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Consumer eHealth

Patient-Generated Health Data

What are patient-generated health data?

Patient-generated health data (PGHD) are health-related data created, recorded, or gathered by or from patients (or family members or other caregivers) to help address a health concern.

PGHD include, but are not limited to:

  • health history
  • treatment history
  • biometric data
  • symptoms
  • lifestyle choices

PGHD are distinct from data generated in clinical settings and through encounters with providers in two important ways:

  1. Patients, not providers, are primarily responsible for capturing or recording these data.
  2. Patients decide how to share or distribute these data to health care providers and others.

Examples include blood glucose monitoring or blood pressure readings using home health equipment, or exercise and diet tracking using a mobile app.

Why are patient-generated health data important?

The use of PGHD supplements existing clinical data, filling in gaps in information and providing a more comprehensive picture of ongoing patient health. PGHD can:

  • Provide important information about how patients are doing between medical visits.
  • Gather information on an ongoing basis, rather than only at one point in time.
  • Provide information relevant to preventive and chronic care management.

The use of PGHD offers an opportunity to capture needed information for use during care, with potential cost savings and improvements in quality, care coordination, and patient safety.

What role does health IT play in enabling the use of patient-generated health data?

New technologies can enable patients to generate important data outside of these settings as often as needed and share it with their providers to expand the depth, breadth and continuity of information available to improve health care and outcomes. The increasing number of smart phones, mobile applications and remote monitoring devices, coupled with providers’ deployment of electronic health records (EHRs), patient portals, and secure messaging, offer innovative ways to connect patients and providers and to strengthen consumers’ engagement in their health and health care. 

ONC has developed brief guides for providers about using health IT to assess patient experience with care [PDF - 976 KB] and to incorporate PGHD into medical practices [PDF - 1.5 MB].

What concerns about the use of patient-generated health data need to be addressed?

Providers will need to build processes and allow time to evaluate whether and what information to include in the patient record, and to determine when to promote PGHD use as part of the care plan. Providers may be concerned about any potential additional burden on their workflow, about increased liability and accountability, and about patient expectations.

Access, usability, education, health literacy, economic disparities, and similar factors can be barriers to PGHD use by patients.

Researchers can help identify what PGHD are most useful to improve health and care processes, as well as what types of consumer and provider education and support can ease its adoption and use. Researchers can look into how best to integrate consumer eHealth tools and information into individuals’ daily lives and into provider workflows. 

Federal and state policies could address important questions about what should (and should not) be documented in medical records, how the patient’s data is shared, and what protections need to be in place, among others.

How has ONC approached the use of PGHD so far?

ONC has identified PGHD as an important issue for advancing patient engagement, care delivery, and research. ONC has initiated a series of activities to gain more information about its value and approaches to implementing it.

Current Activities

In 2015, ONC began a project to identify best practices, gaps, and opportunities for progress in the collection and use of PGHD for care delivery and research through 2024. As part of the two-year project, ONC contracted with Accenture Federal Services to write a white paper [PDF - 2.3 MB] to inform future policy work in the industry. In early 2017, the draft white paper was considered by the joint Consumer Task Force of the Health IT Policy and Standards Committees and made available for public review and comment. As a result, about 200 comments were received and considered for the final white paper published in the fall of 2017.   

The Accenture team also conducted two pilot demonstrations to inform the final white paper and developed a practical guide [PDF - 383 KB]. For the pilot demonstrations, the Accenture team selected Validic to test personalized care leveraging remotely-collected PGHD across patients in partnership with Sutter Health’s diabetes-focused research study. They also selected TapCloud LLC, working with AMITA Health, to gather PGHD across several medical conditions such as orthopedic surgery, stroke, behavioral health, and kidney transplant.

The effort is part of a suite of projects focused on improving use of health IT among researchers for patient-centered outcomes research (PCOR). The PGHD policy project is a necessary step towards a long-term policy solution for the successful implementation of the PGHD requirements of the Federal Health IT Strategic Plan, ONC Interoperability Roadmap, 2015 Edition Certification Rule, Stage 3 of the CMS Meaningful Use Rule, the CMS Quality Payment Program and the administration’s Precision Medicine Initiative.

Past Activities

In April 2012, ONC commissioned a Patient-Generated Health Data White Paper [PDF - 993 KB] to better understand PGHD uses, challenges and opportunities.

ONC’s Federal Advisory Committees (the Health IT Policy Committee (HITPC) and the Health IT Standards Committee (HITSC)) built on this foundation by convening a public hearing in June 2012 to gather additional input on policies and standards needed to support PGHD. In 2014, the Committees provided recommendations about the inclusion of PGHD in Stage 3 of the EHR Incentive Programs (commonly referred to as the Meaningful Use Program), which supports the adoption and use of EHRs.

In 2013, ONC convened a Technical Expert Panel on Patient-Generated Health Data (PGHD TEP) to identify good practices that can reduce concerns and risks and to encourage providers to implement PGHD through Meaningful Use and for purposes outside Meaningful Use. The PGHD TEP’s final report [PDF - 500 KB] and appendix [PDF - 2.1 MB] was completed in December 2013. Also in 2013, ONC commissioned an environmental scan on the issue of data provenance [PDF - 743 KB].

In early 2014, ONC published an issue brief on PGHD and the role of health IT [PDF - 307 KB] to further define the information outlined above