Industry
AI Governance for Healthcare
Healthcare AI operates at the intersection of patient safety and regulatory compliance. Governance is not optional. It is a patient safety and legal imperative.
The Challenge
Navigating AI risk in Healthcare.
01
AI in clinical decisions without oversight
Machine learning tools in diagnostics, treatment recommendations, and patient triage are being deployed without the governance structures needed to ensure safety, accuracy, and accountability.
02
Patient data privacy in AI systems
AI models trained on or operating with patient data create HIPAA exposure when data handling, access controls, and vendor agreements are not properly governed.
03
FDA scrutiny of AI-enabled devices
The FDA's evolving framework for AI/ML-enabled Software as a Medical Device creates new pre-market and post-market obligations that most healthcare organizations are not prepared for.
How We Help
Discover. Govern. Operate.
We identify every AI system operating across clinical, administrative, and operational functions. We map each system to its patient data exposure, clinical risk classification, and applicable regulatory obligations.
We build HIPAA-aligned AI governance policies, clinical AI oversight frameworks, and vendor management controls. We ensure your AI systems meet FDA SaMD requirements and ONC interoperability standards. We build data governance frameworks that define how AI systems interact with protected health information and clinical data under HIPAA requirements.
We provide ongoing AI governance operations, including continuous monitoring of clinical AI systems, vendor AI risk assessments, and audit-ready documentation for regulatory examinations and accreditation reviews.
Regulatory Landscape
Frameworks that apply to you.
HIPAA
Health Insurance Portability and Accountability Act requirements covering protected health information in AI training data, inference systems, and vendor relationships.
FDA AI/ML Guidance
FDA's evolving framework for Software as a Medical Device, including predetermined change control plans and post-market surveillance requirements.
ONC Health IT
Office of the National Coordinator standards for health information technology, interoperability, and information blocking applicable to AI systems.
ISO 42001
International standard for AI management systems applicable to healthcare AI governance programs.
NIST AI RMF
NIST AI Risk Management Framework providing a structured approach to managing AI risk in healthcare settings.
Get Started
Ready to govern AI responsibly?
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