The Standard

Co-authored by Kevin Day, Consent Implementation Guide Co-Lead, FAST FHIR Accelerator

MEET MARIA

Maria is 62 and just home from the hospital after a procedure that requires careful follow-up. Her care team has discharged her with medications, recovery instructions, and a treatment plan her health plan put in place to manage cost. Her husband took time off work to help her recover at home—administering medications, watching for warning signs, coordinating with the visiting home health nurse, and calling the health plan when questions came up about coverage and the treatment plan.

There is one complication. Decades ago, before Maria met her husband, she received sensitive care she has chosen not to share with him; care that is in her medical record and always will be. So when the hospital asked Maria at discharge whether she wanted to grant her husband access to her clinical information, she faced a binary choice: all or nothing. There was no option to share the medications and care plan he needed while keeping the rest of her history private. The system doesn't support that nuance, so Maria selected nothing.

Her husband helps her recover with whatever Maria can tell him in the moment—what each pill is for, when the next appointment is, and what the home health nurse said. When he calls the health plan to ask why one therapy was authorized but another was not, he is told he is not on the consent and the conversation cannot continue. The clinical care suffers. So does the emotional care. Two weeks in, he is frustrated, and Maria is exhausted from carrying both her recovery and the running translation of her own chart.

Maria’s story is not unusual. Across the country, patients, providers, payers, and the family members who do the actual work of recovery face a quiet crisis hiding inside healthcare’s interoperability progress: the problem of consent.

The Hidden Roadblock: When Consent Doesn’t Scale

Healthcare interoperability has made remarkable strides. Data can now move faster, further, and more securely than ever before. Yet one foundational challenge continues to limit what that progress can achieve: how patient consent is captured, communicated, and enforced across organizations.

Today, consent is fragmented. A patient authorizes data sharing at one organization, but that authorization rarely travels with the data. In the context of data privacy and consent, a “policy” is the set of provisions that govern a specific grantor–grantee relationship—what may be disclosed, to whom, for what purpose, for how long, and under what conditions. Those provisions also drive enforcement decisions when consents conflict, such as when an additive permission from one source overlaps with a restriction from another. The operational burden of capturing them varies widely depending on the setting. In clinical environments, consent is typically tied to an encounter or event, such as a 30-minute office visit or a three-week inpatient stay, and expires when that event ends. Health plans, by contrast, capture consent that remains valid until a specified expiration date or until the patient revokes it. The result is a tangled consent relationship tree, where each branch—provider, payer, app, caregiver, personal representative—holds a different fragment of the patient’s intent, with different lifespans, scopes, and enforcement rules. Because no two systems interpret these provisions the same way, organizations fall back on manual review to reconcile conflicts, slowing workflows to a crawl at the exact moments when trust matters most. Compliance burden rises. Patients are left in the dark about how their information is used. And interoperability stalls precisely where it should accelerate.

This is the problem the HL7® FHIR® at Scale Taskforce (FAST) set out to solve.

May Community Roundtable on May 27 Offers More Insight into Proposed Rule and Payer Data Exchange

As the industry prepares for the next wave of healthcare interoperability, the HL7 Da Vinci Project is dedicated to providing the community with the insights and tools necessary for success. With newly proposed regulatory frameworks, the stakes for technical and operational alignment have never been higher. Join us for the May Community Roundtable on Wednesday, May 27, 2026, from 4 – 5:30 p.m. ET to prepare for what’s next.

What You’ll Learn

While our April session established the foundational context for the new federal rule (CMS-0062-P), the May session builds on the momentum by moving from initial impressions to active implementation strategies. We will provide a focused update of the community’s considerations regarding the 2026 Interoperability Standards and Prior Authorization for Drugs proposed rule, specifically focusing on the Payer Data Exchange (PDex), PDex Plan Net, and Member Attribution (ATR) List Implementation Guides (IGs) called out in the rule.

Real-World Perspectives & Demonstrations

Following the policy discussion, you will hear directly from implementers successfully deploying these standards in real-world payer environments:

• Onyx: Discover how their implementations focus on moving data out of silos into standardized formats, providing endpoints for payers to make data available via HL7 FHIR IGs.
• Availity: Watch a live demo of core PDex workflows, including member matching and data retrieval, and learn how a centralized network can reduce onboarding friction while preserving payer autonomy and PDex semantics.

Our presenters will share critical insights on scalability and how these implementations support broader policy goals around data access, care coordination, and patient empowerment.

Upcoming Da Vinci Community Roundtable on April 29 at 4:00 pm ET

The momentum for healthcare interoperability continues to accelerate. Following the CMS-0057-F final rule, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have introduced its next major regulatory step: the 2026 Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS-0062-P).

