Governing AI and human actions across the tools your teams already use
- Claude
- ChatGPT
- Slack
- Microsoft Teams
- Microsoft 365
- Gmail
- GitHub
- GitLab
What it does
- Regulatory Response — Continuous, cited evidence for HIPAA, FDA AI/ML guidance, EU MDR and EU AI Act high-risk requirements.
- Evidence — Reconstruct any clinical AI recommendation — defensible under malpractice review and regulatory inquiry.
- One rule set — What one department settles becomes the answer the next one gets, instead of being re-litigated from scratch.
What gets in the way
Clinical decision transparency
When any system assists a diagnosis or treatment recommendation — legacy CDSS or AI — clinicians, patients, and regulators need to understand why. Black-box decisions create liability.
FDA and EU MDR compliance for AI/ML
AI-enabled medical devices face evolving regulatory frameworks. Continuous monitoring and evidence generation is required, not just pre-market approval.
Patient data governance
Systems processing PHI must demonstrate HIPAA compliance at every step. The intersection of technology governance and data privacy creates new accountability requirements.
Liability for AI-assisted decisions
When a technology-influenced clinical decision is challenged, you need forensic evidence of what the system recommended, what data it used, and how the clinician acted.
Start with one service.
A 30-minute scoping session with your risk owner and your IT contact.