LAS VEGAS—The Department of Health and Human Services (HHS) is stepping up the federal government’s major interoperability efforts on several fronts.
As part of this interoperability effort, the Trump administration in July announced a sweeping health technology initiative aimed at modernizing Medicare and promoting next-generation digital health care for patients, including conversational artificial intelligence, digital identity, and easy ways to access health data.
The Centers for Medicare & Medicaid Services (CMS) is spearheading an API-focused data exchange framework that will enable the sharing of patient health records through a new initiative called the CMS Aligned Network. The initiative is aimed at accelerating data sharing at a faster pace than could be achieved through regulation alone, said Amy Gleason, acting administrator of the U.S. DOGE service and strategic advisor to CMS.
“We tried to listen, ‘Why isn’t interoperability working?’ We have all these great rules, regulations, TEFCA (Trusted Exchange Framework and Common Agreement), but in the real world, we don’t know if it’s going to work the way we want it to. There are many cases where we don’t. I have a daughter who has a rare disease, so I live this every day and that’s why I’m so passionate about this field,” Gleason said before an audience of providers, payers and health technology executives. At the 2026 Health Information Management Systems Society (HIMSS) Global Health Conference & Exhibition. “We developed a vision and got people to work with us to make things work in a short period of time. We met our six-month and 12-month goals.”
Since July, more than 700 healthcare organizations have joined the HealthTech Ecosystem Pledge, which is completely voluntary, Gleason said. The goal is to implement concrete results from these pledges by March 31st.
CMS also set another July 4 deadline for organizations to demonstrate more advanced capabilities and workflows, he noted.
“We have about a dozen working groups and Slack channels with government and the private sector that we can collaborate on. It’s kind of like a giant hackathon and we’re working together to make it work,” she said.
Gleason said the CMS Aligned Network is not intended to compete with TEFCA, referring to government-backed health data sharing initiatives that allow patients, providers and payers to share medical records.
Stephen Posnak, principal deputy national coordinator for health IT, said in a December blog post that while TEFCA is “a rising tide that lifts all boats,” the network that promises to be a CMS-aligned network is “more like a speedboat rushing forward to meet certain milestones.”
To encourage the use of digital health tools, CMS recently announced the Medicare App Library as a centralized directory. This will give Medicare beneficiaries access to vetted digital health tools that are integrated with CMS Aligned Networks. Participating apps must complete certain steps to participate, including signing an interoperability pledge and partnering with ID.me or CLEAR to implement identity verification services. Companies must also complete an assessment by the Digital Medicine Society or CARIN Alliance before being reviewed by CMS.
CMS has also joined the Health Tech Ecosystem Pledge and is committed to deploying new innovations to support interoperability.
“CMS is eating their own dog food,” Gleason quipped.
The agency has added enhanced login options to Medicare.gov based on current ID credentials (CLEAR, ID.me, Login.gov), allowing beneficiaries to log in using their digital ID credentials and access their health information on the site.
“Medicare patients can come in and use CLEAR, ID.me and Login.gov to authenticate using only biometrics, just like they do in other areas of their lives,” Gleason said. “Already, in the first five to six days, 25% of people automatically selected one of these new modern credentials. 60% of all new accounts created were using one of these new modern credentials, and 90% of users who created new accounts had already verified their identity,” she said.
Dr. Thomas Keene, Assistant Secretary for Technology Policy and National Coordinator for Health IT, said his office, the Assistant Secretary for Technology Policy (ASTP), and CMS are collaborating on interoperability efforts, but the approaches are different.
“All of the innovations that Amy (Gleason) was able to come up with on her initiative can actually be adopted into regulation. Then, as you know, the regulatory cycle actually takes about 18 months to develop, release, process comments and finalize the rule, followed by typically a two-year implementation schedule. That’s slow. What Amy is able to produce in less than a year is very impressive,” Keene told HIMSS’ Health Policy Committee.
“All of these innovations are things we can embrace. I think the beauty of what CMS is doing under her leadership is shedding the cats. I think Amy is running against (CMS administrator) Dr. Oz’s vision of using collaboration and meetings as a means to advance our goals,” he said.
On the regulatory front, HHS finalized rule HTI-4 last fall, which promotes electronic prior authorization and real-time prescription benefit checks. Additionally, in December, the company released a proposed rule, HTI-5, that would update requirements for health IT certification programs and amend information blackout regulations issued by HHS’s Division of Health IT under the 21st Century Cures Act. Under the proposal, HHS would eliminate 34 of the 60 certification requirements for electronic health records and revise seven certification requirements.
The proposed rule states in its rationale that the majority of existing requirements create obstacles for health IT developers, preventing them from innovating and creating regulatory barriers to new entrants to the certified health IT market.
One of the goals of removing authentication requirements is to facilitate the use of AI through the FHIR API. The agency said it aims to “establish a new foundation” of FHIR API requirements to “support creative AI-enabled interoperability solutions.”
“Our hope is that between this rulemaking and the subsequent rulemaking in 2026, we can actually drive interoperability,” Keene said during a HIMSS panel discussion.
ASTP/ONC has also stepped up its information blackout enforcement. HHS announced in September that it would devote more resources to investigating and enforcing blackout rules.
ASTP/ONC has sent notices to certified health IT developers of potential nonconformities under the ONC Health IT certification program, Keane confirmed.
“They are no longer issued, but we continue to issue them,” he said.
These notices request information and clarification regarding nonconformance issues. If a breach is confirmed, health IT developers could be fined up to $1 million per violation, and health care providers could lose their Medicare payments.
“The way the process works is that people respond to us and tell us if they think they’re non-conforming, and then we develop a corrective action plan. If we feel they’re non-conforming and they don’t meet the limits of the corrective action plan, we can revoke their certification and their customers will no longer have access to CMS payment incentives,” he said.
He noted that more than 1,500 complaints alleging blackouts have been filed since HHS launched the blackout complaint portal.
Keene continued, “Separately, the Office of the Inspector General may impose civil penalties of up to $1 million for each instance of information blackout. The beauty of this law is that it does not specify what constitutes a specific instance. So in theory, the fines could be quite large. The Office of the Inspector General has to approach the case very carefully and establish case law to ensure that if it goes to court, they can win. They are actively considering it.” As for the cases we sent them. ”