Join the HL7 Da Vinci Project for the April Community Roundtable happening on Wednesday, April 29, 2026 at 4 p.m. ET as we break down this new proposal and discuss its implications for HL7 Fast Healthcare Interoperability Resources® (FHIR®) implementation and the industry at large. The new proposed rule relies heavily on the work of the HL7 Da Vinci Project community and could bring significant changes for industry, including adding Da Vinci implementation guides to Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements.

Featured Speakers

• Denise St. Clair: HL7 Da Vinci Project PMO; Vice President, Health Policy & Interoperability, Global Alliant, Inc.
• Alix Goss: Program Manager, HL7 Da Vinci Project; Senior Consultant, Point-of-Care Partners
• Moderator: Casey Thompson: HL7 Da Vinci Project Program Coordinator; Consultant, Point-of-Care Partners

Healthcare interoperability has reached an inflection point.

In 2026, success is no longer defined by the presence of APIs but by the ability tooperate securely, consistently, and at scale across networks, organizations, and increasingly, across borders.

This shift reframes interoperability as something far more consequential:
a shared trust problem spanning cybersecurity, financial sustainability, and patient safety.

At the center of this transformation is FAST Security, emerging not simply as a technical specification, but as thefoundational trust layer for a global healthcare ecosystem.

Interoperability Is Now a Cybersecurity Surface

As healthcare exchange accelerates—payer-to-payer data sharing, automated prior authorization, and network-based access—organizations are no longer just exposing APIs.

They are expanding an identity and authorization attack surface.

Each new connection introduces:

• Additional credentials to manage
• Increasingly complex authorization logic
• More exceptions and edge cases
• Greater exposure to misconfiguration and attack

This is not a scaling API problem; it is a scaling trust problem.

FAST Security directly addresses this by standardizing how trust is established, enforced, and audited across organizational boundaries.

FAST Security as the Foundation of Trust Architecture

FAST Security is not designed to operate in isolation.

It provides the core trust workflows—authentication, authorization, and onboarding—that enable the broader FAST ecosystem:

• FAST Identity → Who is trusted
• FAST Security → How trust is enforced
• FAST Consent → What is permitted
• FAST Directory → Where trust is discovered

Together, these form a layered, reusable trust architecture aligned with modern interoperability demands.

This architecture allows trust to move from fragmented, one-off integrations to repeatable, scalable infrastructure.

How States Can Move From Fragmented Programs to Shared, Scalable Infrastructure Using FAST

The CMS Aligned Networks Pledge marks a clear inflection point in federal health IT policy. For the first time, Centers for Medicare & Medicaid Services (CMS) is not simply setting compliance requirements for individual programs—it is asking the healthcare ecosystem to operate as connected networks, capable of secure, real-time, standards-based data exchange across payers, providers, public health and patients.

For states, this shift is significant.

States are no longer just one participant among many. They are increasingly the anchor for trust, identity, consent and directory infrastructure that enable CMS-aligned networks to function at scale. Medicaid programs, state CIO offices and HIEs sit at the intersection of policy, operations and technology. The CMS Aligned Networks Pledge makes that role explicit.

This blog explains:

1. What the CMS Aligned Networks Pledge really changes for states
2. Why traditional, program-by-program approaches will not scale
3. How the  HL7® FHIR® at Scale Taskforce (FAST)  provides the infrastructure states can reuse across initiatives
4. How states can leverage existing systems and vendors without starting over

The CMS Aligned Networks Pledge: A Shift from Programs to Infrastructure

Historically, CMS initiatives have been implemented as discrete programs:

• A new reporting requirement
• A new API mandate
• A new exchange use case
• Trusted digital identity and patient matching
• Scalable security and partner onboarding
• Computable, portable consent
• Authoritative directories for endpoint discovery

The CMS Aligned Networks Pledge represents a different expectation.

CMS is signaling that future interoperability depends on shared infrastructure capabilities, including:

• Trusted digital identity and patient matching
• Scalable security and partner onboarding
• Computable, portable consent
• Authoritative directories for endpoint discovery

These are not features of a single application. They are ecosystem functions.

For states, this means success is no longer measured by whether a single system goes live, but by whether multiple programs can reuse the same trust and exchange foundations.

Those of us working across health policy, technology, and standards are reimagining a system where individuals experience better outcomes, lower costs, and greater trust in how their health information is used and shared.

At HL7® International, a global standards development organization with members and affiliates in more than 50 countries, we are meeting our challenge head-on through collaboration and innovation. The HL7® FHIR® at Scale Taskforce (FAST) Accelerator takes that mission further by tackling the hard problems of scalability: Identity, Security, Consent, and National Directory services. These components are the backbone that supports the CMS Health Tech Ecosystem and Aligned Networks Pledge.

