The National Law Forum

Passport Entry Date Stamps to Be Eliminated

U.S. Customs and Border Protection (CBP) plans to eliminate passport entry date stamps in the passports of foreign nationals arriving in the U.S. The new policy measures are already in effect in some ports of entry and CBP will continue to expand the policy at additional ports.

The Form I-94 record of admission will continue to be used as a proof of a foreign national’s travel history and immigration status, which are accessible online. Foreign nationals are strongly encouraged to access and review their I-94 online as soon as they are inspected and admitted. Checking for errors in their I-94 online admission status before they leave the inspection area can help to avoid mistakes that may not be easily fixed after entry.

Since the I-94 governs the foreign national’s immigration status and work authorization for I-9 purposes, employers should also carefully monitor their foreign national employees’ status for Form I-9 employment verification.

For more Immigration Law News, click here to visit the National Law Review.

Canadian PFAS Drinking Water Standards Proposed

We have documented for several years now the U.S. EPA’s efforts to propose enforceable drinking water standards with respect to PFAS, and in September 2022, the World Health Organization (WHO) issues its own draft “PFOS and PFOS In Drinking-Water” Background Document. Now, on the heels of these developments, Canadian PFAS drinking water standards were introduced, which add another regulatory layer to the globally evolving PFAS regulatory scheme. Notably, Canada takes a different approach than both the United States and the WHO in addressing PFAS drinking water issues, but the proposal will nonetheless have impacts on U.S. PFAS litigation if passed.

Canadian PFAS Drinking Water Standards

Canada’s draft proposal sets a limit of 30 ppt for any detected PFAS combined in a given drinking water source. This is in contrast to the WHO, which only addressed PFOA and PFOS in its draft recommendations for drinking water standards, and the EPA, which by all indications will only propose enforceable drinking water standards for a small subset of the over 12,000 PFAS that exist. The Canadian standards, though, do propose requiring that EPA Testing Methods 533 or 537.1 be used for detection, which only tests for 29 PFAS types. Nevertheless, the large group approach to PFAS drinking water standards is unique for the moment to Canada, although the WHO did include in its proposal a similar limited subset of PFAS for countries to consider when setting or proposing drinking water standards.

Comments to the Canadian draft document are being accepted through April 12, 2023.

EPA’s Drinking Water Actions

We previously detailed how, on June 15, 2022, the EPA issued Health Advisories (HAs) for five specific PFAS, PFOA (interim), PFOS (interim), PFBS (final) and GenX (final). While not enforceable levels for PFAS in drinking water, the EPA’s PFAS Health Advisories are nevertheless incredibly significant for a variety of reasons, including influence on future federal and state drinking water limits, as well as potential impacts on future PFAS litigation.

The levels set by the EPA’s PFAS Health Advisories were as follows:

PFOA	.004 ppt
PFOS	.02 ppt
GenX	10 ppt
PFBS	2,000 ppt

Since the HAs were published, the EPA has faced several lawsuits challenging the HAs. The lawsuits generally allege that the HAs should be struck down and are not valid, as they were created “arbitrarily and capriciously.” In support, the moving parties say that the HAs were created in an improper manner because (1) they incorporated toxicity assumptions that deviate from the EPA’s own standard methods; and (2) EPA incorporated grossly incorrect and overstated exposure assumptions―in essence, EPA used the wrong chemical when making its exposure assumptions, thereby resulting in a significantly less tolerant health advisory for [PFAS] than is warranted by the data. In addition, the parties argue that the EPA failed to go through the necessary public comment period before issuing its final GenX HA, and that in creating the GenX HA, the EPA exceeded its authority under the Safe Drinking Water Act.

Canadian PFAS Impacts On EPA Efforts and Litigation

When the WHO PFAS report was released, we wrote that the report will have an impact on existing and future litigation that challenges EPA regulatory actions focused on PFAS. Our reasoning for the prediction was that the standards proposed by the WHO were significantly higher than the EPA’s Health Advisories (which may foreshadow where the EPA’s enforceable drinking water limits will be set) even though the WHO had available to it much of the same scientific literature as the EPA. The Canadian PFAS drinking water proposal of 30 ppt is also higher than the EPA’s Health Advisories and what many predict will be the EPA’s proposed enforceable drinking water limit. Future legal arguments challenging the EPA will likely say that the EPA is acting by ignoring the science and putting politics over the merits of scientific endeavor.

Nevertheless, whether the arguments challenging the EPA are found to be meritorious in litigation or not, the Canadian report will certainly provide ammunition to parties looking to challenge EPA action.

