Collaboration Over Regulation: A Path Forward for Interoperability

By Mary Griskewicz, MS, FHIMSS, Regulatory Resource Center Lead

By Alix Goss, Sr. Consultant & Da Vinci Project Program Manager

The health IT industry is entering a new chapter, one that calls for more collaboration, not less. With the Department of Health and Human Services (HHS) moving forward with a massive restructuring plan that includes cutting 20,000 jobs and slashing $1.8 billion from its budget, there’s growing uncertainty around who will drive continued progress in health data interoperability. This moment demands a shift in mindset: while the federal government may be stepping back, the private sector must be ready to step forward.

This article explores the road ahead. We’ll start by reflecting on the vital role HHS has historically played in catalyzing progress. Then we’ll examine how Multi-Stakeholder Initiatives (MSIs), from HL7® FHIR® Accelerators to regional collaborations, have already influenced progress and are positioned to pick up the baton. We'll also explore who’s missing from these efforts, how to get involved even without formal membership, and what’s at stake if the industry doesn’t act. Finally, we’ll end with a call to action: it’s time to double down on engagement, not pull back.

A Fork in the Road

Historically, federal leadership, especially through agencies like the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health IT (ASTP/ONC) under HHS, played a central role in convening stakeholders, funding standards development, and aligning policy with innovation. But as the federal presence becomes less predictable, the responsibility to sustain and accelerate interoperability efforts is shifting.

That’s where MSIs come in. These initiatives and various standards development workgroups have long served as trusted forums for collaboration and consensus-building. Their importance is no longer optional; it’s critical. If we want to keep improving patient outcomes, reducing waste, and building a more efficient system, industry must lean into these efforts with them.

We are not powerless. We are in this together. Progress depends on showing up. That means investing time, resources, and energy into the coalitions already working to solve some of health IT’s biggest challenges. Momentum isn’t lost unless we allow it to be.

What the Federal Government Historically Brought to the Table

Federal agencies have long been a catalyst for interoperability, bringing authority, funding, and visibility to key priorities as well as acting as a convener when needed. The industry has also historically looked to these agencies to expedite progress through policy levers. Here’s a snapshot:

ASTP/ ONC:

• Convened the FHIR at Scale Taskforce (FAST) to address infrastructure challenges that limit scalable exchange with industry partnerships.
• Championed alignment on standards like the U.S. Core Data for Interoperability (USCDI).
• Spearheaded the Intersection of Clinical and Administrative Data (ICAD) Taskforce to tackle siloed data systems and improve access and efficiency (ICAD report).

Centers for Medicare & Medicaid Services (CMS):

• Published the Interoperability and Patient Access final rule (CMS-0057) on January 17, 2024. This rule aims to improve health information exchange and streamline prior authorization processes to reduce burdens on patients, providers, and payers. Certain provisions must be implemented by January 1, 2026, while others, such as application programming interface (API) requirements, have a deadline of January 1, 2027. (CMS Fact Sheet).
• Embedded staff in standards efforts and MSIs to ensure implementation guides matured in line with regulatory goals.

Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA):

• Continued to shape privacy and consent policy, especially in areas like behavioral health, through close collaboration with industry.

Health Resources and Services Administration (HRSA) and Centers for Disease Control and Prevention (CDC):

• Funded major public health infrastructure projects, including immunization registries and syndromic surveillance through the Data Modernization Initiative (CDC DMI).

Today, this scaffolding is at risk:

• The HHS restructuring reduces the department’s convening power and institutional knowledge.
• Proposed budgets would cut discretionary health spending by more than 30%.
• CMS’s recent Request for Information on deregulation signals less regulation and potentially removing rules if they put new ones in place in adherence with several Presidential Executive Orders issued: Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, and Executive Order 14192, known as Unleashing Prosperity Through Deregulation, on January 31, 2025.

Less federal participation may mean fewer mandates and less central coordination. But it also creates room -- and necessity -- for industry to chart the course. Without intentional collaboration, progress could stall, or efforts may fragment. But with the right partners, we have a chance to keep building a smarter, more connected system.

Enter the Multi-Stakeholder Initiatives: A Proven Path Forward

As the federal government pulls back, the spotlight turns to the industry’s most resilient assets: MSIs. These aren’t new experiments. They’re trusted vehicles where providers, payers, health IT vendors, patient advocates, and others come together to tackle common challenges. Many have been quietly doing the hard work of consensus-building and implementation for years. Now, they’re even more essential and need broader participation.