Paired with the Da Vinci Project, which applies FHIR to payer–provider workflows like prior authorization, clinical data exchange, payer data exchange, and patient cost transparency. HL7 is aligning infrastructure with real-world use cases. Da Vinci has recognized the value of FAST standards by selecting FAST Security as part of their security recommendations in their core health record exchange (HRex) specifications, showing a convergency across the ecosystem.

Where Sequoia’s RCE Role Elevates the Work: TEFCA as the National Trust Layer

FAST isn’t building infrastructure in a vacuum. Its work aligns with the Trusted Exchange Framework and Common Agreement (TEFCA), led by The Sequoia Project as the Recognized Coordinating Entity (RCE) for ASTP/ONC. TEFCA is a national framework for the secure and trusted exchange of clinical data across networks.

Join Us for the January Da Vinci Project Community Roundtable on January 28, 2026, from 4 - 5:30 pm ET

As we enter 2026, the healthcare industry continues to move from planning to active implementation of standardized data exchange. Because the first phase of the CMS-0057-F Interoperability and Prior Authorization Final Rule took effect this month, the stakes for technical and operational alignment have never been higher. The HL7 Da Vinci Project Community Roundtable, taking place on January 28, 2026, from 4 – 5:30 pm. ET,  will provide insights and resources to navigate this pivotal year.

What You'll Learn

Our previous sessions focused on how using Da Vinci burden reduction and payer data exchange IGs are transforming healthcare and how best to meet prior authorization regulatory requirements. This January session builds on that foundation by outlining key use cases, IGs, and the progress made in standardized data exchange.

Gain valuable knowledge on operational enhancements and resources to optimize your planning for smoother HL7 FHIR implementations, including implementation guides referenced in federal regulations. Additionally, hear about Da Vinci's 2026 priorities and the HL7 Da Vinci Community Champions program. 

October Da Vinci Community Roundtable on October 22 from  4:00 – 5:30 p.m. ET

As healthcare organizations continue to operationalize CMS-0057 requirements, understanding how to align technology, workflows, and policy is more critical than ever. The HL7® Da Vinci Project Community Roundtable, taking place on October 22, 2025, from 4:00 – 5:30 p.m. ET, will bring together industry leaders to share practical, actionable insights on how Da Vinci Implementation Guides (IGs) are transforming interoperability and reducing administrative burden across the healthcare ecosystem.

This month’s session, “Actionable Insights on Improving Burden Reduction, Payer Data Exchange, and Patient Cost Transparency,” will highlight the real-world value of HL7 FHIR®-based standards in improving efficiency, streamlining workflows, and driving measurable progress in value-based care.

What You'll Learn

The last HL7 Da Vinci Community Roundtable explored how regulatory, technical, and business drivers are shaping the future of prior authorization reform, with a focus on implementation strategies and interoperability alignment. That session underscored a key message: collaboration across payers, providers, and vendors is essential for scaling FHIR adoption.

The upcoming October Roundtable builds on that foundation connecting the dots between Burden Reduction, Payer Data Exchange (PDex), and Patient Cost Transparency (PCT) by highlighting Da Vinci’s pilots to show how these efforts can deliver tangible impact. First-hand accounts from Providence and Multicare as well as an update on recent testing work will be featured.    

August Community Roundtable Provides Multi-Faceted View of Prior Authorization Regulatory Requirements and Da Vinci Implementation Resources   

For the August HL7 Da Vinci Project Community Roundtable, industry leaders will offer an insightful, holistic discussion targeting those who want to better understand how best to meet prior authorization regulatory requirements aiming to increase efficiency and improve patient outcomes.   

With a focus on the latest developments surrounding the Da Vinci Prior Authorization Implementation Guides (IGs), the session begins with an examination of clinical and business drivers and a level-setting overview of federal and state level-activities impacting prior authorization requirements. Then we highlight technical standards, focusing on the underlying requirements of CMS-0057,  HTI-4 and the current status of the IGs.  The session concludes with how Da Vinci responds to industry needs, fostering a supportive environment for implementation and providing education, resources, and learnings from real-world implementers and piloting opportunities for those on their implementation journey. 

The U.S. Department of Health and Human Services (HHS), in collaboration with over 45 of the nation’s largest health insurers, has announced an important step forward in transforming the problematic processes of prior authorization. By pledging to reduce delays, increase transparency, and standardize processes by 2027, these organizations have signaled a long-overdue shift toward easing administrative burdens and improving access to evidence-based care.

The pledge spans insurance markets (commercial coverage, Medicare Advantage and Medicaid managed care) and will benefit an impressive 257 million Americans. But turning that vision into reality will require more than declarations. It will demand the kind of trusted technical infrastructure that HL7’s community has built together for over 35 years.

 As implementation begins, prior authorization reform demands scalable, open and consensus-driven standards.