Additional Health IT Regulations and Regulatory Guidance

ONC’s work is related to regulations issued by other HHS and Federal agencies.  ONC also issues regulatory guidance regarding its rules. 

Read about privacy and security regulations at the HHS Office for Civil Rights’ page.

Read about CMS payment rules and e-prescribing regulations:

  • e-Prescribing - Please note that some e-prescribing regulations may be found within other CMS payment rules.

The table below provides links to other relevant regulations.

Title

Type of Rule and Date of Publication

Keywords

Medicare, Medicaid, and CLIA Programs; Patient Access to Laboratory Test Reports  

Proposed Rule – September 14, 2011 [PDF - 209 KB]  

Clinical Laboratory Improvement Amendments, CLIA, laboratory reports, EHR, patient access

Medical Devices; Medical Device Data Systems  

 

Final Rule – February 15, 2011 [PDF - 197 KB]

FDA, Medical Device Data Systems, MDDS, EHR, personal health record

Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act  

Interim Final Rule – December 1, 2010 [PDF - 2.5 MB]

Affordable Care Act, ACA, medical loss ratio

Electronic Medicare Claims Submission  

Final Rule – November 25, 2005 [PDF - 233 KB]

Administration Simplification Compliance Act, Medicare, electronic claims

ONC Regulatory Guidance

ONC HIT Certification Program; Program Policy Guidance #14-01 – ONC ACB Surveillance Guidance Regulatory Guidance – July 31, 2014 [PDF - 263 KB] 

ONC HIT Certification Program; Program Policy Guidance #13-01 – ONC ACB Surveillance Guidance Regulatory Guidance – July 2, 2013 [PDF - 492 KB]