Artificial Intelligence

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice” (the Workshop). Although the individual presentations and panel discussions throughout the Workshop covered a range of topics and raised a number of interesting questions and hypotheticals, the panelists did not draw any specific conclusions or reach any kind of consensus about next steps to address the critical issues. Even so, the panelists provided some crucial insights that companies and regulators must grapple with in the context of expanding use cases for AI in human research and creating rules governing such uses.

Read about the FTC’s launch of Operation AI Comply, the agency’s new law enforcement sweep focused on companies using AI to further deceptive or unfair conduct in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about the FTC Staff Report on the data collection and data use practices of large social media and video streaming service platforms in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about the Democratic Senators urging the heads of the FTC and DOJ’s Antitrust Division to investigate generative AI models that may violate competition laws in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about the second draft guidance released by the National Institute of Standards and Technology (NIST) in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about five AI bills Senator Mike Rounds (R-SD) introduced for Congress to consider when its members return on September 8 in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS). As summarized in this handy Mintz/ML Strategies timeline of the actions set forth in President Biden’s AI executive order, DHHS has a mandate to “develop a strategy for regulating the use of AI in the drug development process” and a deadline of October 29, 2024 to meet that obligation. Notably, earlier this year DHHS announced a functional reorganization within the department that included creating the position of Chief AI Officer in response to the presidential order.

Read about the AI priorities of both presidential candidates and their likely actions if they take office in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about an FTC final rule banning fake reviews and testimonials, which takes effect in October, in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about 10 AI-related bills recently advanced by the Senate Commerce Committee for consideration in the full Senate in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about the Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) joint workshop in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about the joint statement on competition in generative AI foundation models and AI products in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about a bill introduced by a bipartisan group of senators to address AI deepfakes and protect intellectual property in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about two significant federal agency actions taken within 240 days of the issuance of President Biden’s executive order on artificial intelligence in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about a federal rule aimed at creating safeguards for automated valuation models (AVMs) in the real estate industry in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read about the Treasury Department’s final proposed rule to implement the Biden administration’s 2023 Executive Order on US investments in national security technologies and products in certain countries in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has generated plenty of cross-industry interest, for good reason. In some ways similar to the risk-based approach taken by the European Union (EU) in the EU AI Act, the Act aims to regulate developers and deployers of AI Systems, which are defined by the Act as “any machine-based system that, for any explicit or implicit objective, infers from the inputs the system receives how to generate outputs, including content, decisions, predictions, or recommendations, that can influence physical or virtual environments.”

The two letters “AI” seem to be everywhere today. But what do people actually mean when they use them, particularly in the compliance context? More importantly, aside from adding the letters “AI” into marketing decks, how do current AI-powered technologies differ from similar technologies just a few years ago, how easy is it to implement AI, and what are the real-world benefits, and risks, of using AI tech?

Read about the bill introduced by Senators for AI procurement and use by federal agencies

Read about the FTC and the DOJ’s agreement to divide responsibility over AI oversight in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.