Advancing Artificial Intelligence Enabled Interoperability through Modern APIs
This is arguably the most forward-looking aspect of HTI-5. The administration is not just clearing the past; it is actively laying the foundation for the next technological wave: widely deployed, secure, and effective Artificial Intelligence in clinical settings. AI needs clean, standardized fuel—and that fuel is high-quality, readily available data accessed via modern Application Programming Interfaces (APIs).
Establishing a Modernized Foundation for FHIR-Based Application Programming Interfaces
The rule proposes to cement Fast Healthcare Interoperability Resources, commonly known as FHIR, as the non-negotiable, standard protocol for future data exchange capabilities required for certification. This standardizes the technical “language” of data exchange, moving away from proprietary or legacy methods to a universally accepted, modern specification that facilitates secure data translation. FHIR isn’t just a trend; it is becoming the central nervous system of health data exchange.
The alignment with frameworks like the Trusted Exchange Framework and Common Agreement (TEFCA) is also part of this modernization, as standardized FHIR APIs enhance the overall trust fabric necessary for nationwide data sharing under those governance structures.
Catalyzing the Development of Artificial Intelligence Solutions
By standardizing the underlying data exchange through FHIR, the HTI-5 rule aims to create the necessary infrastructure for a new wave of innovation. The creation of a robust, reliable, and standardized API layer is presented as the essential foundation upon which secure, AI-enabled interoperability solutions can be developed and deployed at scale across the healthcare continuum.
A Practical Look: An AI model designed to predict sepsis risk needs access to a patient’s latest vital signs, lab results, and medication history—all structured in a consistent way, regardless of the EHR vendor. By mandating FHIR for certified products, HTI-5 makes it possible for an AI developer to build *one* integration that works everywhere, drastically lowering development costs and accelerating deployment.
Integrating Artificial Intelligence Capabilities into Certification Pathways
The proposal seeks to ensure that the evolution of the Certification Program actively promotes, rather than hinders, the safe and effective integration of artificial intelligence tools into clinical and administrative workflows. This involves creating specific pathways or modifying existing requirements to accommodate the unique needs of AI-driven applications that rely on high-quality, readily available, and trustworthy data streams. This proactive approach contrasts sharply with past regulatory efforts, which often played catch-up with technology.. Find out more about HHS HTI-5 Proposed Rule simplification guide.
The future certification may look less like testing static data elements and more like verifying the **quality and integrity of the data pipeline** feeding an algorithm. This moves the focus from the *what* (the data element) to the *how* (the reliable, real-time access to it).
Enhancing Provider Access to Payer-Held Information via New Certification Criteria
Beyond traditional clinical data exchange, the rule intends to expand the utility of certified Application Programming Interfaces. This expansion includes the proposal to adopt new criteria, such as “provider access API – client” and “provider access API – server” specifications, which would specifically allow providers to access relevant patient claims data and other administrative information directly from payer systems.
It is essential to understand the distinction here: while the *CMS Interoperability and Patient Access Final Rule* mandates that *payers* build the Provider Access API using FHIR, the HTI-5 proposal ensures that *certified Health IT developers* build the necessary capabilities (the ‘client’ and ‘server’ components) into their products so providers can actually *use* that payer data effectively within their workflows. This closes the critical loop between payer data availability and provider usability. This direct link between clinical and administrative systems is key to tackling issues like the pain points surrounding electronic prior authorization.
The Future Landscape of Interoperability and Care Coordination. Find out more about HHS HTI-5 Proposed Rule simplification tips.
Where do all these pieces—deregulation, strong anti-blocking, and FHIR mandates—lead? To a healthcare environment where data moves before the patient does, enabling better, faster decisions.
Optimization of Certification Processes to Reduce Cumulative Burden and Costs
The regulatory refinement initiative is not solely about removing criteria but also about optimizing the entire certification lifecycle. This encompasses streamlining procedural steps, clarifying submission requirements, and ensuring that the ongoing maintenance of certification is as efficient as possible for developers who have already proven their technology’s capabilities against core standards.
This continuous optimization is vital. If developers spend less time proving they still meet the old rules, they spend more time meeting the *new* ones—like those supporting the next iteration of the USCDI or addressing advanced security needs. It is a self-fulfilling cycle of efficiency.
Implications for Interoperability Between Clinical and Administrative Systems. Find out more about HHS HTI-5 Proposed Rule simplification strategies.
