A Comprehensive Approach to Patient Access and Patient-Generated Health Data

By Drew Schiller, CEO, Validic, and Jodi Daniel, Partner, Crowell & Moring

Our healthcare system is in the midst of a fundamental shift toward value-based care to drive down costs and improve the quality of care. We won’t be able to achieve that goal without technology that allows providers to collect and use health data and puts patients front and center. Patient access to clinical and claims data is essential. When patients have access to their own information, they can better understand their condition and feel empowered to ask questions and shape their own care plan.

Congress and the federal government are pushing to liberate data from within the healthcare system and to promote patient access to health information. However, it is equally important to focus on the flow of data from the patient back into the healthcare system. The patient – who is gathering data at home, managing her condition, and making day-to-day decisions that impact her health – holds information that is critical to treatment decisions and outcome improvements.

The First Step: Patient Access

Policymakers are focused on the first step – patient access to data.  Giving patients easy electronic access to their health data is critical.  The government has supported patient access in many ways over the years:

  • The HHS Office of Civil Rights has issued guidance to encourage and improve patients’ right of access under HIPAA, without undue burden or cost.
  • Meaningful Use regulations have promoted the patient’s ability to view, download, and transmit their information electronically and to use application programing interfaces (APIs) to enable patients to gain easier access to information in electronic health records.

In the past few months, HHS has pushed for more data access:

  • MyHealthEData Initiative. CMS announced a new initiative focused on value-based care and increasing patient access to healthcare data, including BlueButton 2.0, which has been updated to include a standards-based API that will allow beneficiaries to connect their claims data to secure applications, services, and research programs they trust.
  • Department of Veterans Affairs Open-API Pledge. The VA announced the Open API Pledge, which will provide API access to developers for veteran-designated mobile and web-based applications and clinician-designated applications for those who serve Veterans.
  • National Institutes of Health Sync for Science Pilot. NIH and ONC launched the Sync for Science Pilot to allow individuals to access their health data and voluntarily “donate” it to researchers as part of the Precision Medicine Initiative (PMI), allowing patients to authorize the extraction of their data in EHR systems to fuel future scientific breakthroughs.

Despite these efforts, there are still many hurdles and not enough patients are accessing their data and using it to support the management of their health.  Even if this improves, access is not enough.

The Next Step: Patient-Generated Health Data

To see real health system transformation, we need to reimagine patient-provider information sharing. Think about a patient who can better monitor his diabetes at home and receive feedback from his healthcare provider who has access to his blood-glucose levels and trends. Consider a psychiatrist who can use a simple daily mood tracker to determine if a medication is helping and whether to consider changing a dose or using a new medication. Or software that can do pre-onset cognitive monitoring of a patient to detect early Alzheimer’s and provides alerts to his clinician.

Patient-generated health data (PGHD) are data created, recorded, or gathered by or from patients (or family members or other caregivers) to support their health. This data may include health history, biometric data, symptoms, and lifestyle information. Most of the factors leading to positive health outcomes or prevention of health conditions are dependent on activities, choices, and information about the patient that all occur outside of the healthcare system. And not all of this information is what you’d traditionally think of as “health data.” A person’s health and prognosis can depend as much on factors like income, access to transportation, diet and exercise choices, and level of community support – often called “social determinants of health.” An outcomes-based approach to healthcare demands inclusion of PGHD.

HHS has taken initial steps to support the incorporation of PGHD into clinical care, specifically:

  • The EHR certification rule, which includes a requirement for Patient Health Information Capture;
  • PGHD components of Meaningful Use and QPP have been a help (although the recent proposal would eliminate patient generated health data requirements from the new, streamlined version of Meaningful Use);
  • ONC released a PGHD framework to identify best practices, gaps, and opportunities for the collection and use of PGHD in care delivery and research. Validic was excited to be part of one of the pilots to test personalized care leveraging PGHD across patients for a diabetes-focused research study;
  • CMS has provided more avenues for reimbursement for remote patient monitoring.

But policy makers should do more to create the right incentives and focus as much on PGHD as on patient access to health data. As a next step, ONC should expand the API certification criteria to mandate the capability for bi-directional information exchange – right now, EHRs only have to deliver patient access. CMS should revise remote monitoring reimbursement policy to reflect (1) bi-directional data flow; and (2) more kinds of data than just biometric, such as social determinants and behavioral data. VA should enable PGHD as part of its open API project, so clinicians can better support Veterans with chronic conditions, including those with post-traumatic stress disorder and other mental health conditions, and Veterans can more easily bring their health information to providers both in and out of the VA system.

It’s About the Patient

We believe that technology can support this new model for provider/patient communication and improved patient engagement to support value-based care goals.  To get to patient-centered care, we should focus as much on listening to and getting information from the patient as we do on sharing information with the patient. A health system that embraces bi-directional data exchange can reach more effective treatment and better outcomes – and makes the patient an active partner in their care.

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