Regulatory review expected to take 90 days
Officials from the Department of Health and Human Services Office for Civil Rights (OCR) said March 26 that a long-awaited rule updating Health Insurance Portability and Accountability Act regulations has been sent to the White House Office of Management and Budget, signaling the rule will be released publicly in the near future.
OMB received the final omnibus rule – which covers four previously released proposed and interim final rules – on March 24, according to the OMB Office of Information and Regulatory Affairs website.
The OMB review process is expected to take a full 90 days.
OCR plans to issue guidance documents in the coming months to address certain provisions in the rule, including how to de-identify data and how to define “minimum necessary” for HIPAA purposes.
OCR has said that the omnibus rule will include:
- The final breach notification rule.
- The final HIPAA enforcement rule.
- The final rule implementing HIPAA privacy and security changes that were mandated in the Health Information Technology for Economic and Clinical Health (HITECH) Act.
- A final rule implementing HIPAA changes mandated in the Genetic Information Nondiscrimination Act.
HHS said in reports issued in September that it had received tens of thousands of complaints about violations of HIPAA rules since 2003.
In addition to the guidance documents, OCR plans to develop compliance tools for small providers to ensure that risk assessments and safeguards are implemented to protect health information.