Posts in Health Privacy.
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The Connecticut Attorney General’s Office (“OAG”) has released a Report on the status of Connecticut’s Data Privacy Act (“CTDPA”), which took effect on July 1, 2023. The Report covers complaints, inquiries, and early enforcement activities under the CTDPA.

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As reported by Bloomberg Law, on February 27, 2024, at RemedyFest, a conference hosted by Bloomberg Beta and Y Combinator, Federal Trade Commission Chair Lina Khan said that sensitive personal data that is linked to health, geolocation and web browsing history should be excluded from training artificial intelligence (“AI”) models.

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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.

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On February 16, 2024, the U.S. Department of Health and Human Services' Office for Civil Rights (“OCR”) and the National Institute of Standards and Technology (“NIST”) published a final version of Special Publication 800-66 Revision 2, “Implementing the Health Insurance Portability and Accountability Act (“HIPAA”) Security Rule: A Cybersecurity Resource Guide.” The publication features guidance and recommendations for cybersecurity measures for HIPAA covered entities to consider in the development of their information security programs, a ...

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On December 21, 2023, the Court of Justice of the European Union (“CJEU”) issued its judgment in the case of Krankenversicherung Nordrhein (C-667/21) in which it clarified, among other things, the rules for processing special categories of personal data (hereafter “sensitive personal data”) under Article 9 of the EU General Data Protection Regulation (“GDPR”) and the nature of the compensation owed for damages under Article 82 of the GDPR.

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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”). 

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On November 8, 2023, the Network Advertising Initiative (“NAI”) issued its best practices guidance (“Guidance”), which advocates for the use of demographic data for health advertising, rather than sensitive health information.

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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.” 

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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.

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On April 27, 2023, Washington adopted the My Health My Data Act (“WMHMDA”). Most of the law’s provisions are not effective until March 31, 2024 (or June 30, 2024 for small businesses). The law’s geofencing prohibition, however, is set to take effect on July 23, 2023. The prohibition is part of stringent requirements that Washington added when it became the first state to enact a comprehensive consumer health information privacy law in the United States.

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On June 2 and June 5, 2023, the Connecticut and Nevada state legislatures, respectively, voted in favor of sending legislation to their governors for signature that would impose restrictions, among others, on the processing of consumer health data, including geofencing provisions.  Nevada S.B. 370 was signed by Nevada Governor Joe Lombardo on June 16, 2023. These bills contain provisions similar to Washington’s My Health My Data Act and expand on protections in the Health Insurance Portability and Accountability Act of 1996 and other privacy laws.

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On May 18, 2023, the Federal Trade Commission announced it is seeking comment to proposed changes to the Health Breach Notification Rule (the “Rule”). The Rule requires  vendors of personal health records (“PHR”), PHR-related entities and service providers to these entities, to notify consumers and the FTC (and, in some cases, the media) in the event of a breach of unsecured identifiable health information, including cybersecurity intrusions and other instances of unauthorized access. By clarifying the Rule’s scope and applicability, and by modernizing allowable methods of notice, the proposed amendments seek to update the Rule to account for technological change since the Rule’s issuance, which includes the proliferation of health apps and connected devices, and the emergence of a widespread market for health data.

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On May 17, 2023, the Federal Trade Commission issued a consumer alert regarding the Premom Ovulation Tracker app (“Premom”) sharing sensitive information with third parties without users’ permission. According to the alert, Premom is a free app that is marketed as an accurate fertility calendar, which can be used to assist users who are trying to become pregnant.

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On May 3, 2023, New York Governor Kathy Hochul signed into law fiscal bill A.3007C/S.4007, which contains provisions prohibiting the establishment of a geofence around health care facilities.

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On April 27, 2023, Washington State Governor Jay Inslee signed the My Health My Data Act into law, making Washington the first state to establish a comprehensive health data privacy law in the United States.

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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.

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On March 2, 2023, the FTC announced a proposed order against BetterHelp, Inc., an online mental health counseling service, for sharing consumer data, including sensitive mental health information, with third parties for targeted advertising and other purposes. The FTC’s proposed order is notable, in that it is the first such order that would return funds to consumers whose health data was affected.