Conclusion

Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. The EPA has also for the first time publicly stated when they expect such regulations to be enacted. These regulations will require states to act, as well (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Beyond drinking water, though, the EPA PFAS Roadmap shows the EPA’s desire to take regulatory action well beyond just drinking water, and companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.

For more Environmental Law News, click here to visit the National Law Review.

The FTC Announces First Health Breach Notification Rule Enforcement Action

On February 1, the Federal Trade Commission (“FTC”) announced enforcement action for the first time under its Health Breach Notification Rule[1]. The complaint against telehealth and prescription drug discount provider GoodRx Holdings Inc. (“GoodRx”), alleges its failure to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google and other companies.

In a first-of-its-kind proposed order, filed by the Department of Justice on behalf of the FTC, GoodRx will be prohibited from sharing user health data with applicable third parties for advertising purposes, and has agreed to pay a $1.5 million civil penalty for violating the rule. The proposed order must be approved by the federal court to go into effect. The Health Breach Notification Rule requires vendors of personal health records and related entities, which are not covered by the Health Insurance Portability and Accountability Act (HIPAA), to notify consumers and the FTC of unauthorized disclosures. In a September 2021 policy statement, the FTC warned health apps and connected devices that they must comply with the rule.

According to the FTC’s complaint, for years GoodRx violated the FTC Act by sharing sensitive personal health information with advertising companies and platforms—contrary to its privacy promises—and failed to report these unauthorized disclosures as required by the Health Breach Notification Rule. Specifically, the FTC claims GoodRx shared personal health information with Facebook, Google, Criteo and others. According to the FTC, since at least 2017, GoodRx deceptively promised its users that it would never share personal health information with advertisers or other third parties. GoodRx repeatedly violated this promise by sharing sensitive personal health information—such as including its users’ prescription medications and personal health conditions.

The FTC also alleges GoodRx monetized its users’ personal health information, and used data it shared with Facebook to target GoodRx’s own users with personalized health and medication-specific advertisements on Facebook and Instagram.

The FTC further alleges that GoodRx:

Failed to Limit Third-Party Use of Personal Health Information: GoodRx allowed third parties it shared data with to use that information for their own internal purposes, including for research and development or to improve advertising.
Misrepresented its HIPAA Compliance: GoodRx displayed a seal at the bottom of its telehealth services homepage falsely suggesting to consumers that it complied with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a law that sets forth privacy and information security protections for health data.
Failed to Implement Policies to Protect Personal Health Information: GoodRx failed to maintain sufficient policies or procedures to protect its users’ personal health information. Until a consumer watchdog publicly revealed GoodRx’s actions in February 2020, GoodRx had no sufficient formal, written, or standard privacy or data sharing policies or compliance programs in place.

In addition to the $1.5 million penalty for violating the rule, the proposed federal court order also prohibits GoodRx from engaging in the deceptive practices outlined in the complaint and requires the company to comply with the Health Breach Notification Rule. To remedy the FTC’s numerous allegations, other provisions of the proposed order against GoodRx also:

Prohibit the sharing of health data for advertising: GoodRx will be permanently prohibited from disclosing user health information with applicable third parties for advertising purposes.
Require user consent for any other sharing: GoodRx must obtain users’ affirmative express consent before disclosing user health information with applicable third parties for other purposes. The order requires the company to clearly and conspicuously detail the categories of health information that it will disclose to third parties. It also prohibits the company from using manipulative designs, known as dark patterns, to obtain users’ consent to share the information.
Require the company to seek deletion of data: GoodRx must direct third parties to delete the consumer health data that was shared with them and inform consumers about the breaches and the FTC’s enforcement action against the company.
Limit Retention of Data: GoodRx will be required to limit how long it can retain personal and health information according to a data retention schedule. It also must publicly post a retention schedule and detail the information it collects and why such data collection is necessary.
Implement a Mandated Privacy Program: GoodRx must put in place a comprehensive privacy program that includes strong safeguards to protect consumer data.

For more Cybersecurity and Privacy Legal News, click here to visit the National Law Review

FOOTNOTES

[1] 16 CFR Part 318

FDA’s Digital Health High Notes from 2022

There has been a lot of discussion lately of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023 (you can find our blog post on it here). As important as these kinds of future reforms are to medical product developers, we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA) and to reflect on the transformations that have been taking place at the agency as a result of the rapid pace of innovation in the field. The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things, although FDA’s digital health policies generally remained consistent. In this post, we summarize the agency’s key actions in the digital health space in 2022.

