All Times EDT
Keywords: digital health, AI/ML, statistical learning, SaMD, digital wearables, algorithm development, validation, regulatory interaction
In the last decade, significant progress in information technology and AI/ML-based (artificial intelligence/machine learning) statistical learning models enables rapid development of a wide variety of digital health products, including digital wearables and smartphone-based SaMD's (Software as Medical Devices). This also brings unique challenges to manufacturers and regulators regarding the development, validation, and regulatory concerns for new digital health products that have the potential to affect the health outcomes of a significant part of the population. This roundtable brings together all interested stakeholders and let various issues be heard and ideas exchanged in an engaging and unhindered fashion. Experiences and best practices will also be shared among participants.