Privacy & Information Security Law Blog

On April 26, 2019, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights announced reductions in available penalties for three out of four tiers of privacy and security violations set forth in the HITECH Act, based on the severity of the violation. Previously, all four tiers of violation were subject to a maximum annual civil monetary penalty of $1.5 million. The revised regime provides for maximum civil penalties of $25,000 for the lowest tier of violation (i.e., unknowing violations), $100,000 for the second tier of violation (i.e., violations where ...

On August 31, 2018, the California State Legislature passed SB-1121, a bill that delays enforcement of the California Consumer Privacy Act of 2018 (“CCPA”) and makes other modest amendments to the law. The bill now goes to the Governor for signing. The provisions of the CCPA will become operative on January 1, 2020. As we have previously reported, the CCPA introduces key privacy requirements for businesses. The Act was passed quickly by California lawmakers in an effort to remove a ballot initiative of the same name from the November 6, 2018, statewide ballot. The CCPA’s hasty passage resulted in a number of drafting errors and inconsistencies in the law, which SB-1121 seeks to remedy. The amendments to the CCPA are primarily technical, with few substantive changes.

The Department of Health and Human Services (“HHS”) recently published two advance notices of proposed rulemaking that address the accounting of disclosures and the potential distribution of civil monetary penalties to affected individuals.

On February 17, 2017, Horizon Blue Cross Blue Shield of New Jersey (“Horizon”) agreed to pay $1.1 million as part of a settlement with the New Jersey Division of Consumer Affairs (the “Division”) regarding allegations that Horizon did not adequately protect the privacy of nearly 690,000 policyholders.

On July 10, 2015, the United States House of Representatives passed the 21st Century Cures Act (the “Act”), which is intended to ease restrictions on the use and disclosure of protected health information (“PHI”) for research purposes.

The Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced that it intends to survey up to 1,200 covered entities and business associates to determine their suitability for a more fulsome HIPAA compliance audit. In a notice published in the Federal Register, OCR stated that the survey will collect information such as “number of patient visits or insured lives, use of electronic information, revenue, and business locations” to assess the organizations’ “size, complexity and fitness” for an audit.

On December 31, 2013, the Federal Trade Commission announced that Accretive Health, Inc. (“Accretive”) has agreed to settle charges that the company’s inadequate data security measures unfairly exposed sensitive consumer information to the risk of theft or misuse. Accretive experienced a breach in July 2011 that involved the protected health information of more than 23,000 patients.

On May 21, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $400,000 settlement with Idaho State University (“ISU”) for a breach that affected 17,500 individuals.

The ISU settlement relates to servers that had their firewall protections disabled, which left the electronic protected health information (“ePHI”) of patients at ISU’s Pocatello Family Medicine Clinic unsecured for at least ten months. Following the submission of a breach report to the HHS Office for Civil Rights (“OCR”), an investigation determined that ISU allegedly had not complied with HIPAA Security Rule requirements, including by conducting an incomplete and inadequate risk analysis and by failing to “adequately implement procedures to regularly review records of information system activity to determine if any ePHI was used or disclosed in an inappropriate manner.”

On January 17, 2013, the U.S. Department of Health and Human Services issued a final omnibus rule modifying prior regulations enacted pursuant to the Health Insurance Portability and Accountability Act of 1996. Among the key changes that will come into effect this September is the addition of a provision that dramatically increases the number of organizations directly subject to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. In an article published in the March/April issue of Storage & Destruction Business Magazine, Lisa J. Sotto, partner and head of the ...

The wait is over. On January 17, 2013, the Department of Health and Human Services’ (“HHS’”) Office for Civil Rights (“OCR”) released its long-anticipated megarule (“Omnibus Rule”) amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act and the Genetic Information Nondiscrimination Act of 2008. The Omnibus Rule is effective March 26, 2013, and compliance is required with respect to most provisions no later than September 23, 2013. Coming into compliance will require significant effort and attention by covered entities and business associates alike. Below we highlight some of the more significant aspects of the Omnibus Rule and provide critical compliance tips.

