Womble Bond Dickinson (JD Supra United States)

1989 results for Womble Bond Dickinson (JD Supra United States)

  • Considerations for Implementing AI/ML in Your Business

    Business technology changes constantly, and every solution we implement has a lifespan. You may have been a Microsoft shop for the past thirty years, but your company is not currently operating on Windows 95. To run a successful company, you need to find advantages anywhere possible.

  • Addressing Government Subpoenas

    Subpoenas from the government can often be viewed as unwelcome intrusions into the business of a passive custodian and its accountholders. With a few fundamentals in place, though, custodians can use subpoenas as an opportunity to show themselves an ally to the regulatory community, to assist in protecting accountholders from fraud, and to test their own internal practices to identify areas that...

  • Inventor Assignments – Problems on the Horizon

    Two weeks ago, the Supreme Court heard oral argument in Minerva Surgical Inc. v. Hologic, Inc. over the rather arcane issue of assignor estoppel. Stop - I can figuratively feel your eyes rolling after reading the phase “assignor estoppel” – “why would I care about that!?” Well, the potential validity of patents developed by your employees that are assigned to (i.e., owned by) your company are...

  • FDA Signals Reporting Requirements for Clinical Trials Enforcement with First-ever Notice of Noncompliance to Drug Maker

    On April 28, 2021, the US Food and Drug Administration (FDA) issued the first-ever Notice of Noncompliance after the drug maker did not comply with its legal reporting obligations for clinical trials upon earlier receipt of a Pre-Notice of Noncompliance from the agency. FDA notified the company that it has 30 days to correct the issue or face up to $10,000 per day in civil monetary penalties or...

  • The Churl Nextdoor

    What gets us into trouble is not what we don’t know. It’s what we know for sure that just ain’t so. (Attributed (probably wrongly) to Mark Twain) - A funny thing happened to me on the way to this blog: I learned that what I thought I knew about moderation of online content and Section 230 of The Communications Decency Act just ain’t so.

  • Schrems II, Reverse Schrems, and Schrems with a Half-Twist from the Pike Position

    Just when you thought it was safe to send your data across the water, the distinctive dorsal fin of Schrems II breaks the surface. The EU, who can barely be convinced that the UK’s data privacy law is “adequate” despite the UK developing its rules as part of the EU for the past 25 years, decides that US business should be punished because the US government monitors some data for...

  • Regulation of Dark Patterns Protects Consumers on the Web

    When I was in college, I attended an old fashioned tent revival show. My roommate was taking a comparative religion class and I accompanied him to a number of spiritually-focused events outside the frame of most college students’ experiences.

  • FDA Suspends Review for Non-COVID-19 In Vitro Diagnostics (IVD) Submissions and Expects Review Delays in Non-IVD Products

    A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.” Dr. Jeff Shuren, Director, CDRH, and Dr. William Maisel, Director, Office of...

  • The Perilous Seas of Prop 65: Safe Harbors Should Not Be Controversial

    Should companies be forced to label their products as containing chemicals “known” to cause cancer despite controversial scientific information? A federal court in California doesn’t think so. On March 29, the U.S. District Court for the Eastern District of California granted a preliminary injunction to the California Chamber of Commerce (“the Chamber”), halting new lawsuits by both the State of

  • Windstream Bankruptcy Court Slams Charter Communications for Violating Automatic Bankruptcy Stay, Holds Company in Contempt

    The breadth and scope of the Bankruptcy Code’s automatic stay and the potential cost a company may face for violating the stay made national news last week in a dust-up between two telecom providers, when the U.S. Bankruptcy Court overseeing Windstream’s bankruptcy case ordered Charter Communications to pay Windstream more than $19 million in damages. The automatic stay is triggered immediately...

  • Surveillance is All About the (Software) Brain

    Eyes are important, don’t get me wrong. So are ears, noses, tongues, fingers, balance calibration organs and everything else that feeds that massive brain of yours. Salinity detectors in narwhals, electrical sensors in freshwater bottom feeders, echolocation in bats all provide sensory input that humans couldn’t adequately process. Every beast has its own senses relevant to its own living...

  • Eleventh Circuit Holds Subsequent FCRA Claim Subject to Arbitration Provision Under Terminated Subscriber Agreement

    In Hearn v. Comcast Cable Communications, LLC, the Eleventh Circuit Court of Appeals held that a FCRA claim arising nearly a year after the termination of a subscriber agreement was subject to the arbitration provision included in the terminated subscriber agreement. 2021 WL 1246263 (11th Cir. 2021). Hearn was a Comcast subscriber, subject to a subscriber agreement (the “2016 Subscriber...

  • Virginia Accelerates Adult-Use Cannabis Legalization

    We previously highlighted the Virginia Legislature’s move to legalize adult-use cannabis. This week the Virginia Legislature passed a bill legalizing adult-use cannabis. In doing so, Virginia greatly accelerated the timeline for legalization.

  • BREAKING: Supreme Court Agrees with Facebook that TCPA’s Autodialer Provision is Narrow

    In a potentially game-changing decision, the Supreme Court today unanimously agreed that the TCPA’s definition of autodialer is narrow. Writing for the Court, Justice Sotomayor determined that “Congress’ definition of an autodialer requires that in all cases, whether storing or producing numbers to be called, the equipment in question must use a random or sequential number generator.” Justice...

