California is the latest state to take steps toward
defining permissible uses and restrictions relating to obtaining, retaining,
and sharing individuals’ genetic information.
Senator Alex Padilla recently introduced Senate Bill 1267, the Genetic
Information Privacy Act, designed to protect individuals against surreptitious testing of their genetic material without consent. SB 1267 is a comprehensive piece of
legislation which would require a specific authorization to obtain, analyze, or
disclose genetic information unless otherwise exempted or allowed by law (exemptions
include activities such as newborn screening, duties of the medical examiner, using some
types of data for research, and law enforcement uses). The legislation also contains a civil penalty
structure for violations and provides a private right of action for aggrieved
individuals who suffer economic, bodily, or emotional harm proximately caused
by such violations.
California’s legislation classifies genetic information within
a privacy framework and seeks to increase individual control by requiring the individual
to understand the purposes of how the information will be used and stored, as
well as which entities have access to the information. Other states such as Alabama, Massachusetts,
South Dakota, and Vermont have introduced similar legislation that govern the
collection, retention, and sharing of DNA, genetic information, and or genetic
test results. These states differ in
their comprehensiveness and scope- from South Dakota’s paragraph long House Bill 1260
to Alabama’s extensive eleven page House 78.
Unlike California, these states seek to classify DNA,
genetic information, and or genetic test results within a property law
framework rather than under the umbrella of privacy, which carries distinct legal
requirements for transfer, use, and retention.
As legislatures race to define
individual rights within existing legal
concepts, they should be well aware of property law’s limitations at upholding individual
autonomy while appropriately and efficiently defining permissible research uses
depending on how the legislature crafts the language of the statute.
As we witnessed in the progression of the Bearder v. Minnesota litigation (related to collecting, retaining, and disseminating newborn blood spots) even
if a law is seemingly clear, individuals, clinicians, and investigators still
may face confusion over relevant terminology and obligations relating to the meaning
of key terms and the scope of consent exemptions. (Blogs and article on that topic here.) Specifically, will these statutes govern the
collection, use, and dissemination of genetic information after the analysis
of a genetic test using a blood sample or will the language broadly address collecting blood
samples, DNA, and genetic test information?
Public health officials, investigators, and individuals have vehemently
disagreed over the meaning and scope of these terms and when consent is required. Individuals have claimed immense
injury to privacy and dignity when public health officials and investigators collect, retain, and disseminate their blood samples without consent, while public health officials and investigators
decried setbacks to research efforts after they were legally ordered to destroy their improperly obtained blood samples.
Last November, the
Minnesota Supreme Court clarified its state Genetic Privacy Act, holding that
an individual’s blood sample contains biological information and biological
information falls within the definition of genetic information. That
is, any statutory references to genetic information also applies to blood
samples. It appears that the majority adopted
the Plaintiffs' argument that a blood
sample contains DNA and the structure of DNA is genetic information, which
means statutory requirements governing the collection, use, storage, and
dissemination of genetic information necessarily include blood samples.
Although this seminal holding is jurisdictionally limited,
defining the meaning and scope of biological specimen, blood sample, DNA, and
genetic information requires painstaking semantic precision. Furthermore, the concurrence/dissent in
Bearder demonstrates even keen legal minds apply varying logic to interpret terminology
and arrive at starkly divergent conclusions.
Defining these terms becomes even more pressing should this or similar state
legislation pass because it carries the compliance incentive of a penalty
structure for violation. Legislators should
take note of litigation in this area and aim to meticulously and unambiguously
define relevant terminology so individuals, public health officials, and
investigators can understand their interrelated rights, obligations, and statutory exemptions.
--Katherine Drabiak-Syed
No comments:
Post a Comment