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HHS/ONC RIN: 0955-AA01 Publication ID: Fall 2017 
Title: ●Health Information Technology: Interoperability and Certification Enhancements 

The proposed rule would update certain provisions of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) and implement certain provisions of the 21st Century Cures Act (Cures Act) including provisions related to conditions of certification and maintenance of certification for a health information technology (IT) developer or entity, the voluntary certification of health IT for use by pediatric health providers, health information network voluntary attestation to their adoption of a trusted exchange framework and common agreement in support of network-to-network exchange, and provisions related to reasonable and necessary activities that do not constitute information blocking.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 114-255   
Legal Deadline:  None

Statement of Need:

In part, Title IV of the 21st Century Cures Act requires the Secretary to engage in notice and comment rulemaking that would help advance interoperability and the exchange of health information, including by addressing information blocking. The interoperability of health information is central to the efforts of the Department of Health and Human Services to enhance and protect the health and well-being of all Americans.

Summary of the Legal Basis:

The proposed provision would be implemented under the authority of the Public Health Service Act, as amended by the HITECH Act and the Cures Act.


ONC will consider different options to improve interoperability and access to electronic health information so that the benefits to providers, patients, and payers are maximized and the economic burden to health IT developers, providers, and other stakeholders is minimized.

Anticipated Costs and Benefits:

The majority of costs for this proposed rule will be incurred by health IT developers in terms of meeting new requirements and continual compliance with the regulations. We expect, however, that through implementation and compliance with the regulations the market particularly providers, patients, and payers will benefit greatly from increased interoperability and access to electronic heath information (e.g., the need for less interfaces or making health information more accessible at lower costs). Other proposed changes are aimed at relieving some administrative burdens for health IT developers. 


None identified at this time.

Action Date FR Cite
NPRM  04/00/2018 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Michael Lipinski
Director, Regulatory Affairs Division
Department of Health and Human Services
Office of the National Coordinator for Health Information Technology
Mary E. Switzer Building, 330 C Street SW,
Washington, DC 20201
Phone:202 690-7151