On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure of electronic protected health information (ePHI). As long as the app is independent of the covered entity and its EHR system and is instead controlled by the individual patient, the covered entity and its EHR system have no HIPAA liability once ePHI is delivered to the app at the patient’s request.
In its FAQ, HHS specified that if, at the request of a patient, a HIPAA covered entity’s EHR system transfers ePHI to an app that is not developed by or specifically provided to the covered entity by the EHR system, neither the covered entity nor the EHR system developer would face HIPAA liability for the app’s subsequent impermissible use or disclosure of the information. But if an EHR system transfers patient data from a covered entity to an app that the EHR system provides “through, or on behalf of, the covered entity (directly or through another business associate)” and either owns the app or has a business relationship with the app developer, the EHR system developer may be subject to HIPAA liability for subsequent impermissible use or disclosure of the ePHI.
This attempt to clarify the boundaries of HIPAA liability will likely be welcomed by a wide range of covered entities, EHR systems, and developers of apps that process ePHI, including apps that connect patients with doctors, pharmacy apps, and apps that focus on fertility, mental health, smoking cessation, and more. Patients, on the other hand, should be aware that the information being collected by an app (which can be substantial and sensitive, depending on the nature of the app) has no protection under HIPAA unless the app was offered to them by a covered entity as part of its overall EHR system.