Expanding into Extended Reality

Over the past few years, FDA has started a number of initiatives to explore the use of virtual, mixed, and augmented reality (the agency typically uses the term “extended reality” to cover all types of immersive digital systems) as therapeutic devices for use by patients in clinical environments and at home. The agency granted marketing authorization to two virtual reality devices for patient use, EaseVRx for chronic pain (de novo classification) and Luminopia One for treatment of lazy eye in children, in 2021 and the CureSight system, also for lazy eye in children, in 2022. It is also conducting multiple internal research projects on medical extended reality within the Center for Devices and Radiological Health (CDRH).

In conjunction with its internal research, FDA is engaging health care professionals and the industry to learn about possible benefits, as well as the risks and limitations, of medical extended reality systems to guide future decisions about the therapeutic and clinical uses of such devices. A meeting of FDA’s Patient Engagement Advisory Committee in July 2022 provided an opportunity for the agency to hear from experts and researchers in the field of extended reality and its uses, as well as companies developing medical extended reality devices and patients who have experienced such devices. The materials from the meeting are available here.

FDA also published a list of medical extended reality devices that have received marketing authorization on its website devoted to the Digital Health Center of Excellence (DHCoE), which is part of CDRH.

Application of extended reality technology and the metaverse to medicine is an exciting area of development, and we expect FDA to continue to be active in the space and to develop formal policies and guidance on extended reality devices in the near future.

Precertification Pilot Ends with Uncertain Future

FDA’s Software Precertification Pilot Program, launched in 2017 to explore innovative methods and approaches to regulating software as a medical device (SaMD), officially ended in September 2022 (see our previous posts on the Precertification program here and here). Although FDA was able to glean some key insights from the pilot, including a better understanding of SaMD manufacturer practices throughout the product life cycle, including design, development, and management of SaMD products, the agency ultimately admitted that it had encountered significant challenges in implementing the pilot program. Such challenges included:

limited statutory authorities, which hindered FDA’s ability to gather consistent and harmonized information on manufacturer practices and SaMD performance;
focusing only on SaMD for De Novo classification, which limited the number of eligible devices and created issues for testing pilot-specific special controls; and
the small number of participants (only nine SaMD manufacturer were accepted to the pilot program).

You can read FDA’s final report from the pilot program here.

FDA may use its observations from the pilot program when developing new guidance or other policies pertaining to SaMD, but any new rules or guidances must be consistent with the agency’s current statutory authorities. It is very likely that we have seen the end of any FDA software precertification program, unless or until Congress decides to grant the agency specific authority to implement a new or different regulatory regime for SaMD.

Leadership Changes at the Digital Health Center of Excellence

The past year marked a number of watershed changes at the DHCoE, including the departure of Bakul Patel, longstanding CDRH official in many capacities and the first director of the DHCoE, and the naming of a new acting director, Brendan O’Leary. Subsequently, in January 2023, the agency named Troy Tazbaz, former senior vice president at Oracle, as the new director of DHCoE. It will be interesting to see how Mr. Tazbaz, a newcomer to the agency, will direct the DHCoE in further developing the regulatory framework for digital health devices and in building strategic partnerships with industry stakeholders.

Digital Health Guidances

FDA introduced a number of new and revised guidance documents relating to digital health technologies in 2022. The following is a list with brief descriptions of each such agency guidance:

