ChatMD Risk Management

Proactively Identifying & Mitigating Risks in Digital Healthcare

ChatMD follows a comprehensive risk management framework to ensure the safety, compliance, and effectiveness of ChatMD as an FDA Class 1 medical device. Our proactive risk mitigation strategies help us maintain high standards in regulatory compliance, patient safety, and data security.

Our Risk Management Approach

Regulatory Compliance Risk Assessment – Regular audits to ensure adherence to FDA, FTC, and HIPAA requirements.
Data Privacy & Security – Encryption protocols, access controls, and monitoring for cybersecurity threats.
Incident Reporting & Response – A structured adverse event reporting and compliance violation handling system.
Post-Market Surveillance – Continuous monitoring of ChatMD’s performance, user feedback, and safety signals.

Key Risk Management Policies & Procedures

Our detailed risk assessment and mitigation strategies are outlined in the following documents:

📜 ChatMD Risk Management Protocol and Procedure
📜 ChatMD Post-Market Surveillance Policy, Procedure, and Process

Reporting & Incident Management

💡 Have a safety concern? ChatMD provides a streamlined way for users, providers, and stakeholders to report potential risks, compliance concerns, or adverse events related to ChatRx.

📩 Report an Issue HereSubmit a Concern (Coming Soon)

For further inquiries regarding our risk management framework, contact trust@chatrx.md