Conceptualizing a Data Infrastructure for the Capture and Use of Patient-Generated Health Data

Building the foundation to develop data infrastructure needed for patients to share their data with others
Background
Purpose & Goals
Achievements & Highlights
Resources
Related Projects
Agency
  • Office of the National Coordinator for Health Information Technology (ONC)
Start Date
  • 6/16/2015
Functionality
  • Collection of Participant-Provided Information
  • Standardized Collection of Standardized Clinical Data

 

 

STATUS: Completed Project

BACKGROUND

Patient-generated health data (PGHD) are health-related data (e.g., health history, device data, and patient-reported outcomes (PROs)) that are created, recorded, or gathered by or from patients, family members, or other caregivers to help address a health concern or promote health. The use of PGHD offers a unique opportunity to fill in gaps in information and provide a more comprehensive picture of ongoing patient health for use during care, resulting in potential cost savings and improvements in health care quality and outcomes, care coordination, and patient safety.

PROJECT PURPOSE & GOALS

Under the Office of the National Coordinator for Health Information Technology (ONC), this project is conceptualizing the development of the data infrastructure needed for patients to share their data with caregivers, providers, researchers, and others according to their preferences. This project consists of two areas of development: a policy framework for the use of PGHD in research and care delivery and several pilots that test the concepts and implementation of the framework.

The policy framework will address the following topics while identifying best practices, gaps, and opportunities for progress:

  • Collection and Validation of Data and Tools

  • Data Donation

  • Regulatory Gaps

  • Ability to Combine PGHD Data with EHR Data in Multiple Ways

  • Patient Recruitment

  • Data Interoperability

PROJECT ACHIEVEMENTS & HIGHLIGHTS

  • The two pilot demonstrations concluded at the end of 2017. In one pilot demonstration, Validic and Sutter Health partnered to test personalized care that leveraged remotely-collected PGHD across patients participating in a diabetes-focused research study. In the other pilot demonstration, TapCloud, worked with AMITA Health, to gather PGHD across several medical conditions, such as orthopedic surgery, stroke, behavioral health, and kidney transplant. 

  • The pilot demonstrations informed the development of the practical guide, which offers suggested practices for implementing of the capture, use, and sharing of PGHD in clinical and research settings. The guide and a supporting infographic are publicly available and published on ONC’s website. 

PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES

Publications:

Resources:

RELATED PROJECTS

Below is a list of ASPE-funded PCORTF projects that are related to this project

  • PCOR: Privacy and Security Blueprint, Legal Analysis and Ethics Framework for Data Use, & Use of Technology for Privacy - Patient level data are essential to understanding and improving health outcomes. These data must be made available to researchers in a way that ensures the protection of patient privacy while providing sufficient granularity to allow meaningful research questions to be assessed. However, current laws and policies around the use of patient level data are nuanced and sometimes conflicting, creating confusion for researchers, providers, and patients. This is a collaborative effort between ONC and Centers for Disease Control (CDC) to conduct research and create resources to improve the privacy of patients and their data.

  • Collection of Patient-Provided Information through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research - The FDA has identified a need for patient-provided data to fill gaps and mitigate the impact of potential biases in existing data, and is targeting mobile devices as a viable option that is significantly less time and resource intensive than traditional data collection with research cohorts. This project will create the infrastructure for collecting data from patients on medical product exposures, outcomes, risk factors and confounders through a mobile device application, allowing patient generated data to be linked with a single data partner that participates in the Sentinel and PCORnet distributed networks. The project will develop and pilot a mobile application to capture these types of data from pregnant women, who represent a traditionally understudied population and for whom significant gaps in research on drug safety exist. As a result, researchers will be able to query Sentinel for both the new patient generated health data (PGHD) (also known as patient provided information, PPI) and the data routinely captured by the Sentinel data partner.