Privacy & Information Security Law Blog

On October 31, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights announced two settlements over medical providers’ failures to comply with the HIPAA Security Rule, one with Plastic Surgery Associates of South Dakota and one with Bryan County Ambulance Authority.  The settlements mark the sixth and seventh OCR enforcement actions related to ransomware attacks with the latter being the first enforcement action in OCR’s Risk Analysis Initiative.

On November 1, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights and the Assistant Secretary for Technology Policy announced the release of a new version of the Security Risk Assessment Tool.

On September 26, 2024, the U.S. Department of Health and Human Services Office for Civil Rights entered into a resolution agreement and corrective action plan with Cascade Eye and Skin Centers, P.C. following a ransomware attack that impacted approximately 291,000 files containing electronic PHI.

On October 3, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights announced a monetary penalty of 240,000 dollars against Providence Medical Institute, an interstate network of medical providers, for violations of the HIPAA Security Rule in relation to a series of ransomware attacks against an orthopedics practice acquired by the entity.

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 April 22, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights announced its final “HIPAA Privacy Rule to Support Reproductive Health Care Privacy,” which strengthens privacy protections under HIPAA for reproductive health care-related PHI.

Last week, Utah Governor Spencer J. Cox signed three privacy-related bills into law. The bills are focused on, respectively, protection of motor vehicle consumer data, regulations on social media companies with respect to minors, and access to protected health information by third parties. The Utah legislature appears to be focused on data-related legislation this session, as Governor Cox signed two other bills related to AI into law last week as well.

On February 21, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement and corrective action plan with Green Ridge Behavioral Health LLC (“GRBH”) stemming from the organization’s failure to comply with the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (“HIPAA”) and subsequent failure to protect against a 2019 ransomware attack that impacted the personal health information (“PHI”) of more than 14,000 patients. This marks the second such settlement with a HIPAA-regulated entity for violations that were discovered following a ransomware attack, according to HHS.

On October 31, 2023, the Department of Health and Human Services (“HHS”) announced the issuance of a settlement agreement with Doctors’ Management Services (“DMS”), a Massachusetts-based medical management company, related to alleged violations of the Health Insurance Portability and Accountability Act’s (“HIPAA’s”) Privacy and Security Rules (collectively, the “HIPAA Rules”). DMS is a HIPAA business associate (“BA”) that provides payer credentialing and medical billing services to HIPAA Covered Entities (“CEs”). 

On September 15, 2023, the Federal Trade Commission and the Department of Health and Human Services (“HHS”) published an updated version of the two agencies’ joint publication, entitled “Collecting, Using, or Sharing Consumer Health Information? Look to HIPAA, the FTC Act, and the Health Breach Notification Rule.” 

On September 13, 2023, the National Coordinator for Health Information Technology (“ONC”) and the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services released version 3.4 of the Security Risk Assessment (“SRA”) Tool under the Health Insurance Portability and Accountability Act (“HIPAA”) Security Rule.

On April 12, 2023, the U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (“NPRM”) to modify protections under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) to strengthen reproductive health care privacy.

On December 1, 2022, the Office for Civil Rights at the U.S. Department of Health and Human Services (“HHS”) released a Bulletin on the obligations of HIPAA covered entities and business associates under the HIPAA Privacy, Security, and Breach Notification Rules when using online tracking technologies. 

On July 11, 2022, the Federal Trade Commission’s Bureau of Consumer Protection issued a business alert on businesses’ handling of sensitive data, with a particular focus on location and health data. The alert describes the “opaque” marketplace in which consumers’ location and health  data is collected and exchanged amongst businesses and the concerns and risks associated with the processing of such information. The alert specifically focuses on the “potent combination” of location data and user-generated health and biometric data (e.g., through the use of wellness and fitness apps and the sharing of face and other biometric data for app/device authentication purposes). According to the alert, the combination of location and health data “creates a new frontier of potential harms to consumers.”

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.”

On December 15, 2021, the New Jersey Acting Attorney General Andrew J. Bruck announced that its Division of Consumer Affairs had reached a $425,000 settlement with New Jersey-based providers of cancer care, Regional Cancer Care Associates LLC, RCCA MSO LLC and RCCA MD LLC (collectively, “RCCA”), over alleged failures to adequately safeguard patient data.