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On February 10, 2023, an Illinois federal district court ordered the dismissal of a putative class action lawsuit alleging that an online tool that allowed users to virtually try on sunglasses violated the Illinois Biometric Privacy Act (“BIPA”).

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On February 1, 2023, the Federal Trade Commission announced that it entered into a proposed order with GoodRx, a telehealth and prescription drug discount provider, for violations of the FTC’s Health Breach Notification Rule stemming from GoodRx’s unauthorized disclosures of consumers’ personal health information to third party advertisers and other companies. This is the first enforcement action taken under the FTC’s Health Breach Notification Rule, which was issued in 2009.

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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. 

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On December 7, 2022, the Federal Trade Commission released an updated Mobile Health App Interactive Tool to help developers determine what federal laws and regulations apply to apps that collect and process health data. The updated version of the tool, which revises the initial release in 2016, aims to assist developers of mobile apps that will access, collect, share, use or maintain information related to an individual consumer’s health, such as information related to diagnosis, treatment, fitness, wellness or addiction.

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On November 3, 2022, Pennsylvania Governor Tom Wolf signed Senate Bill 696 into law (the “Act”), amending Pennsylvania’s breach notification law. 

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On October 18, 2022, the New York State Department of Financial Services (“NYDFS”) announced that EyeMed Vision Care LLC (“EyeMed”) agreed to a $4.5 million settlement for violations of the Cybersecurity Regulation (23 NYCRR Part 500) that contributed to the exposure of hundreds of thousands of consumers’ health data in connection with a cybersecurity event in 2020.

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On September 27, 2022, California Governor Gavin Newsom signed into law a pair of bills designed to prevent medical information and other data held by California entities from being used in out-of-state abortion prosecutions. 

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On August 23, 2022, the U.S. Department of Health & Human Services, Office for Civil Rights (“HHS”) announced that it had settled a case involving the disposal of physical protected health information (“PHI”).

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On August 29, 2022, the Federal Trade Commission announced a civil action against digital marketing data broker Kochava Inc. for “selling geolocation data from hundreds of millions of mobile devices that can be used to trace the movements of individuals to and from sensitive locations.” The lawsuit seeks a permanent injunction to stop Kochava’s sale of geolocation data and to require the company to delete the geolocation data it has collected.  

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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.

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Following the ruling in Dobbs, the National Institutes of Health’s (“NIH’s”) certificates of confidentiality offer an important layer of privacy protection to reproductive health research data. The Public Health Service Act created the certificates of confidentiality program, which prohibits the disclosure of identifiable, sensitive research data “in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding” without the research subject’s consent. These certificates add a layer of protection to abortion and fertility data collected as part of NIH research.

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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.”

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On July 8, 2022, President Biden issued an Executive Order titled, “Protecting Access to Reproductive Health Care Services,” in response to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that overturned Roe v. Wade. The Executive Order aims, in part, to “ [p]rotect[] the privacy of patients and their access to accurate information” regarding reproductive health care services. It directs the Department of Health and Human Services (“HHS”) and the Federal Trade Commission to take certain steps to address the potential threat to patient privacy caused by the transfer and sale of sensitive health-related data, and by digital surveillance related to reproductive health care services from fraudulent schemes or deceptive practices.

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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.

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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.

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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.”

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As reported in the Hunton Employment & Labor Perspectives Blog:

Assembly Bill 1651, or the Workplace Technology Accountability Act, a new bill proposed by California Assembly Member Ash Kalra, would regulate employers and their vendors regarding the use of employee data. Under the bill, data is defined as “any information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular worker, regardless of how the information is collected, inferred, or obtained.”  Examples of data include personal identity information; biometric information; health, medical, lifestyle, and wellness information; any data related to workplace activities; and online information. The bill confers certain data rights on employees, including the right to access and correct their data. 

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On April 8, 2022, the Food and Drug Administration (“FDA”) issued Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, a draft guidance document for industry and FDA staff. Industry stakeholders will have until July 7, 2022 to comment on the proposed guidance.

