The Digital Therapeutics Alliance (DTA) and USP announced a collaboration to explore the development of appropriate standards and guidelines for digital therapeutics at a roundtable discussion co-hosted by the two organizations today at USP headquarters in Rockville, MD.
“Innovative digital therapies have the potential to dramatically affect the way healthcare is delivered,” said Megan Coder, PharmD, DTA executive director. “Without quality as a priority in delivering these therapies, patients face a challenging landscape in determining which products to trust when it comes to technology in their health care. Working with USP enables us to promote the development of quality standards that allow patients and clinicians to have even greater confidence using digital therapeutics.”
Digital therapeutics deliver medical interventions via clinically-validated technologies to prevent, manage, and treat medical conditions and may be used standalone or in conjunction with therapeutic pathways to optimize patient care and health outcomes. From device and medication sensors to patient-focused applications and software, digital therapeutics create opportunities to strengthen current clinical interventions and disease management options for patients with diabetes, asthma, heart disease, substance abuse, pain, sleep disturbances, and other conditions.
“DTA’s commitment to ensuring quality aligns well with USP’s nearly 200-year mission of ensuring quality through standards,” explained USP CEO Ronald Piervincenzi, Ph.D. “Digital therapeutics represent an emerging industry, and this collaboration is an opportunity for USP to demonstrate how public standards can help ensure quality for patients even on the cutting edge of technology.”
The roundtable included stakeholders who shared their perspectives on the future of digital therapeutics and the collaboration with USP, as well as their concerns with quality in this area.
“Digital therapeutics offer new treatment options and completely change our definition of medicine,” said Eddie Martucci, Ph.D., Akili Interactive’s co-founder and CEO. “We envision a future where medical treatments continue to be quality-focused and effective but can also be highly engaging and interactive. Working with USP, we can deliver on both the promise of this field and the assurance of quality we’ve come to expect in medicine.”
“Mapping between the rigor of USP’s approach and the digital therapeutics landscape is a key opportunity for all of us,” offered Anand Iyer, Ph.D., MBA, WellDoc’s Chief Strategy Officer. “We have to find ways to match the accelerated evolution of the digital therapeutics industry with the commitment to quality standards at USP to capture the future of technology in health care each of us desires.”
This collaboration will explore ways to safeguard product quality and integrity for digital therapeutics, with input from relevant stakeholders. If areas of need are identified, any development of standards or guidelines will follow USP’s usual, rigorous public processes.