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Six Weeks, Six Regulatory Moves: What CMS's Busiest Summer Means for Your Roadmap

From a new federal tech office to a FHIR deadline that already passed, interoperability stopped being a compliance checkbox this summer. Here's a recap of six CMS and industry moves, and what each one means for your roadmap.

Regulatory Recap
Six weeks, six regulatory moves: what CMS's busiest summer means for your roadmap

From a brand-new federal tech office to a FHIR deadline that already came and went, interoperability stopped being a compliance checkbox this summer. Here's the recap — and where Intely fits into each chapter.

Over the past several weeks, we ran a six-part series tracking U.S. healthcare IT and interoperability news — real CMS actions, real deadlines, real deal data, nothing hypothetical. Taken individually, each story is a data point. Taken together, they're a pattern: the standards that used to be "nice to have" are becoming the standards everyone is contractually required to build on, on a clock. Here's the recap, and where our platform already meets each one of these moments.

01 — Infrastructure

CMS created a permanent office for health technology

On June 9, CMS stood up the Office of Health Technology and Products (OHTP) — a new enterprise-level office with its own Standards & Interoperability Group, reporting through the CMS CIO. It's not a task force; it's a policy division with a budget line, led by Deputy Administrator Amy Gleason, who summed up the problem it exists to solve: "It's still too hard for patients to get their information, and it's still too hard for doctors to get the right information."

For any company whose product has to talk to an EMR, a lab system, or a payer API, this means the standards you integrate against are about to move faster and more often — from a single office whose entire job is to make them move.

Where Intely fits

This is the build-vs-buy argument in one sentence: when the standard-setter itself is accelerating, an in-house integration team is chasing a moving target with your own engineering budget. Intely's model is fixed-cost, fixed-timeline delivery precisely because we absorb that churn on our side of the contract — you don't re-budget every time OHTP issues new guidance.

02 — Deadline

A real FHIR deadline already passed — July 4

Twenty-one health data networks signed on as voluntary "CMS Aligned Networks." By July 4, 2026, they were required to expose patient data via FHIR APIs built to the US Core Implementation Guide and USCDI v3 — not a proprietary format. It's voluntary, and critics have rightly pointed out there's no fine for missing it. But it's explicitly a dry run for CMS-0057-F's hard, penalty-bearing prior authorization deadline on January 1, 2027. In May, CMS named 29 early adopters — including Cleveland Clinic, Epic, Oracle, Aetna, Cigna, Humana, and UnitedHealthcare — working through the same FHIR workflow problems every implementer eventually hits.

Where Intely fits

US Core and USCDI v3 aren't a special project for us — they're the substrate our connectors are already built on. This is also exactly where our Da Vinci workflow support comes in: Coverage Requirements Discovery, Documentation Templates and Rules, and Prior Authorization Support all run on the same FHIR rails these Aligned Networks are standing up. Clients don't have to stand up a parallel FHIR program to participate — the pipe already speaks the required dialect.

03 — Expansion

Prior authorization rules are coming for drugs next

CMS-0062-P, proposed in April with comments closing in June, extends CMS-0057-F's FHIR-based prior auth requirements from medical items and services to prescription drugs — tightening decision windows to 72 hours standard and 24 hours urgent. The part that doesn't show up in the press release: pharmacy benefits run on NCPDP standards, medical benefits run on FHIR, and this rule requires reconciling both inside one workflow, not picking one.

Where Intely fits

Reconciling standards families that were never designed to talk to each other is the exact problem our orchestration layer solves — and it's the subject of our next content series, where we go deep on how HL7 v2, X12, and FHIR increasingly have to operate as one workflow instead of three silos.

04 — Enforcement

Information blocking enforcement got real — while certification paperwork got cut

Since February, ASTP/ONC has been issuing actual notices of nonconformity to certified EHR developers, and OIG's $1M-per-violation penalty authority — on the books since 2023, unused until this year — is now active, with over 1,600 complaints already in the queue. At nearly the same time, ASTP/ONC's proposed HTI-5 rule would strip out 34 of 60 certification criteria to cut developer busywork. Read together: fewer boxes to check, but the ones that remain get checked for real.

