UK Sets Out It’s “Pro-Innovation” Approach To AI Regulation
On 29 March 2023, the UK’s Department for Science Innovation and Technology (“DSIT”) published its long awaited White Paper on its “pro-innovation approach to AI regulation” (the “White Paper”), along with a corresponding impact assessment. The White Paper builds on the “proportionate, light touch and forward-looking” approach to AI regulation set out in the policy paper published in July 2022. Importantly, the UK has decided to take a different approach to regulating AI compared to the EU, opting for a decentralised sector-specific approach, with no new legislation expected at this time. Instead, the UK will regulate AI primarily through sector-specific, principles based guidance and existing laws, with an emphasis on an agile and innovation-friendly approach. This is in significant contrast to the EU’s proposed AI Act which is a standalone piece of horizontal legislation regulating all AI systems, irrespective of industry.
EU Moving Closer to an AI Act – Key Areas of Impact for Life Sciences/MedTech Companies
The European Union is moving closer to adopting the first major legislation to horizontally regulate artificial intelligence. Today, the European Parliament (Parliament) reached a provisional agreement on its internal position on the draft Artificial Intelligence Regulation (AI Act). The text will be adopted by Parliament committees in the coming weeks and by the Parliament plenary in June. The plenary adoption will trigger the next legislative step of trilogue negotiations with the European Council to agree on a final text. Once adopted, according to the text, the AI Act will become applicable 24 months after its entry into force (or 36 months according to the Council’s position), which is currently expected in the second half of 2025, at the earliest.
U.S. Department of Commerce Seeks Input on AI Policy, Calls Trustworthy AI an Important Federal Objective
On April 13, 2023, the United States Department of Commerce National Telecommunication and Information Administration (“NTIA”) published a request for comment (“RFC”) seeking public input on Artificial Intelligence (“AI”) accountability. The RFC seeks to understand which measures—both self-regulatory and regulatory—have the capacity to ensure that AI systems are “legal, effective, ethical, safe, and otherwise trustworthy.” The RFC adopts a broad definition of “AI systems,” noting that they include all automated or algorithmic systems that generate predictions, recommendations, or decisions.
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.
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.