Managing Digital Therapeutic Approvals

Digital therapeutics (DTx), a growing trend across life sciences, is emerging as a popular form of assisting physicians to transform patient behavior and improve clinical outcomes. It is defined as the use of any technology that is capturing, storing, and transmitting data for a therapeutically proven outcome and today is the fastest-growing part of life sciences.

Digital therapeutics is part of the broader digital-health landscape, but to be called DTx, a product has to be software-driven, evidence-based, and confirm a claim to prevent, manage, or treat a medical disease or disorder.

The increasingly dominant role of mobile technology and artificial intelligence in our everyday lives has broadened the role of DTx in healthcare. Although historically, interest in developing DTx was mainly confined to academia and technology companies, the potential to use DTx in conjunction with medicines to improve health outcomes has sparked the interest of big pharma, who have started to venture into the DTx space through investments and strategic partnerships with tech companies.

The Managing Digital Therapeutic Approvals program is designed to provide an intensive dive into the regulatory and legal landscape for the successful management of digital therapeutic approvals. Participants will learn the necessary strategies and features to ensure regulatory compliance for their digital therapeutics.

To learn more about this program, please contact Co-Director Stan Kachnowski at swk16@gsb.columbia.edu.