generated: '2026-07-19' method: searched source: https://flywheel.io/compliance/ docs: https://flywheel.io/compliance/ notes: >- Flywheel is a medical imaging data management platform; its conformance surface is regulatory/compliance rather than API-protocol standards. Claims captured from flywheel.io compliance and product pages. No public OpenAPI is available (the REST API is per-instance), so protocol conformance is not derivable. standards: - id: hipaa conforms: true evidence: flywheel.io publishes HIPAA compliance for protected health information (medical imaging). - id: soc2 conforms: true evidence: Flywheel is a SOC 2 certified organization (security, availability, processing integrity, confidentiality, privacy). - id: soc3 conforms: true evidence: Flywheel publishes SOC 3 compliance alongside SOC 2. - id: gdpr conforms: true evidence: flywheel.io states GDPR compliance with role-based access control. - id: 21-cfr-part-11 conforms: true evidence: Supports FDA 21 CFR Part 11 (audit/change logging, digital signatures, approval workflows) for regulated submissions. - id: irb conforms: true evidence: Enables Institutional Review Board (IRB) compliant research workflows.