Compliance Updates for Employer’s use of Automated Decisionmaking Tools: New York City Finalizes Rules on Automated Employment Decision Tools and Sets Enforcement Date for July 5, 2023, Upcoming California Regulations, and Federal Guidance
Employers in New York City may soon be subject to a new law, Local Law 144, that regulates employers’ use of automated employment decision tools (“AED tools” or “AEDT”) – software and other programs used to make decisions about who to hire, who to promote and other employment decisions. Local Law 144, the first of its kind law regulating these AED tools, was originally supposed to go into effect on January 1, 2023; however, because needed regulatory guidance had not been issued, the effective date was repeatedly pushed back and is now set for July 5, 2023. Final rules were released on April 6, 2023, so further delays are unlikely. We summarize below the key provisions of Local Law 144 and what employers need to know to prepare.
New U.S. FDA Draft Guidance Outlines Path To Faster Modification of AI/ML-Enabled Devices
The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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treatments according to individual users’ particular characteristics and needs.”3 Those wishing to comment on the draft guidance should note that the comment period closes on July 3, 2023.
Equal Employment Opportunity Commission Looks at AI
2023 is rapidly becoming the year of AI policy and regulation. A particular focus of regulatory concern relates to AI impacts on employees, and the U.S. Equal Employment Opportunity Commission (EEOC) is not sitting on the sidelines. On January 31, 2023, the EEOC held a public hearing to examine the use of automated systems, including artificial intelligence (AI), in employment decisions. This hearing, titled “Navigating Employment Discrimination in AI and Automated Systems: A New Civil Rights Frontier,” continues the work of the Artificial Intelligence and Algorithmic Fairness Initiative, which was launched in 2021 by the EEOC. Through this initiative, the EEOC has already published a guidance titled “The Americans with Disabilities Act and the Use of Software, Algorithms, and Artificial Intelligence to Assess Job Applicants and Employees.” Below are a few high-level takeaways from the hearing:
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.
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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One Step Forward, Two Steps Back: FDA’s Final Guidance on Clinical Decision Software Raises More Questions Than Answers
Recently, the U.S. Food and Drug Administration (FDA) published a suite of guidance documents relating to software, automation, and artificial intelligence. One guidance document in particular, addressing clinical decision support (CDS) software, may signal a tightening in FDA’s oversight on software tools with artificial intelligence and machine learning (AI/ML) that could introduce confusion and frustrate innovation in this important, fast-developing area. On October 18, 2022, FDA held a webinar to provide additional clarifications on this final guidance.
White House Publishes In-Depth Guidance on the Use of Automated Systems and Recognizes Privacy as Foundational Principle of Framework
On October 4, 2022, the White House Office of Science and Technology Policy published The Blueprint for an AI Bill of Rights: Making Automated Systems Work for the American People (the “AI Blueprint”). The AI Blueprint outlines non-binding guidelines for the development and deployment of automated systems and is the culmination of a year-long process of public engagement and deliberation.
Data Regulation Ramps Up in Europe: The AI, Data, and Data Governance Acts
Join Sidley and OneTrust DataGuidance for Part two of the “Data Regulation Ramps Up in Europe” webinar series, where our panel will discuss legislative proposals, including the Artificial Intelligence Act, the Data Act, and the Data Governance Act (DGA). (more…)
5 Global Data Protection Trends To Watch In 2022
*This article was first published by Law360 on January 3, 2022.
A recent discussion with Elizabeth Denham and Claudia Berg of the U.K. Information Commissioner’s Office provided ample food for thought on the direction in which data protection regulation both in the U.K. and internationally is headed, including key trends to watch for in data protection.
View article.
FTC Announces it May Pursue Rulemaking to Combat Discrimination in AI
On December 10, the Federal Trade Commission (FTC) announced it is considering a rulemaking on commercial Artificial Intelligence (AI). The purpose of the rulemaking, according to an advanced notice of proposed rulemaking (ANPRM) titled “Trade Regulation in Commercial Surveillance,” would be “to curb lax security practices, limit privacy abuses, and ensure that algorithmic decision-making does not result in unlawful discrimination.”
While not formally part of the rulemaking process mandated by the Administrative Procedure Act, advanced notices allow agencies to solicit public comment before drafting more specific proposals. The FTC has not yet issued privacy or artificial intelligence rules, though it has indicated that such rulemaking is on the horizon. The December 10 ANPRM is another signal that the FTC is gearing up to develop substantive privacy guidelines. (more…)
