“Micky has been a leading expert in our AI work and will provide tremendous expertise and relationships across HHS and externally to guide our efforts in the coming months,” the spokesperson said. “Micky already serves as co-chair of the HHS AI Task Force. He will continue in his role as National Coordinator for Health IT during the search for a permanent Chief AI Officer.”  

Greg Singleton, the previous CAIO, is still part of the agency’s IT workforce, the spokesperson confirmed. But they also noted that the Office of Management and Budget required agencies to designate CAIOs at the executive level in an effort to improve accountability for AI issues. 

HHS didn’t say when the department had named Tripathi as acting CAIO, but the change appears to have been made recently on the agency’s website. Singleton was still listed as CAIO as of at least May 14, per a copy of HHS’s Office of the CAIO webpage archived in the Wayback Machine. According to the webpage at the time of this story, the content was last reviewed on May 24.

Under President Joe Biden’s AI executive order, CAIOs serve as the official in charge of promoting the use of the technology within an agency and managing its risks. The requirement to have such an official went into effect 60 days after OMB’s memo on AI governance, which would have been May 27.

Many agencies moved quickly to designate CAIOs after the order, tapping officials such as chief information, data and technology officers to carry out the role. Other agencies already had a CAIO, including HHS and the Department of Homeland Security. In fact, the position at HHS has been around since 2021 when the agency named Oki Mek as its first CAIO. Singleton replaced Mek as the department’s top AI official in March 2022.

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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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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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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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Dubbed the Public Health Informatics & Technology Workforce Development Program, the $80 million consortium will create a curriculum; recruit and train participants; secure paid internships; and place people at public health agencies, nonprofits, clinics and companies.

The program will encourage minority-serving colleges, universities and other institutions to apply for funding, in keeping with the American Rescue Plan’s goal of addressing health and socioeconomic inequalities highlighted during the COVID-19 pandemic.

“With this funding, we will be able to train and create new opportunities for thousands of minorities long underrepresented in our public health informatics and technology fields,” said HHS Secretary Xavier Becerra in the announcement. “Investing in efforts that create a pipeline of diverse professionals, particularly in high-skilled public health technology fields, will help us better prepare for future public health emergencies.”

The pandemic showed race and ethnicity-specific data was lacking during public health reporting and data analysis due, in part, to limited IT infrastructure and underfunding of staff needed at the state and local levels. Data on infections, hospitalizations, mortality rates, and health and social vulnerabilities must be disaggregated by variables like race, ethnicity, age and gender to paint a complete picture of a disease’s spread.

About 4,000 participants will be trained by the PHIT Workforce Program over four years, with the Office of the National Coordinator for Health IT awarding up to $75 million for cooperative agreements and spending the remaining $5 million on administration. Awardees must show their training, certificate, degree and placement programs sustain a continuous pipeline of diverse public health IT professionals.

Participants will not only be part of the consortium but a community of practice for sharing resources and lessons learned with each other.

ONC’s notice of funding opportunity supports President Biden‘s executive order on ensuring a sustainable public health workforce. The office will hold an information session on the opportunity on June 23.

“The limited number of public health professionals trained in informatics and technology was one of the key challenges the nation experienced during the COVID-19 pandemic,” Micky Tripathi, national coordinator for health IT, said in a statement. “This new funding will help to address that need by supporting the efforts of minority serving institutions and other colleges and universities across the nation to educate and launch individuals into public health careers.”

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Dubbed the Trusted Exchange Framework and Common Agreement, or TEFCA, it aims to achieve the network interoperability that has been lacking as health care providers attempt to share clinical information for treating patients and state and local governments attempt to share public health information for monitoring disease outbreaks.

Interoperable networks are critical for sharing real-time data nationwide on disease outbreaks that could help HHS prevent the next pandemic before it starts.

The 21st Century Cures Act passed in 2016 required the creation of a common set of data standards, but only with the onset of the COVID-19 pandemic did gaps in the public health data system become readily apparent.

“By all accounts it was very, very far from meeting the mark that all of us would’ve hoped for,” said Micky Tripathi, national coordinator for health IT, during an ACT-IAC event Tuesday.

With TEFCA, the HHS Office of the National Coordinator for Health IT wants to create a more integrated environment where the federal government can not only pull data as needed on demand but also send information to state and local governments and clinical settings on the frontlines of response efforts.

The Health IT for Economic and Clinical Health (HITECH) Act of 2009 spurred $40 billion of spending over the last decade on “pretty highly functional” electronic health record (EHR) systems — with adoption among hospitals and ambulatory providers jumping from around 15% to 90%, Tripathi said.

The HHS technology executive added that the way in which private vendors connect their systems with state and local health information exchanges is one of the hardest issues needing to be addressed. According to Tripathi, it is also a key reason why a clear timeline is necessary.

“How do all of those connect up in a way that it doesn’t require people having to think about connecting to four or five different networks, which is a little bit of the challenge today,” he said.

Tripathi added also that federal agencies including the Department of Veterans Affairs and the Department of Defense can help accelerate interoperability efforts by opening up their own platforms and adopting Fast Healthcare Interoperability Resources Release 4 (FHIR R4) standards ahead of government’s December 2022 deadline.

Meanwhile, private sector providers have until October 6, 2022 to make notes, narratives, scanned images and other unstructured data part of the electronic health information they share.

ONC continues to work on TEFCA to make it appetizing to more participants, but the framework remains voluntary until timelines are released.

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