The Patient Safety and Quality Improvement Act (PSQIA) is a potential game-changer in health care providers’ ongoing effort to secure the privilege against disclosure in litigation that is necessary to achieve the frank, effective, and reliable patient safety reviews they seek. PSQIA shields from disclosure certain materials used by certain providers in connection with their certain patient safety activities. Notably, materials that can fall under PSQIA’s protection are both over- and under-inclusive of documents and information typically protected under the various states’ statutes governing the litigation disclosure of “peer review,” “quality assurance,” or “patient safety review” materials. In this respect, while PSQIA potentially protects more types of materials, its protections apply only to those providers that have joined “patient safety organizations” (PSOs). Joining (and remaining compliant in) PSOs is a significant undertaking for any institution, which may explain in part why PSOs have been relatively slow to take off. PSOs are becoming more widespread, however, and membership is expected to swell in the coming years, including as a result of endorsement and promotion of the PSO system by the U.S. Centers for Medicare & Medicaid Services.¹

As PSO membership grows, so does the body of case law interpreting the privilege protections that PSQIA provides. The most recent appellate court to confront this issue is Pennsylvania’s Superior Court, delivering the state’s most recent appellate-level examination of the PSQIA on July 17, 2025, in Boyle v. Main Line Health, Inc., 2025 Pa. Super. Lexis 322.

The Boyle Decision

In Boyle, the Pennsylvania Superior Court recognized and upheld the privilege protections of PSQIA. It held that since the documents at issue were “produced solely in accordance with the patient safety evaluation system and reported to the patient safety organization,” they were “a quintessential example of ‘patient safety work product’ privileged documents as … ‘deliberations or analysis [materials’ of] a patient safety evaluation system” under PSQIA.² The court also noted that “there is no requirement in the PQSIA that such “‘deliberations and analysis,’ … be reported to a patient safety organization to qualify as protected ‘patient safety work product.’”³

The discovery demand that set the stage for the privilege dispute in Boyle called for the production of materials “relating to the review and investigation of issues relating to [the medical care at issue]."⁴ The hospital defendant, confronted with this demand, claimed that certain responsive materials were privileged from disclosure. As is common for these types of cases, the hospital asserted multiple grounds for privilege: it argued that it was entitled to privileges under the MCare Act (which is a Pennsylvania state law providing for the privilege of certain patient safety documents) in connection with a “patient safety reporting document” and the federal PSQIA for both a “patient safety occurrence worksheet” and a “situation background & assessment” report.⁵The defendant hospital identified these documents in a privilege log, prompting the motions that ultimately led to the appeal.

NOTE: The Pennsylvania Peer Review Protection Act, another Pennsylvania State law privilege, is sometimes also implicated in Pennsylvania cases similar to this one. In Boyle, however, the privilege this statute affords was not invoked because, as the court informs us, the defendant hospital conceded that no peer review was conducted concerning the events at issue.⁶

In recognition that it bears the burden to establish that the privileges it claims apply, the hospital defendant submitted multiple fact affidavits and a privilege log. In spite of these efforts, the trial court directed disclosure. The hospital defendant appealed.

NOTE: As the Superior Court pointed out, the parties benefitted from Pennsylvania’s rules permitting an interlocutory appeal of the privilege issues implicated in the case.⁷ Still, the case reflects a reality all too familiar to appellate practitioners in that the underlying disclosure order at issue was nearly two years old by the time the Superior Court ruled on the matter. 

As to the document claimed to be privileged under MCare, the court relied on the existing cases of Ford-Bey v. Professional Anesthesia Services of North America, LLC, 229 A.3d 984, 991 (Pa.Super. 2020), appeal denied, 663 Pa. 444 (2020) and Lahr v. Lehigh Valley Hosp., Inc., 311 A.3d 587, 2023 WL 8665017 (Pa.Super. 2023) (unpublished memorandum) in affirming the disclosure order. The court reasoned that MCare disclosure protections require that the patient safety committee or the hospital’s governing board review the event that had given rise to the creation of the allegedly privileged documents. The court observed that the hospital defendant failed to establish in its initial submission that such a review occurred. The court refused to consider the hospital defendant’s further affidavit attesting to just such a review because that affidavit had been submitted later in connection with a reconsideration motion, and not with the moving papers that led to the order on appeal. Since the defendant thus did not show each necessary element of the privilege, held the court, MCare protections were not established and the document was required to be disclosed.⁸

Of greater national import is the Boyle court’s determination with respect to two other documents, which the court held were privileged from disclosure under PSQIA.⁹ To arrive at this determination, the Superior Court reviewed the core tenets of PSQIA, including its purpose (which, in a nutshell, is to encourage frank self-reflection upon adverse events by guaranteeing their privilege against disclosure in litigation), mechanism (which, as is relevant here, entails providers joining PSOs), and the object of its privilege protection. PSQIA terms the latter “patient safety work product” (aka PSWP). It is in courts’ mastery of the intricate definition of “PSWP” that privilege is won or lost. In the case of Boyle: won. 

The Superior Court excerpted the PSQIA language that describes the two pathways for creating protected materials – “reporting” and “deliberation and analysis” – and observed that the hospital defendant asserted privilege protections under the latter category.¹⁰ In this context, the court noted that “there is no requirement in the PQSIA that such “‘deliberations and analysis’ … be reported to a patient safety organization to qualify as protected ‘patient safety work product.’”¹¹ The court recounted the hospital defendant’s showing about each element of PSQIA protection under the “deliberation and analysis” pathway: that the hospital had joined a PSO, that it developed and implemented a formal patient safety evaluation system, and that the documents at issue were part of that system with one of the two having been sent to the PSO and both reflecting the hospital defendant’s deliberations and analysis of the patient safety event.¹² Given this showing, the Pennsylvania Superior Court concluded, the hospital established its entitlement to the PSQIA privilege for the two documents over which it claimed such protection.¹³ Notably, since the hospital defendant claimed (and established) PSQIA privilege under the “deliberations and analysis” pathway of PSQIA, the privilege applied regardless of whether the documents had been sent to the PSO.¹⁴

Conclusion

As this new Pennsylvania case takes its place among the developing body of case law concerning the PSQIA privilege, it is becoming increasingly evident that strong evidentiary support for PSQIA privilege protections is required in most courts to successfully assert the privilege. Courts can be unforgiving of procedural and evidentiary errors committed in motion papers and briefing presenting these issues to the trial court or appellate courts. Ultimately, however, the diligent litigators (and their appellate counsel) stand to secure any rightful entitlement to the privilege in federal and state courts – now specifically including Pennsylvania. 

^{1 See 73 FR 70732.
2 Id. at 15.
3 Id. at 20.
4 Id. at 2.
5 Id. at 2.
6 Id. at 3.
7 Id. at fn. 1, citing Berkeyheiser v. A-Plus Investigations, Inc., 936 A.2d 1117, 1123-24 (Pa. Super. 2007) and Farrell v. Regola, 150 A.3d 87, 95 (Pa. Super. 2016).
8 Id. at 14.
9 Id. at 21.
10 Id. at 20.
11 Id. at 20.
12 Id. at 19.
13 Id. at 21.
14 Id. at 20.}