New U.S. FDA Draft Guidance Outlines Path To Faster Modification of AI/ML-Enabled Devices
The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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treatments according to individual users’ particular characteristics and needs.”3 Those wishing to comment on the draft guidance should note that the comment period closes on July 3, 2023.
UK GDPR Reform Is Back! Department of Science, Innovation and Technology Introduces New Data Protection and Digital Information Bill
On 8 March 2023, the newly created Department of Science, Innovation and Technology (“DSIT”) introduced the Data Protection and Digital Information (No. 2) Bill. The “Bill” is in substance a re-introduction of the previous Data Protection and Digital Information Bill which was withdrawn from Parliament on the same day as the new Bill was published. The Bill, which has been hailed by the UK Government as one that will “save billions” and “cut down pointless paperwork” is the UK’s latest attempt to create a more streamlined piece of data protection legislation for the UK whilst still “ensur[ing] data adequacy.” The Information Commissioner’s Office (“ICO”) also welcomed the re-introduction of the Bill, with the Commissioner stating that he would “support [the Bill’s] ambition.” While much of the Bill remains the same as its previous iteration, we set out the key provisions and notable amendments below.
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.
UK’s New Pro-innovation Approach to Regulating Digital Technologies
On 15 March 2023, the UK Government published, alongside its Spring Budget, a report on the Pro-innovation Regulation of Technologies Review (the “Report”). The Report was led by the government’s Chief Scientific Advisor and National Technology Officer, Sir Patrick Vallance, who was tasked with “bringing together the best minds to advise how the UK can better regulate emerging technologies, enabling their rapid and safe introduction.” In response, the UK Government has accepted all of the Report’s recommendations, and set out some next steps for their implementation.
New FTC Guidance for Mobile Health Apps
Healthcare providers, health plans, and technology companies that use mobile health apps to access, collect, share, use, or maintain information related to an individual’s health should take note of the recently issued Federal Trade Commission (FTC) Mobile Health App Interactive Tool. The purpose of the tool is to help mobile health developers determine the federal regulatory, privacy, and security laws and regulations that may apply to the use of a consumer’s health information, such as information related to diagnosis, treatment, fitness, wellness, or addiction. While the tool should not be considered legal advice and cannot guarantee compliance with legal requirements, it can help healthcare providers, health plans, and technology companies issue-spot to manage risk in this heavily regulated space.
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.
Unpacking Digital Data Laws Across Europe: Addressing the Digital Markets Act
The EU Digital Markets Act (DMA) is set to revolutionize the way in which so-called ‘Big Tech’ is regulated in the EU, shifting toward ex-ante rulemaking and away from traditional after-the-fact enforcement. The DMA imposes a stringent regulatory regime on large online platforms (so-called “gatekeepers”) and gives the European Commission (Commission) new enforcement powers, including an ability to impose severe fines and remedies for noncompliance.
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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EU Publishes New NIS2 Cyber Directive Imposing Liability and Obligations on Senior Management
On 17 January 2023, the new Network and Information Systems Security Directive (“NIS2 Directive”), which is aimed at establishing a minimum level of cybersecurity standards across the EU and is set to replace its predecessor (the NIS or “NIS1 Directive”), entered into force. The new NIS2 Directive aims to further harmonize and strengthen cybersecurity and resilience throughout the EU in response to a continued increase in digitization and rise in cyber (and in particular ransomware) threats – which is estimated to have reached a total cost of €5.5 trillion at the end of 2020 (double the figure of 2015) and continues to rise in the EU and globally notably due to ongoing geopolitical conflicts in Ukraine and Russia. (more…)