Clinical Decision Support Software (final guidance) – After a long wait (the previous draft version was published in September 2019), FDA issued a final guidance covering clinical decision support (CDS) software devices on September 28, 2022. You can find our analysis of this critical guidance in this previous post. In addition, FDA created some helpful resources to determine the regulations that may apply to a company’s CDS software or other types of SaMD: a CDS software flowchart, and a Digital Health Policy Navigator.
Policy for Device Software Functions and Mobile Medical Applications (revised final guidance) – FDA issued an updated version of this guidance in September 2022 to implement changes consisted with the CDS final guidance.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (draft guidance) – In recent years, FDA has repeatedly emphasized the importance of addressing cybersecurity in medical devices and has made great efforts in keeping its policies and guidance documents aligned with current cybersecurity recommendations. This guidance describes methods for incorporating cybersecurity into the design and development process for connected medical devices (including SaMD) and for maintaining cybersecurity as part of device quality systems throughout the product lifecycle. Once finalized, this guidance will supersede final guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued in October 2014. It is also worth noting that FDORA grants the agency new authorities to require cybersecurity plans as part of premarket submissions for so-called “cyber devices,” which will need to be considered and incorporated into any upcoming final guidance on this topic.
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions (final guidance) & Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions (final guidance) – This pair of final guidances describes FDA’s expectations for information included in premarket notification submissions for CADe devices, and specifically for the design of clinical studies to support marketing authorization of such devices. Many companies have developed, or are interested in developing, software with CADe functionality to detect lesions or abnormalities in radiology images for the purpose of assisting human readers, and with the rapid risk of artificial intelligence/machine learning-based software, some manufacturers may seek to develop CADe software that replaces human readers altogether. These guidances are especially useful for companies developing CADe software and preparing for clinical testing and submission to FDA.
Electronic Submission Template for Medical Device 510(k) Submissions (final guidance) – Although this guidance does not specifically apply to digital health technologies, it represents an important development for all medical device companies, including digital health device manufacturers. FDA released this guidance in conjunction with the announcement that CDRH will accept electronic submissions of device premarket notifications from all applicants using the electronic submission template and resource (eSTAR) tool. The guidance describes the structure of the template (and helpfully cross-references other guidance documents that relate to each section of the template). FDA has designated October 1, 2023 as the date of full transition to electronic submission for premarket notifications, meaning that FDA will no longer accept eCopies of premarket notification submissions for filing and review as of that date.

As the preceding list highlights, digital health is an active and rapidly advancing field both in the private sector and at FDA. We will continue to monitor and report on notable developments in terms of regulatory policies affecting developers and investors in the broader field.

For more Food and Drug Legal News, click here to visit the National Law Review

Was This The Least Transparent Report In SEC History?

Professor Alexander I. Platt at the University of Kansas School of Law has just released a draft of a forthcoming paper that takes the Securities and Exchange Commission to task for the lack of transparency in its whistleblower program, Going Dark(er): The SEC Whistleblower Program’s FY 2022 Report Is The Least Transparent In Agency History. As Professor Platt notes in a footnote, I have been complaining about the whistleblower’s lack of transparency since at least 2016. See Five Propositions Concerning The SEC Whistleblower Program. Last summer, I observed that “There is certainly no dearth of irony in a federal agency dedicated to full disclosure cloaking in secrecy a billion dollar awards program”.

Professor Platt offers four possible reasons for the SEC’s lack of transparency: (1) resource constraints; (2) lack of respect for public participation and accountability; (3) data problems; and/or (4) an intent to bury something controversial or embarrassing. My concern is, and has been, that whatever the reason(s), the SEC’s lack of transparency creates an ideal substrate for fraud. Unless the SEC drops its cloak of secrecy and exposes its whistleblower program to public scrutiny, it is highly likely that the next article will be about how the whistleblower program was used and abused.

Article By Keith Paul Bishop of Allen Matkins Leck Gamble Mallory & Natsis LLP

For more SEC and securities legal news, click here to visit the National Law Review.

SUPERBOWL CIPA SUNDAY: Does Samsung’s Website Chat Feature Violate CIPA?

Happy CIPA and Super Bowl Sunday TCPA World!

So, Samsung is under the spotlight with a new CIPA case brought by a self-proclaimed “tester.” You know like Rosa Parks?? Back to that in a bit.

The California Invasion of Privacy Act (“CIPA”) prohibits both wiretapping and eavesdropping of electronic communications without the consent of all parties to the communication. The Plaintiff’s bar is zoning in to CIPA with the Javier ruling.

If you recall, Javier found that “[T]hough written in terms of wiretapping, Section 631(a) applies to Internet communications. It makes liable anyone who ‘reads, or attempts to read, or to learn the contents’ of a communication ‘without the consent of all parties to the communication.’ Javier v. Assurance IQ, LLC, 2022 WL 1744107, at *1 (9th Cir. 2022).

Here, Plaintiff Garcia claims that Defendant both wiretaps the conversations of all website visitors and allows a third party to eavesdrop on the conversations in real time during transmission. Garcia v. Samsung Electronics America, Inc.

To enable the wiretapping, Plaintiff claims that Defendant has covertly embedded software code that functions as a device and contrivance into its website that automatically intercepts, records and creates transcripts of all conversations using the website chat feature.

To enable the eavesdropping, Defendant allows at least one independent third-party vendor to secretly intercept (during transmission and in real time), eavesdrop upon, and store transcripts of Defendant’s chat communications with unsuspecting website visitors – even when such conversations are private and deeply personal.

But Plaintiff currently proceeds in an individual action but if Samsung does not take appropriate steps to fully remedy the harm caused by its wrongful conduct, then Garcia will file an amended Complaint on behalf of a class of similarly aggrieved consumers.

