This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded.
Yes. If requested by an individual, a covered entity must transmit an individual’s PHI directly to another person or entity designated by the individual. The individual’s request must be in writing, signed by the individual, and clearly identify the designated person or entity and where to send the PHI. See 45 CFR 164.524(c)(3)(ii). A covered entity may accept an electronic copy of a signed request (e.g., PDF or scanned image), an electronically executed request (e.g., via a secure web portal) that includes an electronic signature, or a faxed or mailed copy of a signed request.
The same requirements for providing the PHI to the individual, such as the timeliness requirements, fee limitations, prohibition on imposing unreasonable measures, and form and format requirements, apply when an individual directs that the PHI be sent to another person or entity. For example, just as when the individual requests a copy for herself, a covered entity cannot require that an individual make a separate in person trip to the covered entity’s physical location for the purpose of making the request to transmit the individual’s PHI to a person or entity designated by the individual. In addition, the individual can designate the form and format of the PHI and how the PHI is to be sent to the third party, and the covered entity must provide access in the requested form and format and manner if the PHI is “readily producible” in such a way. Whether PHI is “readily producible” depends on the capabilities of the covered entity and whether transmission or transfer of the PHI in the requested manner would present an unacceptable level of security risk to the PHI on the covered entity’s systems (based on the covered entity’s Security Rule risk analysis).
The following are just a few examples of how these provisions apply:
- A patient requests in writing that the hospital where she recently underwent a surgical procedure use its Certified EHR Technology (CEHRT) to send her discharge summary to her primary care physician, or to her own personal health record, and she supplies the corresponding Direct address (an electronic address for securely exchanging health information using the Direct technical standard).
- A patient sends a written request to his long-time physician asking the physician to download a copy of the PHI from his electronic medical record, and e-mail it in encrypted form to XYZ Research Institution, at XYZResearch@anywhere.com, so XYZ Research Institution can use his health information for research purposes.
- A patient requests in writing that her ob-gyn digitally transmit records of her latest pre-natal visit to a new pregnancy self-care app that she has on her mobile phone. The ob-gyn’s EHR has the ready capability to establish the connection in a manner that does not present an unacceptable level of security risk to the PHI in the EHR or other of the ob-gyn’s systems, based on the ob-gyn’s Security Rule risk analysis.
In each of these three examples, the covered entity has the capability to transfer the PHI in the requested manner and doing so would not present an unacceptable level of security risk to the PHI in the covered entity’s systems. Thus, after receiving the patient’s written request, the covered entity has 30 days (or 60 days if an extension is applicable) to send the PHI to the designated recipient as directed by the individual. However, in most cases, it is expected that the use of technology will enable the covered entity to fulfill the individual’s request in far fewer than 30 days.