Why take this course

Digital health products have become integral to the prevention, diagnosis, treatment, and management of health and disease. Consumers rely on digital health apps to improve their focus, track their fitness, and optimize their wellbeing. Clinicians use digital health products to gain insights on patient outcomes, conduct telehealth visits, and treat aspects of diseases otherwise unaddressed by traditional medications.​

In theory, consumers and clinicians know that there is a difference between these products. But in practice, how do they differentiate between products that accurately collect health information versus those that do not, or those that provide clinicians with informational versus actionable insights?

Not all digital health products are the same. But what are their differences? How should each product be used? What should expectations be about product outcomes? How much evidence is needed to go to market? What type of clinical evidence or regulatory oversight is necessary?​

Digital Health is a broad category that encompasses Digital Medicine, which in turn includes Digital Therapeutics. Products in these categories make different levels of claims and therefore have different levels of risk. As such, they have varying requirements for clinical evidence and regulatory oversight.​ In parallel industries such as transportation, higher levels of research and regulation are required for higher risk functions (e.g., operating autonomous vehicles) than lower risk functions (e.g., bluetooth enabled hands-free car kits). Similarly, end users and clinicians should expect that higher levels of evidence and oversight are required for digital health products that make higher risk claims.​