May a covered entity that is not a party to a legal proceeding disclose protected health information in response to a subpoena, discovery request, or other lawful process that is not accompanied by a court order?
Yes, if certain conditions are met. A covered entity that is not a party to litigation, such as where the covered entity is neither a plaintiff nor a defendant, may disclose protected health information in response to a subpoena, discovery request, or other lawful process, that is not accompanied by a court order, provided that the covered entity:
- Receives a written statement and accompanying documentation from the party seeking the information that reasonable efforts have been made either (1) to ensure that the individual(s) who are the subject of the information have been notified of the request, or (2) to secure a qualified protective order for the information; or
- Itself makes reasonable efforts either (1) to provide notice to the individual(s) that meets the same requirements as set forth below for sufficient notice by the party making the request, or (2) to seek a qualified protective order as defined below. See 45 CFR 164.512(e).
The covered entity must make reasonable efforts to limit the protected health information used or disclosed to the minimum necessary to respond to the request. See 45 CFR 164.502(b) and 164.514(d).
The requirement to provide sufficient notice to the individual(s) is met when a party provides a written statement and accompanying documentation that demonstrates:
- A good faith attempt was made to notify the individual (or if the individual’s location is unknown, to mail a notice to the individual’s last known address);
- The notice included sufficient detail to permit the individual to raise an objection with the court or administrative tribunal; and
- The time for the individual to raise objections under the rules of the court or tribunal has lapsed and no objections were filed or all objections filed by the individual have been resolved by the court and the disclosures being sought are consistent with the resolution.
A qualified protective order is an order of a court or administrative tribunal or a stipulation by the parties that prohibits the parties from using or disclosing the protected health information for any purpose other than the litigation or proceeding for which such information was requested; and requires the return to the covered entity or destruction of the protected health information (including any copies) at the end of the litigation or proceeding. The party requesting the information must provide a written statement and accompanying documentation that demonstrates:
The parties to the dispute have agreed to a qualified protective order and have presented it to the court or administrative tribunal; or
- The party seeking the protected health information has requested a qualified protective order from the court or administrative tribunal.