2025 Health IT Policy Milestones: Cutting Through the Noise

  By Mary Griskewicz, Regulatory Resource Center Lead

If 2025 could be summed up in one phrase, it would be “We’ve been collectively drinking from the firehose.” Nearly every week brought communications from government officials announcing a new reorganization, budget shift, pledge, or “big announcement.” For many across the healthcare information technology (health IT) and policy community, keeping up has been a full-time job, and fatigue is understandable.

Historically, the industry navigated by the predictable, measured beam of the lighthouse—formal rulemaking, multiyear strategic plans, and structured agency roadmaps that reliably signaled where to steer and where to exercise caution. In 2025, that steady beam has been replaced by a high-volume, decentralized barrage of flashes: daily social media posts, executive orders, general calls for comments, and rule rescissions. The high-visibility but often low-durability announcements have created distractions that leaders must sift through to determine which, if any, require resources or a change in strategy.

If you compare the first 10 months of 2021, Biden’s new term, and 2025, Trump 2.0 term, this year’s communication output has reached unprecedented levels. The 2025 administration has produced not only a higher volume of announcements from the White House, Department of Health and Human Services (HHS), and its agencies but also a fundamentally different mix—one driven by rapid executive actions, high-profile pledges, and decentralized communications from visible figures such as Secretary Robert F. Kennedy, Jr. and Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz, MD. The administration’s approach has effectively replaced a relatively predictable regulatory rhythm with a high volume and velocity of communication.

The result of this higher volume, nonstop velocity is a communication environment where announcements arrive faster than stakeholders can assess their significance. This validates the exhaustion many feel as they try to separate what’s truly actionable from what’s performative.

To help our readers out, we want to highlight the past year’s developments we believe will drive change and should demand attention or affect operations in the next 12 to 18 months. This article cuts through the clutter to spotlight the most consequential policy milestones of 2025, those worth tracking, resourcing, and planning for.

Key 2025 Rules and Amendments

Before diving into enforcement or volunteer pledges, it helps to anchor in the foundational rulemaking that set the tone for 2025. These regulations define the technical and operational framework for interoperability, prior authorization, and quality reporting across the system.

CMS and ASTP Rulemaking

HTI-4 Final Rule

On July 31, 2025, the Assistant Secretary for Technology Policy (ASTP), in coordination with the Office of the National Coordinator for Health IT, released the HTI-4 Final Rule. It updates electronic prescribing certification criterion by adopting the National Council for Prescription Drug Programs’ (NCPDP) SCRIPT standard version 2023011 and introduces new certification requirements for real-time prescription benefit checks and electronic prior authorization. It also codifies Fast Healthcare Interoperability Resources (FHIR)-based standard specifications from the Health Level 7 (HL7) Da Vinci Project into system developer certification criteria.

The intent is to streamline interoperability across prescribing, benefit verification, and prior authorization workflows. For developers, it means aligning certified health IT products with new standards. For providers and patients, it means faster, more transparent prescription and authorization processes. The Healthcare Information Management Systems Society covered the updates here. Providers will also need to meet new Medicare Promoting Interoperability and Merit-based Incentive Payment System (MIPS) performance measures starting in 2027.

CMS-0057 Final Rule

Although finalized in early 2024, the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) continues to drive implementation efforts throughout 2025. The rule mandates the use of FHIR application programming interfaces (APIs) to automate data exchange and prior authorization processes, with major deadlines taking effect in 2026 and 2027. It also continues to influence vendor design, payer data strategy, and interoperability readiness. For additional background, see the CMS press release announcing the final rule.

Patient Access and Transparency

As interoperability rules advanced, 2025 also brought a sharper focus on patient empowerment through accessible, accurate cost and coverage data.

Under HTI-4, certified health IT must support NCPDP Version 13 standards for real-time prescription benefit checks beginning January 1, 2027. This functionality allows patients and providers to compare drug coverage and pricing at the point of prescribing. Fierce Healthcare reported the update reflects a growing demand for actionable cost transparency at the point of care.

In a related effort, a new rule effective November 17, 2025, requires Medicare Advantage organizations to make provider directory data available to the CMS Medicare Plan Finder by January 1, 2026, improving the accuracy and usability of provider information for beneficiaries.

