“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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The $31 million dollar agreement follows allegations that the company misrepresented what some versions of its electronic health record (EHR) software was could do and provided “unlawful remuneration” to users as an inducement to recommend the product, the Department of Justice said in a Friday statement.

The DOJ alleged that NextGen “improperly obtained certification for its EHR product” under the 2014 edition of certification program for health technology operated by the Office of the National Coordinator, according to a DOJ complaint filed with the settlement. It then used that certification “to obtain incentive payments.”

NextGen, DOJ alleged, used “an auxiliary product” during the certification that was designed to run test scripts it needed to perform for approval. As a result, the EHR released to users lacked functionalities, such as “the ability to record vital sign data, translate data into required medical vocabularies, and create complete clinical summaries,” the statement said.

The government also alleged that NextGen violated the Anti-Kickback Statute by giving credits to users whose recommendation resulted in a sale of the EHR system. Those credits “often worth as much as $10,000,” DOJ said.

The settlement includes resolution of whistleblower claims brought by two health care professionals — Toby Markowitz and Elizabeth Ringold — under the False Claims Act. The whistleblowers in the case will receive roughly $5.6 million, the DOJ said.

In a written statement regarding the settlement, a NextGen spokesperson said: “The Company denies that any of its conduct violated the law, and the settlement agreement does not include any admissions of wrongdoing. This agreement relates to claims from more than a decade ago.”

The spokesperson added that the settlement doesn’t change NextGen’s products or policies for compliance. They added: “To avoid the distraction and expense of litigation, we believe it is in the best interest of the Company to put this historical matter behind us and keep our attention focused on innovating solutions that enable better healthcare outcomes for all.”

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While this proposed rule has received less attention, the inclusion of algorithms represents an important example of how Biden administration regulators are hoping to rein in AI. ONC wants to get that final rule out as soon as possible, “perhaps as early as later this year,” an ONC spokesman said in an email.

The proposal — the comment period closed earlier this month — would require electronic health record systems using predictive tools like AI and algorithms to provide users with information about how that technology works, including a description of the data it uses. That would add to a certification process already overseen by ONC.

“The idea is that you should have a standardized nutrition label for an algorithm,” Micky Tripathi, who leads the health IT division housed within the U.S. Department of Health and Human Services, said in an interview with FedScoop.

ONC’s certification program for health IT — which includes electronic health record technologies — is voluntary. It’s incentivized, however, by requirements that hospitals and physicians use certified systems when participating in certain Centers for Medicare and Medicaid Services payment programs.

While ONC hopes that more transparency will help avoid unintended consequences of algorithmic bias, the rule has received some pushback from medical professionals, health IT companies, and associations for both not going far enough and being too hard to comply with. The division will next review those comments and work on finalizing the rule.

The AI and algorithm requirements are part of ONC’s proposed rule titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” (HTI-1), which includes a variety of updates for the division’s Health IT Certification Program.

Specifically, the artificial intelligence portion of the rule would build upon its existing certification requirements for clinical decision support (CDS) systems by defining a new category for predictive tools, which includes AI and algorithms. 

Artificial intelligence presents “a whole new dimension in this area of clinical decision support,” Tripathi said. There are things about AI that are “fundamentally different” and require ONC to again weigh in on how these technologies are incorporated into electronic health records systems, he explained.

ONC doesn’t want to be in the position of telling people they can’t use a particular algorithm, Tripathi said, which is why it’s pointing to transparency as a way to help people “navigate” the technology.

For example, Tripathi said, a user in San Juan, Puerto Rico, might learn that an algorithm in an electronic health record system was trained on data from the Mayo Clinic in Minnesota and question whether that would be appropriate for their patient population. 

ONC’s emerging approach to AI regulation has won support from a variety of healthcare industry stakeholders, public comments revealed. For example, the College of American Pathologists — a nonprofit with thousands of members — has said that more information about the datasets AI systems are trained on would boost transparency, and also help pathologists with their “AI-related responsibilities.”

Ron Wyatt, the chief scientist and medical officer at the Society to Improve Diagnosis in Medicine, said the rule didn’t go far enough, and argued that the information that’s made available to “end users,” like health systems and patients, should also be shared in the public domain — so that it’s “exposed to the expert academic research and developer communities that now are sensitized” to the problems with using AI in healthcare. 

Unsurprisingly, there’s also been pushback. The HIMSS Electronic Record Association, on behalf of 30 companies, has suggested that ONC’s requirements for “decision support interventions” would be hard for electronic health record developers to implement, since — they argue — these tools are often created by third parties. 