Now back to Civil Rights.

According to this Complaint, Garcia is like Rosa Parks, you know, the civil rights activist. Why?

Well, because “Civil rights icon Rosa Parks was acting as a “tester” when she initiated the Montgomery Bus Boycott in 1955, as she voluntarily subjected herself to an illegal practice to obtain standing to challenge the practice in Court.”

Because Wiretapping and civil rights are similar right??

Disgusted.

The Plaintiff’s bar has no problem muddying the waters to appeal to the courts.

Do better.

CIPA is some dangerous stuff. Websites use chat features to engage with consumers all the time. It seems like it is easier to communicate via chat or text than to sit on a call waiting for an agent – assuming you get an agent. But maybe not?

Stay safe out there TCPA World!

Til next time Countess!! back to the game, GO EAGLES!!! #Phillyproud

Article By Jenniffer Cabrera of Troutman Firm

For more communications, media, and internet legal news, click here to visit the National Law Review.

EU PFAS Ban Should Raise U.S. Corporate Concerns

On February 7, 2023, the European Chemical Agency (ECHA) unveiled a 200 page proposal that would ban the use of any PFAS in the EU. While the proposal was anticipated by many, the scope of the ban nonetheless drew reactions from a myriad of sectors – from environmentalists to scientists to corporations. U.S. based companies that have any industrial or business interests in the EU must absolutely pay close attention to the EU PFAS ban and consider the impact on business interests.

EU PFAS Ban Proposal

The EU PFAS ban currently proposed would take effect 18 months from the date of enactment; however, the ECHA is contemplating phased-in restrictions of up to 12 years for uses that the group considers challenging to replace in certain applications. The proposal is only the inception of the ECHA regulatory process, which next turns to a public comment period that opens on March 22, 2023 and will run for at least six months. ECHA’s scientific committees to review the proposal and provide feedback. Given the magnitude of comments expected and the likely hurdles that the ECHA will face in finalizing the proposal, it is not expected that the proposal would be finalized prior to 2025.

The EU PFAS ban seeks to prohibit the use of over 10,000 PFAS types, excluding only a sub-class of PFAS that have been deemed “fully degradable.” The proposal indicates: “…the restriction proposal is tailored to address the manufacture, placing on the market, as well as the use of PFASs as such and as constituents in other substances, in mixtures and in articles above a certain concentration. All uses of PFASs are covered by this restriction proposal, regardless of whether they have been specifically assessed by the Dossier Submitters and/or are mentioned in this report or not, unless a specific derogation has been formulated.” (emphasis added) Several specific types of uses and consumer product applicability would be included in the first phase of the proposed ban, including cosmetics, food packaging, clothing and cookware. This first phase of the ban implementation would include uses where alternatives are known, but not yet widely available, which is the reason why the first phase would take effect within 5 years. The second phase of the ban anticipates a 12 year period of time for ban implementation and encompasses uses where alternatives to PFAS are not currently known. Significantly for U.S. business, the proposed ban includes imported goods.

Impact On U.S. Companies

In 2022, U.S. companies exported just shy of $350 billion in goods to the EU. In many instances, companies do not deliberately, intentionally, or knowingly add or utilize PFAS in finished products that are sent to the EU. However, PFAS may be used in manufacturing processes that inadvertently contaminate goods with PFAS. In addition, many U.S. companies rely on overseas companies for supply chain sourcing. Quite commonly, supply chain sources outside of the U.S. do not voluntarily provide chemical composition information for components or goods that they supply. Inquiring of those companies for such information, or certifications that the good contain no PFAS, can be extremely difficult. Getting overseas companies to provide such information often proves impossible and even when certifications are made, the devil may be in the details in terms of what is actually being certified. For example, certifying that goods contain “no hazardous substances” or “no hazardous PFAS” sound reassuring, but by what measure of “hazardous” is the statement being made? Under what country’s regulations? Using which scientific definition? The result of all of these complexities may be that many U.S. based companies need to test their products themselves, which not only increases time to market issues and financial costs associated with production, but also risks to the companies doing business in the U.S. that they may open themselves up to environmental pollution or personal injury lawsuits by conducting such testing. In addition, alternatives may not be as cost effective as PFAS, which impacts businesses and has the potential trickle-down impact of passing some of the costs on to consumers.