On October 12, 2021, New Jersey Acting Attorney General Andrew J. Bruck and the Division of Consumer Affairs announced a settlement with Diamond Institute for Infertility and Menopause, LLC, over a data breach that compromised the personal information of 14,663 patients, including 11,071 New Jersey residents. The Division of Consumer Affairs alleged that the fertility clinic violated the New Jersey Consumer Fraud Act and the federal Health Insurance Portability and Accountability Act’s (“HIPAA”) Privacy and Security Rules by removing protected health information (“PHI”) safeguards.

On May 25, 2021, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) announced that it had reached a settlement with Peachstate Health Management, LLC (“Peachstate”) for violations of the HIPAA Security Rule. As part of this settlement, Peachstate (dba AEON Clinical Laboratories) agreed to pay OCR $25,000 and to implement a robust corrective action plan.

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) recently announced more settlements associated with its HIPAA Right of Access Initiative. The settlements with Village Plastic Surgery ("VPS") and The Arbour, Inc. (“Arbour”) resulted in combined civil monetary penalties of $95,000.

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 September 21, 2020, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a $1.5 million settlement with Athens Orthopedic Clinic PA (“Athens Orthopedic”) for alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy and Security Rules.

On September 15, 2020, the U.S. Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) announced five more settlements under its HIPAA Right of Access Initiative. The OCR announced its Right of Access Initiative in 2019, promising vigorous enforcement of HIPAA’s access rules. The five newly announced settlements bring OCR's total to seven completed enforcement actions under the Right of Access Initiative.

On June 11, 2020, the California Senate amended AB-713 to the California Consumer Privacy Act of 2018 (“CCPA”). The Senate’s recent amendments impose new contractual obligations on the use or sale of de-identified information and modify the exemption from the CCPA for information used for public health purposes. The California Assembly had originally passed AB-713 in 2019 to (1) explicitly carve out from coverage by the CCPA information de-identified pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, and (2) expand the CCPA exemption for information used for research purposes. AB-713 is intended to “preserv[e] access to information needed to conduct important health-related research that will benefit Californians.” The revised version of AB-713 containing the Senate’s recent amendments has not yet passed either house of the California legislature.

Join us on May 19, 2020, for an in-depth webinar on the Key Privacy Considerations for Reopening Businesses in the EU. Our featured speakers, Hunton Brussels lawyers Claire François and Laura Léonard, will highlight key data protection issues that arise in connection with the measures employers may take to limit or prevent the spread of COVID-19, including:

• The types of health information that may be collected from employees and visitors;
• Measures to consider when processing that information; and
• Whether and how to conduct temperature checks.

Update: View the recording of this ...

The Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) issued a Bulletin on sharing and protecting patients’ protected health information (“PHI”) in compliance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) during the COVID-19 national emergency. The Bulletin emphasizes that the HIPAA Privacy Rule is still in effect during this national emergency, but that HIPAA-covered entities may use or disclose patients’ PHI when necessary to treat a patient, to protect the nation’s public health and for other critical purposes.

The District Court for the District of Columbia recently invalidated certain Department of Health and Human Services (“HHS”) rules regarding an individual’s access to their protected health information (“PHI”). The Court held that: (1) individuals can only direct their electronic PHI to third parties (and not hard copy PHI); and (2) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Omnibus Rule provisions regarding the caps on fees that HIPAA-covered entities may charge for such requests did not follow relevant administrative law procedures.

On December 12, 2019, the U.S. Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) announced its second enforcement action and settlement under its HIPAA Right of Access Initiative. Under the terms of the settlement, Korunda Medical, LLC, agreed to pay $85,000 to settle a potential violation of HIPAA’s right of access.

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.

Arizona Attorney General Mark Brnovich recently announced a settlement with healthcare software provider Medical Informatics Engineering Inc. (“MIE”) and its wholly owned subsidiary NoMoreClipboard, LLC. The settlement resolves a multistate litigation arising out of a May 2015 data breach in which hackers infiltrated WebChart, a web application run by MIE, and stole the electronic Protected Health Information (“ePHI”) of over 3.9 million individuals. Arizona and 15 other states (the “Multistate AGs”) filed the suit in December 2018, asserting claims under the federal Health Insurance Portability and Accountability (“HIPAA”) as well as various applicable state data protection laws. Notably, the lawsuit was the first-ever multistate litigation alleging claims under HIPAA.

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.

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 ...

As we move closer to implementation of the California Consumer Privacy Act of 2018 (“CCPA”), companies should consider how the new law could affect their operations in multiple ways – including, for example, data collected through their employee benefit plans.

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 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.

