For the FDA's Center for Devices and Radiological Health (CDRH), Rackner built and deployed an AI mission platform supporting AI-assisted document summarization, structured/unstructured data extraction, and automated review workflows for medical device submissions.
Clear visibility into how AI models process data and generate recommendations, with explainable outputs for reviewers.
Unbiased processing of medical device submissions with consistent application of regulatory criteria across all cases.
Human reviewers maintain final decision authority with full audit trails and comprehensive logging of all AI-assisted actions.
Protection of sensitive medical device information through encryption, access controls, and organizational data isolation.
Rackner supports the Defense Health Agency (DHA), including the DHMS (Defense Health Management System). Our platform engineering and AI capabilities translate directly to Health IT use cases requiring secure data processing, compliance with healthcare-specific regulations, and integration with existing clinical and administrative workflows.
Demonstrates commitment to information security management - critical for healthcare data protection