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The Sickle Cell Disease Foundation (SCDF) and the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) have entered into a research collaboration agreement to develop best practices for the use of artificial intelligence and machine learning in understanding patients’ real-world experiences and evaluating meaningful benefit for those living with rare diseases. This collaboration aims to improve quality of care and advance personalized medicine for underserved communities affected by complex chronic and rare diseases.