Regulatory Frameworks for Evaluation of AI/ML-Enabled Digital Health Technologies in Healthcare Institutions
The Role of Regulations in Managing Patient Harms Affiliated with AI-enabled Clinical Decision Support Tools
Our project focuses on making healthcare safer when doctors use Artificial Intelligence (AI) enabled computer programs. AI helps doctors make decisions about patients' treatment, like a helpful computer assistant. However, AI can make mistakes and harm patients, just like humans can. We want to understand why this happens and how to prevent it.
In the United States and Europe, there are rules to make sure medical devices, including AI, are safe for patients. But some AI tools don't follow these rules because they're seen as low-risk.
We will review how these tools report on patient harm and suggest better ways to keep patients safe. We'll also create educational materials for the public to learn about AI in healthcare.
Our research will help doctors, policymakers and patients make sure AI is used safely and effectively, benefiting everyone.
Project lead / contact: Brenna Loufek | Oxford University Department for Continuing Education
ARC theme: Digital Transformation of Health and Care
Who we're working with
- University of Massachusetts – Amherst; School of Public Health & Health Sciences (https://www.umass.edu/public-health-sciences/about/directory/jamie-hartmann-boyce)
ARC OxTV Associated Project
Associated projects are projects which the ARC has helped support in some way, but does not itself directly fund or run.