Why Interoperability and Safety Must Evolve Together
On December 29, 2025, HHS published a notice of proposed rulemaking: Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5), which reflects a significant regulatory shift in U.S. health IT. As federal agencies pursue streamlined certification, stronger information-blocking protections, and FHIR-driven, AI-enabled interoperability, Qualifacts reaffirms its longstanding commitment: innovation thrives when built on a foundation of strong compliance.
The intent of HTI-5 is clear. The rule aims to reduce developer burden, update information blocking regulations, and prioritize modern interoperability standards with FHIR as the backbone for future health data exchange. Proposed changes include eliminating more than 50% (34 of 60) of ONC’s current certification criteria and reorienting the Certification Program around FHIR-based APIs designed to enable safe and transparent AI-supported workflows.
At the same time, HTI-5 proposes to revise or remove definitions and exceptions under information-blocking rules to provide clarity and prevent misuse with the goal of helping ensure patients can access their electronic health information without unnecessary barriers. Learn more in this HTI-5 Fact Sheet from HealthIT.gov.
Our Stance: Innovation Requires Discipline
At Qualifacts, we welcome the spirit of HTI-5: reducing redundancy, streamlining certification, and accelerating interoperability capabilities that benefit our customers and the individuals they serve.
But we also hold firmly to a principle that has shaped our product, compliance, and engineering practices for decades:
We will innovate the right way—regardless of who is watching.
While HTI-5 proposes to remove or simplify regulatory requirements, we believe the future of health technology must not trade rigor for speed, but rather work in parallel. Interoperability is not just about exchanging data—it’s about exchanging trustworthy, secure, high-quality data that supports effective, equitable care across the nation.
FHIR-first design and AI-driven capabilities hold extraordinary potential to reduce administrative burden, enhance clinical decision support, and make care coordination more seamless. HTI-5 itself highlights this by positioning FHIR-based APIs as the core of a next-generation interoperability framework. But these tools are only as strong as the foundation to support data integrity and consistency in how APIs are implemented.
Why Compliance Remains Essential
A strong compliance culture does more than check a box—it ensures stability, safety, and predictability in a rapidly evolving ecosystem.
- Consistency Enables Trust
As HTI-5 pares back certification criteria and resets program scope, uniformity becomes even more important. With fewer guardrails, the industry must rely even more on intentional, principled implementation to maintain consistent quality.
- Safety Must Scale with Innovation
HTI-5 places increasing emphasis on AI-enabled data exchange and FHIR API infrastructure. These advancements are powerful—but also require unwavering focus on responsible use, privacy, and risk mitigation. The proposed updates to information-blocking rules underscore the need to prevent misinterpretation and misuse.
Qualifacts’ Commitment
As a leading behavioral health EHR and interoperability partner, Qualifacts remains fully aligned with the national movement toward a more open, connected, and modernized health IT environment.
- We support a FHIR-first architecture as the future of secure and scalable data exchange.
- We embrace AI capabilities that meaningfully enhance care and reduce burden—always with safety, fairness, and accountability at the forefront.
- And we maintain our uncompromising belief that compliance is not an obstacle to innovation, but the very platform that enables durable, trustworthy progress.
HTI-5 represents a major opportunity for the industry to move faster and more collaboratively than ever. We will continue to champion that progress while upholding the highest standards of compliance—because individuals, providers, and communities deserve nothing less.