AI in Regulated Environments
Planning Data, Access, Review, and Evidence Within the Applicable Regulatory Scope
By
Tenten AI FDE Team
Enterprise & Compliance
Published
Updated
Read time
4 min
Abstract
Healthcare, finance and legal workflows need a defined regulatory scope before an AI architecture is selected. Identify the jurisdiction, regulated activity, organization’s role, data categories and proposed actions. The controls appropriate to one use case do not automatically establish compliance in another.
For US healthcare, HHS explains which entities HIPAA regulates. For EU investment services, ESMA’s 30 May 2024 statement describes relevant MiFID II responsibilities when firms use AI. This guide connects those scoped examples to practical data, access, review and evidence decisions. The responsible legal, clinical or compliance owner determines the requirements for the actual deployment.
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