In KD v. United States, a decision by the United States District Court for the District of Delaware, both granting and denying a motion for a protective order in parts, indicates that PSQIA of 2005 has changed its opinion regarding the protection of peer review documents under federal common law privilege. 

The opinion notes that the federal common law provides that all evidence is discoverable unless privileged, and analyzes the relevant Maryland statute and federal law regarding whether certain records generated through peer review at the National Heart, Lung and Blood Institute (NHLBI) within the National Institutes of Health (NIH) should be protected. The United States was asserting that the documents were privileged under the applicable Maryland medical peer review statute and federal common law. The plaintiff, seeking discovery of the medical records, obviously asserted that the information was discoverable. 

The interesting aspect of this case is the reference to PSQIA of 2005, which was not directly involved in the action. The court’s opinion discussed the history of federal common law privilege and medical peer review information, and acknowledged the significant impact of the Health Care Quality Improvement Act of 1986 (HCQIA); which statute expressly provided that information reported to the National Practitioner’s Data Bank was privileged, but was silent on the issue of confidentiality of records outside of the National Practitioner’s Data Bank. The court stated, “…hence, the prevailing analysis of the HCQIA is that Congress spoke loudly with its silence and not enacting a broad privilege against discovery of peer review materials.”

The Delaware District Court then goes on to state that, while not disputing the prior analysis of HCQIA, that:

“That legislation no longer represents Congress’s final word on the issue of medical peer review. The PSQIA of 2005, which postdates those cases turning on the HCQIA, announces a more general approval of the medical peer review process and more sweeping evidentiary protections from materials used therein… The text of the PSQIA corroborates this shift in congressional policy…The PSQIA was thus designed to encourage this culture of safety by providing for broad confidentiality and legal protections of information collected and reported voluntarily for the purposes of improving the quality of medical care and patient safety.”

The court relied upon this shift in federal policy to conclude that Federal Rule of Evidence 501 did not compel the disclosure of the NHLBI/NIH records. 


Category: Peer Review