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The Federal Trade Commission has reached a settlement with WW International, Inc. and Kurbo, Inc. over allegations the companies improperly registered children for the “Kurbo by WW” online weight loss management program. In pleadings filed on February 16, 2022, in federal court in the Northern District of California, the FTC claims WW and Kurbo offered a service that was tailored for children but that failed to ensure parental involvement in the registration process. According to the FTC, the defendants created an age gate that children could easily evade, and that ...
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On January 21, 2022, the Federal Trade Commission published two new resources for complying with the Health Breach Notification Rule (the “Rule”). In September 2021, the FTC issued a Policy Statement clarifying that the Rule applies to makers of health apps, connected devices and similar products. As we previously blogged, the Rule requires vendors of personal health records (“PHR”), PHR-related entities and service providers to these entities, to notify consumers and the FTC (and, in some cases, the media) in the event of a breach of unsecured identifiable health information, including cybersecurity intrusions and other instances of unauthorized access.

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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.

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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.

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During the week of October 4, 2021, California Governor Gavin Newsom signed into law bills amending the California Privacy Rights Act of 2020 (“CPRA”), California’s data breach notification law and California’s data security law. Additional bills, amending the California Confidentiality of Medical Information Act (“CMIA”) and the California Insurance Code, also were also signed into law. The Governor also signed into law a bill protecting the privacy and security of genetic data processed by direct-to-consumer genetic testing companies and a bill designed to prevent the sale, purchase and use of data obtained by illegal means.

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On October 1, 2021, Florida’s Protecting DNA Privacy Act (the “Act”), took effect. The Act, signed into law by Governor Ron DeSantis on June 29, restricts certain willful collection, retention, analysis and disclosure of the DNA samples or DNA analysis results of persons in Florida without their express consent.

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On September 30, 2021, the U.S. Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) issued guidance regarding when the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule applies to disclosures and requests for information about a person’s COVID-19 vaccination status.

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On September 15, 2021, the Federal Trade Commission issued a Policy Statement to clarify the scope of the FTC’s Health Breach Notification Rule (the “Rule”) as it relates to health apps and connected devices. In its Policy Statement, the FTC emphasized that the Rule was designed to ensure that entities not covered under HIPAA must still be held accountable in the event of a breach of consumers’ sensitive health information. The Rule requires vendors of personal health records (“PHR”), PHR related entities, and service providers to these entities, to notify consumers and the FTC (and, in some cases, the media) in the event of a breach of unsecured identifiable health information. Failure to provide such notice can result in civil penalties under the Rule. While the Rule was established more than a decade ago, in 2009, it has never been enforced by the FTC.

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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.

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On March 12, 2021, France’s highest administrative court (the “Conseil d’État”) issued a summary judgment that rejected a request for the suspension of the partnership between the French Ministry of Health and Doctolib, a leading provider of online medical consultations in Europe, for the management of COVID-19 vaccination appointments.

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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.”

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On January 13, 2021, the FTC announced that fertility-app developer Flo Health, Inc. (“Flo”) agreed to a settlement over allegations that the company shared app users’ health information with third-party data analytics providers despite representations that Flo would keep such information private.

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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.

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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.

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The UK Prime Minister, Boris Johnson, announced on June 23, 2020, that restrictions relating to COVID-19 would be eased as of July 4. Although many measures remain in place to prevent the virus’ spread, certain businesses, including restaurants and pubs, will be able to reopen in the UK, with the recommendation that staff-customer contact be minimized.

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The UK Information Commissioner’s Office (“ICO”) has released guidance to assist employers in implementing appropriate safeguards as workplaces reopen, titled “Coronavirus Recovery - Six Data Protection Steps for Organisations” (the “guidance”). This guidance sets out the key principles of data protection that should be kept in mind as employers put measures in place to prevent the spread of COVID-19.

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On June 16, 2020, the European Data Protection Board (the “EDPB”) released a statement on the processing of personal data in the context of reopening borders following the COVID-19 outbreak (the “Statement”).

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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.

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On June 5, 2020, the Belgian Data Protection Authority (the “Belgian DPA”) published guidance on its website (the “Guidance”) regarding temperature checks during the COVID-19 crisis. The Guidance aims to provide advice to organizations looking to control access to their premises by restricting individuals with fevers in order to prevent further spread of the virus.

