Privacy & Information Security Law Blog

On June 20, 2024, the U.S. District Court for the Northern District of Texas Fort Worth Division ruled that guidance issued by the U.S. Department of Health and Human Services (“HHS”) relating to online tracking technologies exceeded HHS’ authority and ordered that it be vacated. 

On July 21, 2022, the National Institute of Standards and Technology (“NIST”) released an updated draft of its HIPAA Security Rule guidance. The draft guidance, titled “Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide” (NIST Special Publication 800-66, Revision 2), is designed to assist HIPAA regulated entities “maintain the confidentiality, integrity and availability of electronic protected health information (ePHI).” NIST issued the updated draft guidance to align it with other NIST cybersecurity guidance documents that have been published since the original HIPAA Security Rule guidance was issued in 2008.

On June 29, 2022, the U.S. Department of Health and Human Services (“HHS”) issued two guidance documents to “help protect patients seeking reproductive health care, as well as their providers” following the Supreme Court’s decision in Dobbs vs. Jackson Women’s Health Organization. These guidance documents address the legal protections for individuals’ protected health information (“PHI”) relating to abortion and other reproductive health care, as well as how individuals can protect their medical information on personal devices, menstruation tracking apps and other health-related apps.

On June 13, 2022, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) released guidance to help covered entities understand how they can use remote communication technologies for audio-only telehealth in compliance with the HIPAA Privacy and Security Rules (the “Guidance”). Specifically, the Guidance clarifies how audio-only telehealth can be conducted after OCR’s Notification of Enforcement Discretion for Telehealth (the “Telehealth Notification”), put in place during the COVID-19 pandemic, is no longer in effect.

On May 26, 2022, California Attorney General Rob Bonta issued a press release reminding health app providers that California’s Confidentiality of Medical Information Act (“CMIA”) applies to mobile apps that are designed to store medical information, which includes health apps such as fertility trackers. The press release reminds health app providers that the CMIA requires businesses to preserve the confidentiality of medical information and prohibits the disclosure of medical information without proper authorization. It also urges mobile app providers to adopt robust security and privacy measures to protect reproductive health information. According to the press release, this should include, at a minimum, “assess[ing] the risks associated with collecting and maintaining abortion-related information that could be leveraged against persons seeking to exercise their healthcare rights.”

The United States Court of Appeals for the Fifth Circuit recently vacated a $4.3 million civil monetary penalty imposed by the Department of Health and Human Services’ Office for Civil Rights (“OCR”) in 2017 against the University of Texas M.D. Anderson Cancer Center (“MD Anderson”). The Court held that OCR’s civil monetary penalty for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule and HIPAA Security Rule was “arbitrary, capricious, and otherwise unlawful.”

On November 7, 2019, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) announced a $1.6 million civil penalty imposed against the Texas Health and Human Services Commission (“TX HHSC”), a state agency, for violations of HIPAA Privacy and Security Rules in connection with the unauthorized disclosure of electronic protected health information (“ePHI”). The ePHI breach – which exposed names, addresses, Social Security numbers, and treatment information of at least 6,617 individuals – was first reported to OCR on June 11, 2015, by Texas’s Department of Aging and Disability Services (“DADS”).

On July 11, 2019, Washington Attorney General Bob Ferguson announced that his office had entered into a consent decree and $10 million settlement with Premera Blue Cross (“Premera”) that stems from a 2014-2015 breach that affected more than 11 million individuals. The settlement, which includes a payment of roughly $5.4 million to Washington state and $4.6 million to a coalition of 29 other state Attorneys General (the “Multistate AGs”), is one of the largest ever for a breach involving protected health information (“PHI”) and comes just one month after another notable HIPAA settlement involving a similar coalition of state AGs.

On May 6, 2019, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had entered into a resolution agreement and $3 million settlement with Touchstone Medical Imaging (“Touchstone”). The settlement is the first OCR HIPAA enforcement action in 2019, following an all-time record year of HIPAA enforcement in 2018.

Recently, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement and record settlement of $16 million with Anthem, Inc. (“Anthem”) following Anthem’s 2015 data breach. That breach, affecting approximately 79 million individuals, was the largest breach of protected health information (“PHI”) in history.