Digital Quality Measures (dQMs)

Building on interoperability progress, CMS continued its multiyear transition toward digital quality measurement. The 2025 Medicare Physician Fee Schedule Final Rule introduced seven new quality measures and modified 66 others under the Quality Payment Program.

The goal is to phase out manual reporting altogether and replace it with measures derived directly from certified electronic health records and FHIR-based APIs. CMS underscored that digital quality reporting is becoming the expected default, not a pilot initiative.

Coverage Transparency

Coverage and Price Transparency became a top-level White House priority in 2025. Executive Order 14221, Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information, issued in February, directs CMS to strengthen and simplify existing transparency rules.

The order calls for standardized data formats, clearer dollar amounts in machine-readable files, and higher penalties for noncompliance—up to $2 million per year. This marks a shift from policy development to enforcement, signaling CMS’ expectation that hospitals and insurers move beyond check-the-box compliance toward meaningful usability.

Prior Authorization Reforms

If interoperability defined the first half of 2025, prior authorization reform dominated the second. Both CMS and private payers launched initiatives to reduce administrative burden and improve care timeliness.

On June 27, CMS announced the Wasteful and Inappropriate Service Reduction (WISeR) Model, a pilot using artificial intelligence (AI) to expedite authorization decisions and detect fraudulent requests. The pilot will begin January 1, 2026, in several states.

In parallel, major insurers joined HHS and CMS in signing a Prior Authorization Reduction Pledge, committing to streamline and automate prior authorization processes using FHIR-based APIs and other interoperability standards. Though voluntary, this pledge aligns with many of the same objectives as the CMS-0057-F rule and reflects the administration’s emphasis on public-private collaboration. The initiative aligns closely with CMS-0057 and HTI-4 requirements. Healthcare Dive described the pledge as a “test of industry follow-through” in an area long criticized for inefficiency. The pledge is discussed further in the Government and Private Sector Pledges section.

Information-Blocking Enforcement

On September 2, 2025, ASTP and the HHS Office of Inspector General jointly announced that ASTP will lead enforcement of information-blocking provisions under the 21st Century Cures Act. The announcement, covered by HHS, represents a clear signal that federal agencies intend to back up policy with enforcement.

Violations may incur penalties of up to $1 million per incident for certified health IT developers, health information networks, and exchanges. For providers, disincentives finalized in 2024—including potential loss of MIPS credit—are now active.

Compliance Deadlines Coming Fast

While 2025 was full of announcements, the true test lies ahead as enforcement and reporting deadlines from prior rulemakings take effect. The next two years will determine whether organizations can shift from policy preparation to operational execution.

CMS-0057 Key Dates

• Electronic Prior Authorization API: By January 1, 2026, payers must implement FHIR-based APIs that support end-to-end prior authorization automation, including turnaround times of 72 hours for urgent and seven days for standard requests.
• Public Reporting of Metrics: Starting with the 2026 plan year, payers must collect and publish prior authorization metrics such as approval rates and turnaround times. The first data set will go public on January 1, 2027.
• Payer-to-Payer Data Exchange: Effective January 1, 2027, payers must support five years of patient data exchange to ensure continuity of care.
• Provider Access API: Also required by January 1, 2027, this API will allow clinicians to view patients’ prior care, medication, and coverage information directly.

Quality Reporting Transitions

For 2026 reporting, hospitals must submit core data for the hybrid Hospital-Wide Readmission (HWR) and Mortality (HWM) measures, marking another step toward fully digital quality reporting. Details are available in the FY 2026 IPPS/LTCH PPS Final Rule Fact Sheet.

Government and Private Sector Pledges

In 2025, public-private collaboration surged. Federal agencies increasingly leaned on voluntary pledges to accelerate progress toward policy goals without the delays of formal regulation. These pledges created structured forums for dialogue and accountability—participants report ongoing meetings and workgroups to demonstrate tangible progress toward shared objectives within agreed-upon timelines.

Prior Authorization Reduction Pledge

On June 23, 2025, HHS and CMS announced the Prior Authorization Reduction Pledge in partnership with America’s Health Insurance Plans (AHIP). This voluntary commitment by major insurers aims to make meaningful improvements in the efficiency and transparency of prior authorization—a long-standing administrative pain point.