  • A Strike Against the Sandbox: Practical Results of Oracle v. Google

    If you want to make big money, offer something that people want, but no one else can offer. The Portuguese sourced spices in the Fifteenth Century. Rockefeller locked up East Coast oil distribution in the Nineteenth Century. AT&T was once the only option for phone calls in much of the last century. They made huge profits.

  • The Legislative Battles Have Begun: Markey and Eshoo Vow to “Fix” The Supreme Court’s Facebook “Error”

    Mere hours after the Supreme Court’s historic decision in Facebook v. Duguid was released, the legislative fight to overturn it began. Not surprisingly, leading the charge is Senator Edward J. Markey (D-Mass.), a member of the Senate Commerce, Science, and Transportation Committee, and one of the original authors of the TCPA. In 2019, Senator Markey proposed legislation that would have redefined...

  • Quo Vadis: A Foodie Tale

    Do you know where your last meal came from? Can you trace your vegetables to the field where they were grown? Do you know where the goat whose milk was used to make your feta lives? Why would you even want to know the answers to those questions? Last Fall, the FDA published a proposed Rule titled “Requirements for Additional Traceability Records for Certain Foods” which would add extra record

  • Supreme Court’s Skepticism of NCAA’s Arguments Could Lead to Win for Student-Athletes, Changes in Antitrust Law

    At the tail end of the NCAA tournament, this year’s biggest sports upset may come from an unlikely source—the Supreme Court. In Wednesday’s oral arguments in NCAA v. Alston, Justices from both sides of the ideological aisle seemed uncharacteristically unified in their skepticism of the NCAA’s caps on the “education-related benefits” that colleges provide student athletes. And while the NCAA...

  • FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

    On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” The CARES Act, passed by Congress on March 27, 2020, established OMUFA, FDA’s newest user fee program,...

  • How Your Car Became a Surveillance Weapon

    Your car is spying on you, and you may have invited others to spy on you in the car too. We have long known that connected devices have the capabilities of tracking our movements and behavior to send to unknown data collectors. Most people understand that their smartphone apps have this capability and are capturing information about our lives and sending it to unknown businesses.

  • Federal Agencies Intensify Focus on CARES Act Fraud

    After the Department of Justice charged more than 100 people last year with fraudulently seeking over $360 million in CARES Act emergency loans and other payments, the federal government has taken additional steps this year to combat fraud in federal COVID relief programs. These new efforts include expanding investigations and charging more criminal cases, initiating civil enforcement and...

  • New York to Join in the Legalization of Adult-Use Cannabis

    After years of debate, New York is poised to join a growing number of states, including neighboring New Jersey, in legalizing adult-use cannabis.  Over the weekend, Governor Andrew Cuomo and legislative leaders announced an agreement on legislation to legalize adult-use cannabis.

  • Can US Government Help Improve Broadband?

    What do you think about when we speak of infrastructure? Roads, bridges or even a wall? A key component to this country’s critical infrastructure is broadband connectivity, which has become even more important during the pandemic.

  • Joint Impact Indicators for Impact Investors

    As the impact investing market has grown and continues to grow, so has the need for a unified set of standards for measuring the social, economic and environmental impacts of investments in the market. In an effort to address this need and create a workable and pragmatic industry framework, on March 16, 2021, the International Finance Corporation, the Global Impacting Investing Network (GIIN) and

  • What’s In A Name? How Should Cell-Based Seafood Be Labeled?

    Cell-based or cell-cultured seafood products (seafood products grown in a bioreactor from tissue specimens from fish / seafood) are not yet commercially available, but the FDA is working to decide how they will be labeled. Last October the FDA announced that it was seeking comments from the public to determine what regulatory action it should take to ensure that cell-based seafood products are...

  • FCRA Claim Regarding the Reporting of Charged Off Balances Dismissed for Lack of Article III Standing

    The U.S. District Court for the District of Maryland recently dismissed FCRA claims advanced by a borrower on a charged-off vehicular loan for lack of standing in Deysi Arriaza v. Experian Information Solutions, Inc., et al., Civil No. 20-3073, 2021 WL 1019937 (D. Md, Mar. 17, 2021). After the plaintiff admittedly defaulted on her loan, Toyota Motor Credit Corporation and Experian reported that...

  • Can hashtags get you in trouble?

    They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc. FDA has specific labeling requirements for products and they look at hashtags related to products the same way they evaluate other written labeling.

  • The Era of Retail Biometric AI Crime Has Begun

    Each new technology seems to offer creative tools for both criminals and law enforcement.  Telegraphs and telephones spawned wire and phone fraud. The era of digital networking ushered in the age of hacking. Digital banking allowed distance identity theft.

  • Homing in On a Way Out of Disorders of Consciousness

    People sometimes use the term “brain-dead” flippantly, referring to a clueless co-worker or zoned out gamer, but to families of patients with disorders of consciousness [DoC], it’s no joke. DoC include coma, minimally conscious state, persistent vegetative state, also known as unresponsive wakefulness syndrome, and brain death. The majority of DoC are due to traumatic brain injuries [TBI] which...

  • Computer Science Meets Medicine in Drug Discovery

    AI has the potential to revolutionize healthcare worldwide. In drug discovery, AI has already shown success. Sumitomo Dainippon Pharma and the UK-based AI company Exscientia developed DSP-1181 to treat obsessive compulsive disorder. In clinical trials for treatment of solid tumors, the clinical-stage, AI-powered biotech BERG’s BPM31510 (ubidecarenone) has already been granted Orphan Drug...

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