HTI-5 Public Comment

Re: Docket No. HHS-ONC-2025-0005

RIN: 0955-AA09

90 FR 60970

Federal Register Document No. 2025-23896

Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule

Submitted by: James Cummings, Founder, Participatory Health – Fairfield, CT

Executive Position

HTI-5 proposes to modernize certification and refine information blocking enforcement in support of AI-enabled interoperability.

However, the rule does not address a structural prerequisite for that vision:

• Interoperability cannot be enforced, measured, or scaled without enumerable and attributable endpoints.

• Certification creates technical capability. Enumerability creates accountability.

• Absent enumerability, HTI-5 risks reinforcing a system where interoperability is nominally required but operationally unverifiable.

• If AI-enabled interoperability is the policy objective, longitudinal completeness must be treated as core infrastructure — not optional downstream behavior.

  
  

  AI interoperability vision cannot succeed without consumer-controlled longitudinal health records (LHRs) and enumerable endpoints. In practice, no provider holds a patient’s complete record; LHRs emerge only when patients can discover and retrieve data from all their providers. Today’s certified FHIR APIs are necessary but insufficient: without a National Provider Directory (NPD) of endpoints, interoperability is reactive and brittle. To make HTI‑5 meaningful, policy must embed NPD infrastructure and accountability into the standards, enabling measurable enforcement and true LHR aggregation for AI use.

I. AI Utility Is Limited by Fragmented Data Architecture

AI confined to a single EHR environment does not deliver transformation. It delivers optimization. True AI-enabled interoperability requires cross-institutional data aggregation, reliable retrieval across networks, structured provenance, and predictable SMART-based access.

No institution holds a complete record for complex patients. A longitudinal health record (LHR) only exists when a patient can discover and retrieve data from all providers involved in their care. Without infrastructure that enables predictable discovery and retrieval across systems, AI remains siloed — regardless of certification updates.

II. Certification Without Enumerability Produces Paper Compliance

The interoperability failures patients and developers experience are operational, not theoretical. FHIR certification confirms that an API exists. It does not confirm that it can be reliably found, consistently reachable, or operationally mature. If endpoints cannot be systematically enumerated, they cannot be systematically audited.A regime that certifies APIs without enumerating and measuring them creates the appearance of interoperability without its enforcement. Certification without enumerability produces compliance without accountability.

III. The Structural Role of a National Provider Directory (NPD)

A machine-readable, publicly enumerable directory of FHIR endpoints tied to accountable entities is enforcement infrastructure. Enumerability enables systematic discovery, attribution of responsibility, measurement of operational maturity, scalable integration, and proactive oversight. Without enumerability, enforcement remains complaint-driven and systemic immaturity persists. With enumerability, interoperability becomes measurable and longitudinal aggregation becomes predictable.

IV. Longitudinal Health Records Are Consumer-Activated

Longitudinal health records do not exist within institutions. They emerge when consumers activate retrieval across systems. Consumer-mediated aggregation requires predictable endpoint discovery, standardized metadata, reliable SMART connectivity, and attributable accountability. HTI-5’s AI framing implicitly depends on LHR capability. LHR capability implicitly depends on enumerability. This dependency should be made explicit.

V. Recommendations

1. Explicitly recognize consumer-mediated longitudinal aggregation as a national interoperability objective.

2. Align API certification with machine-readable endpoint publication.

3. Explicitly recognize enumerability as a structural prerequisite for scalable information blocking enforcement.

4. Encourage operational transparency in API reliability and SMART configuration.

5. Preserve computable, reusable EHI export suitable for aggregation and AI use.

   
   

VI. Enumerability Is Foundational to Effective Information Blocking Enforcement

Information blocking enforcement cannot function effectively in an environment where endpoints are not publicly enumerable and attributable.

When FHIR endpoints are opaque, inconsistently published, or operationally undiscoverable:

• Patients cannot reliably exercise their right of access.

• Developers cannot systematically test connectivity.

• Regulators cannot detect systemic non-compliance.

• Enforcement becomes dependent on individual complaints rather than measurable oversight.
  

A National Provider Directory that enumerates FHIR endpoints and binds them to accountable entities transforms information blocking enforcement from reactive to structural. Without enumerability, regulators cannot distinguish isolated technical failures from systemic non-compliance — and systemic non-compliance becomes structurally invisible.

Enumerability enables:

• Proactive auditing of access pathways

• Identification of persistent operational failures

• Detection of patterns across networks

• Public accountability for API maturity
  

Without enumerability, compliance remains largely declarative.With enumerability, compliance becomes observable.

If HTI-5 seeks to modernize information blocking enforcement, it must recognize that enforcement depends not only on legal definitions but on infrastructure that makes access measurable.

Conclusion

AI without longitudinal completeness is limited. Longitudinal completeness without enumerable infrastructure is unenforceable. Certification without enumerability produces compliance without accountability. HTI-5 is an opportunity to align modernization with structural transparency.