Health Law Advisor

On March 18, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued updated guidance regarding the use of online tracking technologies by entities and business associates subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

Notably, the updated guidance replaces OCR’s original guidance issued in December 2022, both of which warn companies subject to HIPAA, Covered Entities and their Business Associates (collectively “Regulated Entities”), that use of online tracking technologies, such ...

Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent and well-publicized cybersecurity incident affecting Change Healthcare further evidences these risks. As a result of the widespread and disruptive impact of this most recent cyberattack on the healthcare ecosystem, on March 5, 2024 the U.S. Department of Human Services (HHS) issued a public statement and has also announced that it opened an ...

On January 16, 2024, New Jersey Governor Phil Murphy signed into law Senate Bill No. 332, “An Act concerning online services, consumers, and personal data” (“SB 332”).  New Jersey is the fourteenth state to pass a comprehensive consumer privacy bill, and the obligations and rights created by SB 332 follow the format used in a growing number of states that have passed comprehensive consumer privacy laws.

Scope and Exemptions

SB 332 imposes obligations on “controllers”  – entities or individuals that determine the purpose and means of processing personal data – that ...

On July 26, 2023, the Securities and Exchange Commission (“SEC”) adopted its long-anticipated cybersecurity reporting rule (the “Final Rule”). The Final Rule applies to public companies subject to the reporting requirements of the Securities Exchange Act of 1934 and, in some cases, to foreign private issuers. As quoted in the SEC’s press release, SEC Commissioner Gary Gensler noted that many public companies already make cybersecurity disclosures to investors, and the Final Rule provides uniformity and structure for these future disclosures. The Final Rule also imposes a tight timeline for cybersecurity incident reporting and may include disclosure of an ongoing cybersecurity incident, as well as requiring periodic disclosures concerning organizational cybersecurity risk management processes and governance.

On July 13, 2023, the White House issued the first iteration of its National Cybersecurity Strategy Implementation Plan (the “Implementation Plan”), which will be updated annually. The two overarching goals of the Implementation Plan are to address the need for more capable actors in cyberspace to bear more of the responsibility for cybersecurity and to increase incentives to make investments in long-term resilience. The Implementation Plan is structured around the five pillars laid out in the White House’s National Cybersecurity Strategy earlier this year, namely: (1) defend critical infrastructure; (2) disrupt and dismantle threat actors; (3) shape market forces to drive security and resilience; (4) invest in a resilient future; and (5) forge international partnerships to pursue shared goals. The Implementation Plan identifies strategic objectives and high-impact cybersecurity initiatives under each pillar and designates the federal agency responsible for leading the initiative to meet each objective. The following summarizes some of the key initiatives included in the Implementation Plan that will directly impact critical infrastructure organizations, including healthcare, energy, manufacturing, information technology and financial services.

On June 16, 2023, Nevada enacted Senate Bill 370 (“SB 370”), which imposes broad restrictions on the collection, use, and sale of consumer health data. This law is set to go into effect on March 31, 2024.

Recently, Florida Governor Ron DeSantis signed Senate Bill 262 and Senate Bill 264 into law. These new laws grant Floridians greater control over their personal data and establish a new standard for data handling and protection. Senate Bills 262 and 264 take effect on July 1, 2023.

Introduction

Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps to protect reproductive health privacy, some of which we previously discussed here. Specifically, the EO called for agencies to protect “women’s fundamental right to make reproductive health decisions.” Shortly following issuance of the EO, the Biden Administration created its HHS Reproductive Healthcare Access Task Force, requiring all relevant federal agencies to draft measurable actions that they could undertake “to protect and bolster access to sexual and reproductive health care.”  

On May 18, 2023, the Federal Trade Commission (FTC) filed a Notice of Proposed Rulemaking and Request for Public Comment (“NPRM”) seeking to amend the Health Breach Notification Rule (“HBNR”). We previously wrote about the FTC’s policy statement, in which the FTC took the position that mobile health applications that are not covered by the Health Insurance Portability and Accountability Act (“HIPAA”) are covered by the HBNR. In our post, we highlighted concerns raised in dissent by commissioner Noah Joshua Phillips that the FTC’s interpretation of “breach of security” was too broad. Commissioner Phillips has since resigned.