In its most recent cybersecurity newsletter, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) provided guidance regarding identifying vulnerabilities and mitigating the associated risks of software used to process electronic protected health information (“ePHI”). The guidance, along with additional resources identified by OCR, are outlined below:

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 February 1, 2018, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a settlement with dialysis clinic operator, Fresenius Medical Care (“Fresenius”). Fresenius will pay OCR $3.5 million to settle claims brought under Health Insurance Portability and Accountability Act rules, alleging that lax security practices led to five breaches of electronic protected health information.

On January 23, 2018, the New York Attorney General announced that Aetna Inc. (“Aetna”) agreed to pay $1.15 million and enhance its privacy practices following an investigation alleging it risked revealing the HIV status of 2,460 New York residents by mailing them information in transparent window envelopes. In July 2017, Aetna sent HIV patients information on how to fill their prescriptions using envelopes with large clear plastic windows, through which patient names, addresses, claims numbers and medication instructions were visible. Through this, the HIV status of some patients was visible to third parties. The letters were sent to notify members of a class action lawsuit that, pursuant to that suit’s resolution, they could purchase HIV medications at physical pharmacy locations, rather than via mail order delivery.

On October 3, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement clarifying when protected health information (“PHI”) can be shared with family, friends and others. This announcement, prompted by the recent mass shooting in Las Vegas, outlines the purposes for which PHI can be disclosed to these parties pursuant to HIPAA and the conditions that apply, which are summarized below:

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.

On June 26, 2017, Airway Oxygen, a provider of oxygen therapy and home medical equipment, reported that it was the subject of a ransomware attack affecting 500,000 patients’ protected health information. The attack is the second largest health data breach recorded by the Office for Civil Rights (“OCR”) this year, and the largest ransomware incident recorded by OCR since it began tracking incidents in 2009.

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 May 10, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $2.4 million civil monetary penalty against Memorial Hermann Health System (“MHHS”) for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule. 

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 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 February 16, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Memorial Healthcare System (“Memorial”) that emphasized the importance of audit controls in preventing breaches of protected health information (“PHI”). The $5.5 million settlement with Memorial is the fourth enforcement action taken by OCR in 2017, and matches the largest civil monetary ever imposed against a single covered entity.

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 January 18, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with MAPFRE Life Insurance Company of Puerto Rico (“MAPFRE”) relating to a breach of protected health information (“PHI”) contained on a portable storage device. This is the second enforcement action taken by OCR in 2017, following the action taken against Presence Health earlier this month for failing to make timely breach notifications.

On January 7, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Presence Health stemming from the entity’s failure to notify affected individuals, the media and OCR within 60 days of discovering a breach. This marks the first OCR settlement of 2017 and the first enforcement action relating to untimely breach reporting by a HIPAA covered entity.

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”).

The Office of Management and Budget (“OMB”) recently issued updates to Circular A-130 covering the management of federal information resources. OMB revised Circular A-130 “to reflect changes in law and advances in technology, as well as to ensure consistency with Executive Orders, Presidential Directives, and other OMB policy.” The revised policies are intended to transform how privacy is addressed across the branches of the federal government.

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.

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced resolution agreements with Raleigh Orthopaedic Clinic, P.A., (“Raleigh Orthopaedic”) and New York-Presbyterian Hospital (“NYP”) for HIPAA Privacy Rule violations.

The Federal Trade Commission recently released an interactive tool for mobile health apps. The tool was developed in conjunction with several other federal agencies, including the Department of Health and Human Services’ Office for Civil Rights, the Office of the National Coordinator for Health Information Technology, and the Food and Drug Administration.

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 February 3, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced that an Administrative Law Judge (“ALJ”) ruled that Lincare, Inc. (“Lincare”) violated the HIPAA Privacy Rule and ordered the company to pay $239,800 to OCR.

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 November 30, 2015, the U.S. Department of Health and Human Services (“HHS”) announced that Triple-S Management Corporation ("Triple-S"), an insurance holding company based in San Juan, Puerto Rico, agreed on behalf of certain of its subsidiaries to settle potential violations of the HIPAA Privacy and Security Rules with HHS’s Office for Civil Rights (“OCR”).

