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HHS/ONC RIN: 0955-AA05 Publication ID: Fall 2023 
Title: Establishment of Disincentives for Health Care Providers Who Have Committed Information Blocking 

The rulemaking implements certain provisions of the 21st Century Cures Act (Cures Act) to establish appropriate disincentives for health care providers determined by the HHS Inspector General to have committed information blocking. Consistent with the Cures Act, the rulemaking establishes a first set of disincentives using HHS authorities under applicable Federal law, including authorities delegated to the Centers for Medicare & Medicaid Services.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 45 CFR 171    42 CFR 414    42 CFR 425    42 CFR 495   
Legal Authority: 42 U.S.C. 300jj–52    42 U.S.C. 1302    42 U.S.C. 1306    42 U.S.C. 1395hh    42 U.S.C. 1395jjj    42 U.S.C. 1395rr(1)    5 U.S.C. 552.2   
Legal Deadline:  None

Statement of Need:

The rulemaking would implement a provision of the Cures Act which requires the HHS Office of the Inspector General (OIG) to refer health care providers that OIG determines to have committed information blocking to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking. Release of the proposed rule is needed to implement this critical component of the Cures Act and ensure effective enforcement of information blocking rules.

Summary of the Legal Basis:

The provisions would be implemented under the authority of the Public Health Service Act, as amended by the Cures Act.


ONC will consider different available authorities under which appropriate disincentives could be established deter information blocking and still minimize regulatory burden for health care providers.

Anticipated Costs and Benefits:

The costs of this proposed rule would be minimal. Investigated parties may incur some costs in response to an OIG investigation or the application of a disincentive by an HHS agency, however, this would depend on the frequency of prohibited conduct. The expected benefits of the regulation are deterring information and its negative impacts on many important aspects of health care, including effective health information exchange, patient access, duplicative testing and costs, and the availability and quality of care.


We anticipate that health care providers will express concern with the potential complexity of the approach (i.e., the application of a range of disincentives based on available authorities) as compared to a range of civil monetary penalties or fines. ONC will continue to consider additional potential risks, identify them for stakeholders, and seek comment from stakeholders during the comment period for the proposed rule.

Action Date FR Cite
NPRM  11/01/2023  88 FR 74947   
NPRM Comment Period End  01/02/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Alex Baker
Federal Policy Branch Chief
Department of Health and Human Services
Office of the National Coordinator for Health Information Technology
330 C Street SW, 7th Fl,
Washington, DC 20201
Phone:202 690-7151