In the absence of a comprehensive federal data privacy law, state legislators continue to add to the often-contradictory array of laws aimed at protecting the security and privacy of their residents’ data. Very recently, Washington State’s My Health My Data Act was signed into law by Governor Jay Inslee in late April, Florida lawmakers passed Senate Bill 262 in early May, and the Tennessee Information Protection Act was signed into law earlier this month as well. While preparing this update, Montana’s enacted its Consumer Data Privacy Act on May 19^th, which we will address in subsequent guidance due to its recency. These newly enacted state laws build upon the growing patchwork of laws enacted in California, Connecticut, Colorado, Virginia, and Utah, all of which we previously discussed here and here. Yet, among these state laws there is significant variety, including inconsistencies as to whether the laws allow for private rights of action, and whether the laws provide affirmative defenses and other incentives based on compliance with relevant best practices.

In the absence of a federal law directly aimed at regulating artificial intelligence (AI), the Federal Trade Commission (FTC) is seeking to position itself as one of the primary regulators of this emergent technology through existing laws under the FTC’s ambit. As we recently wrote, the FTC announced the establishment of an Office of Technology, designed to provide technology expertise and support the FTC in enforcement actions. In a May 3, 2023 opinion piece published in the New York Times entitled “We Must Regulate A.I. Here’s How,” Lina Khan, the Chairperson of the FTC, outlined at least three potential avenues for FTC enforcement and oversight of artificial intelligence technology.

On February 17, 2023, the Federal Trade Commission (“FTC”) announced the creation of the Office of Technology (the “OT”), which will be headed by Stephanie T. Nguyen as Chief Technology Officer. This development comes on the heels of increasing FTC scrutiny of technology companies. The OT will provide technical expertise and strengthen the FTC’s ability to enforce competition and consumer protection laws across a wide variety of technology-related topics, such as artificial intelligence (“AI”), automated decision systems, digital advertising, and the collection and sale of data. In addition to assisting with enforcement matters, the OT will be responsible for, among other things, policy and research initiatives, and advising the FTC’s Office of Congressional Relations and its Office of International Affairs. 

The California Privacy Protection Agency Board (the “Board”) held a public meeting on February 3, 2023, adopting and approving the current set of draft rules (the “Draft Rules”), which implement and clarify the California Consumer Privacy Act of 2018 (“CCPA”) as amended by the California Privacy Rights Act of 2020 (“CPRA”). The Draft Rules cover many CCPA requirements, including restrictions on the collection and use of personal information, transparency obligations, consumer rights and responding to consumer requests, and service provider contract requirements. At the meeting, the Board also addressed additional proposed rulemaking processes concerning cybersecurity audits, risk assessments, and automated decision-making. 

On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for using advertising technologies on its websites and mobile app that resulted in the unauthorized disclosure of consumers’ personal and health information to advertisers and other third parties. On the same day, the U.S. Department of Justice, acting on behalf of the FTC, filed a Complaint and Proposed Stipulated Order detailing the FTC’s allegations and the terms of the proposed settlement. 

More than just New Year’s resolutions went into effect when the clock struck midnight on January 1, 2023. The California Privacy Rights Act (“CPRA”) and the Virginia Consumer Data Protection Act (“VCPDA”) are now effective in California and Virginia, respectively. These comprehensive data privacy laws, along with three other state laws going into effect this year, establish new and complex obligations for businesses. If your business has not taken steps to prepare for these privacy laws, it is high time to start that process to avoid violations and enforcement likely to follow later in the year. See below for a timeline of key dates.

On December 1, 2022, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a bulletin warning that commonly used website technologies, including cookies, pixels, and session replay, may result in the impermissible disclosure of Protected Health Information (“PHI”) to third parties in violation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The bulletin advises that “[r]egulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of Protected Health Information (“PHI”) to tracking technology vendors or any other violations of the HIPAA Rules.” The bulletin is issued amidst a wider national and international privacy landscape that is increasingly focused on regulating the collection and use of personal information through web-based technologies and software that may not be readily apparent to the user.

The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) gives consumers increasingly more control over their personal information when collected by businesses subject to the law. We have previously discussed the compliance requirements of these data privacy laws on organizations doing business in California.[1] Significantly, CCPA/CPRA defines the term “consumer” to mean any California resident; which from a business perspective, such a broad definition encompasses not only the business’s individual customers, but also its employees, job-applicants or even business-to-business (B2B) contacts.  With the moratoriums currently in place for B2B and employee/applicant data sunsetting on January 1, 2023 and not likely to be extended, and the prospect for federal data privacy legislation with wide preemptive effect of state law looking less likely, businesses should be actively preparing to meet these expanded statutory obligations.