On February 13, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it entered into a resolution agreement with the receiver appointed to liquidate the assets of Filefax, Inc. (“Filefax”) in order to settle potential violations of HIPAA. Filefax offered medical record storage, maintenance and delivery services for covered entities, and had gone out of business during the course of OCR’s investigation. 

On September 7, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement containing disaster preparedness and recovery guidance in advance of Hurricane Irma. The announcement follows a bulletin issued in late August during Hurricane Harvey that addressed how protected health information (“PHI”) can be shared during emergencies. Together, these communications underscore key privacy and security issues for entities covered by HIPAA to help them protect individuals’ health information before, during and after emergency situations.

On July 25, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced the release of an updated web tool that highlights recent data breaches of health information.

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) and the Health Care Industry Cybersecurity Task Force (the “Task Force”) have published important materials addressing cybersecurity in the health care industry.

On April 24, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had entered into a resolution agreement with CardioNet, Inc. (“CardioNet”) stemming from gaps in policies and procedures uncovered after CardioNet reported breaches of unsecured electronic protected health information (“ePHI”). CardioNet provides patients with an ambulatory cardiac monitoring service, and the settlement is OCR’s first with a wireless health services provider.

On April 12, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Metro Community Provider Network (“MCPN”) that stemmed from MCPN’s lack of a risk analysis and risk management plan that addressed risks and vulnerabilities to protected health information (“PHI”).

On February 1, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $3.2 million civil monetary penalty against Children’s Medical Center of Dallas (“Children’s”) for alleged ongoing violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules, following two consecutive breaches of patient electronic protected health information (“ePHI”). This is the third enforcement action taken by OCR in 2017, following the respective actions taken against MAPFRE Life Insurance of Puerto Rico and Presence Health earlier in January.

On November 22, 2016, the Department of Health and Human Services (“HHS”)  announced a $650,000 settlement with University of Massachusetts Amherst (“UMass”), resulting from alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules. 

Earlier this month, the Department of Health and Human Services’ Office for Civil Rights issued guidance (the “Guidance”) for HIPAA-covered entities that use cloud computing services involving electronic protected health information (“ePHI”).

On August 4, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Advocate Health Care Network (“Advocate”), the largest health care system in Illinois, over alleged HIPAA violations. The $5.5 million settlement with Advocate is the largest settlement to date against a single covered entity.

On July 21, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into resolution agreements with two large public health centers, Oregon Health & Science University (“OHSU”) and the University of Mississippi Medical Center (“UMMC”), over alleged HIPAA violations.

On June 30, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had settled potential HIPAA Security Rule violations with Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”). This is the first enforcement action OCR has taken against a business associate since the HIPAA Omnibus Rule was enacted in 2013. The HIPAA Omnibus Rule made business associates directly liable for their violations of the HIPAA rules. The settlement with CHCS is also notable because it involved a breach that affected fewer than 500 individuals.

Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid. Aegerion allegedly failed to comply with risk evaluation and management strategies and marketed Juxtapid (which is labeled with a warning about liver toxicity) without proper directions for use. 

On March 16, 2016, and March 17, 2016, respectively, the Department of Health and Human Services (“HHS”) announced resolution agreements with North Memorial Health Care of Minnesota (“North Memorial”) and The Feinstein Institute for Medical Research (“Feinstein Institute”) over potential violations of the HIPAA Privacy Rule.

On March 21, 2016, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it has commenced Phase 2 of the HIPAA Audit Program. Phase 1 of the HIPAA Audit Program ran from 2011-2012 and produced several notable findings, including that two-thirds of covered entities had not performed a risk assessment as required by the HIPAA Security Rule.

Recently, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published two guidance documents related to HIPAA compliance. To help mobile app developers understand HIPAA compliance obligations, OCR published guidance on the use of mobile health apps (the “Health App Guidance”). OCR also released a crosswalk (the “Crosswalk”) that maps the National Institute of Standards and Technology (“NIST”) Framework for Improving Critical Infrastructure Cybersecurity Framework (the “NIST Cybersecurity Framework”) to the HIPAA Security Rule.