While debate continues in the U.S. as to the scientific validity of the “whole class” approach to regulating PFAS (of which there are over 12,000 types according to the EPA), the EU PFAS ban leapfrogs the U.S. debate stage and goes directly to proposing a regulation that would embrace such a “whole class” regulatory scheme. Without a doubt, chemical manufacturers, industrial and manufacturing companies, and some in the science community are expected to strenuously oppose such an approach to regulations for PFAS. The underlying arguments will follow ones advanced and debated already in the U.S. – i.e., not all chemicals act identically, nor have the vast majority of PFAS been shown to date to present health concerns. Proper scientific method does not permit sweeping attributions of testing on legacy PFAS like PFOA and PFOS to be extrapolated and applied to all PFAS. The EU’s response to this via their proposal is that the costs of remediating PFAS from the environment are significant enough that it warrants regulating PFAS as a class to avoid costly, decades-long, and potentially repetitive remediation work in the EU.

Conclusions

It is of the utmost importance for businesses to evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate these compounds in the U.S. and abroad. One major point of contention among members of various industries is whether to regulate PFAS as a class or as individual compounds. While each PFAS compound has a unique chemical makeup and impacts the environment and the human body in different ways, some groups argue PFAS should be regulated together as a class because they interact with each other in the body, thereby resulting in a collective impact. Other groups argue that the individual compounds are too diverse and that regulating them as a class would be over restrictive for some chemicals and not restrictive enough for others.

Companies should remain informed so they do not get caught off guard. States are increasingly passing PFAS product bills that differ in scope. For any manufacturers, especially those who sell goods overseas, it is important to understand how the various standards among countries will impact them, whether PFAS is regulated as individual compounds or as a class. Conducting regular self-audits for possible exposure to PFAS risk and potential regulatory violations can result in long term savings for companies and should be commonplace in their own risk assessment.

For more Environmental Law news, click here to visit the National Law Review

Breaking News – Hermès Makes History With First NFT Trademark Trial Victory

A New York City jury just returned a verdict in favor of Hermès in a historic dispute between the luxury fashion house and digital artist Mason Rothschild over Hermès’ alleged trademark rights relating to Hermès’ famous Birkin handbag. The jury awarded Hermès $133,000 in total damages for trademark infringement, dilution, and cybersquatting.

The jury finding that the First Amendment did not shield Rothschild from liability in connection with his MetaBirkins NFTs project is significant, particularly as this matter involved the first trial by jury to consider the interplay of free speech and trademark protection in the context of NFTs. This decision, which may be appealed, provides guidance for artists, brands, and others seeking ingress into metaverse, including to what extent “real world” intellectual property rights apply to and may be enforced in virtual worlds.

***Haute*-ly Contested NFTs**

Throughout the dispute over this past year, the parties have contested each other’s characterization of the MetaBirkins NFTs. To Hermès, the MetaBirkins NFTs are merely the instruments of a “digital speculator” looking to exploit one of its most exclusive assets via NFTs. In contrast, Rothschild argues that the MetaBirkins NFTs project, a series of 100 NFT images that depict a range of reimagined Hermès Birkin bags featuring a variety of colorful fur, is digital art and a commentary on the famed BIRKIN bag, consumerism, and animal cruelty within the fashion industry. As a result, he argues that the MetaBirkins NFTs are artistic works that should be shielded from liability under the free speech principles of the First Amendment of the Constitution. The nine-member jury disagreed, finding that the MetaBirkins NFTs were more like commodities that are subject to trademark and other laws, rather than artwork. A factor that may have influenced the jury’s decision was evidence suggesting that Rothschild may have seen the MetaBirkins NFTs as a “cash cow.” This may have cast doubt on the authenticity of his characterization of the MetaBirkins NFTs as an art project.

The Test is Yet to Come

Although the jury found the MetaBirkins NFTs to be infringing, the final disposition of this dispute remains pending with the possibility of appeal. Given the importance of the issues at stake, the outcome of this case is bound to be subject to debate regardless of any appeal.

Moreover, while no NFT-specific legal test appears to have emerged from this case and the legal landscape for IP in the Metaverse (and beyond) continues to lack clear guidance, this case has nonetheless provided insight on how courts (and juries) may view the interplay of IP and NFTs. The ultimate outcome of this landmark case is likely to form the basis of the emerging law involving IP rights and NFTs.

For more Intellectual Property Legal News, click here to visit the National Law Review

Available Options for Completing Form I-9 in Remote-Work Scenarios

The American Immigration Lawyer’s Association (AILA), through its Verification and Documentation Liaison Committee (“Verification Committee”) recently issued an FAQ compiling updated information related to employment verification (I-9) compliance requirements during the COVID-19 Pandemic.