Establishing and maintaining effective systems to protect sensitive personal data and confidential business information from outside interference while also assuring that privacy interests are protected is among an organization’s highest priorities. Our security and privacy team at Epstein Becker & Green has written extensively about the guidance and best practices issued by federal and state regulatory and enforcement agencies. Execution, monitoring and continually updating these preventive practices define an organization’s first line of defense. But what happens in the event that an organization actually suffers a breach? Is there guidance that might be available, particularly to healthcare organizations, to deal with continuity and disaster planning (BC/DR) directed towards assuring resilience and recovery in the event of a potentially-disastrous cyberattack?

Connecticut becomes the fifth state to pass a comprehensive privacy law. Are you prepared for state privacy law compliance required in 2023?

The past several years have proven difficult for healthcare entities due to increasing cybersecurity threats, breaches and regulatory enforcement. Following these trends, on April 6, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a Request for Information (RFI) soliciting public comment on how regulated entities are voluntarily implementing security practices under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) and also seeking public input on sharing funds collected through enforcement with individuals who are harmed by Health Insurance Portability and Accountability Act of 1996 (HIPAA) rule violations.

In this episode of the Diagnosing Health Care Podcast:  How does the U.S. Department of Justice (DOJ) intend to leverage its enforcement authority under the False Claims Act to advance DOJ’s recently announced Civil Cyber-Fraud Initiative?

On March 15, 2022, President Biden signed into law the 2022 Consolidated Appropriations Act containing the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (the “Cyber Incident Reporting Act”). While President Biden’s remarks highlighted the $13.6 billion in funding “to address Russia’s invasion of Ukraine and the impact on surrounding countries,” the 2022 Consolidated Appropriations Act contained numerous other laws, including the Cyber Incident Reporting Act, which should not be overlooked. The Cyber Incident Reporting Act puts in motion important new cybersecurity reporting requirements that will likely apply to businesses in almost every major sector of the economy, including health care, financial services, energy, transportation and commercial facilities. Critical infrastructure entities should monitor the upcoming rule-making by the Cybersecurity and Infrastructure Security Agency (“CISA”), as the final regulations will clarify the scope and application of the new law.

The U.S. Cybersecurity and Infrastructure Agency (CISA) has urged a “Shields Up” defense in depth approach, as Russian use of wiper malware in the Ukrainian war escalates. The Russian malware “HermeticWiper” and “Whispergate” are destructive attacks that corrupt the infected computers’ master boot record rendering the device inoperable. The wipers effectuate a denial of service attack designed to render the device’s data permanently unavailable or destroyed. Although the malware to date appears to be manually targeted at selected Ukrainian systems, the risks now escalate of a spillover effect to Europe and the United States particularly as to: (i) targeted cyber attacks including on critical infrastructure and financial organizations; and (ii) use of a rapidly spreading indiscriminate wiper like the devastating “NotPetya” that quickly moves across trusted networks. Indeed, Talos researchers have found functional similarities between the current malware and “NotPetya” which was attributed to the Russian military to target Ukranian organizations in 2017, but then quickly spread around the world reportedly resulting in over $10 billion dollars in damage.[1] The researchers added that the current wiper has included even further components designed to inflict damage.

Recent decisions from the European Union (EU) have placed renewed focus on the use of common cookies used on ecommerce and other websites used by consumers and employees and transfers of personal data collected through cookies to the United States. The EU Data Protection Authorities (DPAs) found that the use of widely used website technologies (i.e., cookies and java script) to automatically collect identifiers from the users’ devices or through their use of internet protocols (e.g., IP addresses) resulted in the collection of personal data. The DPAs further found that the subsequent transfer of this data to Google servers located in the United States violated EU cross-border data transfer requirements because there were inadequate safeguards under the Schrems II decision invalidating the EU-US Privacy Shield. One notable impact of the decisions is to dismiss the adequacy of encryption technologies where the service provider (such as Google) has access to the cryptographic key and can be compelled to surrender it in order for the data to be decrypted and read by U.S. surveillance authorities. Consideration of the impact of these decisions is critically important for ecommerce and other websites operating in the EU, as well as more generally for organizations that transfer personal data of consumers and employees to the U.S.

