HIPAA Proposed Rules and Regulations
- Modifications to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act – Notice of Proposed Rulemaking - The proposed new regulations will improve patient privacy and security in health information exchange by extending the Office for Civil Rights’ (OCR) enforcement, giving patients the right to receive their medical information electronically, and setting new limits on the use of protected health information.
- CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports - The proposed rule would modify the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the HIPAA Privacy Rule in order to give patients the right to get a copy of their health information, including test results, directly from a clinical lab.
The HIPAA Privacy Rule gives patients the right to access health information held by most health care providers. However, the Privacy Rule states that there is no patient right of access under HIPAA if access would be prohibited by CLIA. As currently written, CLIA often prohibits laboratories from directly releasing test results to patients. Under the proposal, the CLIA regulation will be amended to expressly permit laboratories to release test results directly to patients. The proposed rule would also change the HIPAA Privacy Rule to remove the CLIA exception. Together these changes will give patients the right to access a copy of their test results from their lab in the same manner that they have the right to access health information held by other health care providers.
- Metadata Standards [PDF - 82 KB] – The Office of the National Coordinator for Health Information Technology (ONC) issued an advance notice of proposed rulemaking (ANPRM) on August 5, 2011, which solicited public comments on the metadata standards recommended by the HIT Standards Committee. ONC accepted public comments on the ANPRM [PDF – 217 KB] for 45 days following publication in the Federal Register. The public comment period is now closed.
- Comments Sought on Potential Stage 2 Meaningful Use Objectives [PDF - 187 KB] – Comments were solicited for potential stage 2 meaningful use objectives. The public comment period is now closed. View the Federal Register notice [PDF - 13 KB].