New EU Cyber Law for the Financial Services Industry with Significant Impact on ICT Service Providers
The new EU Regulation on Digital Operational Resilience for the Financial Sector (DORA) recently entered into force. DORA establishes cybersecurity requirements for information and communication technology (ICT) systems supporting the business processes of financial entities and represents a paradigm shift for the ICT sector. Critical ICT third-party service providers, who are providing services to regulated financial entities, will also be directly regulated under DORA and subject to regulatory supervision by a regulator to be established under DORA (a so-called ‘Lead Overseer’).
U.S. Securities and Exchange Commission Proposes Three Rules Related to Cybersecurity, Reopens Comment for One Rule
On March 15, 2023, the U.S. Securities and Exchange Commission (SEC) proposed three rules related to cybersecurity and the protection of consumer information and reopened the comment period for a proposed cybersecurity rule for investment advisers and funds. This significant action would impose new cybersecurity requirements for several SEC-registered entities, including with respect to these entities’ policies, incident response and notification procedures, and cybersecurity risk management. This Sidley commentary and analysis discusses the key features of each proposal, including new requirements and differences among each of the proposals.
New U.S. FDA Draft Guidance Outlines Path To Faster Modification of AI/ML-Enabled Devices
The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”1 that discusses a “science-based approach to ensuring that AI/ML-enabled devices can be safely, effectively, and rapidly modified, updated, and improved in response to new data.”2 This approach should offer more certainty to industry as FDA’s stated goal is to allow AI/ML-enabled devices to be modified faster in accordance with FDA requirements while being “built to adapt to the data and needs of individual health care facilities” and “adapt to deliver treatments according to individual users’ particular characteristics and needs.”3 Those wishing to comment on the draft guidance should note that the comment period closes on July 3, 2023.
Biden Administration Announces National Cybersecurity Strategy
On March 1, 2023, the Biden administration announced its long-awaited National Cybersecurity Strategy. The strategy is part of the administration’s efforts to bolster and modernize public and private responses to cybersecurity threats.
FCC Proposes Updated Data Breach Reporting Requirements, Comment Period Ongoing
On January 6, 2023, the Federal Communications Commission (the Commission) released a unanimously adopted Notice of Proposed Rulemaking, “In the Matter of Data Breach Reporting Requirements” (Proposed Rule). The Commission sought comments through February 22, 2023 on the Proposed Rule which will update its current data breach reporting rule. Reply comments are due on or before March 24, 2023.
FINRA Issues 2023 Report on Its Examination and Risk Monitoring Program
On January 10, 2023, the Financial Industry Regulatory Authority (FINRA) published its 2023 Report on its Examination and Risk Monitoring Program (the Report).1 The 75-page Report includes four new topic areas for 2023: (1) manipulative trading, (2) fixed income — fair pricing, (3) fractional shares — reporting and order handling, and (4) Regulation SHO.
Digital Health Transformation: A Practical Guide for Life Sciences Companies
In 2022, many if not most pharmaceutical, medical device, and other life sciences companies established strategies to innovate digital health technology complementary to their existing strategic focus. The digital transformation of the life sciences industry is still widely unfolding across the marketplace. In 2023 and beyond, the race is on to launch the next generation of digital health technologies to innovate the delivery of therapies to patients.
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