The American College of Cardiology, a nonprofit association that credentials cardiovascular professionals, said the algorithms proposal was “overly broad,” could potentially cover “thousands of technology solutions utilized in health care,” and may also be confusing for clinicians dealing with software that’s defined differently by other agencies. 

It’s not yet clear how ONC will incorporate this feedback. Still, the proposal and the feedback it received show the mounting effort to regulate AI across the Biden administration. 

The Office of Science and Technology Policy, for example, has emphasized fighting algorithmic discrimination in the Blueprint for an AI Bill of Rights, which was released in October. The Department of Justice and the Department of Housing and Urban Development have looked at algorithmic bias in systems used to screen tenant applications. Senator Charles Schumer highlighted fighting bias in the SAFE Innovation Framework he introduced earlier this month. 

ONC’s own work on artificial intelligence isn’t limited to the proposed rule. Separately, Tripathi said the ONC is working on the department’s broader efforts to develop AI regulatory strategies and is exploring how to make sure a type of application programming interface (API) used for healthcare interoperability — known as Fast Healthcare Interoperability Resources (FHIR) — is able to interact with AI. 

“As ONC, and as the HHS, and as the federal government, we want to balance the ability to allow us to continue to have innovation in a really — what we recognize is — a really important space that could offer tremendous benefit at the end of the day,” Tripathi said.

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Morris, who was placed on a detail as chief health information officer in June to stand up the Department of Veterans Affairs’ new Office of Electronic Health Record Modernization (OEHRM), also resigned from her role as principal deputy national coordinator for health IT in the Department of Health and Human Services.

While she formally submitted her resignation to both VA Secretary Robert Wilkie and HHS Secretary Alex Azar by letter, Morris kept the public in the loop, posting the text of it in a Twitter thread last Friday. In it, she cites that “Over the last few weeks, it has become clear to me that VA’s leadership intends to take the EHR modernization effort in a different direction than we were headed.”

Morris did not specify what she meant by that comment. The VA has seen major leadership turmoil under the Trump administration, and the turnover has worried overseers on Capitol Hill who believe it could affect the department’s ability to deliver on EHR modernization. Her resignation also came just three days after that of Ashwini Zenooz, the chief medical officer for the modernization.

One lawmaker in particular hopes that politics and personal differences are not what’s undermining the efforts of the new office. Rep. Jim Banks, R-Ind., the chair of the new House Veterans’ Affairs Subcommittee on Technology Modernization, said in a letter to Wilkie “it would be a tragedy for the program to be undermined by personality conflicts and bureaucratic power struggles before it even begins in earnest.”

Banks urged Wilkie in his letter to find permanent replacements immediately and to provide him with a detailed organizational chart of the office by Sept.7.

The VA Office of Electronic Health Record Modernization was created specifically to oversee the agency’s $10 billion electronic health record modernization project. The VA signed a contract with Cerner in May to replace its legacy electronic health record system, VistA, with a new system over the next 10 years. The Cerner system is also used by the Department of Defense’s EHR modernization, MHS GENESIS — leaders hope this will help improve interoperability and coordination between the agencies.

“OEHRM, the Veterans Health Administration and the Office of Information and Technology will continue to collaborate closely to ensure this important transition is as smooth as possible for our Veterans, clinicians and staff,” Morris said in a statement at the time of the office’s public launch. “We are working hard to configure and design a system focused on quality, safety and patient outcomes, which will allow health IT innovations within one VA facility to be used across the entire VA health-care system.”

“HHS would like to thank [Morris] for her service to this administration and the American people,” an HHS spokesperson told FedScoop in an email.

John Windom, executive director of VA’s EHR modernization, will take over the office in Morris’ absence.

FedScoop did not receive comment from the VA.

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The head of the Office of the National Coordinator for Health Information Technology (ONC) says his team is in the “early stages” of developing health care data standards for population-level data to help make it more shareable across electronic health records (EHR) systems.

“There is no broad-based computable standard to look at the care that American providers provide,” he said April 27 at the AcademyHealth Health Datapalooza. “Think about that for a second: There is no computable accountability of the care that we are providing. That’s a pretty stunning type of thing to say in 2018.”

