2023 New York Laws › CVR - Civil Rights › Article 7 - Miscellaneous Rights and Immunities › 79-L - Confidentiality of Records of Genetic Tests.

§  79-l.  Confidentiality  of  records of genetic tests. 1. As used in
this section, the following terms shall have the following meanings:
(a) "genetic test" shall  mean  any  laboratory  test  of  human  DNA,
chromosomes,  genes,  or  gene  products  to  diagnose the presence of a
genetic variation linked to a predisposition to  a  genetic  disease  or
disability  in  the  individual or the individual's offspring; such term
shall also include DNA profile analysis. "Genetic  test"  shall  not  be
deemed  to  include any test of blood or other medically prescribed test
in routine use that has been or may be hereafter found to be  associated
with  a  genetic  variation, unless conducted purposely to identify such
genetic variation.
(b) "genetic predisposition" shall mean the presence of a variation in
the composition of the genes of an individual or an individual's  family
member  which  is  scientifically or medically identifiable and which is
determined to be associated with an increased statistical risk of  being
expressed  as  either  a physical or mental disease or disability in the
individual or having offspring with a  genetically  influenced  disease,
but which has not resulted in any symptoms of such disease or disorder.
(c) "biological sample" shall mean any material part of the human body
or  of  discharge  therefrom  known  to  contain  DNA, including but not
limited to tissue specimen, blood, or urine.
(d) "institutional review board" shall mean a  human  research  review
committee  established  and  approved  under  the  provisions of article
twenty-four-A of the public health law, or an institutional review board
established and approved under the provisions of 45 CFR part  46  or  42
USC  30  V-1,  for  the  purpose  of  reviewing  and monitoring research
involving human subjects.
2. (a) No person shall perform a genetic test on a  biological  sample
taken  from  an individual without the prior written informed consent of
such individual as provided in paragraph (b) of this subdivision, except
as otherwise provided  in  paragraph  (c)  of  subdivision  two  and  by
subdivision nine of this section.
(b)  Written  informed  consent  to  a  genetic  test shall consist of
written authorization that is dated and signed and includes at least the
following:
(1) a general description of the test;
(2) a statement of the purpose of the test;
2-a. a statement indicating that the individual  may  wish  to  obtain
professional genetic counseling prior to signing the informed consent.
(3)  a statement that a positive test result is an indication that the
individual may be  predisposed  to  or  have  the  specific  disease  or
condition  tested  for  and  may  wish  to  consider further independent
testing, consult their physician or pursue genetic counseling;
(4) a general description of each specific disease or condition tested
for;
(5) the level of certainty  that  a  positive  test  result  for  that
disease  or condition serves as a predictor of such disease. If no level
of certainty has been established, this subparagraph may be disregarded;
(6) the name of the person or categories of persons  or  organizations
to whom the test results may be disclosed;
(7)  a  statement  that  no tests other than those authorized shall be
performed on  the  biological  sample  and  that  the  sample  shall  be
destroyed  at the end of the testing process or not more than sixty days
after the sample was taken, unless  a  longer  period  of  retention  is
expressly authorized in the consent; and
(8)  the  signature  of the individual subject of the test or, if that
individual lacks the capacity to consent, the signature  of  the  person
authorized to consent for such individual.
(c)  A  general waiver, wherein consent is secured for genetic testing
without compliance with paragraph (b) of  this  subdivision,  shall  not
constitute  informed  consent.  Notwithstanding  the  provisions of this
section, for purposes of  research  conducted  in  accordance  with  the
provisions of subdivision nine of this section, a general waiver for the
use of samples for research may be granted which would authorize the use
of samples for these research purposes.
(d)  Any  further  disclosure  of  genetic  test results to persons or
organizations not named  on  the  informed  consent  shall  require  the
further informed consent of the subject of the test.
(e)  Written  consent  by an individual for tests to be conducted on a
biological sample and to the lawful possession  and  ownership  of  such
sample  by a laboratory shall not be deemed written informed consent for
the performance of any genetic test on that sample,  except  as  further
provided in subdivision four of this section.
(f)   For   medical   research  purposes,  with  the  approval  of  an
institutional review board and  the  written  informed  consent  of  the
subject, samples may be kept for longer than sixty days and utilized for
scientific  research.  The requirements of subparagraphs three, four and
five of paragraph (b)  of  this  subdivision  may  be  modified  by  the
institutional review board in case the research protocol does not permit
such degree of specificity.
3. (a) All records, findings and results of any genetic test performed
on  any  person  shall be deemed confidential and shall not be disclosed
without the written informed consent of the person to whom such  genetic
test  relates.  This  information shall not be released to any person or
organization not specifically authorized by the  individual  subject  of
the  test.  Unauthorized  solicitation or possession of such information
shall be unlawful, except  for  the  unintentional  possession  of  such
information  as  part  of a health record created prior to the effective
date of this section and provided no action adverse to the interests  of
the  subject  are  taken as a result of such possession. Nothing in this
section shall  preclude  the  release  of  such  information,  with  the
subject's   consent,   to   a   health  insurer  or  health  maintenance
organization of any information  reasonably  required  for  purposes  of
claims  administration,  provided,  however,  that  further distribution
within the insurer or to other recipients shall  require  the  subject's
informed consent in each case.
(b)  No  person  who  lawfully  possesses  information  derived from a
genetic test on a biological sample from an individual shall incorporate
such information into the records of a non-consenting individual who may
be  genetically  related  to  the  tested  individual;  nor  shall   any
inferences  be  drawn,  used,  or  communicated  regarding  the possible
genetic status of the non-consenting individual.
4. (a) Notwithstanding the  provisions  of  subdivision  two  of  this
section,  genetic  tests  may  be  performed  on  anonymous  samples for
research or  statistical  purposes,  pursuant  to  a  research  protocol
approved by an institutional review board which assures the anonymity of
the sources of the samples.
(b) Notwithstanding the provisions of subdivision two of this section,
genetic  tests may be performed without the consent of the person who is
the subject of the tests pursuant to an order of a  court  of  competent
jurisdiction  or  as  provided  pursuant  to article forty-nine-B of the
executive law or as provided by section  twenty-five  hundred-a  of  the
public health law.
(c)  Notwithstanding  the  provisions  of paragraph (a) of subdivision
three of this section, the results of a genetic test may be disclosed to
specified individuals without the consent of the subject of the test  as

