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On January 28, 2020, the Department of Health & Human Services (“HHS”) Office for Civil Rights (“OCR”) addressed a federal court’s January 23rd invalidation of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) rule relating to the third-party requests for patient records. In Ciox Health, LLC v. Azar,[1] the court invalidated the 2013 Omnibus Rule’s mandate that all protected health information (“PHI”) maintained in any format (not just that in the electronic health record) by a covered entity be delivered to third parties at the request of an individual, as well as the 2016 limitation on fees that can be charged to third parties for copies of protected health information (“PHI”).

As enacted, HIPAA’s Privacy Rule limits what covered entities (or business associates acting on behalf of covered entities)[2] may charge an “individual” requesting a copy of their medical record to a “reasonable, cost-based fee”[3] (the “Patient Rate”). The Privacy Rule did not, however, place limitations on the fees that can be charged to other requestors of this information, such as other covered entities that need copies of the records for treatment purposes or for disclosures to attorneys or other third parties. In order for some of these third parties to obtain the records, the patient would have to provide the covered entity with a valid HIPAA authorization.

In 2009, Congress passed the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which entitled patients to direct the covered entity to send their PHI contained in an electronic health record to a third party “in an electronic format”[4] without the need for a valid authorization (the “third-party directive”).[5] HITECH also implemented a limitation on the fees that can be charged to patients, but not third parties, for the delivery of these requested records.[6]

Ciox Health’s challenge centered around later regulatory changes to HIPAA stemming from the 2013 Omnibus Rule and a 2016 guidance document issued by OCR (the “2016 Guidance”).

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This is an excerpt from a previously published article.