Conceptualizing a Data Infrastructure for the Capture and Use of Patient-Generated Health 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 ONC, this project conceptualized 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 consisted 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 addresses 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. 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

Resources:

• The project team published a project summary with links to additional resources, available here: https://aspe.hhs.gov/sites/default/files/private/pdf/259016/ConceptualizingDataInfrastructure.pdf

• The final version of the white paper is called “Conceptualizing a Data Infrastructure for the Capture, Use, and Sharing of Patient-Generated Health Data in Care Delivery and Research through 2024.” The white paper was published in January 2018: https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf.

• Funded by an FDA grant, the Duke-Margolis Center for Health Policy, convened a workgroup to create an action plan for accelerating the use of PGHD in research. The working group used the draft white paper to inform their discussions and was referred to in the Duke-Margolis Center action plan as a resource to readers: https://louisville.edu/mobileelsi/our-research-project/background-articles/s_okun-material-1/mobilizing-mhealth-innovation-for-real-world-evidence-generation/view

• Conceptualizing a Data Infrastructure for the Capture, Use, and Sharing of Patient-Generated Health Data in Care Delivery and Research through 2024 (Practical Guide) was published in January 2018: https://www.healthit.gov/sites/default/files/onc_pghd_practical_guide.pdf

• The white paper Infographic is available at: https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper_infographic.pdf

• The Practical Guide Infographic is available at: https://www.healthit.gov/sites/default/files/onc_pghd_pilot_demonstrations_infographic.pdf

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 project was 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 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 created 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 developed and piloted 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 were 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.