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Permanent certification program for health information technology; revisions to ONC-Approved Accreditor processes.
Federal Register
|December 7, 2011
Summary
This final rule details processes for addressing improper conduct by the ONC-Approved Accreditor (ONC-AA) and clarifies the status of ONC-Authorized Certification Bodies (ONC-ACBs) during accreditation changes.
Area of Science:
- Health Information Technology
- Regulatory Affairs
- Healthcare Policy
Background:
- The Health Information Technology for Economic and Clinical Health (HITECH) Act grants authority to the National Coordinator for Health Information Technology.
- The permanent certification program relies on accredited organizations to ensure health IT standards.
Purpose of the Study:
- To establish a formal process for handling misconduct or non-performance by the ONC-Approved Accreditor (ONC-AA).
- To clarify the operational status and responsibilities of ONC-Authorized Certification Bodies (ONC-ACBs) during transitions in ONC-AA.
- To ensure continued integrity and function of the permanent certification program.
Main Methods:
- Publication of a final rule outlining procedures and responsibilities.
- Definition of protocols for addressing ONC-AA conduct.
- Clarification of ONC-ACB status under new accreditation.
Main Results:
- A defined process is established for addressing ONC-AA improper conduct or failure to perform.
- Guidelines are provided for managing ONC-ACBs when the ONC-AA changes.
- Responsibilities of a new ONC-AA are clarified.
Conclusions:
- The final rule ensures accountability and stability within the health IT certification process.
- This regulation supports the ongoing effectiveness of the permanent certification program.
- Clear procedures mitigate risks associated with changes in accreditation oversight.
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