The pathway to patient data ownership and better health

Digital health data are rapidly expanding to include patient-reported outcomes, patient-generated health data, and social determinants of health. Measurements collected in clinical settings are being supplemented by data collected in daily life, such as data derived from wearable sensors and smartphone apps, and access to other data, such as genomic data, is rapidly increasing.

Katherine A. Mikk, JD; Harry A. Sleeper; Eric J. Topol, MD, JAMA Network September 25, 2017

One projection suggests that a billion individuals will have their whole genome sequenced in the next several years.1 These additional sources of data, whether patient-generated, genomic, or other, are critical for a comprehensive picture of an individual’s health.

Enabling access to personal health data, clinical or patient-generated, may benefit patients and health care professionals. Research is beginning to show that providing patients with their complete health data may help improve their health. For example, timely access to laboratory results can increase patient engagement.2 Access to physician notes after appointments appears to encourage individuals to improve their health and participate in decision-making, with electronically engaged patients demonstrating more successful medication adherence, quality outcomes, and symptom management.3

Economic benefits may include the avoidance of duplicative imaging or laboratory tests.4 Clinicians may also benefit from more informed patients. For example, they may score higher in quality performance programs because patients who are more informed may better adhere to treatment plans and hence may improve clinician scores. Despite growing evidence of such benefits, albeit with limited patient outcomes, and legislative and regulatory initiatives that facilitate electronic patient engagement, patients’ access to a complete, longitudinal digital health record remains rare. While such access may be possible for certain patients who receive care within a few select health systems, it remains elusive for many others, including patients who have changed physicians, lived in different places, have multiple chronic conditions, or who have had services provided outside of a clinical setting such as through a home health service.5

Health care, under pressure to embrace interoperability, is poised for transformation. The potential for future system improvements is vast, but depends, in part, on increased patient participation. Health care must find a way to shift from “the doctor will see you now” to “the patient will see the doctor now.” 6 Patients need engagement beyond passively receiving services, but this will be challenging until they can easily access and use their health data. For this to proceed, control of health data must be transferred to the patient or the patient’s authorized representative.

More specifically, to obtain active patient engagement and health system improvement, 3 components are necessary:

  1. common data elements that enable the sharing and merging of health data from multiple sources;
  2. a patient encounter data receipt, comprised of relevant health data from each health care encounter, automatically pushed to the patient’s complete digital health record; and
  3. a contract between patients and third-party health data managers (eg, health care organizations and commercial entities) that enables individuals to control their longitudinal digital health record.

Most of these components already exist in some form, requiring only minor adjustments to effect health system transformation.

Clinicians, patients, and health care systems need a way to efficiently receive, integrate, understand, compute, and use digital health data from other practitioners and health encounter locations. This requires the merging of what is often disparate data from multiple sources, and the most effective way to do this is to establish common data elements agnostic of any particular vendor’s electronic health record (EHR) system.

With widespread implementation of common data elements and value sets, semantic and clinical interoperability can be achieved, and health information can be merged, while maintaining data integrity. New initiatives, such as the Standard Health Record,7 that focus on standardizing data within health records instead of solely on exchange standards enable the development of one complete, digital health record per patient containing health data merged from all of a patient’s clinicians and related health data sources. For example, applying common data elements to platforms can enable patients to add patient-generated data into the record in addition to clinician-generated data. With its common, unifying template, the Standard Health Record can also support a host of secondary uses, such as patient-centered outcome research, precision medicine, and precision public health surveillance. This common digital health data language is also anticipated to reduce translation and comprehension errors.

Common data elements have legislative and regulatory support. For example, one Meaningful Use objective is to provide patients with the ability to view, download, or transmit certain health information, including vital signs and laboratory test results. Section 4003 of the 21st Century Cures Act also requires the Department of Health and Human Services to evaluate the need for a “core set of common data elements and associated value sets” to enhance the exchange of structured health information.

Common data elements enable information from anywhere (eg, clinicians, patients, sensors, and smartphones) to be added to a patient’s digital health record. These additions can be automatically pushed to the record by EHRs, similar to receiving an itemized receipt after banking, only with health data. Receipts must be timely and contain all information from the encounter, including not just the visit summary, but images, billing, and any other related information. Receipts ensure timely updates to the patient’s complete digital health record. Modest EHR system changes would be required to implement receipt processes and, since automated, could minimize clinician and patient burden.

Levers to implement receipts include amendments to Meaningful Use, the Merit-Based Incentive Payment System, or other programs that require use of certified EHR technology. The 21st Century Cures Act enables the Department of Health and Human Services to expand guidance on transmitting health information pursuant to a patient’s right of access to the health record. Alternatively, minor amendments to the Health Insurance Portability and Accountability Act could expand patients’ right of access to require automatic generation of receipts. With common data elements, the transfer of receipt data to a patient’s complete health record can occur seamlessly as a background business process.

