Find here all our blog posts tagged with: data governance.

Abstract image of data streams flowing through open gates toward a sealed vault, symbolizing ungoverned data pipelines feeding a regulated endpoint.

AI Drug Discovery's Real Exposure Isn't the Data. It's the Custody Chain No One Regulates Yet

FDA's change control framework governs AI devices after authorization, but the real-world data pipelines feeding discovery-stage models before submission remain ungoverned.

A digital medical record shown crossing from a secure vault into open, unprotected space, illustrating data leaving regulatory coverage.

Your Patients Are Uploading Health Data Into a Regulatory Gap

Life sciences firms building patient-facing AI tools are relying on a HIPAA and FDA perimeter that consumer health AI routinely sits outside.

Abstract visualization of data nodes split between localized and centralized routing paths across a translucent regional boundary.

The Architecture Decision Pharmacovigilance AI Cannot Defer

Cross-jurisdictional data rules are forcing pharma safety teams to choose between centralized and localized AI architectures before regulators force the choice for them.

Illustration of patient health data flowing from a regulated zone into an unregulated open space.

When Health Data Leaves the Regulated Perimeter

FDA's wellness classification determines more than marketing claims. It decides whether patient data uploaded to AI tools carries any regulatory protection at all.