45 CFR 170 - HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY

Under the authority granted to the National Coordinator for Health Information Technology by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this final rule establishes a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule also addresses the status of ONC-Authorized Certification Bodies (ONC-ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA.

Through this advance notice of proposed rulemaking (ANPRM), the Office of the National Coordination for Health Information Technology (ONC) is soliciting public comments on metadata standards to support nationwide electronic health information exchange. We are specifically interested in public comments on the following categories of metadata recommended by both the HIT Policy Committee and HIT Standards Committee: patient identity; provenance; and privacy. We also request public comments on any additional metadata categories, metadata elements, or metadata syntax that should be considered. The immediate scope of this ANPRM is the association of metadata with summary care records. More specifically, in the scenario where a patient obtains a summary care record from a health care provider's electronic health record technology or requests for it to be transmitted to their personal health record. Public comment, however, is also welcome on the use of metadata relative to other electronic health information contexts.

Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this rule proposes a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule also proposes to address the status of ONC-Authorized Certification Bodies (ONC-ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA.

This document is a request for comments regarding the provisions of section 1322 of the Patient Protection and Affordable Care Act (the Affordable Care Act), enacted on March 23, 2010, which requires the Secretary to establish the Consumer Operated and Oriented Plan program. The Secretary of Health and Human Services invites public comments in advance of future rulemaking and grant and loan solicitations.

This final rule establishes a permanent certification program for the purpose of certifying health information technology (HIT). This final rule is issued pursuant to the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The permanent certification program will eventually replace the temporary certification program that was previously established by a final rule. The National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record (EHR) technology, such as Complete EHRs and/or EHR Modules. The permanent certification program could also be expanded to include the certification of other types of HIT.