On January 17, 2013, the Department of Health and Human Services (“HHS”) issued a Final Omnibus Rule modifying the Privacy, Security and Enforcement Rules promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as well as the Breach Notification Rule promulgated pursuant to the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act) enacted in 2009. The Final Rule comes two and a half years after the proposed rule was published in July 2010.

On January 2, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $50,000 settlement with Hospice of North Idaho (“HONI”) for a breach that affected 441 individuals. This action is notable because prior HHS enforcement actions relating to breaches have involved a greater number of affected individuals (for example, the first breach-related enforcement action in March 2012 affected more than 1 million). The Health Information Technology for Economic and Clinical Health (“HITECH”) Breach Notification Rule sets 500 as a threshold number of affected individuals triggering certain notification requirements such as the obligation to notify HHS within 60 days of discovery of the breach.

On November 26, 2012, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule. The guidance, which was required by the Health Information Technology for Clinical and Economic Health (“HITECH”) Act, has been developed over several years by OCR in collaboration with healthcare entities and other industry experts and builds upon the discussions from a workshop on de-identification that took place in March 2010.

On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule. In connection with the announcement, the HHS Office for Civil Rights (“OCR”) Director Leon Rodriguez stated that organizations should pay special attention to safeguarding information “stored and transported on portable devices such as laptops, tablets, and mobile phones” and that “compliance with the HIPAA Privacy and Security Rules must be prioritized by management and implemented throughout an organization, from top to bottom.”

On July 31, 2012, Minnesota Attorney General Lori Swanson announced a $2.5 million settlement with Accretive Health, Inc. (“Accretive”) for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations, and various Minnesota debt collection and consumer protection laws. As we previously reported in January 2012, Accretive, which acted as a business associate to two Minnesota hospital systems, experienced a breach in July 2011 that involved the protected health information of more than 23,000 patients.

On June 26, 2012, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $1.7 million settlement with the Alaska Department of Health and Social Services (“DHSS”) for violations of the HIPAA Security Rule. This is the first HIPAA enforcement action taken by HHS against a state agency. In connection with the announcement, the HHS Office for Civil Rights (“OCR”) Director Leon Rodriguez stated that OCR “expect[s] organizations to comply with their obligations under [the HIPAA Security and Privacy Rules] regardless of whether they are private or public entities.”

On June 7, 2012, at the annual Safeguarding Health Information: Building Assurance through HIPAA Security Conference hosted in Washington, D.C. by the Department of Health and Human Services Office for Civil Rights (“OCR”) and the National Institute of Standards and Technology (“NIST”), OCR Director Leon Rodriguez said that, given HIPAA’s 15-year history and the substantial technical assistance OCR and NIST have provided covered entities, tolerance for HIPAA non-compliance is “much, much lower” than it has been in the past.

In the past month, the Department of Health and Human Services (“HHS”) sent its final omnibus rule modifying the HIPAA Privacy, Security and Enforcement Rules to the White House Office of Management and Budget (“OMB”) and announced a $100,000 settlement with Phoenix Cardiac Surgery, P.C. for violations of the HIPAA Rules.

On March 13, 2012, the Department of Health and Human Services (“HHS”) announced that it had settled the first case related to the HITECH Act Breach Notification Rule. BlueCross Blue Shield of Tennessee (“BCBS Tennessee”) agreed to pay $1.5 million to settle potential HIPAA violations related to the October 2009 theft of 57 unencrypted hard drives containing protected health information (“PHI”) from a network data closet at a leased facility leased in Chattanooga, Tennessee.

On January 19, 2012, Minnesota Attorney General Lori Swanson announced a lawsuit against Accretive Health, Inc., (“Accretive”) for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations, the Minnesota Health Records Act, Minnesota’s debt collection statutes and Minnesota’s consumer protection laws. The suit, which was filed in Federal District Court in Minnesota, alleges that Accretive failed to adequately safeguard patients’ protected health information (“PHI”). This failure contributed to a July 2011 information security breach when an Accretive employee left an unencrypted laptop containing information of approximately 23,500 patients in a rental car. The laptop was stolen and has not yet been recovered.

