Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK. Our speakers review the major legal developments for medical devices in the last few years, including the issues surrounding the
Administration Proposes Increased Childcare Tax Credit for Employers
As we have been discussing in recent blog posts, the Treasury Department released its Fiscal Year 2024 General Explanations of the Administration’s Revenue Proposals, commonly called the “Green Book,” on March 9, 2023. This year’s Green Book includes a proposal that both employers and employees are likely to embrace: an enhanced tax credit for employers that provide childcare.
Iowa Passes Comprehensive Privacy Statute
On March 15th, the Iowa legislature passed S.F. 262 (the “ICDPA”), making it the sixth U.S. state to pass a comprehensive state privacy statute. The Iowa statute most closely resembles the Utah Consumer Privacy Act (“UCPA”), though it also shares some similarities with the approaches adopted in Virginia, Colorado, and Connecticut. The statute will next go to the governor’s desk for signature. If signed into law, the ICDPA would take effect on January 1, 2025.
Eleventh Circuit to Reconsider Standing Decisions
The Eleventh Circuit is poised to reconsider recent standing decisions favorable for defendants seeking to invoke Article III’s standing requirements to defeat class certification.
At issue is the Eleventh Circuit’s July 2022 decision in Drazen v. Pinto, holding that (i) all class members must have Article III standing in order to receive individual damages (whether through a settlement or otherwise), and (ii) the standing determination is decided under Eleventh Circuit law, even where certain class members do not reside within the Eleventh Circuit’s geographic boundaries and may have standing under other circuit precedent. 41 F.4th 1354, 1360–61 (11th Cir. 2022). The dispute in Drazen arose in the context of the Telephone Consumer Protection Act (“TCPA”), and addressed both unwanted phone calls and text messages. While a settlement in Drazen was pending, the Eleventh Circuit held in Salcedo v. Hanna, 936 F.3d 1162, 1168 (11th Cir. 2019), that, contrary to precedent in other circuits, a single unwanted text message was not sufficient to give rise to Article III standing under the TCPA. Because the panel was bound by Salcedo, and because the proposed class definition in the Drazen settlement included individuals whose sole harm was an unwanted text message, those individuals did not have standing. The panel therefore vacated the district court’s approval of the settlement.
The Commission adopts its Temporary Crisis and Transition Framework relaxing State aid rules as a response to the US Inflation Reduction Act
As part of “A Green Deal Industrial Plan for the Net Zero Age” to respond to the US Inflation Reduction Act (IRA) (see our alert), the European Commission (the “Commission”) adopted on 9 March 2023 its Temporary Crisis and Transition Framework for State Aid measures to support the economy following the aggression against Ukraine by Russia (the “TCTF”). The text amends the Temporary Crisis Framework last amended on 28 October 2022 (see our blog).
These are the three most important things you need to know about the TCTF:
- To avoid that an investment would be located outside the European Economic Area (EEA), EU countries may support investments in the manufacturing of relevant equipment for the transition towards a net-zero economy, such as batteries, solar panels, wind turbines, heat pumps, carbon capture usage and storage (CCUS), as well as their key components and critical raw materials necessary for their production. They may even grant aid matching foreign subsidies to support those investments, provided that they are located in the poorer areas of the EU.
- EU countries’ possibilities to grant aid for accelerating the rollout of renewable energy are extended to any renewable technologies, including hydropower, and no longer require a bidding process to select the aided projects that are considered as less mature.
- The TCTF is not a subsidy program, and it is up to EU Member States to provide public funding.
Aid to cover investment costs for the production of relevant equipment for the transition towards a net-zero economy
UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation
NTIA Seeks Public Comment on the Development of a National Spectrum Strategy and Spectrum-Sharing “Pipeline”
Yesterday, the National Telecommunications and Information Administration (NTIA) issued a Request for Comment that seeks input on a “National Spectrum Strategy,” which would include a plan to study federal spectrum usage to identify spectrum that could be reallocated or repurposed to commercial or shared federal/commercial use. This National Spectrum Strategy also would include a process for identifying the spectrum bands best suited for repurposing (a “Spectrum Pipeline”). NTIA seeks input in creating a Spectrum Pipeline for the next decade, with the goal of identifying at least 1,500 megahertz of spectrum to study for potential repurposing to meet the future requirements of both commercial and federal users.
HHS Releases Guidance to Help Healthcare Organizations Align with the NIST Cybersecurity Framework
On March 8, 2023, the United States Department of Health and Human Services (“HHS”), through the Administration for Strategic Preparedness and Response and the Health Sector Coordinating Counsel Joint Cybersecurity Working Group, released an updated version of its Cybersecurity Framework Implementation Guide (the “Guide”) “to help the public and private health care sectors prevent cybersecurity incidents.” Specifically, the Guide aims to help healthcare organizations leverage the NIST Cybersecurity Framework to “determine their cybersecurity goals, assess their current cybersecurity practices, or lack thereof, and help identify gaps for remediation.”
Losing Less than a Penny Suffices for Standing for Class Certification, the Ninth Circuit Rules
The Ninth Circuit recently held that a class could be certified with class members who lost less than a penny of interest. But it also held that where some class members may have lost nothing at all, the district court must take a hard look at whether the predominance requirement has been met.
So the Auditor Says You Violated CAS? Remember, Your Business Judgment Matters When Determining Compliance
Contractors often assume that government auditors have special authority to interpret the Cost Accounting Standards. That assumption is easy to understand — auditors frequently take the position that there is just one “right” way for a company to do its contract cost accounting, based on how other companies do things. But contractors should know that CAS is flexible and generally gives them options about how to comply, based on the circumstances of their business. In short, a contractor’s business judgment matters, and contractors can use it to push back on auditors who take an overly rigid view of CAS.