The Digital Medicine Society (DiMe) announced a collaboration with Peterson Health Technology Institute (PHTI), ZS Associates and other industry groups to improve the development and implementation of integrated evidence plans (IEPs) for digital health products.
The goal of the collaboration is to align best practices pertaining to streamlining the path to commercialization for digital health products by providing information on IEPs, including regulatory requirements, commercial considerations and the needs of key stakeholders, such as regulators, payers, purchasers and end users.
“By identifying pathways to market for digital product developers and the pathways and evidence they require for buyers, we can speed up the process of development and deployment for the innovators, that comprehensively and early on takes into account the specific evidence requirements,” Smit Patel, associate program director for DiMe, said in a statement.
“This results in early and substantial investments in evidence generation being overly focused on regulatory decision-makers, missing the opportunity for more efficient and effective studies that address the requirements of all decision-makers.”
THE LARGER TREND
The collaboration builds on DiMe’s prior efforts and will span the next year, aiming to create resources aligning with U.S. Digital Health Regulatory Pathways for DHPs and the Evidence DEFINED framework.
As healthcare experiences an ongoing wave of digital transformation, encouraging—and convincing—consumers to use digital health products remains a challenge.
The FDA is also facing challenges as it looks to regulate the fast-evolving digital health landscape, consisting of services, apps and tools for patients, from digital therapeutics to chronic condition management.
