their platforms, ahead of the federal deadline in December 2022.

Still Stage 3 of FHIR adoption, QHIN-to-QHIN brokered exchange, remains “furthest down the road” in terms of maturity, Tripathi said Tuesday.

“The reason that we have a roadmap for incremental adoption of FHIR over time — and efforts to accelerate the maturity of it for the purposes of TEFCA exchange — are precisely because it’s not at a point of maturity yet for network enablement,” Tripathi said. “But, that said, there are a number of networks across the country who are starting to either run pilots or think about putting things into production that would help with the scalability of FHIR-based exchange.”

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