As AI systems become increasingly embedded in healthcare, the conversation is shifting. No longer are we simply asking whether AI can help. The question now is: how do we ensure we design AI systems that healthcare professionals and regulators can trust.

At BIO 2025, the Alliance for Artificial Intelligence in Healthcare (AAIH) hosted a high-impact panel to explore a timely question: where is AI actually making a difference in biopharma, and what challenges still stand in the way? Expertly moderated by Megan Nacar of DeciBio, the session featured experts across drug discovery, diagnostics, safety prediction, and regulatory strategy. The discussion tackled everything from platform sustainability and model explainability to what it will take for AI to become a trusted decision-making tool across the drug development lifecycle.

AI has demonstrated its potential to substantially impact healthcare systems across the value chain and will continue to transform drug research & development, drive equitable healthcare, and deliver better outcomes for patients.

This opinion piece from AAIH explores relevant use cases and what regulatory bodies should consider when evaluating AI technologies being used in healthcare. We will share what AAIH is doing to influence policy, engage stakeholders, educate, and learn together as we drive AI adoption to benefit the industry, patient well-being, and global humanity.

At BIO 2024, the Alliance for Artificial Intelligence hosted a panel of our members to discuss the challenges of AI and Regulatory Innovation. Expertly moderated by Paul Howard, Senior Director, Amicus Therapeutics, the panel worked through a SWOT analysis on the current state of AI and regulation. The panel brought together diverse perspectives from Chris Escobedo Hart, JD, Partner, Foley Hoag; Mida Pezeshkian, PhD, Founder, Principal, STEMA_cg; Brandon Rice, Chief Product Officer, Weave; and Alex Zhavoronkov, PhD, Founder and CEO, Insilico Medicine.

The Alliance for Artificial Intelligence in Healthcare commends the recent joint publication by the FDA's Centers for Biologics Evaluation and Research (CBER), Drug Evaluation and Research (CDER), Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP). This article outlines four key recommended areas of focus, and underscores the transformative potential of AI in healthcare while highlighting the crucial steps needed to ensure we safely harness this potential. This is one of the key missions of the Alliance for AI in Healthcare.

At a post-JPM roundtable, AAIH members distilled several key 2024 predictions and takeaways.

Amidst the tumult of the first quarter of 2023, marked by macroeconomic headwinds, banking crises, and a sluggish biotech economy, one topic with its hype and truths has captured the imagination of the masses more than any other: Artificial intelligence (AI).