Medical Imaging Data Strategies for Catalyzing AI Medical Device Innovation.

Continuous and consistent access to quality medical imaging data stimulates innovations in artificial intelligence (AI) technologies for patient care. Breakthrough innovations in data-driven AI technologies are founded on seamless communication between data providers, data managers, data users and regulators or other evaluators to determine the standards for quality data. However, the complexity in imaging data quality and heterogeneous nature of AI-enabled medical devices and their intended uses presents several challenges limiting the clinical translation of novel AI technologies. In this commentary, we discuss these challenges across different characteristics of data, such as data size, data labels, data diversity, data sequestration and reuse, and data drift. We discuss strategies around a data platform that incorporates protocols and checklists for ensuring data quality, tools and interactive guidelines that may help assess data diversity, study design and performance metrics for data usage and monitoring for data analytics. We envision this data platform to catalyze AI-enabled medical device innovation by providing a more efficient development and evaluation environment for bringing safe and effective AI technologies to the clinic.