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. Led by biopharma and digital health industry veteran, Kal Patel, MD, CEO & Co-Founder, BrightInsight, this Masterclass will dive into the DTx regulatory landscape.

Key themes we'll 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?