The ATA Brief: Clinical Informatics Headwinds; Virtual School Health; AI RFI, and more

For Leaders Driving Digital Transformation Across Every Dimension of Care.

Hospitals Hesitant to Adopt Fully Autonomous AI

Hospitals and health systems are largely cautious about deploying fully autonomous AI in clinical settings, with leaders viewing unsupervised AI as too risky for high-stakes decision-making and preferring models that include human oversight. A recent survey found most organizations rely on clinician validation for AI outputs and believe AI should augment rather than replace clinical judgment. Read More »

7 Headwinds Clinical Informatics Will Face in 2026

Clinical informatics leaders warn that 2026 will bring significant challenges as AI adoption outpaces governance, workforce readiness and clinician engagement, while unclear role definitions strain teams and slow transformation efforts. Financial pressures, labor shortages, persistent interoperability and cybersecurity issues, and immature cross-functional governance further complicate efforts to scale technology safely and effectively across health systems.

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FEDERAL POLICY UPDATES

NEW! HHS and ASTP/ONC Just Released RFI on AI in Clinical Care

The Health and Human Services (HHS) Office of the Deputy Secretary, in collaboration with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), just released a Request for Information (RFI) seeking broad public comment on what HHS can do to accelerate the adoption and use of artificial intelligence as part of clinical care. Public feedback "will inform HHS-wide use of three different approaches: regulation, reimbursement, and research & development." The request is scheduled for publication in the Federal Register on December 23, 2025, and allows 60 days for comment. The RFI is available here.

ATA Action will be scheduling a call early in 2026 to discuss further, in the meantime please contact Alexis Apple at aapple@ataaction.org with your comments and concerns.

Happenings on the Hill

In early December 2025, the Senate held votes on multiple healthcare proposals tied to the impending expiration of the enhanced Affordable Care Act (ACA) COVID subsidies. Both the Republican and Democrat-led proposals failed to receive the 60 votes need to end debate and move to final passage. The Democrat proposal was a straight three-year extension of the subsidy. The Republican proposal offered different healthcare affordability measures such as contributions to health savings accounts, but no insurance subsidies.

In the House this week, the Republican-backed healthcare bill, Lower Health Care Premiums for All Americans Act, passed 216-211. It aims to expand options like association health plans, increase transparency in drug pricing, and offer targeted cost-sharing reductions. We do not expect this to pass the Senate because 60 votes are still required and Senate Democrats are unlikely to support the House Republican measure.

Looking forward, we would expect the ACA subsidies to expire on December 31, 2025, unless there is some kind of grand compromise among the parties, which we do not expect at this time.

Medicare Telehealth Flexibilities
We continue to monitor the situation with the Medicare telehealth flexibilities expiring at the end of the January 2026 (extended as part of the package to reopen the federal government during the shutdown). Our federal team has been in talks with leaders on both sides of the aisle and feel confident that we will have another extension as part of any funding package in January. While we expect another extension, that length is unknown and we could unfortunately be at the whims of another potential government shutdown next month. We have heard rumblings of a two-year extension coming in the spring and there is strong bipartisan appetite to make the flexibilities permanent, which is our ultimate goal. At this point, the January deadline remains a key milestone and a potential point of further legislative urgency.

Acute Hospital Care At Home

Separate from the stopgap continuing resolution, the House of Representatives recently passed the bipartisan Hospital Inpatient Services Modernization Act, which would extend the Acute Hospital Care at Home (AHCAH) program, a CMS waiver supporting hospital-level care in the home, through 2030. The legislation now awaits action in the Senate, where leadership could consider moving it under unanimous consent later in January. As of this week, the companion measure in the Senate has not yet been taken up on the floor. Sponsors and industry stakeholders are optimistic that the bill could be fast-tracked in early 2026, ideally before the current short-term extension expires on January 30. A successful Senate passage and Presidential signature would provide long-term predictability for providers participating in the AHCAH program.

Senator Wyden’s Letter to Electronic Health Record Companies

As part of his ongoing efforts urging electronic health records (EHR) companies to adopt gold-standard privacy measures, Ranking Member of the Senate Finance Committee Ron Wyden sent a letter on December 12, 2025, to a number of EHR companies touting EPIC’s recent efforts to develop new privacy features and requesting the following information:

EHR functionality for patient-facing portal and interoperability framework to:
- opt out of record sharing
- hide their records’ existence from other healthcare organizations
- list of healthcare organizations that have accessed an individual’s health records
- prompt to confirm record sharing preferences when an individual receives sensitive categories of care
If not offered, a commitment and timeline from the company to build and deploy this functionality.
Description of any additional patient-facing functionality currently offered that allow individuals to control health record sharing.
Description and timeline of any patient-facing functionality currently being developed that allow individuals to control health record sharing.

New IRS & Treasury Guidance on OBBB HSA Provision

On December 9, the Department of the Treasury and Internal Revenue Service (IRS) issued guidance (Notice 2026-05) on expanded access to Health Savings Accounts (HSAs) under the One Big Beautiful Bill Act (OBBBA). Topics addressed include making permanent the ability to receive remote care services before meeting the high-deductible health plan (HDHP) deductible while remaining eligible to contribute to HSAs, treating Affordable Care Act bronze and catastrophic plans as HDHPs, and allowing certain direct primary care service arrangement enrollees to contribute to an HSA. Notice 2026-05 is available here.

