Corporate Compliance

News: HHS announces new lab/HIPAA rules, new OCR director

Compliance Monitor, September 14, 2011

Patients may have easier access to lab results under a proposed rule announced by Department of Health & Human Services (HHS) Secretary Kathleen Sebelius during the first-ever HHS Consumer Health IT Summit in Washington, DC. September 12.

The proposed rule would allow patients to access test results reports directly from labs, which would provide such information directly to patients or their personal representatives, according to an HHS press release.

“When it comes to healthcare, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care,” Sebelius said.

CMS, the Office for Civil Rights (OCR), and the Centers for Disease Control and Prevention (CDC) drafted the proposed rule. It would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations to strengthen patients’ rights to access their own laboratory test result reports, according to the HHS press release.

Sebelius also announced Monday the appointment of Leon Rodriguez as the new director of OCR. Rodriguez brings Department of Justice experience to HHS. He replaces Georgina Verdugo. OCR did not immediately return an e-mail Monday about the status of Verdugo.

“Consumers need to know that private and secure access to their health information is a given,” OCR Director Rodriguez said in the HHS release. “The privacy and security of health data will be a top priority for OCR during my tenure.”

Sebelius also unveiled a voluntary Personal Health Record (PHR) Model Privacy Notice, which creates an easy-to-read, standardized template allowing consumers to make informed decisions based on their privacy and security policies and data practices about PHR products.

The new template is similar to Nutrition Facts Labels in that it presents certain complex information in a simple way to improve transparency and consumer understanding about data practices. By making this Model Privacy Notice available, PHR companies can help build greater trust in PHRs, according to the HHS press release.

For more information about the proposed amendments to the CLIA and HIPAA Privacy Rule, please visit

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