The U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) has released for public comment a draft of a white paper identifying opportunities and challenges in the capture, use and sharing of patient-generated health data (PGHD) in health care delivery and research.
ONC defines patient-generated health data (PGHD) as health-related data created and recorded by or from patients outside of the clinical setting to help address a health concern. PGHD — which includes a person’s health and treatment history, biometric data, symptoms and lifestyle choices — is captured by patients or their caregivers in various ways, such as through wearable health devices, consumer-focused apps and questionnaires. ONC has identified the use and sharing of PGHD as an important issue for advancing patient engagement in healthcare delivery and research.
The white paper, developed by Accenture Federal Services (AFS), outlines the current state of PGHD use and projects the future state of PGHD and the policy framework also recommends a number of enabling actions for healthcare stakeholders to advance the use of PGHD in clinical care and research.
In the white paper, ONC outlines a number of technical barriers affecting multiple stakeholders in the use of PGHD. Technical challenges including concerns about managing large volume of PGHD, questions about the accuracy of measurements from devices that collect PGHD as well as the lack of PGHD interoperability standards inhibiting data exchange and merging. Additionally, ONC noted that user authentication introduces data accuracy concerns and merging data from disparate sources introduces a number of data curation challenges, particularly in standardizing PGHD and capturing data provenance. There are also gaps in privacy and security protections, according to ONC.
Looking ahead to 2024, ONC noted in the report that while PGHD use for clinical care and research is currently in the early adoption stage, cutting-edge organizations are piloting and beginning to understand the value of PGHD.
“Initiatives like these will likely grow and scale to maturity over the next eight years. In the future, a fully functional health ecosystem will have digital capabilities to seamlessly and electronically capture and share PGHD among patients, clinicians, and researchers, as well as across communities and non-clinical settings,” ONC officials wrote in the draft white paper.
The white paper also outlines a number of enabling actions for healthcare stakeholders. ONC recommends that future PGHD policy framework should support clinicians to work within and across organizations to incorporate prioritized PGHD use cases into their workflows as well as foster collaboration between clinicians and developers to advance technologies supporting PGHD use.
In the white paper, ONC also outlines a role for policymakers, noting that the federal government has the ability to encourage the use of PGHD in clinical care and research by strengthening privacy and security measures and by encouraging innovative uses of PGHD.
To keep pace with the rapidly evolving consumer health technology marketplace, the framework should prompt policymakers to engage with industry leaders to create consensus on policies and practice, according to ONC, and should also call for increased funding for programs that aim to understand the outcomes of PGHD use as part of delivery system reform and advanced care models.
According to ONC, health IT plays a significant role in enabling the use of PGHD. “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 stated in the white paper.
As part of Accenture’s partnership with ONC, the company has contracted Validic and TapCloud to administer pilot demonstrations that will develop systems and processes to test the implementation of PGHD opportunities and challenges identified in the draft white paper. The pilot demonstrations will test and document the successes and challenges for PGHD by key stakeholders, with the results helping to inform the final white paper.
One pilot demonstration, conducted by Validic and Sutter Health, is using PGHD collected from a multitude of devices to inform diabetes care while assessing the infrastructure and workflows needed to implement and scale such initiatives. The pilot demonstration will integrate Validic’s digital health platform and VitalSnap technology within Sutter Health’s electronic health records system.
A second pilot demonstration, conducted by Tapcloud and AMITA Health, is connecting patients and clinicians outside the care setting to obtain biometric data and also identify how patients feel. TapCloud will use its comprehensive platform to gather PGHD across several medical areas such as orthopedic surgery, stroke, behavioral health, and kidney transplantation
Healthcare stakeholders who wish to provide comments about the draft white paper join the conversation about PGHD in the chapter about PGHD in the ONC Playbook or can submit a public comment to the joint Consumer Task Force of the Health IT Policy and Standards Committees.
Public feedback, along with the pilot demonstration results, will be considered for the final white paper that Accenture Federal Services plans to submit to ONC.