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 $125,000 settlement with Cornell Prescription Pharmacy (“Cornell”) in connection with the disposal of prescription records in an unsecured dumpster on Cornell’s premises. After receiving a report from a Denver television station regarding Cornell’s disposal practices, the HHS’ Office for Civil Rights (“OCR”) investigated Cornell and found several HIPAA Privacy Rule violations, including that Cornell had failed to:

On March 4, 2015, the House of Representatives of Washington passed a bill (HB 1078), which would amend the state’s breach notification law to require notification to the state Attorney General in the event of a breach and impose a 45-day timing requirement for notification provided to affected residents and the state regulator. The bill also mandates content requirements for notices to affected residents, including (1) the name and contact information of the reporting business; (2) a list of the types of personal information subject to the breach; and (3) the toll-free telephone numbers and address of the consumer reporting agencies. In addition, while Washington’s breach notification law currently applies only to “computerized” data, the amended law would cover hard-copy data as well.

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 November 21, 2014, Massachusetts Attorney General Martha Coakley announced that Boston hospital Beth Israel Deaconess Medical Center (“BIDMC”) has agreed to pay a total of $100,000 to settle charges related to a data breach that affected the personal and protected health information of nearly 4,000 patients and employees.

On June 23, 2014, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $800,000 settlement with Parkview Health System, Inc. (“Parkview”) following a complaint involving patient medical records that were dumped by Parkview employees and left unattended on a physician’s driveway.

On June 12, 2014, Connecticut Governor Dannel Malloy signed a bill into law that may require retailers to modify their existing Health Insurance Portability and Accountability Act (“HIPAA”) authorizations for pharmacy reward programs. The law, which will become effective on July 1, 2014, obligates retailers to provide consumers with a “plain language summary of the terms and conditions” of their pharmacy reward programs before the consumers may enroll. It also requires retailers to include specific content in their authorization forms that are required pursuant to the HIPAA. If the consumer is required to sign a HIPAA authorization to participate in a pharmacy reward program, the authorization must include the following items “adjacent to the point where the HIPAA authorization form is to be signed:”

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.

The Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently released guidance about the use and disclosure of mental health information. The guidance, entitled “HIPAA Privacy Rule and Sharing Information Related to Mental Health,” contains thirteen questions and answers that address the following topics:

Triple-S Management Corporation reported in the 8-K it recently filed with the U.S. Securities and Exchange Commission that its health insurance subsidiary, Triple-S Salud, Inc. (“Triple S”), which is Puerto Rico’s largest health insurer, will be fined $6.8 million for a data breach that occurred in September 2013. The civil monetary penalty, which is being levied by the Puerto Rico Health Insurance Administration, will be the largest fine ever imposed following a breach of protected health information.

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 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:

This week, the Department of Health and Human Services’ Office for Civil Rights (“OCR”), in conjunction with the Office of the National Coordinator for Health Information Technology, released model Notices of Privacy Practices. The notices, which have been developed for use by health care providers and health plans, come in different formats:

• an 8-page booklet;
• a 5-page layered notice that summarizes key details on the first page and includes the full content of the booklet on the remaining four pages;
• a 5-page condensed version of the 8-page booklet; and
• a 6-page text-only version of the booklet.

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 June 13, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $275,000 settlement with Shasta Regional Medical Center (“Shasta”) that pertained to impermissible disclosures of protected health information (“PHI”) by Shasta officials to the media, as well as to Shasta’s entire workforce.

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 April 9, 2013, the United States Court of Appeals for the Eleventh Circuit held that the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) preempted a Florida law regarding the disclosure of patient records by nursing homes. The law required nursing homes in Florida to provide the medical records of a deceased nursing home resident to the “spouse, guardian, surrogate, proxy, or attorney in fact,” including “medical and psychiatric records and any records concerning the care and treatment of the resident performed by the facility, except progress notes and consultation report sections of a psychiatric nature.”

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 7, 2013, Massachusetts Attorney General Martha Coakley announced that several Massachusetts medical practices have agreed to a consent judgment and $140,000 payment to settle charges they improperly disposed of medical information. The defendants, which include several pathology practices and a firm that provided medical billing services to those practices, were accused of dumping hard copy medical records at the Georgetown Transfer Station, a waste management facility open to the public. The records allegedly contained the names, Social Security numbers and medical diagnoses of approximately 67,000 individuals. The illegal dumping allegations were publicized in a Boston Globe article after a photographer for the newspaper discovered medical records at the facility while he was disposing of his own trash.

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 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 October 15, 2012, the Singapore Parliament passed the Personal Data Protection Act 2012. Though a law has been under discussion for quite some time, this bill was introduced before Parliament only recently, in September of this year. The new law will apply only to data processing in the private sector as data processing by public agencies (or organizations acting on behalf of public agencies) are already subject to internal government rules. Reportedly, the bill will become law in January 2013, enforceable after 18 months, in mid-2014.

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.”