On January 5, 2016, the Federal Trade Commission announced that dental office management software provider, Henry Schein Practice Solutions, Inc. (“Schein”), agreed to settle FTC charges that accused the company of falsely advertising the level of encryption it used to protect patient data. The proposed Agreement Containing Consent Order (“Consent Order”) stems from an FTC complaint that alleged the company engaged in unfair or deceptive acts or practices by falsely representing that the Dentrix G5 software used industry-standard encryption and helped dentists protect patient data in accordance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

On December 14, 2015, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had settled potential HIPAA Security Rule violations with the University of Washington on behalf of the university’s medical center, medical school and affiliated labs and clinics (collectively, “UW Medical”).

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 (“HHS”) recently announced a resolution agreement and $150,000 settlement with Anchorage Community Mental Health Services, Inc. (“ACHMS”) in connection with a data breach caused by malware. ACHMS, which provides nonprofit behavioral health care services in Alaska, experienced a breach in March 2012 that affected the electronic protected health information (“ePHI”) of 2,743 individuals. After ACHMS reported the breach to the HHS Office for Civil Rights (“OCR”), OCR investigated ACHMS and found several HIPAA Security Rule violations, including that ACHMS had failed to:

On May 7, 2014, the Department of Health and Human Services (“HHS”) announced that NewYork-Presbyterian Hospital (“NYP”) and Columbia University (“CU”) agreed to collectively pay $4.8 million in the largest HIPAA settlement to date, to settle charges that they potentially violated the HIPAA Privacy and Security Rules.

On April 23, 2014, the Department of Health and Human Services (“HHS”) announced settlements with two health care companies stemming from allegations of inadequate information security practices in the wake of investigations involving stolen laptop computers. Concentra Health Services (“Concentra”) and QCA Health Plan Inc. (“QCA”) will collectively pay nearly $2 million to settle the claims.

On March 28, 2014, the Department of Health and Human Services’ (“HHS’”) Office for Civil Rights (“OCR”) released a tool to assist covered entities in complying with the HIPAA Security Rule requirement to conduct a risk assessment. The HIPAA Security Rule obligates covered entities to accurately and thoroughly assess “the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information” (“PHI”) they maintain. The tool, which is aimed at small to medium health care providers, was developed jointly by OCR and the HHS Office of the National Coordinator for Health Information Technology (“ONC”), and follows the National Institute of Standards and Technology’s development of a similar toolkit.

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 March 7, 2014, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $215,000 settlement with Skagit County, Washington, following a security breach that affected approximately 1,600 individuals.

On December 26, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $150,000 settlement with Adult & Pediatric Dermatology, P.C. (“APDerm”), a private dermatology practice based in Massachusetts, following a security breach that affected approximately 2,200 individuals. In connection with the announcement, the HHS Office for Civil Rights (“OCR”) Director Leon Rodriguez stated that “[c]overed entities of all sizes need to give priority to securing electronic protected health information.”

Today, September 23, 2013, marks the deadline for compliance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Omnibus Rule that was issued in January 2013. Covered entities, business associates and subcontractors that access, use or disclose protected health information (“PHI”) will need to take the following actions:

On August 14, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $1,215,780 settlement with Affinity Health Plan (“Affinity”) stemming from a security breach that affected approximately 350,000 individuals.

On July 11, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $1.7 million settlement with WellPoint Inc. following a security breach that affected over 600,000 individuals.

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.

In an interview with Marianne Kolbasuk McGee of HealthcareInfoSecurity, Lisa J. Sotto, partner and head of the Global Privacy and Data Security practice at Hunton & Williams LLP, discusses the measures health care organizations should take to prepare for the issuance of the upcoming HIPAA Omnibus Rule. In March 2012, 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. In the interview, Sotto outlines her predictions of the content of the Omnibus Rule, including “modifications to the HIPAA privacy, security and enforcement rules” and “a final version of the HIPAA breach notification rule.”

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.”

The Department of Health and Human Services Office for Civil Rights (“OCR”) has posted an audit protocol on its website to provide information about the procedures currently being used by OCR as part of its new audit program.

The protocol is presented in a sortable table format listing the applicable sections of the relevant rules and the established performance criteria, key activities and audit procedures associated with each section. The audit protocol for the HIPAA Security Rule also lists whether the implementation specification is required or addressable pursuant to that Rule.

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 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.

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.”

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.