Summary<\/em><\/strong>: Patients are increasingly using new electronic tools such as personal health records and mobile applications to track details about their health, and sharing those details with their physicians. However, some physicians are reluctant to receive digital data from patients due to professional liability concerns. In Project HealthDesign, a research program funded by Robert Wood Johnson Foundation, clinical care teams tested the incorporation of patient-generated, digital information into clinical care. The research teams documented the professional liability concerns voiced by physicians and other clinicians during the study and the steps they took to manage them. The approach they took to managing these concerns could be helpful to providers seeking to engage patients in their care using technology. Patients are increasingly using new electronic tools like personal health records (PHRs) and mobile applications (apps) to track details about their health and, when relevant, are sharing those details with their physicians — often in real time and wholly separate from the traditional office visit. However, some physicians are reluctant to receive digital data from patients due to professional liability concerns. The vast amounts of information that patients could potentially share electronically leaves many physicians wondering whether they could keep up with, and appropriately respond to, important clinical issues that may be presented by the data. <\/p>\n Project HealthDesign, a program of the Robert Wood Johnson Foundation’s Pioneer Portfolio, recently studied the collection of information by patients in personal health apps. The most recent phase of this program involved the incorporation of this patient-generated, digital information into clinical care. The Project HealthDesign research teams documented the professional liability concerns voiced by physicians and other clinicians during the study and the steps they took to manage them. They are presented here for those physicians whose liability concerns may be preventing them from adopting technological approaches to achieve greater engagement with their patients. <\/p>\n Although Project HealthDesign was a research project, it is likely that care models incorporating electronic patient-generated data will become the norm in the near future, as pressures to improve outcomes at lower costs continue to increase. Indeed, achievement of the “triple aim” of health care (i.e., improving the experience of care, improving the health of populations, and reducing per capita costs of health care) depends on patients — with the guidance of their physicians — becoming more engaged in managing their health.<\/a>[1<\/a>]<\/p>\n Project HealthDesign consisted of five research teams that created personal health apps to help patients better manage their health and keep track of observations of daily living (ODLs).<\/a>[2<\/a>]ODLs are patient-recorded feelings, thoughts, behaviors and environmental factors that are personally meaningful and provide health cues; they can include information about an individual’s mood, what they ate, levels of pain they experienced, medication they took, and their sleep patterns, among others. <\/p>\n Project HealthDesign tested the hypothesis that capturing ODLs in real time enables patients to provide their physicians and other clinicians with more specific information about their health — the kind of information that could become one of the clinician’s most important tools for engaging patients as partners in their health. The theory is that clinicians who can rely on standard clinical measurements like hemoglobin A1C as well as information on medication adherence, sleep, diet, and exercise will be more able to guide patients in managing their chronic illnesses and achieving improved health outcomes. <\/p>\n The physicians (and other clinicians) participating in Project HealthDesign raised the following liability-related concerns:<\/p>\n Although a detailed analysis of the laws governing professional liability is beyond the scope of this paper, it is helpful to know generally that to succeed in a professional liability claim, a plaintiff must prove that the physician failed to meet the applicable “standard of care,” which is generally determined by professional custom. Models of care in which physicians rely on patient-generated health information that is collected and communicated electronically are only beginning to gain acceptance. As a result, professional custom in this area is still forming, leaving physicians with little clear guidance and no \u201cstandard of care\u201d regarding how to address these concerns. <\/p>\n In the absence of clear guidance, each of the five Project HealthDesign research teams developed their own strategies for managing what ODLs would be sent to the clinical care team and how they would be handled once they became part of the clinical care “ecosystem.” In short, each team set reasonable and clear expectations on the part of both the clinical care team and the patients that addressed the “who, what, when, where and how” for the electronic information sharing involved in the study: <\/p>\n Under each research project, it was clear what type of ODLs patients would be communicating and how, where the ODLs would be stored and displayed, and who would review the ODLs, under what circumstances and how often. Consequently, the “data flows” were not uncontrolled but instead were tightly managed. Below are examples of how two of the research projects managed their patient-generated data flows. <\/p>\n \tThe BreatheEasy research team worked with asthma patients to capture ODLs and share them with their primary care physicians (and their clinical care teams) in order to make lifestyle and treatment adjustments to better manage their asthma symptoms. One of the principal investigators on this team is a family physician, so workflows typical of a busy family practice were part of the study design. Patients used smartphones to collect ODLs including peak flow rates, controller medication adherence, rescue medication use and reason for use, asthma symptoms and triggers, mood, physical activity, and smoking habits.