The long-delayed omnibus privacy and security final rule governing protection of health information is coming in the not-so-distant future, if not sooner, says Susan McAndrew, deputy director for health information privacy in the Department of Health and Human Services’ Office for Civil Rights.
“Certainly by the end of the year, or one of us will be out of the door by the end of the year and I hope it will be the regulation,” she joked during remarks at the Safeguarding Health Information conference OCR is hosting with the National Institute of Standards and Technology in Washington. “I really hope we are now targeting months, if not weeks, for the new regulation.”
The omnibus regulation will include final versions of proposed rules to expand HIPAA privacy and security protections that were issued in July 2010, the breach notification interim final rule issued in August 2009, the enforcement and compliance interim final rule issued in October 2009, and the Genetic Information Non-Discrimination Act proposed rule issued in October 2009. The rules, excepting GINA, are mandated under the HITECH Act. “We want to ensure that when we do the final HITECH action it contains as much activity as we can,” McAndrew said.
Major provisions of the omnibus final rule cover new information protection requirements for business associates and subcontractors, electronic access, research authorizations, student immunization records, and restrictions on marketing, fundraising and the sale of protected health information.
Separate from the omnibus rule, because it won’t be ready to sync with the regulation, will be a proposed rule that will govern accounting for disclosures even for payment, treatment and health plan operations. Individuals, for instance, will be able to demand that covered entities not transmit information to health plans regarding treatment paid for out-of-pocket. The accounting for the disclosures proposed rule is “very close” to being ready, McAndrew said.
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