Premier Submits Comments on FDA DHT Framework

Premier submitted comments to the Food and Drug Administration (FDA) in response to the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development. The Framework provides FDA’s current thinking on the use of digital health technologies (DHTs) to support a multifaceted program for drug development and review. In our comments, Premier urges the FDA to:

• develop data standards for DHTs, in conjunction with the private sector, to minimize confusion around the quality of DHT data that can or cannot be leveraged as part of a clinical trial submission;
• create consistent approaches to the review and evaluation of study submissions;
• work with multiple external stakeholders, including companies such as Premier, to ensure that the Framework incorporates real world knowledge and experience;
• remain nimble and flexible to regularly update the Framework as DHTs continue to evolve and transform.