Jones Day

The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative artificial intelligence ("GenAI") at its initial meeting, receiving stakeholder insight regarding premarket performance evaluation, risk management, and postmarket performance monitoring.

The Situation: The UK Government has published much-anticipated guidance (the "Guidance") on the new corporate offense of failure to prevent fraud (introduced under the Economic Crime and Corporate Transparency Act 2023 ("ECCTA")), which is scheduled to come into force on September 1, 2025.

In France, unlike for instance in the United States or United Kingdom, the scope of attorneyclient privilege is restricted to attorneys-at-law...

The Situation: Germany has no direct equivalent to the U.S. attorney-client privilege, but it offers specific legal protections for in-house counsel...

In Marin Audubon Society v. FAA, the D.C. Circuit held the White House Council on Environmental Quality ("CEQ") lacks authority to issue binding regulations under the National Environmental Policy Act ("NEPA").

As the national implementation deadline for the NIS 2 EU Directive is over, businesses in scope should ensure they will soon be ready to comply with...

“The statutory provisions for inter partes reviews, post-grant reviews, and covered-business method patent reviews caution against overly broad...

The EU Listing Act, approved by the EU Council on October 8, 2024, and entering into force on December 4, 2024, introduces key changes to the EU Prospectus Regulation, offering greater flexibility for issuers of debt securities, including exemptions from certain prospectus requirements, expanded disclosure options, and increased thresholds for prospectus exemptions.

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security,...

The PTAB recently excluded a portion of Duration Media LLC’s (Petitioner) reply declaration for containing improper new evidence in an inter partes...