<\/p>\n \tIn this project, the ODL data from the patients’ smartphones first passed through a nurse triage system, where nurses, who were guided by clinic-directed protocols, determined if patterns were normal, or if further follow-up with the patient or additional review by a physician was needed. The nurses reviewed the ODL data at least once a week using a “Clinician Dashboard,” which graphically depicted patient ODL trends over time in a customizable web-based interface. Physicians then reviewed the ODL data with the patients using the “Clinician Dashboard” when alerted by the nurse or during patient encounters. For one patient, the Clinician Dashboard enabled the patient’s care team to recognize the patient was using her maintenance medication to address acute episodes, and the rescue medication for maintenance. This review allowed the care team to correct this problem with the patient by using the Dashboard as a visual aid.<\/p>\n \tThe BreatheEasy researchers reported that professional liability concerns were low among the project’s participating physicians. They attributed this to the study’s design, in which they purposefully made the data flows track traditional workflows in a primary care practice (ie, a nurse reviews a patient’s ODL Dashboard and reports significant issues to the physician, just as if the nurse had a discussion with the patient over the phone).<\/p>\n \tThe Chronology.MD team helped patients with Crohn’s Disease create visual narratives of their conditions using ODL data, including measures of abdominal pain, energy level and medications, which they could share with their physicians to help determine the appropriate course of treatment. The team employed the use of an “ODL Prescription” to guide the types of ODLs that each patient shared with his or her physician under the project. The ODL Prescription was developed jointly by the participating patients, their physicians, and the entire clinical care team to ensure the most efficient and effective use of physicians’ time. <\/p>\n Physicians only reviewed the ODLs identified in the ODL Prescription when patients came in for an office visit. Physicians or other clinical staff did not review the ODLs at any other time (patients used this data in between visits to help make adjustments to every day behaviors that can impact Crohn’s Disease symptom management). Thus, the value for physicians of ODL collection under the Chronology.MD project was in the transformation of the raw ODL data into charts and graphs that presented visual “narratives” for the physicians and patients to jointly use in making treatment decisions.<\/p>\n To manage liability, the Project HealthDesign research teams took one or more of the steps described below. Physicians seeking to engage patients using digital technologies should consider whether they can implement any of these strategies.<\/p>\n Professional concerns about potential liability for incorporating electronic patient-generated health information into clinical workflows is understandable. There is no clear standard of care or professional custom to guide the actions of physicians engaging in this innovative activity. However, Project HealthDesign has demonstrated that physicians can take steps to mitigate their liability risk, such as setting and honoring clear expectations about the types of information patients can share, how the sharing should take place, and which members of the clinical team will review the information and how often. These and similar approaches can enable physicians to use electronic patient-generated health information to deliver more patient-centered and, potentially, more effective and cost-efficient care. <\/p>\n The authors wish to thank Patti Brennan, Gail Casper, Steve Downs, and the research teams of Project HealthDesign for their feedback on this manuscript. For more on Project HealthDesign visit http:\/\/www.projecthealthdesign.org\/<\/p>\n Copyright: <\/em><\/strong>\u00a9 2013 Deven McGraw, Robert Belfort, Helen Pfister, and Susan Ingargiola. Published here under license by The Journal of Participatory Medicine. Copyright for this article is retained by the authors, with first publication rights granted to the Journal of Participatory Medicine. All journal content, except where otherwise noted, is licensed under a Creative Commons Attribution 3.0 License. By virtue of their appearance in this open-access journal, articles are free to use, with proper attribution, in educational and other non-commercial settings.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" Some physicians are understandably reluctant to receive digital data from patients due to professional liability concerns, yet this means missing patient-generated health data that could be crucial to improving health care outcomes. The authors show some solutions to this dilemma in the form of specific steps physicians can take to mitigate their liability risk.<\/p>\n","protected":false},"author":305,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","jetpack_post_was_ever_published":false,"footnotes":""},"categories":[6,565],"tags":[291,37,484,324,77,747,748,400,325],"coauthors":[743,744,745,746],"class_list":["post-3335","post","type-post","status-publish","format-standard","hentry","category-narratives","category-vol-5","tag-e-patients","tag-feature","tag-health-apps","tag-hit","tag-issue","tag-legal","tag-liability","tag-mobile-applications","tag-phr"],"yoast_head":"\n
\nKeywords<\/em><\/strong>: HIT, PHR, mobile applications, health apps, liability, legal issues, e-patient.
\nCitation<\/em><\/strong>: McGraw D, Belfort R, Pfister H, Ingargiola S. Going digital with patients: managing potential liability risks of patient-generated electronic health information. J Participat Med. 2013 Dec 18; 5:e41.
\nPublished<\/em><\/strong>: December 18, 2013.
\nFinancial Disclosure<\/em><\/strong>: This paper was funded by a grant from Project HealthDesign, which is a Robert Wood Johnson Foundation-funded research project. The authors were under contract with Project HealthDesign to serve as the Project\u2019s regulatory counsel. Project HealthDesign staff members reviewed and provided feedback on the paper and were involved in the decision to submit the paper for publication to the Journal of Participatory Medicine<\/em>.
\nCompeting Interests<\/em><\/strong>: The authors have no competing interests to disclose.<\/p>\nIntroduction<\/h3>\n
Overview of the Research Project<\/h3>\n
Liability Concerns<\/h3>\n
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Strategies for Managing Risk <\/h3>\n
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BreatheEasy<\/h4>\n
Chronology.MD<\/h4>\n
Key Takeaways<\/h3>\n
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Acknowledgements<\/h3>\n
References<\/h3>\n
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