On August 31, 2011, California Governor Jerry Brown signed into law amendments to that state’s security breach notification statute.  The revisions establish new content requirements for breach notification letters to California residents, and mandate notification to the state Attorney General when a breach affects more than 500 Californians.  Senate Bill 24 was the third effort by State Senator Joe Simitian to build on the landmark California breach notification law he authored in 2002.  The two previous bills he proposed were passed by the California legislature, but vetoed by former Governor Arnold Schwarzenegger.

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).

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.

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.

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).

Representative Rick Boucher (D-VA), current head of the House Subcommittee on Communications, Technology and the Internet, lost his reelection bid yesterday to Republican Morgan Griffith, the Majority Leader of the Virginia House of Delegates.  Representative Boucher, widely recognized and respected for his legislative efforts in the areas of technology, telecommunications and privacy law, co-authored the CAN-SPAM Act and also introduced draft privacy legislation earlier this year.  Congressman Boucher’s defeat leaves the House Subcommittee on Communications, Technology and the Internet panel without its top Democrat, and it is unclear who will fill that leadership vacancy.

The Department of Health and Human Services (“HHS”) received numerous comments on its proposed modifications to the Health Insurance Portability and Accountability Act Privacy, Security and Enforcement Rules, which were issued on July 8, 2010.  Some highlights from the comments are outlined below.

Enforcement Rule

The American Hospital Association (“AHA”) suggested that HHS should continue to require the Secretary of HHS to attempt to resolve a complaint or compliance review through informal means, instead of making the informal resolution process optional.  According to the AHA, making “resolution via informal means optional, regardless of the perceived level of culpability of a particular entity” would not be appropriate or effective.  The Coalition for Patient Privacy, on the other hand, recommended stricter enforcement so that “the only category of violators that should not be penalized with fines are those who despite due diligence could not discover the violation, who reported the violation immediately when discovered, and fully corrected the problems within 30 days of discovery.”

On July 8, 2010, the Department of Health and Human Services ("HHS") issued a notice of proposed rulemaking to modify the Privacy, Security and Enforcement Rules promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996.  The modifications implement changes made by the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act) enacted in 2009.

The Office for Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”) has announced that it will more closely examine covered entities’ breach notification and risk mitigation plans.  OCR noted that small and medium sized covered entities have been particularly vulnerable to data breaches.  The National Institute of Standards and Technology (“NIST”) will publish a guide for covered entities that “outlines the steps to mitigate risks for data breaches, training for how to respond to breaches, and overall preparation in the event of a ...

David Holtzman, a health information privacy specialist at the Office for Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), stated at a health privacy conference on May 11, 2010, that OCR has been “vigorously” enforcing the Security Rule, which was promulgated pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”).  Prior to 2009, HHS divided civil enforcement responsibility for HIPAA between OCR, which enforced the HIPAA Privacy Rule, and the Centers for Medicare and Medicaid Services (“CMS”), which enforced the HIPAA Security Rule.  In July 2009, the Secretary of HHS delegated authority to enforce the HIPAA Security Rule to OCR to “facilitate improvements by eliminating duplication and increasing efficiency.”

The Attorney General of Connecticut, Richard Blumenthal, is investigating an alleged breach of medical records at Griffin Hospital in Derby, Connecticut.  The hospital believes that a formerly affiliated radiologist gained unauthorized access to its digital Picture Archiving and Communications System (“PACS”), which stores patient information, including names, exam descriptions and medical record numbers.  In February, the hospital began receiving inquiries from patients who had been contacted by the radiologist to promote professional services offered at another medical facility.  In response to patient inquiries, the hospital conducted an internal investigation that revealed several instances of unauthorized access to the PACS system.  The hospital subsequently notified Attorney General Blumenthal.