Signatories committed to:

• Standardize electronic prior authorization submissions using FHIR-based APIs
• Reduce the number of services subject to authorization by January 1, 2026
• Honor authorizations for 90 days when patients change health plans beginning January 1, 2026
• Provide real-time responses for at least 80% of electronic prior authorization requests by 2027

Although voluntary, the pledge complements the regulatory framework established by CMS-0057, reinforcing expectations that are already being phased in for federally regulated plans. The initiative, detailed in AHIP’s announcement, represents a coordinated government and industry effort to align progress and demonstrate early success before enforcement deadlines arrive.

Health Tech Ecosystem Pledge

Announced July 30, 2025, CMS’ Health Tech Ecosystem Pledge Program invites collaboration between technology firms and healthcare organizations to modernize data flows and strengthen interoperability. Framed as a blueprint rather than a mandate, it reflects the administration’s effort to advance interoperability through cooperation.

Early participants—including Amazon, Apple, Google, and Epic—pledged to deliver new interoperability solutions by early 2026. CMS positioned the initiative as a proving ground for innovation that may inform future policy and help identify best practices that could later be codified into regulation.

Voluntary vs. Regulatory

While such pledges encourage collaboration and flexibility, they are not substituted for formal standards development or rulemaking. They serve as accelerator opportunities for participants to demonstrate leadership and readiness—but without the binding accountability that accompanies regulation.

Projects like HL7’s Da Vinci Project, in contrast, are member-driven, consensus-based initiatives that produce the technical standards and implementation guides later adopted in rules such as CMS-0057. Pledges may influence policy direction, but standards development remains the mechanism through which interoperability becomes operational, meeting regulatory requirements.

Stakeholders should monitor who signs these pledges, what deliverables are promised, and how progress is measured—while maintaining focus on compliance-driven programs like CMS-0057 and HTI-4, which ultimately set the regulatory baseline for participation and accountability across the ecosystem.

Other HHS Agency Highlights and Priorities

Even beyond CMS and ASTP, several HHS agencies underwent realignment and launched pilots that hinted at long-term digital priorities.

Artificial Intelligence

On the federal front, no significant regulatory action has taken place due to the Administration’s current deregulatory posture on artificial intelligence. The Government Accountability Office, referred to as the Congressional watchdog, issued a report that identified 94 government-wide AI requirements from laws, executive orders, and guidance. These include mandates for transparency, risk management, and ethical use of AI across federal agencies.

As of this writing, 46 states introduced healthcare legislation in 2025, with 17 states enacting 27 laws. These bills target AI use in coverage decisions, prior authorization, chatbots, and bias mitigation—especially in Medicaid and insurance contexts. States are expected to introduce even more AI-in-healthcare legislation in 2026, with a focus on prior authorization, bias mitigation, and transparency. The trend is toward stronger oversight of health plans and clearer protections for patients.

TEFCA Expansion

The Trusted Exchange Framework and Common Agreement (TEFCA) started the year under a pall of uncertainty, but as the priorities of HHS and ASTP became clearer, it has been reestablished as a cornerstone of nationwide interoperability. Under ASTP’s leadership, 2025 saw an expanded roster of qualified health information networks and early testing of FHIR-based exchange. Progress this year underscored growing alignment among federal agencies, standards bodies, and private networks on how to operationalize national data exchange.

Cross-Agency Initiatives

Additional efforts across HHS and related agencies focused on:

• Pilots for digital identity management and patient-controlled consent models
• Exploration of digital identification cards tied to coverage verification and care access
• Preliminary AI and machine learning guidance emphasizing transparency, validation, and bias mitigation
• Cross-agency alignment on pharmacy interoperability and prior authorization standards

Together, these efforts form the infrastructure layer that will support the next phase of digital transformation.

Conclusion

2025 will be remembered as much for the pace of policy activity as for its substance. The constant churn has tested the industry’s endurance, yet staying engaged and discerning remains essential.

As 2026 approaches, early signals from the Spring 2025 Unified Regulatory Agenda suggest the pace is unlikely to slow. Stakeholders will need to focus less on chasing every new announcement and more on executing what truly matters: implementing CMS-0057, aligning with HTI-4, supporting TEFCA’s expansion, and watching as the Health Tech Ecosystem Pledge evolves into a durable framework for the next stage of digital health transformation. If your organization needs support staying on top of regulatory activity at the federal or state level, you might find our regulatory subscription services or a custom landscape analysis helpful for answering your unique policy questions. Contact me to set up a time to chat. I’d love to hear more about your needs and challenges.