Comments on the notice are due by March 6, 2026. If you have questions or believe ATA Action should comment, please contact Alexis Apple at aapple@ataaction.org

New CMS Models to Expand Access to Technology Supported Care and Test Whole-Person Prevention and Lifestyle Interventions

Yesterday, ATA Action issued a statement commenting on several new initiatives launched by U.S. Health and Human Services (HHS) agencies described below, which aim to expand access to technology enabled care and evaluate functional and lifestyle interventions for Medicare beneficiaries. Read our press release here.

The Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model is a 10-year national test of a voluntary “outcome aligned” payment approach under Fee-for-Service Medicare designed to expand access to technology-supported care for people with certain chronic conditions. ACCESS participants must be Medicare Part B enrolled organizations (excluding DMEPOS and laboratory suppliers). Participating organizations will receive recurring payments for managing qualifying conditions, with full payment tied to achieving measurable health outcomes. ACCESS care organizations are expected to offer integrated, technology supported care.

To start, ACCESS will focus on four clinical tracks addressing many of the most common chronic conditions:

Early cardio-kidney-metabolic conditions (eCKM): hypertension (high blood pressure), dyslipidemia (high or abnormal lipids, including cholesterol), obesity or overweight with marker of central obesity, and prediabetes
Cardio-kidney-metabolic conditions (CKM): diabetes, chronic kidney disease (3a or 3b), and atherosclerotic cardiovascular disease, including heart disease
Musculoskeletal conditions (MSK): chronic musculoskeletal pain
Behavioral health conditions (BH): depression and anxiety

The Centers for Medicare & Medicaid Services (CMS) will also host a “Tools Directory” listing of optional technologies that may support the ACCESS model, without CMS endorsement. Vendors who want to be included will submit their own listings and self-certify compliance with all state and federal requirements. More information about ACCESS is available here.

Timeline:

Applications will be accepted on a rolling basis, beginning January 12, 2026. There is conflicting information on the first cohort deadline (the CMS website and a recent MLN say April 1, 2026, while other FAQs say March 20, 2026).
ACCESS will begin on July 1, 2026, and operate through June 30, 2036.

The Make America Health Again: Enhancing Lifestyle and Evaluating Value-Based Approaches Through Evidence (MAHA ELEVATE) Model will provide approximately $100 million to fund three-year cooperative agreements for up to 30 organizations that either provide whole person functional or lifestyle medicine services that are not covered by Medicare directly to patients or partner with other organizations to deliver services. Three awards are reserved for interventions that address dementia. The purpose of the program is to collect evidence on the effectiveness of whole-person functional approaches to health care, focusing on nutrition, physical activity, sleep, stress management, harmful substance avoidance, and social connection.

Services under this program must include a nutrition or physical activity component, and must have documented evidence of the intervention’s safety, efficacy, and cost impact. More information on ELEVATE is available here.

Timeline:

Early 2026: CMS issues the Notice of Funding Opportunity (NOFO).
First cohort begins September 1, 2026.
Second cohort launches 2027.

Many important details for these two new programs are still forthcoming, and we want to hear from you! Please reach out to Alexis Apple at aapple@ataaction.org with your questions and recommendations for making these programs successful.

FDA: Generation and Evaluation of Real-World Evidence

1. Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot

On December 5, the U.S. Food and Drug Administration (FDA) launched its new pilot program aimed at accelerating access to certain digital health technologies used in chronic disease care across four broad categories: early cardio-kidney metabolic; full cardio-kidney; musculoskeletal; and behavioral health. Up to 10 manufacturers will be selected per clinical use area.

TEMPO aligns with the new CMS ACCESS program described above, allowing companies participating in ACCESS to seek temporary enforcement discretion while collecting real world data to support future FDA authorization. Many operational questions have not yet been answered, such as evidence requirements, guardrails, and selection criteria. Read more about the program here.

Timeline:

Device makers can submit a statement of interest beginning January 2, 2026.
FDA expects to issue follow-up information requests around March 2, 2026.
FDA has not yet published dates for selection decisions or a formal program start date.

There are many open questions about TEMPO, and we want to hear from you! Please reach out to Alexis Apple at aapple@ataaction.org with your questions about and recommendations for this new program.

2. FDA Revises Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices

New guidance from FDA states the agency will accept real-world evidence (RWE) for certain types of medical device submissions without requiring identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission. According to the FDA’s press release, “this policy change opens the door to using de-identified databases containing millions of patient records — including national cancer registries like the National Cancer Institute’s Surveillance, Epidemiology, and End Results, hospital systems databases, insurance claims databases, and electronic health record networks — resources that have grown exponentially but remained limited for use under previous FDA policy.” The revised guidance is available here.

State Policy Updates

Kentucky Regulation Regarding Telehealth Diabetes Education Promulgated

A recently promulgated regulation in Kentucky establishes rules for the use of telehealth in the provision of diabetes educator services. The rule also prevents fee-splitting though the use of telehealth and allows for telehealth to be used in the provision of continuing education. There is a hearing scheduled for this rule on January 27, 2026.

Oklahoma Promulgates Telehealth Facility Fee Rule

The Oklahoma Health Care Authority has issued a proposed rule notice adding a facility fee for originating sites when a member receives services via telehealth. The fee is payable to the physical site hosting the member, separate from the distant-site provider's professional claim. Eligible sites include hospitals, outpatient departments, physician and practitioner offices, RHCs, FQHCs, I/T/U clinics, and nursing facilities. The fee is only allowed when the site provides staff or facility resources to support the encounter. It is not reimbursable when the member is at home or when no resources are used. Equipment and transmission costs remain non-covered.

From Washington, DC — with 🧡 for the work our community leads in care.