Secure clinical AI, protect patient data, and enable AI adoption across your health system. Meet HIPAA, FDA, and HITECH requirements while accelerating clinical innovation.
Healthcare organisations face critical AI governance challenges that directly impact patient safety, data privacy, and regulatory compliance.
Clinicians, administrative staff, and researchers are pasting patient records, lab results, and clinical notes into ChatGPT, AI scribes, and other generative AI tools. Without a signed BAA, every interaction with patient data is a potential HIPAA violation and breach notification trigger.
PHI in unapproved AI tools creates immediate HIPAA exposure and potential breach notification obligations.
Clinical decision support AI, diagnostic algorithms, and AI-powered triage systems are being deployed without adequate governance frameworks. These tools directly impact patient safety, yet many health systems lack visibility into which clinical AI systems are in use, how they perform, and whether they meet FDA guidance requirements.
Ungoverned clinical AI can lead to patient safety incidents and FDA regulatory scrutiny.
Across hospitals and health systems, employees are adopting AI tools without IT or compliance awareness -- from AI-powered note-taking to research assistants to scheduling optimisers. Each unsanctioned tool represents an uncontrolled data flow and a gap in the organisation's security posture.
Shadow AI in healthcare creates compliance blind spots across HIPAA, state privacy laws, and accreditation standards.
Healthcare AI governance must address federal, state, and FDA requirements. Here are the frameworks your organisation needs to navigate.
HIPAA requires covered entities and business associates to protect the privacy and security of protected health information (PHI). AI tools that process, store, or transmit PHI must be covered under business associate agreements. Employees using unapproved AI tools with patient data can trigger HIPAA violations and breach notification requirements.
The FDA has issued guidance on AI/ML-based Software as a Medical Device (SaMD), including the Predetermined Change Control Plan framework. Clinical decision support, diagnostic AI, and therapeutic AI tools may require FDA clearance or approval. Manufacturers must document training data, validate performance, and monitor for model drift and bias.
The HITECH Act strengthens HIPAA enforcement with increased penalties for data breaches, mandatory breach notification requirements, and expanded scope to business associates. AI tools processing PHI that experience data exposure can trigger HITECH notification obligations to affected individuals, HHS, and potentially the media.
Many US states have enacted health privacy laws that exceed HIPAA requirements, including California's CMIA, Washington's My Health My Data Act, and New York's SHIELD Act. Healthcare organisations operating across states must ensure AI governance frameworks address the most stringent applicable requirements for patient data protection.
Purpose-built AI governance that protects patient data and enables clinical AI adoption with full regulatory compliance.
Get a complete, real-time inventory of every AI tool used across your health system -- from clinical AI in the EMR to AI scribes in exam rooms to ChatGPT on personal devices. Aona detects Shadow AI across all departments within minutes of deployment.
Full AI visibility across clinical and administrative functionsApply AI-native DLP controls that understand healthcare context. Prevent patient records, lab results, clinical notes, and any PHI from leaking into AI services without signed BAAs. Policies enforce automatically across all endpoints.
Automated PHI protection for HIPAA complianceProduce compliance reports mapped to HIPAA, HITECH, FDA AI/ML guidance, and state health privacy laws. Audit trails capture every AI interaction for compliance review, accreditation surveys, and OCR investigations.
One-click HIPAA and FDA compliance documentationDon't block AI -- govern it. Give clinicians, researchers, and staff access to approved AI tools while protecting patient data and maintaining compliance. Enable AI-driven efficiency gains without patient safety or regulatory risk.
Faster clinical AI adoption with full HIPAA complianceProtect patient data, ensure HIPAA compliance for AI tools, and enable clinical AI adoption safely across your organisation.