A planning committee of the National Academies of Sciences, Engineering, and Medicine will plan a one-day public workshop that will provide a venue to discuss challenges and opportunities in digital health technologies for improving the probability of success in drug development and enabling precision medicine. Workshop participants may consider key components for an evidence-based framework for applying digital health technologies towards drug research and development.

The public workshop will feature invited presentations and discussions to:

• Discuss challenges/questions that digital health technologies may be uniquely suited to address and opportunities for digital health technologies to enable better patient care and more efficient clinical trials;
• Consider strategies for evaluating and selecting digital health technologies that are fit-for-purpose in drug development (e.g. establishing appropriate evidentiary criteria);
• Discuss privacy, ethical, and regulatory issues related to the use of digital health technologies;
• Examine currently validated and/or FDA-approved drug development applications for digital health technologies;
• Consider opportunities to enable the practical application of digital health technologies for improving drug development (e.g. sharing best practices for the validation and use of digital health technologies, harmonizing guidelines across sectors).

The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. Discussions may incorporate examples and lessons learned from other fields, such as direct-to-consumer genetic testing. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.