Introduces students to the ways digital health is revolutionizing the practice of medicine, increasing access to data, and diagnosing and treating diseases. For all its potential, digital health is not without risks. Students will explore the promise that digital health devices offer and investigate the legal, quality, and safety protections in place to help ensure responsible and high-quality innovation. This course will also introduce students to the rapidly evolving field of digital health regulation and the role of the FDA, FTC, OCR, and other legal and regulatory bodies in this space.
Topics:
- key terminology relevant to the fields of digital health innovation and medical device regulation
- relationships between regulators, technology developers, healthcare providers, and patients
- requirements for digital health technology to be considered Software as a Medical Device (SaMD) by the FDA
- various regulatory pathways for SaMD and the main considerations