Artificial Intelligence (AI)

On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines.  As drug development is already governed by a longstanding and detailed EU regulatory framework, EFPIA stresses that care should be taken to ensure that any rules on the use of AI are fit-for-purpose, adequately tailored, risk-based, and do not duplicate existing rules.  The statement sets forth five “considerations”:Continue Reading EFPIA Issues Statement on Application of the AI Act in the Medicinal Product Lifecycle

Earlier this month, lawmakers released a discussion draft of a proposed federal privacy bill, the American Privacy Rights Act of 2024 (the “APRA”).  While the draft aims to introduce a comprehensive federal privacy statute for the U.S., it contains some notable provisions that could potentially affect the development and use of artificial intelligence systems.  These provisions include the following:Continue Reading Certain Provisions in the American Privacy Rights Act of 2024 Could Potentially Affect AI

This quarterly update highlights key legislative, regulatory, and litigation developments in the first quarter of 2024 related to artificial intelligence (“AI”), connected and automated vehicles (“CAVs”), and data privacy and cybersecurity.  As noted below, some of these developments provide industry with the opportunity for participation and comment.Continue Reading U.S. Tech Legislative, Regulatory & Litigation Update – First Quarter 2024

On March 28, the White House Office of Management and Budget (OMB) released guidance on governance and risk management for federal agency use of artificial intelligence (AI).  The guidance was issued in furtherance of last fall’s White House AI Executive Order, which established goals to promote the safe, secure, and trustworthy use and development of AI systems.Continue Reading OMB Issues First Governmentwide AI Policy for Federal Agencies

Earlier this week, Members of the European Parliament (MEPs) cast their votes in favor of the much-anticipated AI Act. With 523 votes in favor, 46 votes against, and 49 abstentions, the vote is a culmination of an effort that began in April 2021, when the EU Commission first published its proposal for the Act.

Here’s what lies ahead:Continue Reading EU Parliament Adopts AI Act

On February 13, 2024, the European Parliament’s Committee on Internal Market and Consumer Protection and its Committee on Civil Liberties, Justice and Home Affairs (the “Parliament Committees”) voted overwhelmingly to adopt the EU’s proposed AI Act. This follows a vote to approve the text earlier this month by the Council of Ministers’ Permanent Representatives Committee (“Coreper“). This brings the Act closer to final; the last step in the legislative process is a vote by the full European Parliament, currently scheduled to take place in April 2024.

The compromise text approved by Coreper and the Parliament Committees includes a number of significant changes as compared to earlier drafts. In this blog post, we set out some key takeaways.Continue Reading EU AI Act: Key Takeaways from the Compromise Text

On January 24, 2024, the European Commission (“Commission”) announced that, following the political agreement reached in December 2023 on the EU AI Act (“AI Act”) (see our previous blog here), the Commission intends to proceed with a package of measures (“AI Innovation Strategy”) to support AI startups and small and medium-size enterprises (“SMEs”) in the EU.

Alongside these measures, the Commission also announced the creation of the European AI Office (“AI Office”), which is due to begin formal operations on February 21, 2024.

This blog post provides a high-level summary of these two announcements, in addition to some takeaways to bear in mind as we draw closer to the adoption of the AI Act.Continue Reading European Commission Announces New Package of AI Measures

On January 30, 2024, the U.S. Office of Management and Budget (OMB) published a request for information (RFI) soliciting public input on how agencies can be more effective in their use of privacy impact assessments (PIAs) to mitigate privacy risks, including those “exacerbated by artificial intelligence (AI).”  The RFI notes that federal agencies may develop or procure AI-enabled systems from the private sector that are developed or tested using personal identifiable information (PII), or systems that process or use PII in their operation.  Among other things, the RFI seeks comment on the risks “specific to the training, evaluation, or use of AI and AI-enabled systems” that agencies should consider in conducting PIAs of those systems. Continue Reading OMB Publishes Request for Information on Agency Privacy Impact Assessments

U.S. policymakers have continued to express interest in legislation to regulate artificial intelligence (“AI”), particularly at the state level.  Although comprehensive AI bills and frameworks in Congress have received substantial attention, state legislatures also have been moving forward with their own efforts to regulate AI.  This blog post summarizes key themes in state AI bills introduced in the past year.  Now that new state legislative sessions have commenced, we expect to see even more activity in the months ahead.Continue Reading Trends in AI:  U.S. State Legislative Developments

On January 29, 2024, the Department of Commerce (“Department”) published a proposed rule (“Proposed Rule”) to require providers and foreign resellers of U.S. Infrastructure-as-a-Service (“IaaS”) products to (i) verify the identity of their foreign customers and (ii) notify the Department when a foreign person transacts with that provider or reseller to train a large artificial intelligence (“AI”) model with potential capabilities that could be used in malicious cyber-enabled activity. The proposed rule also contemplates that the Department may impose special measures to be undertaken by U.S. IaaS providers to deter foreign malicious cyber actors’ use of U.S. IaaS products.  The accompanying request for comments has a deadline of April 29, 2024.Continue Reading Department of Commerce Issues Proposed Rule to Regulate Infrastructure-as-a-Service Providers and Resellers