AI/ML SaMDs: Cybersecurity, Human Factors, and Privacy

Description

Moving beyond the regulatory and clinical data requirements for AI/ML SaMDs, also known as Machine Learning Enabled Medical Devices (MLEMDs), this webinar goes deep into the cybersecurity, human factors, and privacy aspects of these new and challenging medical devices. AI/ML SaMDs often leverage technologies unique to them, for example, wireless connectivity and coexistence, software as a service, and mobile device-based platforms.

Learn how to design your MLEMDs from the beginning to accommodate these important features and mitigate the risks. This advanced session is designed for professionals who are ready to take their knowledge to the next level and ensure their MLEMDs meet the highest standards of regulatory and clinical excellence. Join us to stay ahead in the rapidly evolving digital health landscape!

Key Learning Points:

1. Understand the FDA’s current thinking on privacy, cybersecurity, and wireless coexistence
   • The CFR, GDPR, and HIPAA
2. How to design your product right from the beginning, before you start any clinical trials
3. How to meet FDA’s requirements for formative and summative human factors/usability testing for AI/ML SaMDs

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