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 Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded.
While individuals do not have an unlimited choice in the form of electronic copy requested, and covered entities are not required to purchase new software or other equipment in order to accommodate every possible individual request, the individual does have a right to receive the copy in the form and format requested by the individual if the copy is readily producible in that form and format. For example, an individual may request that an electronic copy of her PHI be provided to her in Microsoft (MS) Word; MS Excel; Portable Document Format (PDF); or as structured, machine readable data (e.g., a document following the Consolidated Clinical Document Architecture (CCDA) standard using LOINC (to represent lab tests) and RxNorm (to represent medications)); or other electronic format; and the covered entity must provide the copy in the requested format if readily producible in that format. Further, if the PHI that is the subject of the request is maintained electronically by a covered entity, the entity is required to have the capability to provide some form of electronic copy (see 78 FR 5633, https://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf) – and this means that some covered entities may need to make some investments (which cannot be charged to individuals) in order to meet this baseline requirement. If an individual requests a form of electronic copy that the covered entity is unable to produce, the covered entity must offer other electronic formats that are available on its systems. If the individual declines to accept any of the electronic formats that are readily producible by the covered entity, only then may the covered entity provide a hard copy to fulfill the access request. Thus, individuals who request electronic access to PHI maintained electronically can be diverted to receiving a paper copy only in circumstances where all of the covered entities’ existing capabilities for readily producing electronic copies have been presented to the individual but the individual has determined that those formats are not acceptable to her.
When an individual requests access to PHI in a particular form or format, the question for the covered entity is whether or not the entity is able to readily produce the copy in that format – which is a matter of capability, not “willingness.” Thus, if a covered entity has the capability to readily produce the requested format, it is not permissible for the covered entity to deny the individual access to that format because the entity would prefer that the individual receive a different format, or utilize other customary record access processes of the entity.