AI and Software Regulation in Biomedical Science

4 Credits.

As artificial intelligence (AI) and software play an increasingly critical role in biomedical science and healthcare, understanding their regulatory landscape is essential. This course explores how the U.S. government, particularly the FDA and other regulatory agencies, oversees AI/ML-based technologies, digital health solutions, and software used in biomedical applications. Topics include the regulation of software as a medical device (SaMD), model-informed drug discovery (MIDD), AI-driven diagnostics and imaging, telehealth platforms, electronic health records, clinical trial technologies, and laboratory information management systems. Additionally, the course examines HIPAA privacy rules, cybersecurity considerations, real-world evidence applications, and evolving policies for AI in regulatory decision-making.