HHS-OIG Rejects Calls for New Safe Harbors for Financial Support to Patients Enrolled in Clinical Trials

Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) declined to establish new safe harbors that would protect arrangements under which clinical trial sponsors provide financial support to participants. Catherine Starks, Deeona Gaskin, Meenakshi Datta, and Taylor Andelman report.

China’s Generative AI Measures Could Affect Life Sciences Companies That Make Apps

Those medtech companies which embed AI into an app allowing healthcare professionals or patients to ask questions and to receive a response will probably need to comply with China’s new Interim Measures for the Management of Generative Artificial Intelligence Services (the “Measures”). Lianying Wang explains.

New EU Subsidies Rules Likely to Catch Global Life Sciences Companies

Given their extensive involvement in public procurement contracting, life sciences companies are likely to be heavily impacted by the EU’s Foreign Subsidies Regulation (the “FSR”), which has the potential to hold up tender awards over competition concerns. Michele Tagliaferri and Alessandra Moroni explain.

AI-Powered Drug Discovery Efforts Could Lead to New Treatments

Stephen Abreu, Sidley partner, talks to Colin Hill, CEO and Co-Founder of AI-powered drug discovery company Aitia, about how the use of AI is revolutionizing the biotech space.

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Europe’s Regulatory Approach to Continuous Learning AI

The regulation of continuous learning models involves the challenge of navigating the future. The EU is striving to stay ahead of the game with its forthcoming AI Act and harmonised standards. Eva von Mühlenen, Oliver Haase of Validate, and Leon Doorn of Aidance discuss.

Innovation, Collaboration, and Access to Capital: Key Takeaways from the Sidley Healthcare Investment Conference

At Sidley’s Healthcare Investment Conference on 12 September, speakers analysed the flow of capital across the global life sciences and healthcare ecosystem in panels discussing collaborative deals, sources of funding, the regulatory scrutiny of deals, and women’s health.

Five Governance Steps To Consider When Using Generative AI Within A Pharma Company

Pharma companies are looking to better understand how Generative AI (GAI) can facilitate innovation. Early adopters can gain distinct advantages while properly managing the top-of-mind potential risks discussed below. Francesca Blythe and Steve McInerney explain the corporate governance principles that should be considered.

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