To fully enable robust, patient-centered health data access and control, a final requirement is a data use agreement (DUA), executed between the patient and an entity that manages the patient’s digital health record (the health data manager). The DUA, with provisions addressing data quality, integrity, privacy, security, and patient control, must necessarily be patient-centered, but must also enable clinicians and payers to trust and use the patient’s digital health data as necessary. DUAs can also be tailored to patient preferences. For example, DUAs may enable patients to contribute data for secondary uses.

DUAs with health data managers will enable patients to collect and access all of their health data. This addresses the independent maintenance of records by every clinician who sees a patient and, if a patient has seen multiple clinicians, the strong likelihood that those various records have not been aggregated. Further, health records shared with patients are often read-only and may contain only basic information, preventing patients from effectively managing their complete health record. Patients often lack real access to electronic health data; in many instances, “for patients, EHRs are remote and unseen.” 8

Simple changes built on business structures already loosely in place can effectuate change. Health data managers may be health care organizations, commercial entities, payers, trusts, or cooperatives. Commercial entities that offer patients health record aggregation services continue to emerge and, in some cases, already enable incorporation of patient-reported health data into an aggregated record. Health information exchanges serving health care organizations and payers could offer such services to patients. Alternatively, a trustee model could be run by an entity that adheres to specific trust requirements, managing and sharing the patient’s health data pursuant to the patient’s predetermined, revocable instructions.

Fostering widespread clinician buy-in to a patient-centric approach to health data may be challenging. Some may resist the proposed structure for reasons such as competitive advantage, skepticism, or concern that changes to EHRs increase clinician burden. Today’s existing architecture, however, fails both patients and clinicians. With a new approach, clinicians can truly partner with patients, receiving the benefit of improved quality performance through increased patient engagement and improved, longitudinal digital health records.

Patients need and deserve the opportunity to control their health data. Clinicians need complete, accurate, and timely data about their patients. In addition, clinicians and other stakeholders, such as payers and health information exchanges, need to truly engage patients as thoughtful partners to create a patient-centered health system.

The 3 components of the proposed system—common data elements, patient encounter data receipts, and DUAs—can improve patient engagement, data accuracy, and health outcomes. The proposed system offers potentially vast returns with amendments to existing regulatory and technical infrastructure. Complete digital health records and standardized health data could serve as a platform for innovation, including personalized medicine and algorithmic services, and pave the road to a true learning health system. Most importantly, the proposed system would provide individuals with the opportunity to control the data that tell some of the most personal stories of their lives.

  1. Big Data: Astronomical or Genomical? Stephens ZD, Lee SY, Faghri F, Campbell RH, Zhai C, Efron MJ, Iyer R, Schatz MC, Sinha S, Robinson GE. PLoS Biol. 2015 Jul 7;13(7):e1002195. doi: 10.1371/journal.pbio.1002195. eCollection 2015 Jul.
  2. Direct Release of Test Results to Patients Increases Patient Engagement and Utilization of Care, Pillemer F, Price RA, Paone S, Martich GD, Albert S, Haidari L, Updike G, Rudin R, Liu D4, Mehrotra. PLoS One. 2016 Jun 23;11(6):e0154743. doi: 10.1371/journal.pone.0154743. eCollection 2016.
  3. A national action plan to support consumer engagement via e-health, Ricciardi L, Mostashari F, Murphy J, Daniel JG, Siminerio EP. Health Aff (Millwood). 2013 Feb;32(2):376-84. doi: 10.1377/hlthaff.2012.1216.
  4. Does health information exchange reduce redundant imaging? Evidence from emergency departments, Lammers EJ, Adler-Milstein J, Kocher KE. Med Care. 2014 Mar;52(3):227-34. doi: 10.1097/MLR.0000000000000067.
  5. Missing clinical and behavioral health data in a large electronic health record (EHR) system, Madden JM, Lakoma MD, Rusinak D, Lu CY, Soumerai SB. J Am Med Inform Assoc. 2016;23(6):1143-1149.
  6. The Patient Will See You Now: The Future of Medicine Is in Your Hands, Topol E, New York, NY: Basic Books; 2015. ISBN 9780465054749
  7. The Standard Health Record. Accessed July 26, 2017.
  8. Toward digital health biographies, Graboyes RF, Bryan DN. RealClear Health. Published December 19, 2016. Accessed July 26, 2017.
Conflict of Interest Disclosures
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Ms Mikk reports receiving funding from the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, MITRE Corp, and the Office of the National Coordinator for Health Information Technology; however, this research was funded only through MITRE internal innovation funds. Dr Topol reports receiving personal fees and/or other funding from Blue Cross Blue Shield, Walgreens, YouBase, Apple, Illumina, and Dexcom. No other disclosures were reported.
Additional Information
The MITRE Corp has developed the Standard Health Record (SHR) as a means of implementing common data elements to ease issues of interoperability between electronic health systems. The SHR is an open-source project freely available to the public for its own use and collaboration, and MITRE earns no commercial profit from SHR nor does it have any intellectual property claims on it.

Source JAMA Network

Also see
How healthcare systems can become digital-health leaders in McKinsey & Company
Will Epic’s new record-sharing tool solve interoperability challenges? in Modern Healthcare
Forget what the doctor said? This MD records visits so you can listen back in White Coat, Black Art, CBC Radio

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