Rucker said that ONC — which is part of the Department of Health and Human Services — was working in collaboration with researchers, health care payers and the informatics nonprofit Health Level Seven International (HL7) to develop standards leveraging Fast Healthcare Interoperability Resources, or FHIR, formats to streamline batch-level processing of data. Sharing data across EHR systems has often been a complex process, thanks in part to a series of entanglements that include interpretations of the Health Insurance Portability and Accountability Act (HIPPA), proprietary information related to data formats and a host of other issues.

Rucker said that if ONC and its partners succeed, the standards will allow for an unprecedented, high-level view of health care information system. He acknowledged, though, that there are concerns that standardization could potentially slow data transmission.

“There will be all kinds of permissions on the level of service and networking,” he said. “Again this is all very early. We invite all of you to work with the HL7 group on setting up these standards, but it is this computer environment that we think is really going to provide the ‘learning health care system’ that I know many of us in this room have spent years working on.”

Rucker also touted ONC’s ongoing support of open application programming interfaces (APIs) to allow developers to design products that can provide health care data to patients on their smartphones.

“Part of policymaking is making this consumer-friendly, so I want to call out one specific thing that’s going to be important, which is persistent access,” he said. “As we sort through the very difficult, thorny issues of electronic consent and privacy, we want to still have people remain connected to the app so they don’t have to sign on every time.”

Rucker compared the persistent access feature to how users might check their flight’s status on an airline app without having to continuously sign-in to access the information when it changes, saying that will be an important technical feature.

The ONC chief also said his office was analyzing around 250 public and industry comments on the draft version its Trusted Exchange Framework and Common Agreement, which debuted in January and aims to connect various disparate health care networks into an information-sharing web of electronic health records.

“We are working through those,” he said. “There were some good points, and I think you are going to see reflected a clear roadmap of the thinking of the [TEFCA] and how we use that to evolve from the data we share now to the data we really want to share in the future.”

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Several conditions have made AI more viable in health care, including the dissatisfaction with legacy systems, the growing ubiquity of smart devices and the convenience of at-home services, says the report, which was conducted by independent policy research group JASON and commissioned by the Office of the National Coordinator for Health IT (ONC), the Agency for Healthcare Research and Quality and the Robert Wood Johnson Foundation.

Those factors and others may have opened the door for AI, the report says, but progress will require overcoming obstructions to the free flow of data — a problem that ONC has been seeking to solve in recent years. The office has crafted several policy standards and production certifications to improve access to health care data while not violating privacy laws. The office’s interoperability roadmap forecasts a series of policy implementations to develop a network of real-time health data access by 2024.

There’s a lot at stake at the clinical level: The report cites several examples of where AI could improve the quality of analysis on medical imaging, such as digital scans of retinas or suspected skin cancers. Other improvements potentially could come in non-invasive diagnostics and other clinical applications.

For AI to do any of that kind of work properly, though, it needs training sets — collections of data that allow the technology to practice. The current landscape for EHR makes that tough, the report says.

“[T]he utility of EHR data can be problematic beyond issues of completeness or interoperability, because it was not collected for the purpose or under the controls of use of research studies. This raises the issue of the actual quality of the data in the EHR,” the report says.

Very little research has been done on the EHR training sets issue, the report says, and it recommends creating “comprehensive training databases” that could be used for creating reliable new tools.

The report’s recommendations also include involving the public in the process of generating better data — through crowdsourcing and competitions, for example — and ensuring that there proper safeguards in place for the use of AI.

In a blog post on ONC’s website, stakeholders from the office, AHRQ and the Robert Wood Johnson Foundation said the report validates ongoing interoperability efforts and highlights the possibilities that AI has in health care.

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Genevieve Morris, principal deputy national coordinator for health IT, said at ONC’s annual meeting that the draft version of the Trusted Exchange Framework and Common Agreement is expected to debut in December, providing a path to share electronic health records across networks.

“We want to make sure we understand your concerns and your challenges and that we’re [meeting] them appropriately,” Morris said.

The office held to other listening sessions earlier in the year and has been fielding public comments on how the framework should account for myriad health care sector concerns.

ONC is charged with developing the TEFCA as part of Section 4003 of the 21st Century Cures Act, which became law in December 2016 and aims, in part, to streamline the interoperability and information sharing of electronic health records.

The law calls for ONC and the National Institute of Standards and Technology to collaborate on a set of policies to establish a trusted and voluntary framework capable of sharing health information across networks while still protecting proprietary information.

