On June 13, 2022, the US Department of Health and Human Services Office for Civil Rights (“OCR”) released guidance to help covered entities understand how they can use remote communication technologies for audio-only telehealth in compliance with the HIPAA Privacy and Security. Rules (the “Guidance”). Specifically, the Guidance clarifies how audio-only telehealth can be conducted after OCR’s Notification of Enforcement Discretion for Telehealth (the “Telehealth Notification”), put in place during the COVID-19 pandemic, is no longer in effect.
Currently, under the Telehealth Notification, health care providers “may use any available non-public facing remote communication technologies for telehealth, even where those technologies, and the manner in which they are used, may not fully comply with the HIPAA Rules.” The Telehealth Notification will remain in effect, however, only until the expiration date of the declared COVID-19 public health emergency, which is expected to be renewed again through October 13, 2022.
In the preamble to the Guidance, OCR acknowledges that audio-only telehealth services address the needs of “certain populations [that] may have difficulty accessing or be unable to access technologies used for audio-video telehealth because of various factors, including financial resources, limited English proficiency, disability, internet access, availability of sufficient broadband, and cell coverage in the geographic area. ” In support of ongoing access to audio-only telehealth services, the Guidance answers the following questions:
Can covered health care providers and health plans provide audio-only telehealth services using remote communication technologies in compliance with the HIPAA Privacy Rule?
Yes, this is permitted under the HIPAA Privacy Rule so long as the covered entity applies reasonable safeguards to limit incidental use or disclosure of protected health information (“PHI”) when providing the audio-only telehealth services. This includes providing such services from a private setting or, if the audio-only services cannot be provided in private, “using lowered voices and not using speakerphone.” In addition, covered entities must verify the identity of any new patients either orally or in writing. Identity verification must be accessible to individuals with disabilities and those with limited English proficiency.
Which remote communication technologies will require covered health care providers and health plans to comply with the HIPAA Security Rule when providing audio-only telehealth services?
The HIPAA Security Rule may apply depending on the technology used by the covered entity; The technology used by the individual receiving telehealth services is immaterial. If a covered entity uses a standard telephone line (ie, a landline), the HIPAA Security Rule will not apply because the PHI transmitted is not electronic in nature. Other communication technologies, however, are subject to the HIPAA Security Rule, including:
- communication apps on a smartphone or another computing device;
- VoIP technologies;
- technologies that electronically record or transcribe a telehealth session;
- messaging services that electronically store audio messages; and
- Other mobile technologies that use electronic media, such as the Internet, intra- and extranets, cellular and Wi-Fi.
Covered entities should identify, assess and address any risks and vulnerabilities posed by such technologies as part of its required risk analysis and management process. OCR recommends that the following issues be considered:
- the risk that the transmission could be intercepted by an unauthorized third party;
- whether the remote communication technology supports encrypted transmissions;
- whether stored PHI (egrecordings or transcripts of a telehealth session) is encrypted;
- the risk that the stored PHI could be accessed by an unauthorized third party;
- whether authentication is required to access the device or app where the PHI may be stored; and
- whether the device automatically locks after a period of inactivity, or the app automatically terminates the session.
When must a health care provider or health plan implement a business associate agreement (“BAA”) with the vendor whose remote communication technologies are used to provide audio-only telehealth services?
A covered entity is not required to enter into a BAA with a telecommunication service provider (“TSP”) that has only “transient” access to the PHI it transmits. For example, a covered entity may use a smartphone to conduct an audio-only telehealth session via phone call without a BAA, so long as the TSP only connects the call and does not create, receive or maintain any PHI from the telehealth session. Conversely, a covered entity must enter into a BAA with a TSP that creates, receives or maintains PHI on behalf of the covered entity, or requires access on a routine basis to the PHI it transmits. For example, a smartphone app developer whose app stores PHI in the developer’s cloud infrastructure for the covered entity’s later use, or translate spoken communications into another language, will require a BAA.