Important Steps to Advance the Use of Patient-Generated Data

Imagine a scenario where information gathered through an app can help you and your provider make decisions about your health and treatment plan. Given the recent proliferation of technologies such as FitBit, Apple Watch and Cardiogram, a future where patient-generated health data features prominently in conversations between providers and patients appears to be on the horizon. 

But even with this promise, obstacles abound.

Beyond the policy and operational issues that have confounded regulators, there are also human behavioral patterns to navigate. Recent research published by the Kaiser Family Foundation found that more than a third of adults have never used the internet or a smartphone to look at their medical records. And less than a quarter of Americans (23 percent) have set up a patient portal, according to a POLITICO/Harvard poll.

Indeed, the technology chasm stands as a barrier to harnessing the information that we, as patients, possess and could readily share with our providers.

On the policy front, we first need a clear regulatory framework and infrastructure in clinician offices to support the sharing and use of patient-generated health data (or PGHD). We’ve made some progress.

Since 2016, the 21st Century Cures Act has guided the Department of Health and Human Services’ work to advance an interconnected health care system in which providers have timely access to medical records and necessary patient information at the point of care. In conjunction with its interoperability initiatives, HHS officials also are endeavoring to ensure patients have easy and timely access to their medical information. Despite notable progress — and much to the chagrin of policymakers — interoperability remains a hurdle for patients, providers and industry.

A critical tipping point in this large-scale effort to bring 21st-century technologies to our health care system could be PGHD and expectations from users (both patients and clinicians) about how to harness it. Much like the way Amazon and other sites have revolutionized the shopping experience for household goods, groceries and countless other items, PGHD combined with advances in interoperability could empower patients and their caregivers to have more fulsome and effective conversations about their health care conditions. 

PGHD has the potential to significantly support individuals with chronic conditions who may require regular and ongoing monitoring. It can help providers and patients detect emergent issues or trends. Certainly, patients have much more on their plate than the constant collection or documentation of their health-related issues.

While still nascent in its availability and use, the Centers for Medicare and Medicaid Services is elevating PGHD as an important facet of patient-centered care. Federal agency leaders have not shied away from embracing the expanding market of affordable devices, sensors and other technologies that facilitate PGHD. CMS strongly believes the increased availability of PGHD offers providers an opportunity to monitor and track a patient’s health-related data from information that is provided by the patient, not the doctor.

The idea of using PGHD is certainly not new. In fact, it is a decades-old concept that has been impeded by insufficient evidence of its effectiveness and resistance among providers to adopt PGHD models.

Now, bolstered by a commitment from administration officials at the highest levels of government, CMS is beginning to build out a new vision for PGHD. Federal agencies are laying the groundwork that would be necessary to make PGHD an effective tool for patients and providers.

For example, CMS has been encouraged by the “ample support from the public for ONC (Office of the National Coordinator for Health Information Technology) and CMS to advance certified health IT capabilities to capture PGHD,” though the agency has not provided more detail on the extent of this support. CMS is already leveraging ONC’s PGHD framework, which identifies best practices, gaps and opportunities for the collection and use of PGHD in care delivery and research.

This summer, CMS took an important step to advance integration of PGHD by issuing a request for information specific to PGHD. The RFI invited patients, providers, industry and other stakeholders to help guide the agency in developing effective incentives and policies to support the use of PGHD in the Medicare program. The agency posed questions about unexplored approaches to incentivize health care providers to utilize PGHD and tackle other barriers and concerns.

Importantly, CMS may choose to incorporate PGHD into quality improvement initiatives, efforts to promote interoperability, or both. Meanwhile, stakeholders will be closely watching whether HHS provides enough time and the necessary guidance to facilitate the behind-the-scenes infrastructure to collect, share and determine the most useful PGHD. Importantly, they will also be monitoring how PGHD factors into the increasingly heated privacy discussions.

The adoption of PGHD as a regular component of the health care landscape hinges on the engagement of patients and providers on the front end. Their respective receptivity and concerns at this early stage will reveal the speed with which CMS can move forward.  


Andrea Maresca is a senior vice president at Thorn Run Partners, where she provides strategic advice on the federal policies and processes impacting innovation, coverage and reimbursement in federal health care programs, and before TRP, she served at CMS, first in the Office of Legislation, then as special assistant and adviser to the Deputy Administrator for Medicaid during the first year of the Trump administration.

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