HTI-5 | Evidence Explorer

What this evidence supports

HTI-5 proposes an updated FHIR-oriented certification foundation and discusses automated access to electronic health information, potentially including autonomous AI systems.

What it does not establish

HTI-5 remains a proposed rule whose comment period closed February 27, 2026. It is not adopted law, a current certification requirement, permission to access EHI, or authorization for autonomous AI; final language may differ materially.

Answer-ready summary

HTI-5 explicitly places automated and potentially autonomous AI access within the health-data interoperability policy discussion.

Record details

Decision priority: Watch
Current status: Proposed rule · comment period closed 2026-02-27 · not final
Evidence tracks: Technologies/care models · Implementation/adoption
Source authority: Primary/authoritative
Source organization: ASTP/ONC
Evidence design: Federal proposed rule
Applicability: Applicable to decisions about the stated program, policy, standard, or development context; not evidence of clinical benefit beyond the cited scope.
Confidence for the stated claim: High
Freshness: Current
Record date: 2025-12-22
Source updated: 2026-06-26
Last verified: 2026-09-03
Review due: 2026-10-03 or sooner if the cited source changes.
Version: 1.1
Revision state: Version 1.1 records the September 3, 2026 re-verification and June 26, 2026 source update, adds current rule-status sources, and makes explicit that HTI-5 remains proposed with comments closed and is not adopted law or authorization.

Evidence record fields

Claim supported: HTI-5 proposes an updated FHIR-oriented certification foundation and discusses automated access to electronic health information, potentially including autonomous AI systems.
Source type and design: Federal proposed rule
Population and setting: Not a participant-level clinical-study population in this source type. The program, policy, regulatory, standards, or research context described by the cited source.
Intervention/exposure and comparator: Not evaluated as a comparative intervention or exposure in the cited administrative or program source. No comparator is reported for this source-bounded claim.
Outcome or endpoint: The program, policy, regulatory, standards, or development state stated in the claim supported; no clinical outcome is inferred.
Follow-up duration: No clinical follow-up duration is reported for this source-bounded claim.
Effect estimate and uncertainty: No clinical effect estimate is reported. No statistical uncertainty estimate is reported; uncertainty is bounded through the source scope and stated limitations.
Harms/adverse events: No harms or adverse-event analysis is reported for this source-bounded administrative or program claim.
Missing data and attrition: Not reported; this record does not analyze participant-level data. Not applicable or not reported; no longitudinal participant cohort is analyzed.
Bias/limitations: HTI-5 remains a proposed rule whose comment period closed February 27, 2026. It is not adopted law, a current certification requirement, permission to access EHI, or authorization for autonomous AI; final language may differ materially.
Applicability/generalizability: Applicable to decisions about the stated program, policy, standard, or development context; not evidence of clinical benefit beyond the cited scope.
Funding/conflicts: Funding or sponsorship is recorded only where the cited source and claim state it; otherwise it is not assessed in this record. No conflict-of-interest assessment is reported for this administrative or program-source record.
Replication or corroboration: The administrative or program claim is anchored to the cited authoritative source; independent clinical replication is not implied.
Decision use: Use as source-bounded context for Clinicians, Innovators, Health-system leaders, Policymakers, Payers/employers; do not use as stand-alone evidence of safety, efficacy, coverage, endorsement, or scaled adoption.
Last reviewed / review due: Last reviewed 2026-09-03; review due 2026-10-03 or sooner if the cited source changes.

For this decision

Clinicians · Innovators · Health-system leaders · Policymakers · Payers/employers

Primary sources

Related intelligence

SIG-2026-024 — ASTP/ONC HTI-5 proposal explicitly contemplates automated and autonomous AI access to electronic health information