The FAQ addresses the viable options for completing the Form I-9 in remote-work scenarios and the most current developments in each type of process. Below are the main takeaways:

Process 1: In-person New Employee and HR/Admin Document Review: HR/Admin timely reviews the employee’s identity and employment authorization documents in the employee’s physical presence. Where employers have fully returned to in-office operations, or where they are no longer maintaining COVID-19 precautions, they must complete an in-person review of Form I-9.

Process 2: “Remote Hire” In-Person New Employee & Employer Authorized Representative Document Review: This is the so-called “Remote Hire” process, typically used in situations of on-boarding and new remote employee. Note that this is still an in-person document review conducted by a third party designated by the employer who acts as the agent. Also note that this process is not restricted only to employees based at remote locations but can also be used in any situation. Since the employer bears the liability for the agent’s errors it is best practice for the employer to train and/or provide instructions to the agents as well as perform a detailed review upon receipt of the completed Form I-9.

Process 3: Limited Temporary Option: HR/Adm’s Electronic Document Review: The virtual review option was first implemented March 20, 2020, and has been extended multiple times. The current extension expires July 31, 2023. With this process, HR/Adm timely reviews the employee’s identity and employment authorization documents electronically, not in the employee’s physical presence, but via video link, fax, email, etc.

Who can benefit from this option? The U.S. Immigration and Custom Enforcement (ICE) confirmed to the Verification Committee the general rule in applying this option:

Before April 1, 2021, the temporary I-9 option was available if a business was operating 100% remotely as a result of the pandemic. If it was not, the in-person verification for Form I-9 was required. ICE acknowledged, however, that the Agency will handle audits and future enforcement on a case-by-case basis. Employers do not need to have 100% of their workforce working remotely to take advantage of the virtual option if the employer has a record supporting that the virtual review option was necessitated by the pandemic.
On or after April 1, 2021, the temporary virtual document review option is available, but only where the remote employment is a result of COVID-19-related precautions. Employers hiring “true remote” employees should conduct in-person reviews as they would have prior to the COVID-19 virtual review option being offered.

While virtual review provides a practical alternative to the in-person review, there are additional requirements in this process in order to maintain compliance:

Create and retain a written document that captures the remote onboarding and telework policy in place when this option is used for any Form I-9 created under this process;
Retain copies of the documents presented, as per the original guidance issued by ICE Note that security of sensitive personal information must be maintained, and the company should work with its information-security team regarding the transmission and/or capture of personal information in these situations;
Add “COVID-19” in the Additional Information field/box on Section 2 of the Form I-9;
Tell the employee that no later than three business days of cessation of this temporary electronic document review option or once the employee commences non-remote employment on a regular, consistent, or predictable basis (whichever is earlier), an in-person meeting and physical inspection of the document(s) will occur;
Within three business days of such a date, coordinate the in-person meeting and physical inspection of the document(s); and,
Add “documents physically examined,” date and initial in Section 2 Additional Information field/box, or to Section 3 of Form I-9, as appropriate.

Importantly, the virtual review process requires the employer to “perfect” the Form I-9 with an in-person meeting at a future date.

The Department of Homeland Security (DHS) is currently reviewing the regulatory framework for document review in considering making virtual review a permanent option for I-9 compliance. DHS published a Notice of Proposed Rulemaking in the Federal Register and, since November 2022, has been reviewing comments. Simultaneously, ICE has ramped up audits and investigations as the pandemic has waned. Therefore, employers should maintain a fluid line of communication with their attorneys and employees to avoid any compliance issues.

Article By Caterina Cappellari of Greenberg Traurig, LLP

For more immigration legal news, click here to visit the National Law Review.

EEOC Announces Enforcement Priorities for 2023-2027

On Tuesday January 10, 2023, the Equal Employment Opportunity Commission (“EEOC”) publicly released its Draft Strategic Enforcement Plan (“SEP”) for fiscal years 2023-2027. The SEP describes the EEOC’s top enforcement priorities, making it critical information for employers around the country.

The Draft SEP sets out the EEOC’s six subject matter priorities for fiscal years 2023-2027:

Eliminating Barriers in Recruitment and Hiring;
Protecting Vulnerable Workers and Persons From Underserved Communities From Employment Discrimination;
Addressing Emerging and Developing Issues;
Enforcing Equal Pay Laws;
Preserving Access to the Legal System; and
Preventing Harassment Through Systemic Enforcement and Targeted Outreach.