“When you talk to health care organizations, there’s just this massive amount of agreements that go on right now, these one-off agreements that they have to do with everyone they want to exchange with,” Morris said. “And that just adds a cost and time component to our system that it really can’t afford. So the Trusted Exchange Framework and Common Agreement is meant to really overcome the barriers of having all of those multiple agreements.”

Officials said ONC plans to release the draft framework this month, followed by a 45-day public comment period and the debut of the final TEFCA in late 2018. But so far, stakeholders have addressed concerns around ensuring standardization and cooperation across networks.

“Folks asked us to focus on some of the critical areas of inconsistency across the networks,” Morris said. “I think the easy example I normally get is things like identity-proofing and authentication requirements, high areas of variation on what folks require. So those are really easy areas that I think we can be helpful on setting some policies around.”

Officials declined to provide specifics on which policies were included in the TEFCA, but they did say that they are working to craft standards that marry flexibility for the adoption of new technologies like blockchain with strong security and privacy models.

“We’re very mindful of new technology. The standards don’t preclude that,” said Don Rucker, national coordinator for health IT. “I think there is a broader issue that as we look at privacy and security, ultimately hackers and people with bad intent are going to look at targets of opportunity globally.

“We want to adopt the best security and privacy authentication standards that are out there. They will evolve, that’s just the nature of the beast,” he said.

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Now that the agency has decided to pursue the same commercial EHR system that the DOD is currently testing, simply achieving interoperability between the systems is no longer its goal. Instead, officials want to create a better way to understand the data they are sharing.

“We’re changing the messaging within VA, and DoD to some extent, from interoperability — which is about electrons and documents and [Extensible Markup Language] stuff — to the experience of seamless care,” said Jonathan Nebeker, chief medical information officer at the Veterans Health Administration.

Nebeker said at the Office of the National Coordinator for Health Information Technology’s annual meeting Thursday that the agencies have, through several applications, the capacity to share most patient information through their respective EHR systems.

But now they want to develop a user-centered program free of the incongruities and imperfections that have plagued health record sharing.

“It’s not about the exchange. It’s not about operations,” he said. “It’s the experience that patients and staff have from encounter to encounter and task to task, such that high-quality decisions form easily and care plans execute smoothly.”

Not every step in the history of integration of health records between the VA and DOD have met that ideal.

The agencies developed multiple programs to share selective medical information like medication data and other items before attempting to develop a joint integrated EHR nearly a decade ago.

That effort fell apart in 2013 when the DOD decided to pursue a commercial off-the-shelf system while VA sought to maintain its custom Veterans Information Systems and Technology Architecture, or VistA, system and share records through an application called the Joint Legacy Viewer.

Current Secretary of Veterans Affairs David Shulkin reversed that decision in March, saying that the agency would contract with Cerner — the DOD’s contracted EHR provider — to build a new system based on its commercial Millennium platform to replace VistA.

With VA now focused on developing an EHR that’s fully interoperable with DOD, Nebeker said the goal now involves moving beyond the tools that could facilitate the secure sharing of patient information to finding the meaning in the information being shared.

“It’s also within an organization that you need seamless care,” he said. “In order to have seamless care, we need to have the information, we need to interpret the information, we need to present the information and then we need to sustain the processes or the care plans that are there.”

For example, Nebeker said, a recent study found that 65 to 100 percent of the VA’s data is encoded to national standards by term but the agency has 0 to 83 percent interoperability by frequency with DOD, which shows that while the data is there, it doesn’t account divergent interpretations that occur in medical records between agencies and offices.

As the two agencies edge closer to being able to transfer health records more easily than ever before, Nebeker said they now are trying to build a process that hones in on how to improve care.

“In the future, we want to get to the word ‘sharing’ and not only have the focus on the data but about sharing the work,” he said.

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ONC officials have launched the Secure API Server Showdown Challenge to industry stakeholders to build Fast Healthcare Interoperability Resources, or FHIR, servers that are deemed secure under current industry standards and then see if they can be hacked.

The challenge offers developers a total of $50,000 in prizes and will be split over two stages.

In the Server Build Stage, teams will build servers operating on FHIR—the draft standard information format and an application programming interface for sharing electronic health records—using industry best practices, technical standards and open source code.

Three teams will advance to the following Vulnerability Discovery Stage based on the technical judging criteria of their server builds. The second stage will consist of two tracks: one where the teams operate their servers and another with team-based hacking to find “’in-scope’ security vulnerabilities” within the servers.

The Server Track teams will then review the security vulnerabilities and be eligible for a $10,000-prize if they operate their servers through the conclusion of the second stage.

