In July of last year, the U.S. Department of Health & Human Services Office for Civil Rights issued a proposed regulation implementing changes to HIPAA resulting from the HITECH Act. As we previously reported, the proposed regulation significantly expands the scope of the privacy, security, and enforcement provisions of HHS’s existing HIPAA rules.
Last month, in the Executive Branch’s Unified Reglatory Plan, the Department indicated that the final regulation will be published in March. According to media reports, HHS officials plan to simltaneously issue a final breach notification rule, final HIPAA enforcement rule, and a final rule implementing HIPAA changes resulting from the Genetic Information Nondiscrimination Act.
The next public step in the process is for the Office of Management and Budget, which is a part of the Executive Office of the President, to review the proposed regulation. Once the rule rule reaches OMB, it is likely to be issued within 120 days.