HTI-1 Ruling and FHIR Compliance: Key Deadlines and Impacts

The HTI-1 ruling introduces transformative changes for healthcare interoperability, enhancing transparency and access to electronic health information. As FHIR remains central to modern data exchange, this blog explores the compliance timelines and key impacts of HTI-1 on FHIR-related systems. 

Key Changes 

The HTI-1 final rule represents a significant regulatory shift in healthcare IT, reinforcing the industry’s commitment to interoperability, data transparency, and patient empowerment. 

With FHIR at the center of modern healthcare data exchange, many of these changes directly impact FHIR-related systems used by providers, developers, and health information networks. 

However, in addition to FHIR-related updates, the rule also introduces other non-FHIR changes, such as expanded information-blocking provisions, enhanced EHR certification requirements, and new transparency mandates, which organizations must address to ensure full compliance.

Notable changes include:

• Algorithm Transparency: Establishes requirements for certified health IT to provide clinical users with greater visibility into AI and predictive algorithms, ensuring they are fair, valid, reliable, and safe for clinical decision-making. This includes disclosing key details about algorithm development, data sources, and potential biases, allowing healthcare providers to make more informed and trustworthy decisions when using AI-driven tools in patient care. 
• Enhanced APIs: Adopts updated baseline FHIR standards within the Certification Program, further improving data exchange capabilities. We’ll get into the details further below. 
• Revised Information Blocking Requirements: Adjusts definitions and exceptions to support information sharing and introduces a new exception to encourage secure data exchange under TEFCA. 
• Interoperability Metrics: Requires developers to report usage metrics under the “Insights Condition” requirements, providing valuable insights into certified health IT’s role in care delivery. 

Compliance Requirements and Deadlines 

The Office of the National Coordinator for Health Information Technology (ONC) requires several revisions to § 170.315(g)(10), the certification criterion that mandates standardized FHIR-based APIs for patient and population services. 

These updates aim to further enhance secure, interoperable access to electronic health information (EHI) using FHIR Release 4 (FHIR R4) and the US Core Implementation Guide, ensuring improved data exchange between patients, providers, and third-party applications.

The changes and deadlines are outlined below.

Adoption of New Standard Baselines (by December 31, 2025) 

This includes transitioning to USCDI v3 & FHIR US Core IG version 6.1.0, retiring USCDI v1 and US Core 3.1.1, as well as implementing SMART App Launch IG version 2.0.0, retiring SMART v1.0.0.

USCDI V3 & FHIR US Core IG Version 6.1.0 (by December 31, 2025)

Provides the latest consensus-based capabilities aligned with USCDI v3 data elements for FHIR APIs. USCDI v3 introduces new data elements, updates vocabulary standards (e.g. LOINC, SNOMED), and modifies existing data classes. Some USCDI highlights include:  

• Health Concerns is renamed Health Status / Assessments: Additional statuses added including Smoking Status, Disability Status, and others. 
• Newly added Health Insurance Information Classification: Coverage, Member, Subscriber, Payer, etc. 
• Patient Demographics is renamed to Patient Demographics / Information: Additional elements added include Occupation, Related Person, Date of Death, and others.

Authentication, Authorization, and Token Introspection (by December 31, 2025) 

Leveraging SMART App Launch IG v2.0.0 to ensure secure and standardized API interactions. This includes HTI-1 making use of granular or fine-grained scopes to limit access, such as limiting conditions by encounter diagnosis as seen below: 

patient/Condition.rs?category=http://terminology.hl7.org/CodeSystem/condition-category|encounter-diagnosis

Insights Condition & Maintenance of Certification (starting January 1, 2026) 

Developers must collect and report interoperability metrics to ONC including: Applications Supported Through Certified Health IT, Use of FHIR in Apps Through Certified Health IT, and Use of FHIR Bulk Data Access Through Certified Health IT.

Patient Authorization Revocation (by December 31, 2024) 

Requires revocation of patient authorization to occur within one hour of a request.

Service Base URL Publication (by December 31, 2024) 

Standardizes and revises API Maintenance of Certification requirements to ensure consistent accessibility and discoverability of service URLs. 

Key Impacts on Stakeholders 

For Developers of Certified Health IT

Developers must align their systems with the latest FHIR standards and implementation guides. This includes implementing robust authentication and authorization mechanisms as well as ensuring API functionality meets the revised requirements by the deadlines mentioned above.

For Healthcare Providers 

Healthcare providers must update their certified electronic health record (EHR) systems to comply with the updated standards. The focus on transparency and real-time access to data will enhance patient care but requires investments in staff training and IT infrastructure.

For Patients 

The adoption of these updates ensures that patients have improved access to their health data through secure, user-friendly applications. The requirement for swift patient authorization revocation enhances privacy and control over personal health information. 

Take the next step

The HTI-1 ruling underscores the importance of FHIR in achieving healthcare interoperability and transparency. While compliance requires effort, the resulting improvements in patient outcomes, data access, and trust in health IT are worth the investment. 

With the January 1, 2026 deadline fast approaching, now is the time to act. At Firely, we specialize in helping health tech vendors and providers navigate FHIR implementation and API development, and we’re here to help you navigate the upcoming changes to ensure compliance with your system. 

Firely Server is fully equipped to meet HTI-1 FHIR API requirements with compliant functionality already operational in production systems. It also includes a robust metric system for ONC Real World Testing requirements, with upcoming support for HTI-1 measures. 

Ready to align with HTI-1 and FHIR compliance? Contact us today to explore how Firely can support you.