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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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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Speaking at AFCEA Bethesda‘s Health IT Event on Tuesday, Sam Michael said the transition to Fast Healthcare Interoperability Resource (FHIR) Release 4 (R4) is “going well” but is essentially an “unfunded mandate.”

To allow for easy sharing of standardized medical data for reporting and research purposes, the 21st Century Cures Act gives health-care providers, information exchanges and IT developers until December 31, 2022, to ensure their applications comply with FHIR R4. That’s easier for large, technically advanced hospital systems than small, non-technical health-care providers.

“This is no judgment at all,” Michael said. “I think everyone realizes there are different degrees of technical skill at different sites that are even submitting the data.”

NCATS, one of the National Institutes of Health, keeps data ingestion basic for non-technical organizations by using a secure file transfer protocol, but that takes some five minutes to complete and others the entire day, he added.

The agency continues to tout the benefits of FHIR R4 as a research tool, because it holds more data, with the hope of convincing more partners submitting data to quickly adopt the standard.

Other Department of Health and Human Services agencies like the Centers for Medicare & Medicaid Services, as well as the Department of Veterans Affairs, are all-in on FHIR standards and have teams working toward implementation. But in the case of the VA, the department is currently more focused on improving data quality between its two electronic health records: VistA and Cerner Millennium, said Chief Data Officer Kshemendra Paul.

“Yes, we have to push on standards really hard but that’s a long-lead-time activity, and we need to create the space to do that by dealing with the dirty, messy work of data management across legacy systems,” Paul said. “That’s kind of what eats my lunch and where I’m focused more than the standards, not because it’s not important, but because I’ve got to create space, and I think that’s probably a pattern that exists in other places.”

The COVID-19 pandemic revealed the “terrible” quality of medical data in many cases due to a lack of standards or following those that did exist, Michael said.

NCATS, like much of HHS, undertook a successful effort to harmonize data to standards by adopting the Observational Medical Outcomes Partnership (OMOP) Common Data Model many hospitals were providing COVID-19 data in, but increasing cloud connectivity has enabled the transition to FHIR.

“The data movement problem has gotten easier in some regards,” Michael said. “I want to say there are still a lot of challenges with that, but I think the ability for us to really adopt standards at an enterprise level, a national level, a global level really has gotten much greater.”

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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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The agency is still setting up its “sandbox” for capturing claims data and making it useful to providers, but the system should be ready by mid-November, according to a CMS spokesperson. Only synthetic claims data is in the sandbox currently, but the plan is to allow a small number of providers production-level access to actual claims data to start.

With better access to Medicare data, health systems will be able to paint a more robust picture of patients’ health, the spokesperson said.

Seema Verma, administrator of the Centers for Medicare and Medicaid Services, announced the Data at the Point of Care (DPC) pilot in July. Part of the appeal is that participating providers won’t have to log into a traditional portal to access Beneficiary Claims Data. The project is using an application programming interface (API) instead.

Ease of use is important, given that the average physician sees between 500 and 1,000 Medicare patients a year, said Shannon Sartin, executive director of digital service at the Department of Health and Human Services.

Speaking at the VMware Public Sector Innovation Summit produced by FedScoop on Oct. 2, Sartin said she and Verma have worked closely the last two years to improve data interoperability.

“CMS has a ton of data on anybody who’s been a member of Medicare, so that’s nearly half the population,” Sartin said. “And we’ve really worked hard to develop models for sharing that data.”

Multiple doctors create data challenges

In the past, physicians’ knowledge of patients’ medical histories was based largely on the information the latter could recall on forms. That presents a challenge when many Medicare beneficiaries see multiple doctors at any given time and they’re expected to remember, say, the last time they were admitted to the emergency department or had a colonoscopy.

Claims data provides physicians with a blueprint of where all those records might be if they need to request them.

CMS’s endgame is an interoperable health system, meaning one that seamlessly moves usable data electronically from a patient or a care provider to other entities, allowed access under the Health Insurance Portability and Accountability Act, the agency’s spokesperson said. Rather than simply printing out the information, it’s transmitted directly into workflows.

Interoperability is a “complex, mostly nontechnical” problem closely tied with incentives, Sartin said.

“We’re actually incentivized to hold onto our data because we want to hold onto our patients,” she said. “For as much as we the general public think that services should be shoppable — or I should be able to go someplace else and take my data — that’s actually not in the incentive model at all in our health care system.”

For that reason, CMS is moving toward value-based health care and encouraging collaboration between providers — developing technology internally before attempting to regulate it, Sartin added.

As for its role, CMS sees itself as a major player building APIs and sharing data, the agency’s spokesperson said.

Prior to the DPC pilot, CMS developed the Blue Button 2.0 API in 2018 to share claims data directly with beneficiaries on the apps of their choice.

CMS isn’t alone in its quest for health data interoperability.

The Department of Veterans Affairs launched a pilot integrating all personal health data on iPhones with the Apple Health Kit. That way a doctor could view sensor data from a patient’s Apple Watch side-by-side with their medical record, said Joseph Ronzio, deputy chief health technology officer.

Making data from divergent sensors usable presents security challenges as well. So the VA is collaborating with the Institute of Electrical and Electronics Engineers on interoperable data standards and pushing analytics, Ronzio said.

“So instead of having to consolidate data in any one place, which obviously is a security risk … you can actually send out an analytic and get back the results,” he said.

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