The FDA defines digital health technologies (DHTs) as systems that use computing platforms, connectivity, software, and/or sensors for healthcare and related uses. DHTs present unique technical and regulatory challenges due to the interactions between the research team, the participant, and the technology.
Historically, research administrative groups performed overlapping independent reviews, which contributed to confusion and increased turnaround times for administrative staff performing reviews and scientific teams seeking institutional approval to launch studies. To address this, WCM streamlined the review process by combining the administrative groups’ key questions into a single starting point. This revised workflow does not introduce a new committee or board for reviewing digital health technologies.
For institutional best practices, please refer to the Compliance & Privacy Office’s guidance on usage of digital health technology. Key points include, but are not limited to:
- Does the research informed consent form (ICF) precisely describe the data used, collected, and shared?
- Once the DHT is developed, how will it be supported? How will it be patched and upgraded?
For more information about working with ITS to develop a custom application, please visit Web & Application Development.
For support in evaluating and implementing a digital health technology, contact ri-review@med.cornell.edu.