Alex G. Lee, Ph.D. Esq. CLP’s Post

Digital Therapeutics (DTx) Product Assessment Frameworks DTx are transforming the healthcare sector by offering software-based treatments that extend beyond conventional therapeutic approaches, marking a significant shift towards more personalized, accessible, and evidence-driven care. The unique nature of DTx, leveraging software algorithms, user interfaces, and engagement strategies, presents distinct challenges in assessing their effectiveness, safety, and impact on health outcomes. As such, there's a critical need for standardized frameworks to thoroughly evaluate DTx products, addressing these challenges and ensuring their integration into healthcare systems enhances patient care. The development of specialized assessment methodologies tailored to the digital and innovative aspects of DTx is essential. Incorporating DTx into existing Health Technology Assessment (HTA) frameworks, and adapting to new sources of evidence, will be key in overcoming these challenges, facilitating their evaluation, and maximizing their potential to improve patient outcomes. These frameworks are based on the following references: Digital Therapeutics Alliance DTx Value Assessment & Integration Guide: https://lnkd.in/dQfbdvFJ Peterson Health Technology Institute (PHTI) Assessment Framework for Digital Health Technologies: https://lnkd.in/dYPTg39i Invitation to review: Dhaval Desai, Matt Perrine, Johannes Boshkow, Emilie Lopes-Fernandes, Varun Ramdevan, Stephen Hamm, MBA, Yoann Sapanel, Scott Kellogg, Lisa Britton, MBA, Przemek Grzywa, Marguerite Manteau-Rao, LCSW, MBA, James Faux, MBA, Wes Hassan, Emanuela Kufel, Bruce Imbert MD, PhD, MPH, Abby (Captain) Doctolero, Patrick Candela, Hakim Yadi Ph.D. OBE, Ryan Douglas, Rick Bartels, MBA, Evans D. Pope, III, Brian Harris, Ed Furlong, Darren R Hocking, Ph.D., Shijun Jo, Klaudia Grzeszczak, Kalyan Kalwa, Robert Andosca, Ph.D., Renata Redondo Bonaldi, PhD, Global MBA, Jessica Ackerman MS,CCC-SLP, Haresh Keswani, William Walters, Rudolf Wagner, Devanathan Raghunathan PhD MBA #healthcare #digitalhealth #healthinnovation #digitaltherapeutics #assessment