in-20261007-IR-410260356FNA: REPORTABLE EVENTS

TITLE 410 INDIANA DEPARTMENT OF HEALTH Notice of First Public Comment Period LSA Document #26-356 REPORTABLE EVENTS PURPOSE OF NOTICE The Indiana Department of Health (IDOH) is soliciting public comment on repealing rules at 410 IAC 15-1.4-2.2, 410 IAC 15-2.4-2.2, and 410 IAC 27-6-2 concerning reportable events. ADDITIONAL DOCUMENTS Regulatory Analysis: 20261007-IR-410260356RAA Notice of Public Hearing: 20261007-IR-410260356PHA CITATIONS AFFECTED: 410 IAC 15-1.4-2.2; 410 IAC 15-2.4-2.2; 410 IAC 27-6-2 AUTHORITY: IC 16-19-3-4; IC 16-21-1-7 OVERVIEW Basic Purpose and Background IDOH established the Medical Error Reporting System (MERS) effective January 1, 2006, and adopted facility-specific reporting rules to mandate electronic reporting within defined timelines and to enable statewide public reporting by facility. In 2023, the general assembly enacted P.L.190-2023, codified at IC 16-21-1-7.1, which requires hospital quality programs to determine and report only "serious reportable events" as identified by the National Quality Forum and expressly prohibits IDOH's executive board from requiring hospitals to report any other event types. Subsection (a) of 410 IAC 15-1.4-2.2 was accordingly voided by statute effective July 1, 2023. While subsection (a) was voided, the remaining sections were not updated, and this results in a gap that dictates how information must be reported without requiring any specific information to be reported. The implementation costs of the proposed rule are not expected to exceed the threshold set in IC 4-22-2-22.7(c)(6). For purposes of IC 4-22-2-28.1, small businesses affected by this rulemaking may contact the Small Business Regulatory Coordinator: For purposes of IC 4-22-2-28.1, the Small Business Ombudsman designated by IC 5-28-17-6 is: Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in IC 5-28-17-6, specifically IC 5-28-17-6(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator. REQUEST FOR PUBLIC COMMENT IDOH is soliciting public comment on the proposed rule. Comments may be submitted in one of the following ways: COMMENT PERIOD DEADLINE All comments must be postmarked or time-stamped not later than November 7, 2026. The rule, Regulatory Analysis, appendices referenced in the Regulatory Analysis, and materials incorporated by reference (if applicable) are on file at the Indiana Department of Health, Office of Legal Affairs, 2 North Meridian Street, Indianapolis, Indiana and are available for public inspection. Copies of the rule, Regulatory Analysis, and appendices referenced in the Regulatory Analysis are available at the Indiana Department of Health office. If IDOH does not receive substantive comments during the public comment period or public hearing, the rule may be adopted with text that is the same as or does not substantially differ from the text of the proposed rule published in this notice. PROPOSED RULE Documents Incorporated by Reference: None Received by Publisher