On August 21, 2023, the Cybersecurity and Infrastructure Security Agency (“CISA”), National Security Agency (“NSA”), and National Institute of Standards and Technology (“NIST”) issued a joint quantum-readiness factsheet (the “Factsheet”) to inform organizations—particularly those that support critical infrastructure sectors—about quantum computing threats and to urge these organizations to begin planning for future migration to
German court strengthens market exclusivity right of orphan drugs and the legal position of their marketing authorization holders
Orphan drugs have a special position under EU pharma laws. Among other things, the EU orphan drug laws grant the marketing authorization holder (MAH) of an orphan drug a 10 year period of so-called “market exclusivity”. According to Article 8(1) of the Regulation (EC) No. 141/2000 on orphan medicinal products, the EU and the EU
Labeling of AI Generated Content: New Guidelines Released in China
On August 25, 2023, China’s National Information Security Standardization Technical Committee (“TC260”) released the final version of the Practical Guidelines for Cybersecurity Standards – Method for Tagging Content in Generative Artificial Intelligence Services (《网络安全标准实践指南——生成式人工智能服务内容标识方法》) (“Tagging Standard”) (Chinese version available here), following a draft version circulated earlier this month.
Corporate Reporting in the UK: The International Sustainability Standards Board
On 26 June 2023, the International Sustainability Standards Board (“ISSB”) published its inaugural International Financial Reporting Standards Sustainability Disclosure Standards (the “ISSB Standards”) (read our previous blog post on this here). In August 2023, the UK Financial Conduct Authority (“FCA”) published Primary Market Bulletin 45, confirming its intentions to update its climate-related disclosures
Brazil’s New Fiscal Framework Approved by Congress
August 28, 2023
- The new fiscal framework introduced by President Lula da Silva in March 2023 was approved by the Brazilian National Congress, the first major legislative victory for the administration.
- Congress made adjustments to the text in order to reduce the framework’s main vulnerability: its over reliance on
Second Circuit Holds that Rule 23(e) Prohibits Presumption of Fairness of Arm’s-Length Negotiated Class Settlements
In Moses v. New York Times Co., 2023 WL 5281138 (2d Cir. Aug. 17, 2023), the Second Circuit vacated and remanded the approval of a class action settlement because the district court applied the wrong legal standard in determining that the settlement was fair. But in doing so, the court reiterated that incentive awards for
FCC Announces Limited Exemption from Forthcoming One-Time Foreign Ownership Disclosure for International Section 214 Licensees
Earlier this week, the Federal Communications Commission (“FCC”) announced a limited exemption from the obligation that holders of international Section 214 authority respond to a forthcoming one-time information request concerning their foreign ownership. The narrow exemption provides relief from the reporting obligation for international Section 214 licensees that have made foreign ownership disclosures to the
July 2023 Developments Under President Biden’s Cybersecurity Executive Order and National Cybersecurity Strategy
This is the twenty-seventh in a series of Covington blogs on implementation of Executive Order 14028, “Improving the Nation’s Cybersecurity,” issued by President Biden on May 12, 2021 (the “Cyber EO”). The first blog summarized the Cyber EO’s key provisions and timelines, and the subsequent blogs described the actions taken by various government agencies to
Key Topics to Watch as Congress Works to Fund Next Year’s DoD Budget
It’s that time of year again: the House and Senate have each passed their respective version of the National Defense Authorization Act for FY 2024 (“NDAA”) (H.R. 2670, S. 2226). The NDAA is a “must pass” set of policy programs and discretionary authorizations to fund Department of Defense (“DoD”) operations. Lawmakers are
The EU e-evidence package is published in the Official Journal
On July 28, 2023, more than five years after the Commission’s original proposal, the EU e-evidence Regulation and Directive were published in the Official Journal of the European Union, signalling the end of the legislative process for this file.
In summary, the Regulation establishes a regime whereby law enforcement authorities (“LEAs”) in one EU Member