January 13, 2017: What’s Next: People-Powered Knowledge Generation from Digital Data

January 13, 2017: What’s Next: People-Powered Knowledge Generation from Digital Data

Slides: Slides


What's Next: People-Powered Knowledge Generation from Digital Data


Harlan M. Krumholz, MD, SM, Professor of Medicine at Yale University School of Medicine, Director of the Center for Outcomes Research and Evaluation at the Yale-New Haven Health System, and Founder of HUGO


Digital health data; Electronic health records; Personal health data; Moonshot; Precision Medicine Initiative; All of Us; PCORI; PCORnet; Patient-centered outcomes; Patient engagement; Patient input

Key Points

  • Current knowledge generation is inadequate to keep up with the information needs of patients, clinicians, health systems, regulators, and others. When we engage people as research partners instead of as research subjects, we advance the means to achieve better, faster, cheaper, and more impactful knowledge generation.
  • Now is the time for people to become active participants in clinical trials, create a movement to build the commons with data, and actively share data. We have a unique opportunity to provide for personal control of health data while also creating a global knowledge medical resource.
  • Accessing and obtaining copies of one’s health information for one’s own purpose is a right, not a privilege.
  • Ideally, collection of patient-reported outcomes (PROs) would be enabled for patients on their own smart devices in flexible user-configurable formats, perhaps through text messages, automated telephone systems, or downloadable apps.

Discussion Themes

Is there anything that regulatory agencies can do to empower patients to actively participate in clinical research?

One idea is to build proof-of-concept communities around empowering people to obtain their data.

With respect to mobile data, there should be no impediments to moving personal health data securely between platforms.

For More Information

The Study is Open: Participants Are Now Recruiting Investigators, by Sharon F. Terry (Sci Transl Med, 2017).

On the Path to a Science of Patient Input, by Margaret Anderson and K. Kimberly McCleary (Sci Transl Med, 2016).

Power to the People: Participant Ownership of Clinical Trial Data, by Sharon F. Terry and Patrick F. Terry (Sci Transl Med, 2011).

Read more about community engagement in research and download the NIH document Principles of Community Engagement, Second Edition at this website: https://www.atsdr.cdc.gov/communityengagement/.

@hmkyale, @PCTGrandRounds, @Collaboratory1, @PCORnetwork