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On June 1, 2020, U.S. Senators Maria Cantwell (WA) and Bill Cassidy (LA) introduced the Exposure Notification Privacy Act (the “Act”), bipartisan legislation that would impose requirements and restrictions on operators of automated exposure notification services. The bill defines automated exposure notification service as “a website, online service, online application, mobile application, or mobile operating system that is offered in commerce in the U.S. and that is designed, in part or in full, specifically to be used for, or marketed for, the purpose of digitally notifying, in an automated manner, an individual who may have become exposed to an infectious disease (or the device of such individual, or a person or entity that reviews such disclosures).” These services are commonly referred to as “contact tracing technology” because they are designed to provide alerts when a user comes in near-contact with someone who tested positive for an infectious disease, such as COVID-19.

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On May 25 and May 26, 2020 respectively, the Belgian Data Protection Authority (the “Belgian DPA”) published two opinions on draft laws introducing COVID-19-related tracking initiatives: (1) the Opinion 42/2020 on the draft law for the creation of a database by Sciensano, a public health institution (“Opinion 42/2020”), and (2) the Opinion 43/2020 on the draft law for the use of contact tracing apps to fight the spread of COVID-19 (“Opinion 43/2020”).

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On May 14, 2020 Democrats in both the House and Senate introduced the Public Health Emergency Privacy Act (“the Act”). In the House, the Act was sponsored by Representatives Jan Schakowsky (IL), Anna Eshoo (CA) and Suzan DelBene (WA), and in the Senate was sponsored by Senators Richard Blumenthal (CT) and Mark Warner (VA). Similar to the recently-introduced COVID-19 Consumer Data Protection Act of 2020, the Act would put temporary rules in place regarding the collection, use and disclosure of emergency health data used to combat the spread of the coronavirus. The rules imposed by the Act would only apply during the course of the Public Health Emergency as declared by the Secretary of Health and Human Services (“HHS”) and would only apply to specific uses of certain personal data.

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On May 7, 2020, the French Data Protection Authority (the “CNIL”) updated its previous guidance for employers relating to the processing of employee and visitor personal data in the context of the COVID-19 outbreak, in particular, in the context of lifting containment measures (the “Updated Guidance”). Some employers may consider implementing systematic body temperature checks at the entrance to their premises. Similarly, employers may wish to assess employees’ exposure to the virus or their health statuses when they return to work. The Updated Guidance analyzes some of these practices and outlines the principles applicable to data processing activities.

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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 ...
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On April 25, 2020, the Philippines National Privacy Commission (“NPC”) issued a statement that it is investigating several breach notifications it has received relating to the unauthorized disclosure of sensitive personal information of confirmed and suspected COVID-19 patients (the “Statement”).

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On April 30, 2020, Senator Roger Wicker (MS), Chairman of the Senate Commerce Committee, along with Senators John Thune (SD), Jerry Moran (KS) and Marsha Blackburn (TN), announced plans to introduce the COVID-19 Consumer Data Protection Act of 2020 (“the bill”), which would put temporary rules in place regarding the collection, processing and transfer of data used to combat the spread of the coronavirus. The bill would only apply during the course of the COVID-19 Public Health Emergency as declared by the Secretary of Health and Human Services, and would only apply to specific uses of certain personal data.

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As the COVID-19 outbreak continues to unfold, businesses are dealing with new and unprecedented operational and legal challenges. There also are key data protection considerations for businesses in connection with the COVID-19 pandemic, including compliance with the requirements around the processing of personal data for health monitoring purposes, crisis management issues and steps to be implemented to ensure the continuity of privacy compliance programs.

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On April 21, 2020, the European Data Protection Board (“EDPB”) adopted Guidelines on the processing of health data for scientific purposes in the context of the COVID-19 pandemic. The aim of the Guidelines is to provide clarity on the most urgent matters relating to health data, such as legal basis for processing, the implementation of adequate safeguards and the exercise of data subject rights.

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On April 16, 2020, the European eHealth Network—a voluntary network connecting national authorities responsible for eHealth designated by EU Member States—published a common EU toolbox for the use of contact tracing and warning apps in response to the coronavirus pandemic (the “Toolbox”). The Toolbox is part of the common EU coordinated approach to using COVID-19 mobile apps, as set out in the European Commission’s Recommendation of April 8, 2020. The Toolbox was accompanied by guidance from the European Commission on data protection and privacy aspects of the use of such apps (the “Guidance”).

