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HHS/ONC RIN: 0955-AA00 Publication ID: Fall 2016 
Title: ONC Health IT Certification Program: Enhanced Oversight and Accountability  
Abstract:

The rulemaking introduces modifications and new requirements under the ONC Health IT Certification Program (‘‘Program’’), including provisions related to the Office of the National Coordinator for Health Information Technology (ONC)’s role in the Program. The proposed rule proposes to establish processes for ONC to directly review health IT certified under the Program and take action when necessary, including requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules. The proposed rule includes processes for ONC to authorize and oversee accredited testing laboratories under the Program. It also includes a provision for the increased transparency and availability of surveillance results.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 45 CFR 170   
Legal Authority: sec. 3001(c0(5) of the Public Health Service Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/02/2016  81 FR 11056   
NPRM Comment Period End  05/02/2016 
Final Action  10/19/2016  81 FR 72404   
Final Action Effective  12/19/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local, State 
Small Entities Affected: Businesses, Governmental Jurisdictions  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Michael Lipinski
Director, Regulatory & Policy 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
Email: michael.lipinski@hhs.gov