Comment from Anonymous

I propose that the FDA consider holding a workshop discussing the use of digital health technologies, particularly wearable technology, and how this could benefit individuals diagnosed with rare diseases. Given that one of the main purposes of these workshops is to advance the regulatory science of rare diseases, this workshop session would be incredibly helpful. I recognize that there are many various types of wearable technology and that the individuals diagnosed with various rare diseases may benefit from different information gathered through wearable technology. However, the workshop session could simply discuss the top 5 most common various wearable technologies and what sort of information each generally gathers. Then, the workshop could split the rare diseases into various categories (e.g., pulmonary, cardiac, endocrine, etc.) and suggest avenues to learn more about a specific wearable that tracks the most information for this system of the body. This would be efficient for the workshop session itself and would allow for the individuals who were interested to gather additional information as they see fit. Also, by having this workshop session, the FDA would empower these individuals to take control of their health by tracking certain metrics regarding their health. For example, by tracking blood oxygen, respiratory rate, body temperature, and more, these individuals could better understand their conditions and care for themselves at home. This could potentially lead to an improved state for the individual, less doctors visits, and less money spent on healthcare. I thank you for the opportunity to submit this suggested topic for future RISE workshops and look forward to seeing how patient outcomes with rare diseases can continue to improve.