In a precedent-setting decision, New York's Appellate Division, First Department held that donor records in an Organ Procurement Organization's (OPO's) possession are entitled to the same confidentiality as the records of hospital patients. Admittedly, these protections are not absolute (and, in fact, limited disclosure consisting of redacted records was directed in the case), but judicial declaration of the protected nature of the records clarifies a longstanding ambiguity in the law and offers assurance to the donation community that the records of those who participate in donations are entitled to the same protection as that due to the records of hospital patients.
Organ Procurement Organizations and Tissue Banks are charitable, nonprofit organizations designated pursuant to the National Organ Transplant Act to identify potential organ donors, obtain authorization for the recovery and transplantation of organs and tissues and to coordinate the recovery and allocation of these donations to save and enhance lives. In the process of facilitating these life-saving donations, OPOs and Tissue Banks gather, create and maintain records relating to donors that contain private, sensitive, medical and social information. Equivalent records maintained by hospitals are unquestionably protected by various confidentiality rules, including HIPAA and physician-patient privilege. Liew v. New York Univ. Med. Ctr., 55 A.D.3d 566 (N.Y. A.D. 2d Dep't 2008). There is much uncertainty in the law, however, about the status of such records in an OPO's possession.
Recently, in McMahon v. New York Organ Donor Network, __ A.D.3d ___, 2018 NY Slip Op 03820 (N.Y. A.D. 1st Dep't, May 29, 2018), New York's Appellate Division took a big step forward in resolving this issue.
It is clear that OPOs are not "covered entities" for the purposes of HIPAA. 45 C.F.R. 160.103. Some states, including New York, also have made clear in case law that OPOs are not medical providers. Rodriguez v. Saal, 43 A.D.3d 272 (N.Y. A.D. 1st Dep't 2007). The question thus arises whether OPOs may protect their records (and the confidentiality of their donors) in the same manner as medical providers protect theirs. The answer, under the McMahon case is "yes."
The McMahon action involves a former OPO employee's purported whistleblower claim. Specifically, it is the plaintiff's claim that his employer OPO had prematurely procured organs from patients who were not (or not yet) candidates for donation and that he was fired when he objected to this practice. The merits of this claim remain highly contested in the underlying litigation. In an effort to advance his case, the plaintiff sought to obtain from the OPO the records of certain donors. Critically, the disclosure of these records had not been authorized by the donor families. The OPO strenuously objected to any disclosure, intent on protecting the confidentiality of the donors. The disclosure dispute ultimately came before the Appellate Division.
Part of New York's version of the Uniform Anatomical Gift Act is New York's Public Health Law § 4351(8), which provides that "any employee or agent of a federally designated organ procurement organization, eye bank or tissue bank ... shall be held to the same standard of confidentiality as that imposed on employees of the hospital." Relying on this statute, the Appellate Division held that the OPO's records are entitled to the same degree of protection as a hospital's records.
Because under New York law disclosure of otherwise confidential records is permitted in certain whistleblower cases, the court went on to state that limited disclosure of the records at issue was required. Limitations will include the redaction of "all identifying patient information." In New York, in a comparable whistleblower case against a medical provider (rather than an OPO), the provider would be obligated to provide precisely this level of disclosure. Seaman v. Wyckoff Hgts. Med. Ctr., 25 A.D.3d 596 (N.Y. A.D. 2d Dep't 2006). New York courts reason that the limited disclosure is warranted because a plaintiff claiming to be a whistleblower is entitled to some form of the records to attempt to prove his theories. What a plaintiff is not entitled to from an OPO is any disclosure above and beyond that which he would be able to get from a medical provider. The fact that this principle is now law is a major step forward in clarifying the state of the law as it relates to OPOs and a key tool in empowering OPOs to defend against unauthorized disclosure of donor information.
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