Throughout 2021, we closely monitored the latest privacy laws and a surge of privacy, cybersecurity, and data asset management risks that affect organizations, small and large. As these laws continue to evolve, it is important for companies to be aware and compliant. We will continue to monitor these trends for 2022.

The attorneys of the Privacy, Cybersecurity & Data Asset Management group have written on a wide range of notable developments and trends that affect employers and health care providers. In case you missed any, we have assembled a recap of our top 10 blog posts of 2021, with links to each, below:

Recent data thefts and systems intrusions, particularly with respect to ransomware, have assured that cybersecurity is top of mind for corporate executives and compliance officials. We at EBG have tried to keep you up to date with respect to legislative, regulatory and litigation developments and recommended best practices and procedures.

As we close out the year, we all should remain mindful that cyber criminals, especially those who are supported or protected by foreign adversaries, have little incentive to rest up during the holidays.

On Tuesday, August 24, 2021, California Attorney General Rob Bonta issued a guidance bulletin (the “Guidance”) to health care providers reminding them of their compliance obligations under California’s health data privacy laws, and urging providers to take proactive steps to protect against cybersecurity threats. This Guidance comes, in part, as a response to federal regulators sounding the alarm over an uptick in cybercrime against hospitals and other health providers. The Guidance follows an October 2020 Joint Cybersecurity Advisory issued by the Cybersecurity and ...

In this episode of the Diagnosing Health Care Podcast:  Although the COVID-19 pandemic exposed cybersecurity vulnerabilities across sectors, it has particularly challenged the resilience of information systems for health care and life sciences companies. Because ransomware attacks have the potential to cripple access to important data, expose patient health records, and shut down machinery and life-saving equipment, it's no surprise that health care executives continue to lose sleep thinking about potential ransomware or other similar malicious attacks.

Epstein Becker ...

Our colleagues Alaap Shah and Stuart Gerson of Epstein Becker Green have written an Expert Analysis on Law360 that will be of interest to our readers: "Health Cos. Must Prepare for Growing Ransomware Threat."

The following is an excerpt (see below to download the full version in PDF format):

Ransomware attacks have become big business, and they are on the rise. And entities in the health care and life sciences space have become primary targets of opportunity for attackers.

As the recent Colonial Pipeline Co. ransomware event illustrates, a small group of black hat hackers, living in ...

Cyber threats and cybersecurity controls have evolved significantly over the past two decades since the HIPAA Security Rule were originally promulgated. During this same time, healthcare entities have increasingly become a prime target of hackers seeking to extort payment using ransomware, exfiltrate patient data to commit fraud, or disrupt operations in other nefarious ways.  Recognizing these challenges, some security professionals have sought further clarity on the HIPAA Security Rule that they deem to be “long in the tooth”. Yet, regulators have not made any ...

Our colleagues Brian Cesaratto and Alexander Franchilli of Epstein Becker Green have a new post on Workforce Bulletin that will be of interest to our readers: “NAME:WRECK” Cybersecurity Vulnerability Highlights Importance of Newly Issued IoT Act".

The following is an excerpt:

A recently discovered security vulnerability potentially affecting at least 100 million Internet of Things (“IoT”) devices[1] highlights the importance of the newly enacted IoT Cybersecurity Improvement Act of 2020 (the “IoT Act”). Researchers at the security firms Forescout ...

On January 5, 2020, HR 7898, became law amending the Health Information Technology for Economic and Clinical Health Act (HITECH Act), 42 U.S.C. 17931, to require that “recognized cybersecurity practices” be considered by the Secretary of Health and Human Services (HHS) in determining any Health Insurance Portability and Accountability Act (HIPAA) fines, audit results or mitigation remedies. The new law provides a strong incentive to covered entities and business associates to adopt “recognized cybersecurity practices” and risk reduction frameworks when complying ...

Ransomware basics

Ransomware is a serious form of cyber extortion that employs malware to prevent users from accessing their systems or data, either by locking the system or encrypting critical files until a ransom is paid. The hacker holds the key to unlock the system and usually demands payment in cryptocurrency.

Ransomware has been a known cyber threat vector for over a decade. In recent years, hackers have embraced increasingly sophisticated methods to exploit vulnerabilities and introduce ransomware into systems. They have also expanded the scope of impact by targeting ...

