Medical Device Regulatory Compliance

August 1, 2023 - January 1, 2028

Healthcare providers are deploying a large number of AI-driven Medical devices to help monitor and medicate patients. For patients with chronic ailments, like diabetes or gastric diseases, usage of these devices becomes part of their daily lifestyle. These medical devices often capture personally identifiable information (PII) and hence are strictly regulated by the Food and Drug Administration (FDA) to ensure the safety and efficacy of the medical device. Medical device regulations are currently available as large textual documents, called Code of Federal Regulations (CFR) Title 21, that cross-reference other documents and so require substantial human effort and cost to parse and comprehend.
This project is working on building a semantically rich framework MedReg-KG to extract the knowledge from the rules and policies for Medical devices and translate it into a machine-processable format that can be reasoned over. By applying Deontic Logic over the policies, we are able to identify the permissions and prohibitions in the regulation policies.

OWL Tweet