This rapidly emerging industry of DTx needs to bring together regulators, engineers, practitioners, and companies to agree on standards that enable innovation. If a digital therapeutic treats a disease, it must be validated and regulated with the same rigor as a pharmacological drug.

Key Themes we will explore:

• What are the requirements of a Software as a Medical Device (SaMD)?
• What knowledge gaps exist that we can solve and share as a collective?
• Any good examples of companies that are doing this right?
• Any learnings from across ponds that may be applicable in other jurisdictions?
• How are de-centralized clinical trials regulated?