Leading MSIs are already delivering tangible value:

• HL7® FHIR® Accelerators include Argonaut, CodeX, CARIN, FHIR at Scale Taskforce (FAST), HL7 Da Vinci Project, Gravity, Helios, and Vulcan. These initiatives have led the charge to identify critical use cases and build implementation guides (IGs) that make standards-based exchange usable in the real world. From streamlining prior authorization to enabling data exchange to address the social determinants of health (SDOH), these projects are helping interoperability efforts go from theory to action.
• The Sequoia Project is stewarding national efforts like the Trusted Exchange Framework & Common Agreement (TEFCA) while supporting real-time industry needs, such as creating practical resources for information blocking compliance. While the future of TEFCA may be impacted by the HHS reorg, The Sequoia Project’s other workgroups and initiatives are important.
• Washington State FHIR-Based PA Workgroup, a collaborative work group with 10+ payers to implement Da Vinci use cases and align with CMS-0057. Washington was the first state to mandate FHIR-based prior authorization. This effort groups participants by FHIR maturity and fosters cross-sector collaboration to streamline workflows and scale automation to support stakeholders in their compliance journey.
• Massachusetts Health Data Consortium, a regional collaborative, proves that meaningful progress can also be led at the state level. It aligns stakeholders on shared goals and builds practical solutions.
• Collaboratives such as the Workgroup for Electronic Data Interchange (WEDI), the Council for Affordable Quality Healthcare (CAQH) and DirectTrust convene members to educate, share best practices and lessons learned, collect and share data, collaborate on operating practices, and provide resources.

This is not an exhaustive list. If there’s an interoperability or health IT challenge, chances are an MSI exists to tackle it. And if it doesn’t, one can be created. POCP has stood up new initiatives when gaps are identified, combining a proven process with a clear-eyed view of how people collaborate and make decisions. Launching new MSIs where needed isn’t just possible; it’s often the most effective path forward.

What makes MSIs different and increasingly necessary is their convening of industry leaders and grounding in real-world experience. These are implementer-led efforts, not theoretical exercises. They assemble those closest to the work, create deliverables on predictable cycles, and serve as bridges between the private sector and public agencies. In a moment where regulatory clarity may lag, MSIs provide continuity and momentum.

The impact is already visible. Da Vinci’s IGs are being used by leading payers and providers to improve data flow for value-based care. Gravity Project’s consensus-driven SDOH standards are being integrated into workflows and implemented at the state-level. FAST is building the infrastructure layer—identity, directory, and consent services—that many assume already exists, but often doesn’t.

Even as federal agencies recalibrate, their missions haven’t disappeared and we will likely see new policy activity that may take the form of rescinding previous policy in concert with introducing new policies that align with the administrations higher level strategies Through their criteria for grants and other funding mechanisms, the federal government also informs the vocabulary and goals that MSIs use and pursue. What’s changing is who moves the work forward. And the answer must increasingly be: we do.

Widening the Tent: Who’s Underrepresented in the Conversation?

MSIs often reflect the perspectives of larger institutions, but many critical voices are still underrepresented. Standards shaped without diverse input risk being hard to implement or reinforcing existing disparities. Inclusive collaboration leads to better, more usable outcomes. Initiatives like the Da Vinci project and Gravity have had success broadening the stakeholder make-up.

You Don’t Have to Be a Member to Engage

One of the most persistent myths about MSIs is that participation is gated behind a membership fee and benefits only those who pay. In reality, many initiatives offer free or low-cost ways to get involved, and doing so can be a powerful way to shape the future of interoperability.

There are numerous low-barrier paths to engagement:

• Attend public calls, webinars, or virtual working sessions
• Join mailing lists or listservs for updates and discussion
• Observe or test at Connectathons, where draft IGs are trialed in real systems
• Participate in pilot programs
• Submit public comments on draft specifications
• Participate in HL7 or NCPDP balloting at a low cost
• Share your organization’s implementation story or lessons learned

It’s about co-creating tools and frameworks that reflect the real complexity of healthcare. If your organization has something to say, there’s likely a forum ready to listen.

What’s at Stake If We Don’t Step Up?

Pulling back right now, whether due to uncertainty, resourcing, or organizational fatigue, is understandable. But it’s also risky. The industry is at a crossroads. Years of progress and built-up momentum toward interoperability, burden reduction, and improved patient outcomes are hanging in the balance. Without active engagement from a wide range of stakeholders, the work could unravel, fracture, or sputter to a halt.

The real risk isn’t just slower progress. It has the potential to entrench inefficiencies and widen disparities in care. Fragmented data systems, duplicative administrative processes, and avoidable patient friction points will persist if we don’t continue to push forward. Without collective commitment, we also risk losing institutional knowledge, missing key opportunities to modernize infrastructure, and having to rebuild consensus from the ground up if federal leadership resurfaces later.

If MSIs shrink or stagnate, the burden shifts to individual organizations to interpret ambiguous policies, untangle standards complexity, and develop one-off solutions, and solutions become even more fragmented than they are today. To be sure, that path leads to increased costs, avoidable technical debt, more confusion, delayed implementation, and diminished results—the exact future we’ve all been working to prevent.

How to Lean In & Benefit Your Organization

This is not the moment to sit on the sidelines. It’s time to get involved.

Whether you’re a payer, provider, public health agency, technology vendor, or patient advocate, your perspective matters. Participation doesn’t always require membership or a big budget. What matters most is contributing your insights and helping to shape the solutions we all need.

POCP can help. We can work with your organization to identify which MSIs are most aligned with your strategic goals or explore whether a new initiative should be launched to address an unmet need. If you have an idea but aren’t sure if someone else is already working on it, we can help you assess the landscape, avoid duplicating efforts, and connect with the right collaborators.

Let’s move forward together. Contact us to explore how you can get involved.