On May 18, 2023, the Supreme Court of the United States issued a unanimous decision in the case of Amgen Inc. et al. v. Sanofi, et al., No. 21-757. After a nine-year saga, beginning when Amgen sued Sanofi for allegedly infringing two of its patents in 2014, the Supreme Court held that Amgen’s asserted patents failed to satisfy the enablement requirement under 35 U.S.C. § 112(a), and are thus invalid.
Continue Reading SCOTUS: “The More a Party Claims for Itself the More it Must Enable”
New York Attorney General Letitia James recently published a guide to help companies in preparing their data security programs and responding to data security incidents. The security program recommendations are paired with highlights from recent investigations by the Attorney General that provide valuable insights into what the Attorney General views as data security pitfalls that should be remedied.
Continue Reading New York AG Releases Guide for Business Data Security
With the Medicare Comprehensive Error Rate Testing program projected error rate for skilled nursing facilities (SNFs) showing a significant increase in 2022 (15.1%, up from 7.9% in 2021), the Centers for Medicare and Medicaid Services (CMS) has instructed each of its Medicare Administrative Contractors (MACs) that review SNF Medicare claims to initiate a five-claim probe and educate medical review for each SNF in the MAC’s jurisdiction.
Continue Reading CMS Takes Steps to Lower SNF Medicare Payment Error Rates
As an update to our previous post, on Monday, May 15, 2023, California Governor Gavin Newsom signed into law Assembly Bill 112 (“AB 112”), which is designed to provide critical relief to qualified struggling hospitals across the state. AB 112 creates the $150 million Distressed Hospital Loan Program, which is intended to provide zero-interest cash flow loans to qualified not-for-profit and public hospitals experiencing financial distress, as well as qualified government entities representing hospitals that closed after January 1, 2022. Hospitals across California, particularly those in underserved areas or serving vulnerable populations, have been hit hard by rising costs,
Continue Reading Update to: A Lifeline Amidst Turbulent Times: California Lawmakers Approve Emergency Loans for Struggling Hospitals
Between Russia’s invasion of Ukraine and growing U.S. tensions with China, U.S. export controls are in the spotlight like never before. As if regulators have not already made it clear enough, recent statements and actions indicate that the enforcement crosshairs are squarely on the semiconductor industry.
Continue Reading Watching the Detectives: Export Control Enforcement Trends Upward
On May 16, 2023, President Joseph Biden vetoed the Congressional Review Act (CRA) resolution that would have nullified the temporary moratorium on the collection of antidumping and countervailing (AD/CVD) duties on imports of certain solar cells and modules from Cambodia, Malaysia, Thailand, and Vietnam. See House Joint Resolution (H.J. Res.) 39.
Continue Reading Biden Veto Maintains Solar Tariff Moratorium
On May 5, the CFPB announced that it has sent payments totaling more than $22 million to approximately 6,500 individuals who were harmed by a Maryland-based debt-relief and credit-repair company that marketed and sold debt-relief and credit-repair services nationwide from 2016 to 2020. In 2021, a federal court entered a stipulated final judgement and order against the company and its executives for allegedly deceiving consumers into hiring the company with false promises to lower or eliminate their credit-card debts and to improve their credit scores in violation of consumer financial protection laws.
Continue Reading CFPB, FTC Continue Crack Down on Debt Relief Schemes
EyeMed recently entered into a settlement with the Attorneys General of Oregon, New Jersey, Florida and Pennsylvania around a 2020 breach of an EyeMed email account that contained the data of more than 2 million individuals. As we previously reported, EyeMed entered into settlement with NYDFS over this breach in October of 2022.
AI-based code generators are a powerful application of generative AI. These tools leverage AI to assist code developers by using AI models to auto-complete or suggest code based on developer inputs or tests. These tools raise at least three types of potential legal issues:
AI-based code generators are a powerful application of generative AI. These tools leverage AI to assist code developers by using AI models to auto-complete or suggest code based on developer inputs or tests. These tools raise at least three types of potential legal issues:
On May 1, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced two investigations of hospitals that failed to offer necessary stabilizing care to a pregnant individual experiencing an emergency medical condition (“EMC”), in violation of the Emergency Medical Treatment and Labor Act (“EMTALA”). The U.S. Department of Health and Human Services (“HHS”) released a public statement and a letter to hospitals and provider associations, emphasizing the obligations of Medicare-participating hospitals’ under EMTALA, including stabilizing treatment, like abortion care, or an appropriate transfer. These investigations represent the first EMTALA enforcement action related to abortion emergency care since the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (“Dobbs”).
Continue Reading EMTALA and Pregnancy Care Remains a Federal Enforcement Priority
The Tennessee governor has signed Tennessee’s comprehensive privacy law, which as we have indicated will go into effect July 1, 2025. As initially proposed, the law would have been effective July 1, 2024, and would have required companies have a written privacy program compliant with NIST’s privacy framework. That obligation -which is unlike that which exists in any other state’s general privacy law- has been toned down in the final version signed by the governor.
Tennessee, like other states, has no right of action for violations of the law, but does provide statutory penalties of up to $7,500 per violation.
Continue Reading Another Governor Signs: Tennessee Volunteers to Join the Privacy Patchwork
AI-based code generators are a powerful application of generative AI. These tools leverage AI to assist code developers by using AI models to auto-complete or suggest code based on developer inputs or tests. These tools raise at least three types of potential legal issues:
On April 20, Washington Governor, Jay Inslee, signed into law HB 1311 creating new regulations for credit repair organizations (CROs) in the state. Among other things, the new law outlines requirements for CROs, which include the following:
On May 1, NYDFS settled with a cryptocurrency trading platform over the company’s cybersecurity deficiencies, resulting in a consent order and $1.2 million fine for the crypto company. NYDFS alleged “multiple deficiencies in the Company’s cybersecurity program” discovered during NYDFS examinations in 2018 and 2020. The examinations prompted an investigation, ultimately leading to the consent order and the fine.
Continue Reading New York Settles with Crypto Company, Proposes Crypto Legislation
Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors are still engaging in conduct that the rules were intended to discourage, in part due to the lack of enforcement rules.
Continue Reading Laboratory and Pathology Information Blocking Concerns