Healthcare and MedTech
Patient data, regulated documents and medical device rules leave little room for error. Fidempli keeps health data out of AI models and gives you evidence that fits regulated quality systems.
How Fidempli handles it
| Requirement | How Fidempli handles it | Capability |
|---|---|---|
| Health data protection (GDPR Art. 9, HIPAA) | Patient data removed or pseudonymised before any AI model sees it | PII and PHI protection |
| AI as a medical device (EU MDR, EU AI Act Art. 6(1)) | Classification and obligations recorded per AI system | Intake and approvalCompliance mapping |
| Medical claims in AI-drafted content | Guardrails stop unapproved claims before content leaves the AI tool | Real-time guardrails |
| Complaint and vigilance processes | Agent actions on complaints wait for a person | Human oversight |
| Records for audits and authorities | Evidence packs with decisions, approvals and policy versions | Evidence and reporting |
Every prompt is checked live. Names, birth dates and insurance numbers are replaced before the request leaves your control.
Related services
Consulting
Cybersecurity for medical device and digital health makers, from threat model to premarket submission.
Learn moreProfessional services
Install, configure and connect the Fidempli platform to your AI providers, identity and data.
Learn moreManaged services
We run AI intake, monitoring, evidence and board reporting for you, ongoing.
Learn moreFidempli provides governance, risk and compliance advisory and works alongside your legal counsel. We do not provide legal advice.
Our consultants assess where you stand; the platform keeps it current.
