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HHS/ONC RIN: 0955-AA02 Publication ID: Fall 2020 
Title: ●Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency 
Abstract:

In light of COVID-19, ONC issued an interim final rule with comment period (IFC) that gives health IT developers and health care providers flexibilities to effectively respond to the serious public health threats posed by the spread of COVID-19. The IFC extends certain applicability and compliance dates and timeframes in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule), including applicability and compliance dates for the information blocking provisions, certain 2015 Edition health IT certification criteria, and Conditions and Maintenance of Certification requirements under the ONC Health IT Certification Program. The IFC also updated certain standards and made technical corrections and clarifications to the ONC Cures Act Final Rule, which was published in the Federal Register on May 1, 2020.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 45 CFR 170    45 CFR 171   
Legal Authority: 42 U.S.C. 300jj–11    42 U.S.C. 300jj–14    ...   
Legal Deadline:  None

Statement of Need:

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. On May 1, 2020, ONC published the 21st Century Cures Act: Interoperability, Information Blocking and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). In the ONC Cures Act Final Rule, ONC set applicability and compliance dates for certain information blocking requirements and Conditions and Maintenance of Certification requirements. In light of the COVID-19 public health emergency, the extensions for the applicability and compliance dates in the interim final rule with comment period (IFC) are necessary to provide health IT developers and health care providers the flexibilities needed to effectively respond to the public health threat posed by the spread of COVID-19, while still maintaining a trajectory that will advance patients’ access to their health information, reduce the cost of care, and improve the quality of care.

 

Summary of the Legal Basis:

The provisions 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:

On April 21, 2020, ONC exercised enforcement discretion in enforcing all new requirements under 45 CFR part 170 that have compliance dates until 3 months after each initial compliance date identified in the ONC Cures Act Final Rule. The IFC provides more certainty for regulated entities and further extend compliance dates for 45 CFR part 170. The IFC also extends the applicability date for the information blocking provisions (45 CFR part 171), which could not be done through the exercise of ONC enforcement discretion. ONC will continue to consider, as needed, the future use of these (enforcement discretion and rulemaking) and additional options to provide health IT developers and health care providers the flexibilities needed to effectively respond to the public health threat posed by the spread of COVID-19.

Anticipated Costs and Benefits:

The provisions in the IFC are limited in nature: applicability and compliance date extensions, standards updates, and regulatory clarifications and corrections. We were unable to identify any new quantifiable costs and benefits beyond the prior analyses we performed for the ONC Cures Act Final Rule. However, we did request comment on additional impacts stakeholders might experience as a result of the IFC.

Risks:

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

Timetable:
Action Date FR Cite
Interim Final Rule  11/04/2020  85 FR 70064   
Interim Final Rule Comment Period End  01/04/2021 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local, State 
Small Entities Affected: Businesses  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