Patients and Advocates

When it comes to health care, nothing is more important than patient safety.

Navigating the FDA process

Verifying that algorithms will work well in a broad range of clinical settings is new territory for many AI developers. Fortunately, it’s an area that we are already very familiar with. We’re working with the FDA and other agencies to develop tools that promote a safe, effective and efficient regulatory process for algorithm approval, and to keep regulatory issues from becoming stumbling blocks to deploying AI. Our use cases define pathways to integrate AI models into the clinical workflow to make these important new tools readily available to physicians as they care for their patients.

Both the DSI use case development process and our validation and monitoring services recognize the diversity of patients and practice settings. Our validation services verify that AI can be trusted in clinical practice and pre-clinical validation tests. Post-implementation surveillance registries ensure AI is helping to improve care.

How is DSI participating in the regulatory process?

An FDA-funded program intended to quickly bring safe and effective medical devices to market has chosen a DSI use case for one of its first demonstration projects. The National Evaluation System for Health Technology (NEST) Coordinating Center selected the Lung-RADS® Assist: Advanced Radiology Guidance, Reporting and Monitoring use case. This collaboration is a testament to the importance of DSI use cases in navigating the regulatory process and the value of more public-private partnerships in the future.