under a specific exception to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.
86 While entities that commonly exchange patient records are usually familiar with the applicable rule, others
that do not regularly transfer records or interact with procurement organizations sometimes resist releasing records, potentially endangering the viability of procured tissue, particularly corneas, which remain viable for only a
matter of days.
In some respects, presumed consent might be more appropriate for eye
and tissue donation than for organ donation. As noted above, one of the
primary objections to presumed consent is the persistent—albeit factually
inaccurate—fear of unethical reduction in care for registered donors in the
interest of “harvesting” their organs.
88 For eye and tissue transplantation,
such concerns should never attach. Organ donors are brain dead—a concept
that still suffers from widespread misunderstanding89—but generally have
artificially-maintained heart and lung function, and procurement most often
takes place within the hospital where the patient has just received medical
treatment. Confusion and concern conflating donation and treatment are
mistaken, but conceptually understandable. Eye and tissue donors, however,
have no cardiopulmonary function. No additional medical care is possible.
Procurement usually takes place hours after death, often at a separate facility, medical examiner’s office, or even funeral home. Based on these distinctions, it might be preferable in theory to separate the consent process for
each type of donation, adopting presumed consent for eye and tissue donation, but maintaining actual consent for organ donation. In practice, however, this might lend unwarranted credibility to persistent fears about organ
donation practices and unintentionally decrease organ donation consent
rates. Moreover, although rare, abuse in the eye and tissue transplant field is
not unheard of.
90 As such, a consistent system across all forms of donation
is the better approach absent future evidence to the contrary.
determine whether a donor’s blood has been too diluted to ensure viability of disease testing
(“hemodilution”). U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY: ELIGIBILITY
DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS (HCT/PS) § (V)(F)-(G) (2007), available at
86. 45 C.F.R. § 164.512(h) (West, WestlawNext through May 15, 2014; 79 Fed. Reg.
87. Based on authors’ own recollection and experience.
88. Healy, supra note 45.
89. See Lawrence O. Gostin, Legal and Ethical Responsibilities Following Brain
Death: The McMath and Muñoz Cases, 311 JAMA 903 (2014); Editorial, Jahi McMath: Expert Criticizes Keeping Girl on Ventilator, L. A. TIMES, Jan. 13, 2014,
90. See Michael Powell & David Segal, In New York, a Grisly Traffic in Body Parts
Illegal Sales Worry Dead’s Kin, Tissue Recipients, WASH. POST, Jan. 28, 2006, at A03.