The top three hacker teams with the most cumulative confirmed vulnerabilities will be eligible for cash prizes of $7,500, $5,000 and $2,500 respectively. The teams are also eligible for two $2,500 bonus prizes for the most confirmed vulnerabilities discovered in a single server and demonstrated ability to alter patient data on a server.

Those vulnerabilities will be made public at the end of the competition, to inform any future open source updates.

“Ultimately, the Challenge aims to identify unknown security vulnerabilities in the way open source FHIR servers are implemented, and will result in a hardened code base from which all stakeholders can benefit as they deploy FHIR servers in the future,” said Steven Posnack, director of ONC’s Office of Standards and Technology, in a blog post on ONC’s website.

Submissions for the Server Build Stage opened on Oct. 10 and will run through Jan. 15, 2018. Winners will be notified on Feb. 5, 2018.

Registration for the Vulnerability Discovery Stage begins on Jan. 8, 2018 and runs until Feb. 5. Winners will be announced on June 29, 2018.

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But for all of its efforts, the Office of the National Coordinator for Health IT concedes that path to interoperability remains winding. That’s why it hosted two panel discussions Tuesday for National Health IT Week to talk about the challenges and successes of the adoption and sharing of electronic health records.

“We certainly still have a long ways to go with health IT, whether it be usability or interoperability, but we wanted to talk a bit about where we’ve come so far,” said Principal Deputy National Coordinator for Health IT Genevieve Morris.

The panels focused on both the interoperability of the digital devices storing EHRs and their usability in an effort to map out where the health sector is and where it still has to go.

Among the takeaways were:

It’s not a tech problem — it’s leadership 

Ed Cantwell, president and CEO of the Center for Medical Interoperability—a nonprofit research lab advancing data sharing in medical technology—said that while innovation is being spurred through the health care sector, the gap in information sharing is coming from a lack of collaboration.

“I have a hypothesis that you could put 20 executives in a room representing comprehensive interoperability, there would be vendors, hospital CEOs and physicians, but it’s not a technology problem,” he said. “It’s a lack of coordinated leadership. I think the call to action is let’s put those people in a room. Every other industry has done it, they’ve come together and put their differences aside.”

Cantwell also said during the panel that while ONC does have the leverage to guide the policy direction of health IT, the private sector will have to lead the move toward greater interoperability.

“I think this is the time where the private market needs to step up,” he said. “Whether it’s for-profit or nonprofit or public or military or [the Department of Veterans Affairs], if we are to start the slurry of digital and set a goal to be on parallel with every other data liquid industry, then I think we need to stop this fantasy of think that ONC can, from the sidelines, impact a $3 trillion market.”

There’s no one-size-fits-all

John Kansky, president and CEO of the Indiana Health Information Exchange, said that part of the challenge of interoperability is that it has to serve a diverse range of needs across a wide network, from physicians to hospitals to insurance providers.

“I don’t think moving health care data around the country is any less complicated than moving people and stuff around the country,” he said. “Interoperability isn’t one thing. Every organization has complex interoperability needs.”

Kansky said that both government and the market have distinct roles in guiding and adapting interoperability and have to collaborate to ensure that they can make it more efficient.

Hard-to-build software to meet every need

Andrey Ostrovsky, chief medical officer at the Centers for Medicare & Medicaid Services and the Children’s Health Insurance Program, said it’s very difficult to design a product centered on its ease of use while also delivering functionality that serves the layers of users in health care.

“It’s very hard to build software well,” Ostrovsky, the former CEO of predictive insights platform Care at Hand, said. “It’s even harder to build software well when you have multiple end users. When we talk about the federal government’s role in somehow influencing how software gets developed or evolves, we not only have the design constraints of what does the patient need but also what does the physician need, what does the practicing admin need, what does the potential payer need in terms of reporting, and then we’ve got what does the federal government need?”

To try to bridge those gaps, at least when it comes to physician adoption, ONC Chief Medical Information Officer Andrew Gettinger said the office is working with MedStar to develop a usability package to help smooth the rocky process physicians face in implementing an EHR system.

“Putting in an EHR is very different than buying an automobile,” he said. “If you are buying an automobile, you have a couple different choices for color and drive off the lot pretty quickly. When you do an EHR, there are hundreds and perhaps thousands of small decisions that the implementation team makes along the way.”

Gettinger said ONC expects the usability package to be out by March 2018, which will hopefully provide doctors with a streamlined process for EHR adoption.

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