On October 12, 2020, the California Attorney General issued its notice and third set of proposed modifications to the regulations implementing the California Consumer Protection Act (“CCPA”). These proposed modifications would change the regulations that were approved by the California Office of Administrative Law on August 14, 2020. The California Department of Justice is accepting written comments from the public on these proposed revisions to the regulations until October 28, 2020 at 5:00 p.m. PST.

Notable changes in these regulations include:

• A requirement for ...

Recently, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), the agency enforcing the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, obtained two large breach-related settlements: one from a HIPAA Covered Entity and one from a HIPAA Business Associate.  These enforcement actions signal that despite COVID-19 related challenges, organizations continue to face rampant data breaches and ensuing HIPAA enforcement.

On September 25, 2020, OCR settled an investigation into a breach suffered by a large health insurer by obtaining the second-largest resolution payment in HIPAA enforcement history ($6.85 million).  This enforcement action resolved an investigation concerning potential violations of HIPAA Privacy and Security Rules related to a breach affecting the electronic protected health information (ePHI) of more than 10.4 million people.  The breach resulted from a phishing attack that introduced malware into the insurer’s IT systems and allowed unauthorized actors to gain access and remain undetected for nearly nine months.  Similarly on September 23, 2020, a business associate providing IT and health information management services to hospitals and physicians clinics entered a settlement ($2.3 million) with OCR for potential violations of HIPAA Privacy and Security Rules related to a breach affecting over 6 million people.  Essentially, these cyberattacks were advanced persistent threats that compromised the privacy and security of ePHI and PHI and revealed longstanding gaps in the companies’ cybersecurity controls.

The Information Sharing and Analysis Organization-Standards Organization (ISAO-SO) was set up under the aegis of the Department of Homeland Security pursuant to a Presidential Executive Order intended to foster threat vector sharing among private entities and with the government. ISAOs are proliferating in many critical infrastructure fields, including health care, where cybersecurity and data privacy are particularly sensitive issues given HIPAA requirements and disproportionate industry human and systems vulnerabilities. Therefore, in advising their companies ...

Reports in the last week stated that the computer manufacturer Lenovo had preloaded software onto various lines of computers which critically compromised cybersecurity. The software in question is a product called Superfish Visual Discovery, a program generally designed to replace advertisements seen while browsing the Internet with ads provided by Superfish. However, the method of implementation opens up a universe of potential problems.

What Does Superfish Do?

Superfish is designed to replace Internet advertisements with advertisements provided by their sponsors. In ...

On January 9, 2015, New Jersey Governor Chris Christie signed new legislation that will require health insurance carriers authorized to issue health benefits plans in the state—including insurance companies, health service corporations, hospital service corporations, medical service corporations, and health maintenance organizations—to encrypt personal information. Triggered by a series of data breaches involving the health information of almost a million residents, Senate Bill No. 562 (“SB 562”) was passed unanimously by both houses of the state legislature ...

On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency’s Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 (“Breach Report”). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.

Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services to prepare an annual report regarding the number and nature of ...

By Marshall Jackson and Alaap Shah

If you have tuned into the news over the last few months, you are likely aware that several major corporations—including one of the nation’s largest retail chains—have suffered data breaches. These breaches have affected hundreds of millions of consumers, and in some cases exposed sensitive financial data such as credit card information, as well as personal information including names, mailing addresses, phone numbers, email addresses, usernames and passwords.

There is no doubt that a primary concern raised by these data breaches is risk ...

   By:  Alaap Shah and Ali Lakhani

Why is data breach such a rampant problem within the health care industry?

As health care rapidly digitizes through adoption of electronic health records, mobile applications and the like, the risk of data breach is rising exponentially.  To effectively manage this risk, health care companies and their business associates must be vigilant by implementing and evaluating security controls in the form of administrative, physical and technical safeguards.  Health care companies also have resources to assist them with managing this risk.  Specifically ...

By: Alaap Shah and Marshall Jackson

Data is going digital, devices are going mobile, and technology is revolutionizing how care is delivered.  It seems to be business as usual, as your health care organization continues to digitize its operations.  You have even taken measures to help guard against the “typical” risks such as lost laptops, thumb drives and other electronic devices.  However, unbeknownst to you, hackers sit in front of their computers looking for ways into your network so that they may surreptitiously peruse through confidential financial records and sensitive ...