With respect to the first category, “Eliminating Barriers in Recruitment and Hiring,” the Draft SEP states the EEOC will focus on “the use of automatic systems, including artificial intelligence or machine learning, to target advertisements, recruit applicants, or make or assist in hiring decisions where such systems intentionally exclude or adversely impact protected groups.” The Draft SEP also expressly emphasizes the “lack of diversity” in both the construction and tech industries, noting the EEOC’s priority will typically involve systemic cases, though claims by an individual or small group may qualify for enforcement focus if it raises a policy, practice, or pattern of discrimination. Employers should note the EEOC’s decision to focus on AI and the tech industry demonstrates a heightened priority on remedying and preventing discrimination from automated and electronic screening tools used in hiring practices and employment decisions.

On January 31, 2023, the EEOC held a public hearing titled “Navigating Employment Discrimination in AI and Automated Systems: A New Civil Rights Frontier” where higher education professors, nonprofit organization representatives, attorneys, and workforce consultants prepared statements regarding the EEOC’s new focus.

The Draft SEP includes specific details regarding the types of hiring practices and policies that the agency seeks to scrutinize. For example, the EEOC aims to prevent employers from isolating and separating workers in certain jobs or job duties based on membership in a protected class. The EEOC plans to achieve this goal by identifying vulnerable workers for more focused attention. In addition, the EEOC will scrutinize practices which limit access to work opportunities, such as (1) job postings which either exclude or discourage some protected groups from applying, and (2) denying training, internships, or apprenticeships based on protected status. The Draft SEP also prioritizes preventing employers from denying opportunities to move from temporary to permanent roles.

As for the second category, “Protecting Vulnerable Workers and Persons From Underserved Communities From Employment Discrimination,” the Draft SEP expands the ”vulnerable worker priority” to include categories of workers who, according to the EEOC, “may be unaware of their rights . . . or reluctant or unable to exercise their legally protected rights.” These categories include workers with intellectual and developmental disabilities, individuals with arrest or conviction records, LGBTQI+ individuals, pregnant workers, individuals with pregnancy-related medical conditions, temporary workers, older workers, individuals employed in low-wage jobs, and persons with limited literacy or English proficiency. The Draft SEP proposes that district EEOC offices and the agency’s federal sector program will identify vulnerable workers and underserved communities in their districts or within the federal sector for focused attention. Employers should be aware that the “vulnerable workers” focused on under this category may vary based on location.

The Draft SEP’s third category, “Addressing Emerging and Developing Issues,” includes a focus on (1) qualification standards and inflexible policies or practices that discriminate against individuals with disabilities, (2) protecting individuals affected by pregnancy, childbirth, and related medical conditions under the Pregnancy Discrimination Act, the Americans with Disabilities Act, and the newly enacted Pregnant Workers Fairness Act, (3) employment issues relating to backlash in response to local, national, or global events, and (4) “employment discrimination associated with the COVID-19 pandemic.” The priorities for the EEOC’s COVID-19-related enforcement in this category include:

pandemic related harassment, particularly against individuals of Asian descent;
unlawful denials of accommodations to individuals with disabilities;
unlawful medical inquiries, improper direct threat determinations, or other discrimination related to disabilities that arose during or were exacerbated by the pandemic; and
discrimination against persons who have an actual disability or are regarded as having a disability related to COVID–19, including individuals with long COVID, and pandemic-related caregiver discrimination based on a protected characteristic

With respect to the fourth category, “Enforcing Equal Pay Laws,” the Draft SEP sets out a focus on pay discrimination based on any protected category. The Draft SEP also states the EEOC may use “Commissioner Charges and directed investigations” to enforce equal pay. Notably, the EEOC has been hesitant to use Commissioner Charges in the past, as they comprise of less than 1% of annual charge volume since 2015. However, Commissioner Charges may become necessary to identify and remedy discrimination based on artificial intelligence or machine learning, as outlined in the first category.

The fifth and sixth categories remain largely unchanged from prior EEOC SEPs. The focus for the fifth category, preserving access to the legal system, will continue to identify and target (1) overly broad waivers, releases, non-disclosure and non-disparagement agreements; (2) improper mandatory arbitration provisions; (3) employers failure to keep proper records; and (4) improper retaliatory practices. As for the final category, the EEOC will continue to focus on promoting comprehensive anti-harassment programs and practices.

The EEOC will vote on a final version of the SEP following the public notice and comment period, which concludes on February 9, 2023.

Article By Dan Syed of Sheppard, Mullin, Richter & Hampton LLP

For more labor and employment legal news, click here to visit the National Law Review.

The National Law Forum

Passport Entry Date Stamps to Be Eliminated

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