We understand that yesterday Adam H. Greene (Office of the General Counsel, Civil Rights Division, U.S. Department of Health & Human Services), speaking at the ABA’s 11th Annual Conference on Emerging Issues in Healthcare Law, indicated that enforcement of the business associate provisions of the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), which became effective on February 17, 2010, will be delayed until final rules addressing those provisions are published.  The HITECH Act’s business associate provisions require business associates to implement the information security safeguards specified by the HIPAA Security Rule, and comply with certain requirements of the HIPAA Privacy Rule.  Similarly, the HITECH Act requires covered entities to provide in their business associate agreements that all of the HITECH Act’s security requirements applicable to covered entities are also applicable to business associates.

Cloud computing raises complex legal issues related to privacy and information security.  As legislators and regulators around the world grapple with the privacy and data security implications of cloud computing, companies seeking to implement cloud-based solutions should closely monitor this rapidly evolving legal landscape for developments.  In an article published on February 3, 2010, Lisa Sotto, Bridget Treacy and Melinda McLellan explore U.S. and EU legal requirements applicable to data stored by cloud providers, and highlight some of the risks associated with the use ...

In a lawsuit he described as “[s]adly . . . historic,” Connecticut Attorney General Richard Blumenthal sued Health Net of Connecticut, Inc. for allegedly failing to secure private patient medical records and financial information involving hundreds of thousands of Connecticut enrollees and promptly notify consumers endangered by the security breach.  The case marks the first action by a state attorney general under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act to enforce provisions of the Health Insurance Portability and Accountability Act (“HIPAA”).  The suit also alleges a violation of Connecticut’s breach notification statute.

The Department of Health and Human Services (“HHS”) released an interim final rule to incorporate the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) categories of violations and tiered civil penalty amounts.  The interim final rule is expected to be published in the Federal Register on October 30, 2009 and takes effect on November 30, 2009.  The rule applies to violations of the Health Insurance Portability and Accountability Act of 2003 (“HIPAA”) that occur on or after February 18, 2009.

The Department of Health and Human Services (“HHS”) has posted to its website a notification form that may be used to report breaches of unsecured protected health information to the agency.  Although some state agencies requiring notice of a breach employ a standard reporting form, the form issued by HHS has several unique features and requests more information than a typical breach reporting form.  Some interesting features of the form include:

• The form may be used to report both breaches affecting 500 or more individuals, as well as breaches affecting fewer than 500 ...

The Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), which was signed into law in February 2009 as part of the economic stimulus package, substantially impacts requirements imposed by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The HITECH Act creates several new and potentially burdensome obligations that affect the relationship between covered entities and business associates. Because these changes are quite substantial and necessitate revisions to existing business associate agreements ...

On August 17, the Federal Trade Commission ("FTC") issued a final rule ("FTC Final Rule") addressing security breaches of personal health records ("PHRs").  The FTC Final Rule applies to all breaches discovered on or after September 24, 2009, and to “foreign and domestic vendors of personal health records, PHR related entities, and third party service providers” that “maintain information of U.S. citizens or residents.”  The FTC Final Rule does not apply to covered entities or business associates as defined under regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").  Full compliance is required by February 22, 2010.

On April 17, the U.S. Department of Health and Human Services ("HHS") issued proposed information security guidance, as required by the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act") passed as part of American Recovery and Reinvestment Act of 2009 on February 17.  The HITECH Act requires covered entities and business associates, as well as vendors of personal health records, to provide notice of information security breaches affecting “unsecured protected health information” or “unsecured personal health record information,” respectively.  The HITECH Act further requires the Secretary of HHS to specify technologies and methodologies that would render protected health information ("PHI") unusable, unreadable, or indecipherable to unauthorized individuals.  If covered entities, business associates and vendors of personal health records apply the technologies and methodologies specified in the guidance to protected health information, they will not be required to provide notice to affected individuals, HHS or the media, as otherwise required by the HITECH Act, in the event the information is breached.