discussion: de-identification. While a recent survey found that a majority of
parents would be interested in utilizing WGS for newborns, interest
dropped when parents were presented with the potential for de-identified
data generated from the WGS to be stored and used for research in the future.115 De-identification, used often for use in future research, separates
any linkable identifiable information from the data. A usable standard for
the de-identification of health information comes from the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, which
finds that de-identification occurs when “there is no reasonable basis to believe that the information can be used to identify an individual.”116 Along
with the consideration for the storage of genetic data, policymakers will
need to consider policies to ensure privacy is maintained and, specifically,
whether any stored data should be maintained in an identified or de-identified manner.117
E. Constitutionality of Mandate
Lastly, newborn screening programs are lawfully mandated under states’
parens patriae power, which provides the states with power to protect the
well-being of children or other groups of a diminished capacity, based on
the fact that they cannot adequately protect themselves.118 In addition, pub-
lic health measures can survive scrutiny based on constitutional challenges,
such as alleged Fourth Amendment violations of unreasonable search and
seizure in the context of blood draws, if the government interest justifies the
intrusion on the right. Since the seminal Jacobson v. Massachusetts, when
the government can demonstrate a public health interest, it may take action
that is proportional to the benefits and minimizes harm to others.119 The
115. Aaron J. Goldenberg et al., Parents’ interest in whole-genome sequencing of newborns, 16 GENETICS MED.
78, 82 (2014).
116. In addition, the HIPAA Privacy Rule allows covered entities to disclose protected
health information to public health authorities, without authorization, for general public
health activities, including conducting public health surveillance. See
164.514(e)( 1)( i), 164.512(b)( 1)( i) (West, through May 15, 2014; 79 Fed. Reg. 27,771); U.S.
Dep’t of Health & Human Servs., Health Information Privacy: Pub. Health (revised Apr. 3,
(stating that covered entities include health care providers, health care clearinghouses, and
health plans); U.S. Dep’t of Health & Human Servs., For Covered Entities and Business Associates,
(last visited May 22, 2014).
117. See Botkin, Retention and Research Use of Residual Newborn Screening Bloodspots, supra note 110.
118. See JAMES G. HODGE, JR., PUBLIC HEALTH LAW IN A NUTSHELL
35 (2014) (“[ A]
state may serve as guardian of, or provide protections for, persons who may otherwise lack
capacity to look after their own interests or welfare.”); Tarini & Goldenberg, supra note 100,
at 384; Jennifer Kraszewski et al., Legal Issues in Newborn Screening: Implications for Public Health Practice and Policy, 121 PUB. HEALTH REP.
119. Jacobson v. Mass., 197 U.S. 11, 25-27 (1905).