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The U.S. Department of Health and Human Services (HHS) has prepublished its highly anticipated modifications to the HIPAA Privacy and Security rules. HHS Secretary Kathleen Sebelius said, “The new rule will help protect patient privacy and safeguard patients’ health information in an ever-expanding digital age.”

The rule specifies when data breaches must be reported to the Office for Civil Rights (OCR), sets new requirements for use of personal health information for marketing and fundraising and expands direct liability to “business associates” of HIPAA-covered entities. Business associates could include a healthcare provider’s data miners and health information technology providers, ModernHealthcare reports.

According to an HHS press release, “Individual rights are expanded in important ways.” The new rule allows patients to request an electronic copy of their health records and “reduces burden by streamlining individuals’ ability to authorize the use of the health information for research purposes.”

OCR Director Leon Rodriguez said, “This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented,” adding, “These changes not only greatly enhance a patient's privacy rights and protections but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a healthcare provider or one of their business associates.”

The omnibus rule is made up of four main rules altering the privacy, security, enforcement and breach notification regulations under HIPAA and is based on the HITECH and Genetic Information Nondiscrimination Act of 2008 (GINA) statutory changes, according to Inside Privacy. It includes final modifications to regulations set forth by the HITECH Act; changes to the HIPAA Enforcement Rule; the Breach Notification for Unsecured Protected Health Information under the HITECH Act, and the HIPAA Privacy Rule as mandated by the GINA.

In comments provided to The Privacy Advisor, George Washington University Law School Prof. Daniel Solove, a TeachPrivacy founder, said, “The regulation strengthens HIPAA in many important ways. Most notably, it expands HIPAA’s scope by applying many HIPAA provisions to business associates, and it deems subcontractors to be business associates. This basically means that if you touch PHI, you fall under HIPAA, and the new enforcement is more vigorous and the penalties are more steep.”

Solove added, “Many companies will need to get more serious about compliance.”

Center for Democracy & Technology Health Privacy Project Director Deven McGraw told the Advisor, "We are very pleased to have the final rules implementing most of the HITECH modifications to HIPAA. Congress intended for these privacy protections to be in place as the EHR incentives went into effect. The delay was unfortunate—but now the rules are out and we can begin the process of understanding and implementing them."

The official publication of the new rule is scheduled for January 25, and they go into effect on March 26 with a compliance date set for September 23.

Editor’s Note: Deven McGraw and Wiley Rein Partner Kirk Nahra, CIPP/US, will be speakers on the upcoming web conference, HIPAA Final Omnibus Rule Announced—Privacy, Security, Enforcement and Breach Notification Rules Modified. Nahra will also lead the breakout session The New HIPAA Era: What’s New, What’s Different and What’s Actually Important, and PricewaterhouseCoopers (PwC) will be hosting a day-long preconference workshop dedicated to healthcare privacy’s key themes this March at the IAPP Global Privacy Summit in Washington, DC. Details on PwC’s daylong session will be forthcoming.


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