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Going Digital With Patients: Potential Liability Risks

Going Digital With Patients: Potential Liability Risks

Key Takeaways


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.

  • Worked with patients to achieve a common understanding of the types of information patients would be sharing, how the sharing would take place, and which members of the clinical team would be reviewing the information and how often. A number of research teams included these elements in their projects' informed consent forms, which each patient signed before participating in the project. Physicians seeking to incorporate patient-generated electronic health information outside of a research protocol may want to document this common understanding through an agreement or compact signed by the physician and the patient. It is critical that the agreed-upon terms of the "deal" between the patient and the physician are consistently honored by all of the parties. If, for example, the parties agree that the patient should only e-mail during business hours – and the patient e-mails after hours and the physician responds and does not correct the behavior – the physician may not be able to rely on the "deal" to excuse an adverse incident.

  • Designated and trained a member of the clinical care team to monitor incoming data and triage as necessary. Certain of the Project HealthDesign research teams learned that the most efficient way to incorporate patient-generated electronic health information into clinical care was to allow non-physician staff to view the information first. These staff members were able to communicate more frequently with patients, allowing physicians to review the information only when it was clinically necessary or as part of an office visit with the patient. Patients benefited from having their information monitored and from having frequent contact with staff while physicians benefited from only having to review information that was more directly relevant to the their treatment recommendations and assessments of the patient's progress over time. However, because such physicians may be held liable for the negligence of staff members, it is important that non-physician staff be well trained to appropriately review and respond to the type of electronic patient-generated data being collected.

  • Put a medical emergency protocol in place. Some of the research teams took care to clearly instruct patients to use traditional emergency communications channels in a medical emergency and not to expect that information communicated through a PHR or other digital tool would be reviewed on a real time basis by the clinicians participating in the research projects. These teams also developed emergency communication plans that were triggered when non-physician staff members identified data indicating the possibility of a medical emergency.

  • Used appropriate judgment in deciding when patient-generated electronic health information would be included in the physician's legal medical record. A physician's legal medical record is "the documentation of health care services provided to an individual during any aspect of healthcare delivery in any type of health care organization." Growth in use of electronic health records and other electronic communications tools has made defining the legal medical record more complex. While there is no one-size-fits all definition, the purpose of the legal medical record is to: support decisions made in a patient's care; support revenue sought from payers; and document the services provided by the physician as evidence of the patient's illness or injury, response to treatment, and caregiver decisions. Patient-generated electronic health data did not automatically flow into the physician's electronic medical record under any of the projects. Rather, the decision to include such information was either made in advance by the research teams or made by physicians and the clinical care team on a case-by-case basis.

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.



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