Editor’s Note: Mobile health technologies are increasingly valuable tools for improving the quality and efficiency of healthcare. The Robert Wood Johnson Foundation’s Project HealthDesign is an important research project that is exploring the use of personal health applications to promote better decision making by both patients and providers. In the most recent research phase, Project HealthDesign provided patients with smartphones for sharing “observations of daily living” (ODLs), along with other information that would give important indicators of patients’ health to providers through personal health record applications. Some physicians, however, had professional liability concerns around receiving digital data from patients.

In a new article published in the “Journal of Participatory Medicine,” the Manatt Health team, along with co-author Deven McGraw of the Center for Democracy and Technology, discuss the professional liability issues that providers expressed and the steps Project HealthDesign took to manage them. The article provides key insights for providers seeking to engage patients in their own care through technology. A summary of key points is below. To read the full article, click here.

Patients are increasingly using new electronic tools, such as personal health records and mobile applications, to track details about their health and share those details with physicians—often in real time and wholly separate from traditional office visits. Some physicians, however, are reluctant to receive digital data from patients due to professional liability concerns.

Project HealthDesign, a program of the Robert Wood Johnson Foundation’s Pioneer Portfolio, recently studied patients collecting information through personal health apps. The most recent phase of the program involved incorporating patient-generated, digital information into clinical care. The research teams documented the professional liability worries voiced by physicians, as well as the steps taken to manage them. Although Project HealthDesign is a research project, it is likely that care models integrating electronic patient-generated data will become the norm in the near future, as pressure to improve outcomes and lower costs continue to increase.

Project Overview

Project HealthDesign consisted of five research teams that created personal apps to help patients better manage their health and keep track of “observations of daily living” (ODLs)—patient-recorded feelings, thoughts, behaviors and environmental factors that are meaningful and provide health cues. It tested the hypothsis that capturing ODLs in real time enables patients to provide physicians and other clinicians with more specific health information. The theory is that by combining patient-provided information with clinical data, physicians will be able to give patients better guidance in managing chronic illnesses and improving outcomes.

Liability Concerns

The physicians and other clinicians participating in Project HealthDesign expressed the following liability-related concerns:

  • Timeliness and adequacy of responses. Key issues were around when physicians become liable for clinical issues related to information communicated through personal health records (PHRs) or apps, whether they have an obligation to share information with specialists, and whether they are responsible, if support staff fails to respond or inaccurately interprets data.
  • Volume of data. Major areas of concern were about data that is unstructured and/or so voluminous that it’s impossible to respond to in a timely manner.
  • Accuracy. Providers worried both about trusting the accuracy of patient information and about accidental deletions or other inadvertent actions that could compromise data integrity.

It’s important to note that, in general, to succeed in a professional liability claim, a plaintiff must prove the physician failed to meet the applicable “standard of care.” Since models based on electronically-communicated, patient-generated health information are new, professional customs are still forming, and physicians have no clear standards of care to guide them.

Strategies for Managing Risk

In the absence of clear guidance, the five Project HealthDesign teams each developed their own strategies for managing which ODLs would be sent to the clinical care team and how they would be handled. Each team set clear expectations around the “who, what, when, where and how” for electronic information sharing, ensuring data flows were tightly managed:

  • Who: Who on the team will receive the patient information? To what extent will it be shared with others? With whom will it be shared if it indicates a medical emergency?
  • What: What specific information will the patient share with the clinical care team?
  • When: When (how often and at what times) will providers receive and review the information?
  • Where: Where exactly will the information be collected? (For example, will it remain on the patient’s mobile device until the care team accesses it?) Under what circumstances, if any, will the information flow into the physician’s electronic health record?
  • How: How will the information be formatted, so the care team can act on it? How will patients be educated on their rights and responsibilities?

Key Takeaways

To manage liability, the Project HealthDesign teams took one or more of the following steps. Providers seeking to engage patients using digital technologies should consider implementing these strategies:

  • Work with patients to achieve a common understanding of the types of information patients would share, how the sharing would take place, which members of the clinical team would review the information and how often. Providers seeking to incorporate patient-generated, electronic health information may want to document this common understanding through an agreement signed by the physician and the patient. It’s critical that this “deal” be consistently honored by both parties.
  • Designate and train a member of the clinical care team to monitor incoming data and triage, as necessary. Some teams learned that it increased efficiency to have non-physician staff view the information first, so physicians only had to review data that was clinically relevant or as part of a patient visit. Because physicians may be held liable for staff member negligence, it is important that non-physician employees be well trained to review and respond to electronic, patient-generated data.
  • Put a medical emergency protocol into place. Some research teams were careful to instruct patients about using traditional emergency communications channels, when needed—and not to count on information collected through digital tools to be viewed on a real-time basis. These teams also developed emergency communications plans that were triggered when non-physician staff identified a potential medical emergency while reviewing data.
  • Use appropriate judgment in deciding when patient-generated electronic health information will be included in the physician’s legal medical record. A physician’s legal medical record is “the documentation of healthcare services provided to an individual during any aspect of healthcare delivery in any type of healthcare organization.”1 The growth of electronic communication tools has made defining legal medical records more complex. For the study, patient-generated electronic health data did not automatically flow into the physician’s electronic health record. Instead, the decision to include the information was either made in advance by the research teams or on a case-by-case basis by physicians and clinical care teams.

Conclusions

Project HealthDesign demonstrates that physicians can take steps to mitigate their liability risks, such as setting clear expectations for what information patients will share, how the sharing takes place, which members of the clinical team will review the information and how often. Through these and similar approaches, physicians can ease their liability concerns and incorporate electronic, patient-generated information to deliver more patient-centered, effective and cost-efficient care.