On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more
Background On 20 February 2023, the United Kingdom’s Financial Conduct Authority (“FCA”) published a discussion paper (DP23/2) on updating and improving the UK regime for asset management (the “Discussion Paper”). As part...more
The discussion paper aims to encourage industry-wide dialogue on sustainability related-governance, incentives, and competence. On 10 February 2023, the FCA published DP23/1: Finance for positive sustainable change:...more
Financial services firms are increasingly reliant upon third-party companies to provide important services, ranging from cloud services and data analytics to machine learning and cash distribution. As these third parties...more
On June 23, 2022, Congressman Patrick McHenry (NC-10), released a discussion draft (“Discussion Draft”) of new legislation set to amend the Gramm-Leach-Bliley Act (GLBA) with the intent to “modernize GLBA to better align...more
On May 26, 2022, the California Privacy Protection Agency (CPPA or the Agency) held a public board meeting to provide updates on the Agency’s rulemaking process. The next day, the CPPA released draft regulations for the...more
The FCA have published the next stage of the Primary Markets Effectiveness Review. They propose that companies who wish to list in the UK would no longer have to choose between two different segments (premium and standard)...more
On 18 May 2022 a draft report on ‘AIFMD II’ was published, containing proposals by a rapporteur presented to the ECON committee. It sets out a list of suggested amendments to the European Commission (the Commission)’s draft...more
On May 17, 2022, the California Division of Occupational Safety and Health (Cal/OSHA) released a revised discussion draft of a proposed regulation for workplace violence prevention in the general industry standards. If...more
In a long-awaited paper, the FRB continues its exploratory approach and emphasizes the need for congressional support. On January 20, 2022, the Board of Governors of the Federal Reserve System (FRB) published its...more
The SFDR and the Taxonomy Regulation: Key Developments and What Firms Can Expect in the Coming Year - Almost a year on from the date on which the European Union’s Sustainable Finance Disclosure Regulation (SFDR) came into...more
On 3 November 2021 the FCA published a discussion paper (DP) seeking views on how best to introduce Sustainability Disclosure Requirements (SDR) for certain asset managers and FCA-regulated asset owners, as well as a...more
Yesterday’s joint Discussion Paper (DP21/2) published by the Bank of England, Prudential Regulation Authority (PRA) and Financial Conduct Authority (FCA, together “the regulators”) on “Diversity and inclusion in the financial...more
Discussion Paper opens debate on potential new rules to improve diversity in financial services. On 7 July 2021, the FCA, the PRA, and the Bank of England published a joint Discussion Paper on diversity and inclusion in...more
The Australian Law Reform Commission (the “ALRC”) has proposed a number of reforms to Australia’s federal corporate criminal liability regime. The entire document bears close examination. In this article, we focus on the...more
The Financial Stability Board has published a discussion paper on financial resources to support CCP resolution and the treatment of CCP equity in resolution. The FSB considers that further evidenced-based guidance is needed...more
The European Commission and the U.K. government published a draft Withdrawal Agreement and an Outline Political Declaration on the framework for the future relationship between the EU and the U.K. The draft Withdrawal...more
UK government publishes Brexit white papers - The UK government has published two white papers, one on the future relationship between the UK and the EU and the other on legislating for the withdrawal agreement between the...more
Following on from the Financial Conduct Authority’s (FCA’s) consumer warning on Initial Coin Offerings (ICOs) in September, the FCA has announced a deeper examination of this area in its Feedback Statement on Distributed...more
In our last post, we looked at the most common protest grounds related to discussions: lack of meaningful discussions, misleading discussions, and unequal discussions. Today we’ll discuss how discussions differ from...more
As Part of an ongoing series, we have previously provided details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program, Medicare therapy caps, and community health...more
On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more
The rise of passive investment strategies and the growing momentum of investment in exchange-traded funds (ETFs) has not gone unnoticed by European regulators. The Central Bank of Ireland (Central Bank) recently released a...more
The Financial Conduct Authority has published a discussion paper on distributed ledger technology (DLT). The FCA is seeking to start a dialogue on the potential for future development of DLT in the markets it regulates. The...more