The Office of the National Coordinator has released a draft of an analysis of the landscape of the role patient-generated health data has to play in clinical research and health care delivery.

The white paper, written by Accenture Federal Services, is now available for public comment and is the latest development in the ONC’s two-year contract with Accenture to identify challenges and opportunities in PGHD and subsequently develop a framework for the ONC on how to collect and use the data. The project is parallel to several of ONC’s initiatives using PGHD in its 10-year vision to achieve interoperable health IT infrastructure by 2024, as laid out in the ONC’s 2015 Shared Nationwide Interoperability Roadmap.

Starting in October 2015, Accenture looked at seven PGHD policy topic areas: the collection and validation of data and tools that capture PGHD; data sharing between clinicians and researchers; the current regulatory landscape; opportunities to combine PGHD with clinical data for analysis and patient care; patient recruitment for research studies and trials; data interoperability and big data analysis. A year later, Accenture tapped Validic and Sutter Health to guide pilot projects exploring the use of PGHD to inform diabetes care while also identifying what is needed in infrastructure and workflows to scale the project. The pilot is using Validic's digital health platform and VitalSnap technology – which allows data from non-connected devices to be captured and digitized by using a smartphone camera – to integrate data into Sutter's electronic health records system. A second pilot demonstration, conducted by Tapcloud and Amita Health, is gathering PGHD across several areas including behavioral health and orthopedic surgery. The results of both pilots will be used to inform the final white paper. 

While PGHD is not a new phenomenon, the methods in which data is generated have changed drastically with the proliferation of smartphones, wearable and connected devices and apps. Furthermore, the recent advances in cloud computing are making it possible to capture and share large amounts of data across multiple platforms. The paper cited a recent Garner forecast that predicts the wearable market will expand from 275 million devices in 2016 to 477 million in 2020, creating rich data collection opportunity for clinicians and researchers.

“The rise of innovative digital health technologies has increased the ease of generating and collecting PGHD,” the paper states. “Such technologies provide a unique opportunity for patients to share their health data in day-today settings and in real time with clinicians and researchers. Although patients are creating an abundance of PGHD, a number of technical and cultural barriers currently exist that have slowed the movement of that PGHD into care delivery for patients.”

Namely, Accenture found, most healthcare and research organizations aren’t seizing the opportunity to use PGHD to advance their medical knowledge or support care delivery, owing to an insufficient understanding of the data. While the ONC has led a few efforts focused on improving understanding of PGHD (such as the commissioning of white papers and consumer working groups), clinicians today still typically make decisions based on data they collect in clinical care settings at single points in time. 

There are several reasons for this, Accenture found. For starters, not all wearable or devices are equal, and clinicians worry about the variance in accuracy as well as security and authentication. While FDA-cleared devices offer reliably trustworthy data, many devices are not subject to FDA approval and thus may not be fit for clinical and research use cases. Moreover, there are still no standards in PHGD interoperability or data provenance, and handling that large amount of data in the absence of standardized tools or guidelines can actually add to inefficiencies and distraction to clinical and research workflows, Accenture found.

That being said, the paper did mention a number of initiatives to address the current technical, security and interoperability challenges in integrating PGHD into clinical and research workflows.

“For example, emerging biometric authentication technologies, such as gait recognition algorithms that analyze body movements to identify individuals, are targeted to address user authentication issues,” the paper states. “Big data companies enable the use of analytics, such as natural language processing and machine learning on unstructured data, to help doctors and hospitals make their data more usable.”

The paper characterized current PGHD use as “in the early adoption stage,” as a number of innovative organizations are piloting and beginning to understand the value of the data.

Accenture expects such initiatives to scale to maturity over the next eight years, and laid out an adoption curve scenario. Moving on from our current early adoption stage, the paper forecasts the time between 2018 and 2023 to be one of growth, with increasing willingness of patients to capture and share data while interoperability standards are adopted and large scale data collection, analysis and storage is done securely. By 2024, PGHD could  “seamlessly and securely flow from the patient to the clinicians and researchers as part of routine care and research,” all while patient and doctor relationships become more collaborative.

To facilitate that, the paper found, the future PGHD policy framework needs to support patients and their caregivers to share their data through educational outreach and solicitation of patient feedback. For clinicians, the framework needs to assist care delivery systems in dealing with PGHD by fostering a relationship between clinicians and developers, and encourage early adopters to share their experience with new technologies in peer-reviewed journals and at conferences. Likewise, researchers should be supported with increased funding for studies to investigate the use of PGHD.

“A look toward 2024 anticipates that digital health technologies will become even more pervasive, offering even more opportunities for patients to capture, use and share their PGHD in support of health care delivery and research,” the paper states. “However, the capture of PGHD alone is not sufficient to cause change within the health IT ecosystem. To progress toward the future bold vision of PGHD use in care delivery and research, cultural, technical and regulatory barriers must be overcome through joint action.”