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On April 9, 2020 the U.S. Senate Committee on Commerce, Science and Transportation held a “paper hearing” entitled Enlisting Big Data in the Fight Against Coronavirus. A “paper hearing” consists of the committee members submitting opening statements and witnesses submitting testimony, which were posted on the Committee’s website. Witnesses were required to submit answers to member questions last week.

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On April 14, 2020, the European Data Protection Board (“EDPB”) adopted a letter concerning the European Commission's (the “Commission”) draft Guidance on apps supporting the fight against the COVID-19 pandemic. This letter was written to the Commission following the Commission’s adoption of a recommendation to develop a common European approach to using mobile applications and mobile location data in response to the pandemic on April 8, 2020.

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On April 7, 2020, the European Data Protection Board (the “EDPB”) announced that it had assigned mandates to its expert subgroups to develop guidance on several aspects of data processing amidst the COVID-19 crisis.

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On March 31, 2020, the Belgian Data Protection Authority (the “Belgian DPA”) published a short statement on its website (the “Statement”) regarding health-related apps. The Belgian DPA indicated that the Statement is in response to numerous questions regarding the use of personal data in the context of the COVID-19 pandemic.

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On March 25, 2020, the European Data Protection Supervisor (“EDPS”) sent a letter to the Directorate-General for Communications Networks, Content and Technology (“DG CONNECT”) addressing the various initiatives involving telecommunications providers at the Member State level to monitor the spread of the COVID-19 outbreak using location data.

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The Dutch Data Protection Authority (Autoriteit Persoonsgegevens, the “Dutch DPA”) recently published materials regarding the COVID-19 crisis, including recommendations and FAQs for employers and recommendations for employees. In the materials, the Dutch DPA emphasizes that, while fighting the virus and saving lives is the top priority, privacy must not be overlooked and the crisis should not become a prelude to a “Big Brother” society.

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The Spanish Data Protection Authority (the “AEPD”) recently published a report on data processing activities carried out by data controllers in the private and public sectors as a result of the spread of the COVID-19 virus (the “Report”).

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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.

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On March 13, 2020, the Belgian Data Protection Authority (the “Belgian DPA”) released a statement regarding workplace-related processing of personal data in the context of the COVID-19 crisis (the “Statement”).

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On March 19, 2020, the European Data Protection Board (“EDPB”) published a new statement regarding processing personal data in the context of the COVID-19 outbreak. The EDPB said that emergency is a legal condition which may legitimize restrictions of individual freedoms, provided that these restrictions are proportionate and limited to the emergency period. Several considerations come into play in weighing the lawful processing of personal data in these circumstances.

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The UK Information Commissioner’s Office (“ICO”) has published guidance regarding its expectations for controllers and health professionals during the COVID-19 outbreak.

In its guidance for controllers, the ICO adopted a pragmatic stance, stating: “We know you might need to share information quickly or adapt the way you work. Data protection will not stop you doing that. It’s about being proportionate - if something feels excessive from the public’s point of view, then it probably is.”

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The French Data Protection Authority (the “CNIL”) recently issued guidance for employers relating to the processing of employee and visitor personal data in the context of the COVID-19 outbreak (the “Guidance”). The Guidance outlines some of the principles relating to those data processing activities.

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The outbreak of COVID-19 has dramatically changed the economy and working landscape of the United States and many other countries across the world. Companies suddenly find themselves dealing with a host of privacy issues and questions about sharing information with employees, customers and others. In addition, transitioning to a remote workforce can create privacy and data security concerns.

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On March 17, 2020, the Executive Committee of the Global Privacy Assembly (“GPA”) issued a statement giving their support to the sharing of personal data by organizations and governments for the purposes of fighting the spread of the COVID-19 pandemic. The GPA brings together data protection regulators from over 80 countries and its membership currently consists of more than 130 data protection regulators around the world, including the UK Information Commissioner’s Office, the U.S. Federal Trade Commission, and the data protection regulators for all EU Member States.

