Top challenges with Compliance Management
Solicitors General Insights: The Tale of Two Washingtons — Regulatory Oversight Podcast
The Capital Ratio Podcast | Entering the US Banking Market
Compliance Tip of the Day: COSO Objective 3 – Control Activities
Solicitors General Insights: The Legal Frontlines in Iowa and Indiana — Regulatory Oversight Podcast
Cannabis Law Now Podcast - Cannabis in the Show Me State: An Interview with BeLeaf Medical's Mitch Meyers
2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition
Compliance Tip of the Day: Board Oversight on Internal Controls
Healthcare Enterprise Risk Management
Understanding MALPB Charters: A Collaborative Approach to Banking Innovation — Payments Pros – The Payments Law Podcast
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — Regulatory Oversight Podcast
The fatal flaws in the 2023 CRA rule
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
From Cell Phones to Tractors: The Right to Repair Movement Drives On — Regulatory Oversight Podcast
AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
AI Legislation: The Statewide Spotlight — The Consumer Finance Podcast
Solicitors General Insights: A Deep Dive With Mississippi and Tennessee Solicitors General — Regulatory Oversight Podcast
Leadership and Innovation at the Illinois AG's Office — Regulatory Oversight Podcast
Navigating the Future of Payment Stablecoins: Legislative Updates and Market Implications — Payments Pros – The Payments Law Podcast
The European Banking Authority (EBA) has published a report and accompanying press release, on its review of the regulatory technical standards (RTS) under the Payment Accounts Directive concerning standardised terminology...more
Three Commission Delegated Regulations supplementing Regulation (EU) 2023/1114 (the EU Markets in Crypto Assets Regulation) (MiCAR) have been published in the Official Journal of the European Union, namely: - Commission...more
The European Securities and Markets Authority (ESMA) has published a consultation paper on draft regulatory technical standards (RTS) on the transparency and integrity of environmental, social and governance (ESG) rating...more
Commission Delegated Regulation 2025/420 has been published in the Official Journal of the EU. This Delegated Regulation supplements Regulation 2022/2554 on digital operational resilience for the financial sector (DORA)...more
Established in 1994, the International Association of Insurance Supervisors (IAIS) is a voluntary membership organisation comprising insurance regulatory authorities, central banks, ministries of finance, and other...more
The European Commission has adopted a Commission Delegated Regulation supplementing the EU Digital Operational Resilience Act with regard to Regulatory Technical Standards on harmonization of conditions enabling the conduct...more
The European Central Bank has published a paper outlining how the European framework for threat intelligence-based ethical red teaming, the TIBER-EU framework, can help competent authorities and financial entities fulfil...more
The European Parliament formally adopted the EU Artificial Intelligence Act (AI Act), a first-of-its-kind comprehensive regulation governing the use of artificial intelligence (AI), on March 13, 2024. While applicable to a...more
In our previous alert “Acquiring or Investing in EU Crypto-Asset Businesses: MiCA’s Impact,” we discussed the impact of the European Union (EU) Markets in Crypto-Assets Regulation (MiCA) on the acquisition or investment in EU...more
On December 8, 2023, EU policymakers reached an agreement on the Artificial Intelligence Act (AI Act). As a standard-bearer for global digital and data governance, the EU has been setting regulatory benchmarks on emerging...more
On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to the final text and knows...more
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more
The advance of the regulation of crypto-assets and crypto-related service providers has been piecemeal in the U.K. The latest round of changes took place in the Money Laundering Regulations 2017 (MLR) on 1 September...more
In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more
The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more
On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more
The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
On 7 January 2020, Directive (EU) 2019/2161 (the "Directive") came into force, setting into motion a swathe of measures aimed at modernizing the existing consumer protection rules, bolstering the level of protection available...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
Whilst political uncertainty may have businesses’ attention fixed, the Hogan Lovells Global Survey on Digital Regulation: ‘A Turning Point for Tech’ suggests that tech companies should be looking elsewhere. During yesterday’s...more
On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more
On 13 September 2019, the European Banking Authority (the “EBA”) updated its guidance in respect of the Securitisation Regulation[1] by publishing an answer to a question submitted to it in November 2018 by the Association...more
In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...more