The drive to enable provider access to payer data directly speaks to the broader goal of breaking down the traditional silos separating clinical care from its financial and administrative aspects. By facilitating smoother data exchange between these domains, the rule supports more holistic patient management and greater efficiency in processes like electronic prior authorization.
Imagine a provider ordering a high-cost diagnostic test. Instead of waiting days for a paper authorization response from the insurer, the EHR, using a certified API capability built under HTI-5 standards, queries the payer system via the Provider Access API, confirms coverage, and initiates the pre-authorization request electronically in one session. That’s efficiency earned through interoperability.
Positioning for Trusted Exchange Framework and Common Agreement Alignment
The proposals within HTI-5 are designed to work in harmony with related national frameworks, such as the Trusted Exchange Framework and Common Agreement (TEFCA). By promoting standardized technical specifications like FHIR, the rule enhances the reliability, security, and overall trust fabric necessary for the successful nationwide adoption and implementation of coordinated data sharing under these governance structures. TEFCA seeks to create a national network of networks; HTI-5 ensures that the Health IT systems connecting to those networks speak the same, secure language.. Find out more about HHS HTI-5 Proposed Rule simplification health guide.
A crucial, often overlooked detail is the permanent codification of previous enforcement discretion notices. By baking flexibility into the permanent rule, the regulatory body reduces the uncertainty that has previously slowed down adoption of broader frameworks like TEFCA. Stability breeds adoption.
Commitment to Transparency and Responsible Technology Adoption Moving Forward
By addressing both the regulatory cost base and the foundation for new technologies like artificial intelligence, the Department signals a continuing commitment to transparent and responsible innovation. The HTI-5 rule frames itself as a necessary recalibration to ensure that the United States maintains its technological leadership while rigorously upholding the imperative of patient safety and data privacy in an increasingly automated healthcare environment.
The commitment to transparency is also evident in the proposal’s focus on revising the information blocking rules to eliminate potential misuse of exceptions. This shows a commitment not just to speed, but to ethical speed. It’s a comprehensive strategy to move the U.S. healthcare technology sector from a reactive compliance posture to a proactive innovation leadership role.
Conclusion: Your Action Plan for the HTI-5 Era. Find out more about Health IT developer compliance hour savings health guide guide.
The HTI-5 Proposed Rule, announced today, December 22, 2025, is far more than a technical update; it is an economic directive rooted in deregulation and a technological imperative focused on FHIR and AI. By eliminating over half of the certification criteria and saving developers millions of hours, the ONC is fundamentally changing the cost-benefit analysis for developing new health IT products. Furthermore, the tightening of information blocking accountability and the standardization around FHIR APIs will accelerate the exchange of clinical and administrative data across the entire care continuum.
Key Takeaways and Actionable Insights
Here is what you must internalize from the HTI-5 announcement:
- For Health IT Developers: Immediately halt development on criteria slated for removal. Reallocate those developer hours—estimated at 4,000 hours per average developer in the first year—to building out your FHIR API capabilities, especially those needed to connect with payer data sources via the new certification criteria. Your roadmap needs to be completely forward-looking.
- For Healthcare Providers: Start anticipating data feeds you haven’t had before. The integration of provider access to payer-held claims data will reshape utilization review and patient financial counseling. Begin conversations with your current EHR vendor about their plans for implementing the new API client/server specifications.. Find out more about Strengthening enforcement against health information blocking insights information.
- For Compliance & Legal Teams: Deep-dive into the proposed revisions to information blocking exceptions. The window for misuse is closing. Ensure your organization’s policies around data sharing, especially when interacting with competitors or new partners, are robust and aligned with the stricter anticipated enforcement posture.
- For Strategists: The foundation for scaled AI in healthcare is being built right now, block-by-block, via FHIR standardization. Any new investment in clinical decision support or predictive analytics should pivot exclusively to solutions that leverage these new, guaranteed data pipelines.
The administration has laid out a clear vision: less compliance paperwork, more actual data sharing, and a technological runway for AI. The total projected savings of $1.53 billion is a serious stake in the ground. The opportunity is real, but it demands agility. The window for public comment is now open, and the time to prepare is today, not when the final rule is published next year.
What part of the HTI-5 proposal do you believe will have the biggest impact on your daily operations in 2026? Share your perspective in the comments below—this discussion needs every stakeholder at the table!
