Tag Archives: Department of Health and Human Services

HHS Issues New Model Privacy Notice for PHR Vendors

On September 12, 2011, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (“ONC”) unveiled a model privacy notice for personal health records (the “PHR Model Privacy Notice”).  The PHR Model Privacy Notice was developed by ONC in collaboration with consumers and vendors of personal health records (“PHRs”).  The PHR Model Privacy Notice is intended to enable consumers to “understand privacy and security policies and data sharing practice information, compare PHR company practices, and make informed decisions.”

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HHS Pressured to Drop Access Report Provision in Proposed Rule

Several health care industry groups requested that the Department of Health and Human Services (“HHS”) either remove or significantly revise a proposed “access report” requirement in its recent notice of proposed rulemaking (the “Proposed Rule”) for the accounting of disclosures of protected health information (“PHI”).  As we reported in May, HHS issued the Proposed Rule that revises existing HIPAA Privacy Rule provisions regarding accounting of disclosures and gives individuals a new right to obtain an “access report” that would list the specific persons who have accessed a patient’s PHI, and describe any actions taken by those persons with respect to the PHI (e.g., create, modify, access or delete).

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IAPP Hosts Webinar on Upcoming OCR Audit Program

On July 28, 2011, the International Association of Privacy Professionals (“IAPP”) hosted a webinar that addressed the upcoming audit program of the Department of Health and Human Services Office of Civil Rights (“OCR”).  Susan McAndrew, the Deputy Director for Health Information Privacy at OCR, provided an overview of the audit program, noting that it stemmed from Section 13411 of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  That section of the HITECH Act authorized the Secretary of the Health and Human Services to “provide for periodic audits to ensure that covered entities and business associates” comply with the requirements of the HIPAA Privacy and Security Rules.

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HHS Announces $865,500 Settlement with UCLA Health System for HIPAA Violations

On June 7, 2011, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $865,500 settlement with the University of California at Los Angeles Health System (“UCLA Health System”) for violations of the HIPAA Privacy and Security Rules.  UCLA Health System employees were accused of violating the Privacy Rule by improperly accessing the protected health information (“PHI”) of patients, including several high-profile celebrities who filed complaints with HHS.  A subsequent investigation by HHS’s Office of Civil Rights (“OCR”) revealed that in addition to neglecting to sanction the employees who had improperly accessed patient PHI, UCLA Health System had failed to train its employees on the HIPAA Privacy and Security Rules or implement security measures to “reduce the risks of impermissible access to electronic protected health information by unauthorized users to a reasonable and appropriate level.”

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HHS Issues Notice of Proposed Rulemaking for Accounting of Disclosures of Protected Health Information

On May 27, 2011, the Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking regarding the HIPAA Privacy Rule provision that requires covered entities to provide an accounting of disclosures of protected health information (“PHI”) to individuals upon request.  The proposed rule revises existing HIPAA Privacy Rule provisions regarding an accounting of disclosures and also gives individuals a new right to obtain an “access report” about which specific individuals have accessed electronic PHI in a designated record set.  The proposed rule also requires covered entities to modify their privacy notices to include that individuals have the right to obtain an access report from the covered entities.

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CVS Sued for Alleged Privacy Violations

On March 7, 2011, Arthur Steinberg and the Philadelphia Federation of Teachers Health and Welfare Fund sued CVS Caremark Corporation (“CVS”), alleging that its unauthorized disclosure of protected health information (“PHI”) constituted an unfair trade practice. The complaint claims that CVS, one of the nation’s largest pharmacies, sent letters to physicians that listed their patients’ names, dates of birth and prescribed medications. The letters encouraged the physicians to prescribe drugs made by pharmaceutical manufacturers, who paid CVS to send them. This purported disclosure of PHI would violate the HIPAA Privacy Rule’s prohibitions against disclosing PHI for marketing purposes without an individual’s authorization.

This is the second major lawsuit filed against CVS in the past few year. Last December, a group of Texas pharmacies filed suit against CVS for violations of Racketeer Influenced and Corrupt Organizations Act (“RICO”) and misappropriation of trade secrets. The Texas complaint alleged that CVS disclosed PHI to pharmaceutical manufacturers for the manufacturers’ marketing purposes. In 2009, CVS paid $2.25 million to the Department of Health and Human Services (“HHS”) to settle charges that it violated the HIPAA Security Rule by dumping prescription records in dumpsters.

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HHS Announces $1,000,000 Resolution Agreement with Mass General for HIPAA Violations

On February 24, 2011, the Department of Health and Human Services Office of Civil Rights (“OCR”) announced a $1,000,000 Resolution Agreement with the General Hospital Corporation and Massachusetts General Physicians Organization Inc. (“Mass General”) that stemmed from the loss of protected health information (“PHI”) of 192 patients.  A Mass General employee had left hard-copy records containing PHI on the subway in March 2009.  The records originated from Mass General’s Infectious Disease Associates outpatient practice and included sensitive records discussing patients’ treatments for HIV/AIDS.  After receiving a complaint from an affected patient, OCR conducted an investigation that demonstrated that Mass General had “failed to implement reasonable, appropriate safeguards to protect the privacy of PHI when removed from Mass General’s premises and impermissibly disclosed PHI potentially violating provisions of the HIPAA Privacy Rule.”

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HHS Fines Cignet Health $4.3 Million for Violation of HIPAA Privacy Rule

On February 22, 2011, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) imposed its first civil money penalty for an entity’s violation of HIPAA’s Privacy Rule.  In its Notice of Final Determination, OCR concluded that Cignet Health withheld patient records despite requests for their disclosure.  Of the $4.3 million penalty, $1.3 million was levied for denying patients access to their own medical records, while an additional $3 million was imposed due to Cignet’s failure to cooperate with OCR’s investigation as required by the Privacy Rule.  Increased penalty amounts were authorized by Section 13410(d) of the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act).

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White House Forms Privacy and Internet Policy Subcommittee

The White House recently announced on its official blog that the National Science and Technology Council’s Committee on Technology has launched a new Subcommittee on Privacy and Internet Policy.  The subcommittee will be co-chaired by a representative from the Department of Commerce and the Department of Justice and will include representatives from over a dozen other departments and federal agencies, such as the Department of Health and Human Services and the National Security Council.  The goal of the subcommittee is to “develop principles and strategic directions” that will foster “consensus in legislative, regulatory, and international Internet policy realms.”  Some of these principles include “facilitating transparency, promoting cooperation, empowering individuals to make informed and intelligent choices, strengthening multi-stakeholder governance models, and building trust in online environments.” Continue reading…

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Rite Aid Pharmacy Pays $1 Million; Settles FTC and HHS Charges Regarding Data Practices

Rite Aid has agreed to pay $1 million and implement remedial measures to resolve Department of Health and Human Services (“HHS”) and Federal Trade Commission allegations that it failed to protect customers’ sensitive health information.  The FTC began its investigation following news reports about Rite Aid pharmacies using open dumpsters to discard trash that contained consumers’ personal information such as pharmacy labels and job applications.  The FTC took issue with this practice in light of the pharmacy’s alleged claims that “Rite Aid takes its responsibility for maintaining your protected health information in confidence very seriously . . . Although you have the right not to disclose your medical history, Rite Aid would like to assure you that we respect and protect your privacy.”  At the same time, HHS began investigating the pharmacies’ disposal of health information protected by the Health Insurance Portability and Accountability Act.

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