On 12 January 2021, the FDA announced a five-part action plan creating a framework which would enable FDA to further their oversight as well as provide a reasonable assurance of safety and effectiveness of artificial intelligence and machine learning-based software as a medical device (SaMD). This multi-faceted plan includes:
- Tailored Regulatory Framework for AI/ML-based SaMD
- Good Machine Learning Practice (GMLP)
- Patient-Centered Approach Incorporating Transparency to Users
- Regulatory Science Methods Related to Algorithm Bias & Robustness
- Real-World Performance (RWP)
FDA’s Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan
CITI Program’s Technology Ethics Content
Technology, Ethics, and Regulations Course
Through this dynamic course, learners will explore a range of technologies that have received significant global attention, with a focus on the ethical issues and governance approaches affecting those technologies.
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Informed Consent and Research with Wearable Tech
This webinar examines the intersection of informed consent and research with wearable technology. It also explores how we can conceptualize and describe risk in this new era.
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