Clinical safety, patient privacy and device classification
Health
Anything that informs care carries a clinical risk-management duty and a privacy duty at the same time. We determine device classification early, build the hazard log and safety case alongside delivery, and specify clinician oversight at every point where a model output can reach a patient pathway.
Pressures
What shapes delivery in this sector.
Clinical safety
Clinical risk management and post-market surveillance apply wherever a system informs care.
Patient privacy
PHIPA, HIPAA and equivalent regimes govern secondary use, de-identification and cross-border flows.
Device classification
Some tools are software as a medical device; that determination must be made early and documented.
Use cases
Where value shows up first.
- Clinical documentation and ambient note drafting with clinician sign-off
- Referral triage and waitlist prioritization support
- Prior-authorization and coding review
- Research cohort discovery under ethics approval
Evidence
What we leave behind.
- Clinical safety case and hazard log
- SaMD classification rationale and regulatory pathway note
- Privacy impact assessment and de-identification method record
Next step
Discuss an health use case.
A confidential discovery call with your risk, compliance and technology leadership.