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HHS/ONC RIN: 0955-AA01 Publication ID: Fall 2019 
Title: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program 
Abstract:

The rulemaking would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric healthcare providers and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
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 informationblocking.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 provision would be implemented under the authority of the Public Health Service Act, as amended by the HITECH Act and the 21st Century Cures Act.

Alternatives:

ONC considered 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 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. 

Risks:

At this time, ONC has not been able to identify any substantial risks that would undermine the implementation of the final rule. ONC will continue to monitor any potential risks and will continue outreach with stakeholders to swiftly address any issues that may result from the final rule.

Timetable:
Action Date FR Cite
NPRM  03/04/2019  84 FR 7424   
NPRM Comment Period Extended  04/23/2019  84 FR 16834   
NPRM Comment Period End  05/03/2019 
NPRM Comment Period Extended End  06/03/2019 
Final Action  11/00/2019 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations  Federalism: No 
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