provided in an order of a court of competent jurisdiction or as provided
pursuant  to  article  forty-nine-B  of  the  executive  law  or section
twenty-five hundred-a of the public health law.
(d)  In  authorizing  a genetic test or the disclosure of genetic test
results to specified individuals, the court shall consider  the  privacy
interests  of  the  individual  subject of the genetic test and of close
relatives of such individual, the public interest, and, in the  case  of
medical  or anthropological research, the ethical appropriateness of the
research. Disclosure shall be permitted only to individuals or  agencies
expressly named in court orders.
5.   Penalties.   (a)  Any  person  who  violates  the  provisions  of
subdivision two or three of this section shall be guilty of a  violation
punishable by a civil fine of not more than one thousand dollars.
(b)  Any  person  who willfully violates the provisions of subdivision
two or three of this section shall be guilty of a misdemeanor punishable
by a fine of not more than five thousand dollars or by imprisonment  for
not more than ninety days or by both such fine and imprisonment.
6.  Nothing  in  this  section  shall  be  applicable to an authorized
insurer, as defined in paragraph ten of subsection (a)  of  section  one
hundred  seven  of the insurance law, or a person acting on behalf of an
authorized insurer who is in compliance with section twenty-six  hundred
twelve of the insurance law nor shall anything in this section be deemed
to  prohibit  or  limit an authorized insurer from obtaining information
pursuant to section twenty-six hundred twelve of the insurance law.
7. Notwithstanding the provisions of subdivision two of this  section,
genetic testing of newborn infants may be performed as provided pursuant
to  article  twenty-five  and section forty-one hundred thirty-five-b of
the public health law.
8. Notwithstanding the provisions of subparagraph seven  of  paragraph
(b)  of  subdivision two of this section, additional genetic testing may
be performed on a given sample without additional consent of the  person
tested  provided  such  testing is necessary and required to demonstrate
the integrity of the sample tested or to resolve the analysis of a  test
with a previously indeterminate result.
9.  (a)  Notwithstanding the provisions of subdivisions two and ten of
this section, samples may be used for tests other than those  for  which
specific  consent  has been obtained, for purposes of research conducted
in accordance with applicable law  and  regulation  and  pursuant  to  a
research  protocol  approved  by an institutional review board, provided
that the individuals who provided the samples have given  prior  written
informed  consent  for  the  use  of  their  sample for general research
purposes and did not specify time limits or  other  factors  that  would
restrict  use  of the sample for the test, and (1) the samples have been
permanently stripped of identifying information; or (2) a coding  system
has  been  established  to  protect  the identity of the individuals who
provided the samples, and an institutional review board has reviewed and
approved the procedures for the coding system.
(b) If consent to storage of the tissue sample  is  withdrawn  at  any
time, the entity storing the sample shall promptly destroy the sample or
portions thereof that have not already been used for research purposes.
(c)  In  no event shall family members of an individual who provided a
stored tissue sample be  contacted  for  clinical,  research,  or  other
purposes  without  consent  from  the individual who provided the tissue
sample with respect to the specific family members who will be contacted
and the specific purpose of the contact.
(d) In no event shall any information about an individual derived from
genetic tests performed on stored human tissue or information linking an
individual with specific results of genetic tests  be  released  to  any

organization  or  person  without  the  explicit  written consent of the
individual who donated the stored tissue to release of  the  information
for the purposes set forth in the written consent document.
(e)  Written  informed  consent  for  use  of  stored human tissue for
general research purposes shall consist of  written  authorization  that
includes at least the following:
(1) a statement that the sample will be used for future genetic tests;
(2)  the  time period during which the tissue will be stored, or if no
time limit is specified, a statement that the tissue will be stored  for
as long as deemed useful for research purposes;
(3)  a  description  of the policies and procedures to protect patient
confidentiality;
(4) a statement of the right to withdraw consent to use of the  tissue
for  future use at any time and the name of the organization that should
be contacted to withdraw consent;
(5) a statement allowing individuals to consent to future contact  for
any  or  all  purposes,  including the following: (i) research purposes;
(ii) provision of general information about research findings; and (iii)
information about the test on their sample  that  may  benefit  them  or
their  family  members in relation to their choices regarding preventive
or clinical care; and
(6) a statement explaining the benefits and  risks  of  consenting  to
future  contact  for the purposes set forth in subparagraph five of this
paragraph. In no event shall information about specific test results  on
stored  human  tissue donated for general research purposes be disclosed
to an individual without obtaining informed consent for  the  disclosure
as required by paragraph (b) of subdivision two of this section.
10. Notwithstanding the provisions of subdivision two of this section,
DNA  samples may be stored for up to ten years in the absence of genetic
testing,  if  authorized  in  writing  by  the  subject.  Prior  to  the
performance  of  any  genetic test upon stored samples, informed consent
must be obtained  as  provided  in  subdivision  two  of  this  section.
Retention  of  a DNA sample past a period of ten years requires explicit
consent for a longer or indefinite period of retention.
11. Genetic testing  may  be  performed  on  specimens  from  deceased
persons  if informed consent is provided by the next-of-kin as specified
in subdivision two of this section.