Mateo Aboy

Jan 15, 2025 | nature.com | Johnathon Liddicoat |Gabriela Lenarczyk |Mateo Aboy |Timo Minssen |Sebastian Mann

Can artificial intelligence improve clinical trial design? Despite their importance in medicine, over 40% of trials involve flawed protocols. We introduce and propose the development of application-specific language models (ASLMs) for clinical trial design across three phases: ASLM development by regulatory agencies, customization by Health Technology Assessment bodies, and deployment to stakeholders. This strategy could enhance trial efficiency, inclusivity, and safety, leading to more representative, cost-effective clinical trials.

Sep 5, 2024 | nature.com | Mateo Aboy |Timo Minssen |Effy Vayena

The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements?

Jun 16, 2024 | nature.com | Mateo Aboy

Analysis of medical artificial intelligence patents reveals substantial gaps in disclosure, underscoring the need for improved examination guidelines to ensure AI patent specifications contain enabling disclosures.

Feb 7, 2024 | nature.com | Mateo Aboy |Ariel Stern

AbstractModerate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago.

Apr 17, 2023 | nature.com | Mateo Aboy

Patent office data show robust and rising patenting of AI inventions in the medical field, contrary to fears that medical machine learning patents might be largely unavailable because of challenges to their subject-matter eligibility. Artificial intelligence (AI) is rapidly entering the field of medicine, but the role of patents in this process remains relatively opaque.