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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.

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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.

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The U.S. Department of Education and the U.S. Department of Health and Human Services released joint guidance on the application of the Family Educational Rights and Privacy Act (“FERPA”) and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule to student records. This is the first update to the agencies’ guidance since it was issued in 2008. The 27-page document includes FAQs clarifying for schools, health care professionals and families how FERPA and HIPAA apply to student education and health records. The FAQs answer which rule ...
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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”).

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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.

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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.

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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.

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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 ...
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On April 11, 2019, the People’s Republic of China’s Network Security Bureau of the Ministry of Public Security, the Beijing Network Industry Association and the Third Research Institution of the Ministry of Public Security jointly released a “Guide to Protection of Security of Internet Personal Information (the “Guide”). The Guide presents itself as a reference, rather than a legally-enforceable regulation, but how it will interact with cybersecurity-related law, regulations and standards in practice remains to be seen.

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On April 17, 2019, the Dutch Data Protection Authority, the Autoriteit Persoonsgegevens (the “Dutch DPA”) issued six recommendations (in Dutch) for companies, to be taken into account when drafting privacy policies for the purpose of Article 24.2 of the EU General Data Protection Regulation (the “GDPR”). Article 24.2 of the GDPR provides the obligation for data controllers to implement privacy policies for accountability purposes, under certain criteria. The published recommendations follow the Dutch DPA’s investigation of companies’ privacy policies. The investigation focused on companies that process sensitive personal data, including health data and data related to individuals’ political beliefs. Alongside the recommendations, the Dutch DPA released a report (in Dutch) summarizing the investigation’s results.

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The Belgian Data Protection Authority (the “Belgian DPA”) recently published the updated list of the types of processing activities which require a data protection impact assessment (“DPIA”). Article 35.4 of the EU General Data Protection Regulation (“GDPR”) obligates supervisory authorities (“SAs”) to establish a list of the processing operations that require a DPIA and transmit it to the European Data Protection Board (the “EDPB”).

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On January 23, 2019, the European Data Protection Board (“EDPB”) released an opinion on the interplay between the European Clinical Trials Regulation (“CTR”) and the EU General Data Protection Regulation (“GDPR”) (the “Opinion”). The Opinion was requested by the European Commission Directorate-General for Health and Food Safety (“DG SANTE”).

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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.

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The U.S. Department of Health and Human Services (“HHS”) recently announced the publication of “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (the “Cybersecurity Practices”). The Cybersecurity Practices were developed by the Healthcare & Public Health Sector Coordinating Councils Public Private Partnership, a group comprised of over 150 cybersecurity and healthcare experts from government and private industry.

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On October 22, 2018, the Centre for Information Policy Leadership (“CIPL”) at Hunton Andrews Kurth LLP co-hosted a workshop in Brussels on “Can GDPR Work for Health Scientific Research?” (the “Workshop”) with the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) and the Future of Privacy Forum (“FPF”) to address the challenges raised by the EU General Data Protection Regulation (“GDPR”) in conducting scientific health research.

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On October 30, 2018, ATA Consulting LLC (doing business as Best Medical Transcription) agreed to a $200,000 settlement with the New Jersey Attorney General resulting from a server misconfiguration that allowed private medical records to be posted publicly online. The fine was suspended to $31,000 based on the company’s financial condition. Read the settlement.

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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.

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On August 15, 2018, U.S. District Judge Lucy Koh signed an order granting final approval of the record $115 million class action settlement agreed to by Anthem Inc. in June 2017. As previously reported, Judge Koh signed an order granting preliminary approval of the settlement in August 2017.

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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:
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On June 6, 2018, the U.S. Court of Appeals for the Eleventh Circuit vacated a 2016 Federal Trade Commission (“FTC”) order compelling LabMD to implement a “comprehensive information security program that is reasonably designed to protect the security, confidentiality, and integrity of personal information collected from or about consumers.” The Eleventh Circuit agreed with LabMD that the FTC order was unenforceable because it did not direct the company to stop any “unfair act or practice” within the meaning of Section 5(a) of the Federal Trade Commission Act (the “FTC Act”).

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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.

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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. 

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