What “satisfactory assurances” must a covered entity that is not a party to the litigation receive before it may respond to a subpoena without a court order?
Under 45 CFR 164.512(e)(1)(ii) of the Privacy Rule, a covered entity that is not a party to the litigation may disclose protected health information in response to a subpoena, discovery request, or other lawful process if the covered entity receives certain satisfactory assurances from the party seeking the information. Specifically, the covered entity must receive a written statement and accompanying documentation that the requestor has made reasonable efforts either (1) to ensure that the individual(s) who are the subject of the information have been given sufficient notice of the request, or (2) to secure a qualified protective order. (Alternatively, the covered entity may make such disclosures if it itself makes reasonable efforts to notify the individual(s) or seek a qualified protective order.) If the conditions above have been met, a court order is not required to make the disclosure.
For notice to the individual(s), the written statement and accompanying documentation must demonstrate that the requestor has made a good faith attempt to provide written notice to the individual; and that the notice included sufficient information about the litigation to permit the individual to raise an objection with the court, the time for the individual to raise an objection has elapsed, and no objections were filed or all objections filed were resolved and the request is consistent with the resolution. Such statements and documentation may include, for example, a copy of the notice mailed to the individual that includes instructions for raising an objection with the court and the deadline for doing so, and a written statement or other documentation demonstrating that no objections were raised or all objections raised were resolved and the request is consistent with the resolution. To the extent that the subpoena or other request itself demonstrates the above elements, no additional documentation is required.
For a qualified protective order, the written statement and accompanying documentation must demonstrate that 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. See the definition of “qualified protective order” at 45 CFR 164.512(e)(1)(v). Such statements and documentation may include, for example, a copy of the qualified protective order that the parties have agreed to and documentation or a statement that the order was presented to the court, or a copy of the motion to the court requesting a qualified protective order.