Digital Health Innovation & Regulatory Science

1 Credit.

From smartwatch apps and telehealth to the use of artificial intelligence (AI) and machine learning (ML) on big data, digital health is shaking up the health care industry. These tools promise to revolutionize how patients and healthcare providers access health data. In some cases, digital health tools will even diagnose and treat diseases. For all its potential, digital health is not without risks, though. There must be adequate legal, quality, and safety protections to ensure responsible and high-quality innovation. This course will 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. At the end of this course, students will be able to: Define key terminology relevant to the fields of digital health innovation and medical device regulation. Discuss the relationships between regulators, technology developers, healthcare providers, and patients. Describe the requirements for digital health technology to be considered Software as a Medical Device (SaMD) by the FDA Identify the various regulatory pathways for SaMD and the main considerations.