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Policymaking, Rules, & Regulation

Health IT Rules & Regulations

The Office of the National Coordinator for Health Information Technology’s (ONC) work on EHRs and health IT is governed by HITECH Act regulations. The following proposed and final rules are the health IT rules and regulations that provide guidance to the health care industry on the use of EHRs.

Proposed Health IT Rules and Regulations

The government issues proposed rules coinciding with a comment period that allows stakeholders to submit comments on the rules. Some comment periods for proposed rules listed below may no longer be active.

CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports [PDF - 163 KB] 

Modifications to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act – Notice of Proposed Rulemaking 

Final Health IT Rules and Regulations

HITECH Breach Notification Interim Final Rule 

Standards and Certification Criteria for Electronic Health Records

Meaningful Use of Electronic Health Records Final Rule [PDF - 14 MB]

Electronic Eligibility and Enrollment

Section 1561 of the Affordable Care Act requires the Department of Health & Human Services (HHS), in coordination with the Health Information Technology (HIT) Policy Committee and the HIT Standards Committee, to develop the following recommendations for interoperable and secure standards and protocols that facilitate electronic enrollment of individuals in Federal and State health and human services programs.

Recommendations
[PDF - 50 KB]

Appendix A: Consumer Usability
[PDF - 37 KB]

Appendix B: Core Data Analysis
[PDF - 241 KB]

Appendix C: Verification Interfaces
[PDF - 46 KB]

Appendix D: Business Rules
[PDF - 45 KB]

Appendix E: Transmission of Enrollment Information
[PDF - 25 KB]