Where Intely fits

If your product depends on pulling data through a certified EHR's API, that API's certification status is now a business risk you have to track. Because Intely operates and monitors the connection layer directly, a nonconformity notice or an API change at the vendor becomes our operational problem to solve — not a support ticket your customers open with you.

05 — Deal Flow

Hospital M&A rebounded — and the mix flipped mid-year

Q1 2026 was the highest Q1 for hospital M&A in six years, and 68% of those deals were divestitures. Q2 flipped the pattern: the highest Q2 deal count since 2018, but divestitures dropped to about a third of activity as three mega-mergers pushed transacted revenue to $7.7 billion. Kaufman Hall's read: "We're witnessing proactive positioning over reactive consolidation." Divestiture and consolidation are not the same migration problem wearing different names — one carves data out cleanly, the other reconciles two or three platforms into one.

Where Intely fits

This is our core ICP#2 motion: 250+ completed migrations, a fastest go-live of four weeks on an 8TB hospital divestiture, and a live, queryable FHIR archive for everything that doesn't move. Whichever direction the deal goes — split or merge — the same platform handles the clinical, financial, and imaging data in one engagement instead of three separate vendor contracts.

06 — Proof

The Connectathon wrapped, and TEFCA volume is up 50x

The 7th annual CMS & HL7 FHIR Connectathon ran July 14–16, with real vendors testing real code against the exact four APIs CMS-0057-F requires. Separately, TEFCA now connects over 71,000 sites through 11 QHINs, and exchange volume went from roughly 10 million records in January 2025 to nearly 500 million by February 2026 — about a 50x increase in a year. Oracle Health is now a designated QHIN in its own right, not just an endpoint other systems connect to.

Where Intely fits

This is the scale our platform was built for: 500+ healthcare system connections already live, running on the same US Core and USCDI v3 rails TEFCA is proving out network-wide. Our Relay Agent removes the slowest part of joining a network like this — VPN provisioning between two separate organizations — so a new connection doesn't wait on a multi-week firewall review.

The throughline

A new CMS office built to move standards faster. A real FHIR deadline that already passed. The same prior-auth requirements expanding to drugs. Enforcement with actual financial teeth. An M&A wave generating fresh migration demand no matter which direction the deal goes. And, proven in production this month, a network already carrying 50 times the FHIR traffic it carried a year ago.

None of this was theoretical twelve months ago. It is now — and 71,000 organizations are already building on it.

If your 2026 roadmap still treats FHIR, Da Vinci workflows, or standards-based data migration as "eventually," this summer's news says otherwise. We'd rather help you get ahead of the deadline than watch you race it.

Sources referenced in this recap

  • Federal Register — Statement of Organization, Functions, and Delegations of Authority (OHTP), June 11, 2026
  • Healthcare Dive, MedTech Dive, Becker's Payer Issues, Gardner Law — CMS OHTP coverage, June 2026
  • CMS Interoperability Framework; CMS press releases, April & May 2026 (Health Tech Ecosystem, Electronic Prior Authorization Acceleration)
  • Federal Register CMS-0062-P (April 14, 2026); CMS Fact Sheet, April 10, 2026; Health Affairs Forefront
  • ASTP/ONC Enforcement Alert; Holland & Knight; Alston & Bird; Healthcare IT News on HTI-5
  • Kaufman Hall M&A Quarterly Activity Reports, Q1 & Q2 2026; Healthcare Dive, July 13, 2026; Bass, Berry & Sims, July 23, 2026
  • CMS & HL7 FHIR Connectathon (eCQI Resource Center); ONC/Sequoia Project TEFCA growth data; Healthcare Dive on Oracle Health's QHIN designation

Building for where interoperability is headed, not where it's been

Whether it's a FHIR deadline, a Da Vinci workflow, or a migration triggered by the next hospital deal — Intely builds the pipes so your team doesn't have to.

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