Patient-Generated Health Data
The use and sharing of PGHD supplement existing clinical data, filling in gaps in information and providing a more comprehensive picture of ongoing patient health. The use and sharing of PGHD in care delivery and research can:
- Gather important information about how patients are doing between medical visits.
- Provide information for use in shared decision-making about preventive and chronic care management.
- Offer potential cost savings and improvements in quality, care coordination, and patient safety.
ONC is addressing the opportunities and challenges that the use of PGHD may present now and in the coming years.
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
- lifestyle choices
PGHD are distinct from data generated in clinical settings and through encounters with providers in two important ways:
- Patients, not providers, are primarily responsible for capturing or recording these data.
- 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 or wearable device.
What are the PGHD-related criteria in the health IT rules and programs?
To encourage innovation related to PGHD capture and use, new criteria have been included in ONC’s 2015 Edition Health Information Technology Certification Rule and in CMS’s Quality Payment Program.
The Patient Health Information Capture Criterion, §170.315(e)(3), states that a certified Electronic Health Record (EHR) product must “enable a user to: 1) Identify, record, and access information directly and electronically shared by a patient (or authorized representative). 2) Reference and link to patient health information documents.”
The intent of this provision is to establish at least one means for accepting patient health information directly and electronically from patients in the most flexible manner possible. There is no standard required for this certification criterion and the criterion does not seek to define the types of health information that could be accepted as ONC believes the range of standards and data types should be as broad as possible. ONC encourages health IT developers to develop innovative and efficient ways to meet this criterion while simultaneously supporting providers accepting health information from patients.
One of the 15 choices of measures for the Advancing Care Information score of the Merit-based Incentive Payment System (MIPS) states:
“Patient-generated health data or data from a non-clinical setting is incorporated into the certified EHR technology for at least one unique patient seen by the MIPS eligible clinician during the performance period.”
This measure supports the objective of increased coordination of care through patient engagement.
How is ONC currently supporting the use of PGHD?
ONC has identified the use of 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.
In 2015, ONC began a project to identify best practices, gaps, and opportunities for progress in the collection and use of PGHD in care delivery and research through 2024. As part of the project, ONC contracted with Accenture Federal ServicesWeb Site Disclaimers 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 winter of 2018.
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 ValidicWeb Site Disclaimers to test personalized care leveraging remotely-collected PGHD across patients in partnership with Sutter Health’sWeb Site Disclaimers diabetes-focused research study. They also selected TapCloud LLCWeb Site Disclaimers, working with AMITA HealthWeb Site Disclaimers, 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, and the 2015 Edition Certification Rule.
What are the opportunities and challenges of patient-generated health data (PGHD) use?
The proliferation of consumer health technologies, including smartphones, mobile applications (apps), and wearable devices, has increased the frequency, amount, and types of PGHD available. These advances can enable patients and their caregivers to independently and seamlessly capture and share their health data electronically with clinicians and researchers more frequently and from any location.
Various stakeholder groups can benefit from new opportunities yet also face some challenges arising from increasing PGHD use. A few are described below; more in-depth discussion can be found in the final white paper [PDF – .2.7MB]
Patients and Caregivers
New technologies can enable patients and their caregivers to generate important data outside of clinical 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 managing their health and health care. However, barriers to access, low health literacy, and concerns about privacy protections can limit PGHD collection, use, and sharing by patients and caregivers.
The use of PGHD can provide a more holistic view of a patient’s health and quality of life over time, increase visibility into a patient’s adherence to a treatment plan, and enable timely intervention before a costly care episode. To integrate this new source of data, providers will need to set up analytical tools, build processes into their workflow, and evaluate whether and what information to include in the patient record. They will need to determine when to promote PGHD use as part of the care plan. Providers may be concerned about any potential negative impact to the efficiency of their workflow, increased liability and accountability, and setting realistic patient expectations. They may also need to address technical challenges such as confirming the accuracy and validity of PGHD from wellness devices, managing the security risk, and standardizing the data collected from multiple devices.
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 health technology and information into individuals’ daily lives and into providers’ workflows.
Federal and state policymakers can help encourage innovation and offer guidance to various stakeholder groups. For example, they can collaborate with other stakeholder groups to address important questions about what should (and should not) be documented in medical records, what standards are needed, how the patient’s data are shared, and what protections need to be put in place.
Developers and Standards Bodies
Developers and standards bodies can provide the technical infrastructure and tools required to enable the capture, use, and sharing of PGHD. Measurements and data elements across devices may vary significantly, and the structure and format of PGHD may not be compatible across devices and apps, posing challenges for combining and comparing PGHD from disparate sources, including clinical data in an EHR. Increased standardization will help to ensure the functionality of these devices and apps as well as the accuracy and validity of data captured by these tools.
Payers and Employers
Payers can help align incentives between clinicians and patients and promote shared decision-making through their reimbursement policies. Payers can motivate interoperability and data sharing by reimbursing clinicians for using PGHD and other data during patients’ transitions of care. To increase access to consumer technologies for all patients, payers can support their members with devices and apps.
Employers can encourage the capture and use of PGHD by providing employees with discounted or free wearable activity trackers, prizes for reaching certain health milestones, and discounts on health insurance premiums. By offering these devices and monitoring programs to employees, employers may also receive discounts and reductions in the cost of offering insurance to their employees from payers.
Research by The Office of the National Coordinator for Health Information Technology (ONC)
For more information go to https://www.healthit.gov/topic/scientific-initiatives/patient-generated-health-data