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Top Challenges to Leveraging Patient-Generated Health Data

Patient-generated health data is source of optimism and uncertainty as a result of the myriad challenges its use presents to providers.

- The role of patient-generated health data is set to change given the increased focus on patient engagement in programs such as meaningful use and the forthcoming Merit-based Incentive Payment Program. But are healthcare organizations and providers equipped to manage this new source of health data?

Patient-generated data in healthcare

Patient-generated data is not a new concept to healthcare and debates about its utility to clinical decision-marking date are ongoing.

The Office of the National Coordinator for Health Information Technology has been exploring the usefulness of patient-generated health over the past few years.

As early as 2012, the federal agency sought to better understand the use cases, challenges, and opportunities of patient-generated data in healthcare and came up with a working definition of patient-generated health data as " health-related data — including health history, symptoms, biometric data, treatment history, lifestyle choices, and other information — created, recorded, gathered, or inferred by or from patients or their designees (i.e., care partners or those who assist them) to help address a health concern."

The federal agency went on to note that this form of data is distinct from clinical health information in two ways — patients are responsible for its capture and recording and patient control how this information is to be shared with providers and others.

Patient-generated data likely brings to mind Fitbits, wearables, and other smart devices — many of which are not approved by the Food & Drug Administration for clinical use — but it can take the form of something as simple as a patient being able to correct erroneous information contained in their electronic health record. That being said, both the private and public sectors are exploring use cases for patient-generated data, such as remote monitoring of cancer and diabetes patients or those recovering from surgery.

Despite this growing optimism, several challenges stand in the way of health systems, hospitals, and physician practices making use of patient-generated health data to inform treatment plans and care strategies.

In 2015, two researchers from the University of North Carolina with funding from the National Institutes of Health identified a handful of challenges the healthcare industry would need to address before patient-generated data could reach its full potential in healthcare.

Provider concerns over liability

The electronic health record serves both a clinical and legal function for providers and the latter are not surprisingly worried by liabilities stemming from their inability to manage and review this external data and act accordingly.

As noted by Arlene Chung, MD, MHA, MMCi, and Ethan Basch, MD, MSc, in the Journal of Oncology Practice, these concerns will soon come face-to-face with regulatory pressure to use patient-generated health data:

The additional time and resources required for review and management of PGHD may outweigh the efficiencies gained from outsourcing data collection to the patient. However, reimbursement models are aligning for the use of PGHD for remote monitoring. Beginning January 1, 2015, the Centers for Medicare & Medicaid Services will cover remote chronic care management using a new current procedural terminology code (99490) to reimburse a monthly unadjusted, nonfacility fee of $42.60 per patient.

Incorporation into clinical workflows

Given the scarcity of use cases for patient-generated health data in healthcare, providers are likewise dubious about how to best incorporate this data source into their clinical workflows.

"Little is known about whether certain types of PGHD are better suited for continuous monitoring or for certain patient populations or conditions," wrote Chung & Basch. "And it is not clear which types of PGHD will be the most valuable for self-monitoring for patients or whether these will be concordant with those that providers feel are the most important."

Medicare physicians, however, won't have much of a choice as a result of MACRA implementation. As part of the advancing care performance category under MIPS, must fulfill a measure for patient engagement (per the proposed rule):

Patient-Generated Health Data Measure: 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.

• Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.

• Numerator: The number of patients in the denominator for whom data from non-clinical settings, which may include patient-generated health data, is captured through the certified EHR technology into the patient record during the performance period.

CMS included a similar measure for participants in the EHR Incentive Programs as part of proposed modifications to Stage 2 Meaningful Use and new measures for Stage 3 Meaningful Use (per the final rule):

Proposed Measure 3: Patient-generated health data or data from a non-clinical setting is incorporated into the CEHRT for more than 15 percent of all unique patients seen by the EP or discharged by the eligible hospital or CAH inpatient or emergency department (POS 21 or 23) during the EHR reporting period.

Denominator: Number of unique patients seen by the EP or the number of unique patients discharged from an eligible hospital or CAH inpatient or emergency department (POS 21 or 23) during the EHR reporting period.

Numerator: The number of patients in the denominator for whom data from non-clinical settings, which may include patient-generated health data, is captured through the CEHRT into the patient record.

Threshold: The resulting percentage must be more than 15 percent in order for an EP, eligible hospital, or CAH to meet this measure.

Exclusion: Any EP who has no office visits during the EHR reporting period may exclude from the measure.

Providers will have to rely on EHR vendors and their certified EHR technology in order to satisfy these measures, perhaps taking sting out of how to incorporate patient-generated data into their clinical workflows. But without a simplified means of reviewing patient-generated health data, providers will struggle to take action on information shared by patients.

"EHRs and clinical decisions support systems will need to provide easily customizable alert systems that can be tailored for individuals without substantial software programming, given that manual review of PGHD is not feasible," added Chung & Basch.

Health IT interoperability

Health IT standards are both an enabler and disabler of health information exchange between providers. Differing interpretations and implementations of health IT standards for patient-generated health data.

"Lack of industry-wide standards for both PGHD and interoperability of devices is a growing concern within the information technology community," Chung & Basch explained. "Although many device companies are using the consolidated care document standard that enables connectivity between sources, many devices (like the popular Fitbit device) still use proprietary architecture, making it more difficult for interoperability given that patients may have multiple devices."

The two researchers did acknowledge the work of several EHR vendors — Allscripts, athenahealth, Cerner Corporation, and Epic Systems — in leveraging Apple's Health Kit and other tools as a means of incorporating data generated by patients through wearables or manually via a patient portal, for instance, directly into their EHR technology. However, these attempts at integrating patient-generated health data are still immature.

Health data privacy and security

The healthcare industry is highly regulated, especially when it comes to providers ensuring the confidentiality of sensitive health information under HIPAA. Both providers and providers will require assurances about the authenticity, integrity, and ownership of patient-generated data.

Again, Chung & Basch captured the complexity of this particular challenge:

Patients, providers, and researchers all desire assurance that the data submitted are indeed authentic and from the patient or designated caregiver and that they are linked to the correct patient record within the EHR. The locus of control over the data should rest with the patient, such that he/she has the choice of who has authorization to view his/her data and how, if at all, it should be shared with other providers. Tracking the source of the data, or data provenance, will be important as it moves from the patient to EHRs, and secure transmission will be critical.

Improvements to care delivery and patient outcomes will rely on the coordinated efforts of providers, patients, policy-makers, regulators, and health IT developers. In light of the rise of consumerism in healthcare as a result of patients assuming more responsibility over the cast of care, the healthcare industry must make strides in enabling more than providers to generate and use meaningful use health data.

Dig Deeper:

Most Hospitals Lagging Behind in Using Patient-Generated Data
What Is MACRA and What It Means to Providers, EHR Technology 

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