House Bill 2485 - Genetic Data and Direct-to-Consumer Testing Companies (Washington, 2020)

Summary

House Bill 2485 of the State of Washington, 66th Legislature, 2020 Regular Session, is an act relating to collection, use, and disclosure of genetic data by direct-to-consumer genetic testing companies. Representatives Kloba, Slatter, Senn, Lekanoff and others are listed as sponsors, and the bill was referred to the Committee on Innovation, Technology & Economic Development. It requires a company to obtain a consumer's express consent for collection, use, or disclosure of genetic data and to require valid legal process for disclosing genetic data to law enforcement without express consent. The attorney general may bring an action to enforce the chapter, with a civil penalty of two thousand five hundred dollars for each violation.

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Full text

     H-3797.1

                                HOUSE BILL 2485


     State of Washington        66th Legislature         2020 Regular Session

     By Representatives Kloba, Slatter, Senn, Lekanoff,         Thai,   Callan,
     Valdez, Smith, Davis, Pollet, Hudgins, and Ormsby

     Read first time 01/15/20.      Referred   to   Committee   on   Innovation,
     Technology & Economic Development.




1        AN ACT Relating to collection, use, and disclosure of genetic
2    data by direct-to-consumer genetic testing companies; adding a new
3    chapter to Title 19 RCW; and prescribing penalties.


4    BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:


 5       NEW SECTION.    Sec. 1.    The definitions in this section apply
 6   throughout   this  chapter   unless  the   context  clearly   requires
 7   otherwise.
 8       (1) "Biological sample" means any material part of the human
 9   body, discharge therefrom, or derivative thereof, such as tissue,
10   blood, urine, or saliva, known to contain deoxyribonucleic acid
11   (DNA).
12       (2) "Consumer" means a natural person who is a Washington
13   resident.
14       (3) "Direct-to-consumer genetic testing company" or "company"
15   means an entity that offers consumer genetic testing products or
16   services directly to consumers without requiring the involvement of a
17   health care provider.
18       (4) "Employer" has the same meaning as defined in RCW 50.04.080.
19       (5) "Express consent" means a consumer's affirmative written
20   response to a clear, meaningful, and prominent notice regarding the


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 1   collection, use, or disclosure of genetic data for a specific
 2   purpose.
 3       (6)(a) "Genetic data" means any data, regardless of its format,
 4   that concerns a consumer's genetic characteristics.
 5       (b) "Genetic data" includes, but is not limited to:
 6       (i) Raw sequence data that result from sequencing of a consumer's
 7   complete extracted or a portion of the extracted DNA;
 8       (ii) Genotypic and phenotypic information that results from
 9   analyzing the raw sequence data; and
10       (iii) Self-reported health data that a consumer submits to a
11   company regarding the consumer's health conditions and that is used
12   for scientific research or product development and analyzed in
13   connection with the consumer's raw sequence data.
14       (c) "Genetic data" does not include deidentified data. For
15   purposes of this subsection, "deidentified data" means data that
16   cannot reasonably be used to infer information about, or otherwise be
17   linked to, an identifiable consumer, and that is subject to:
18       (i) Administrative and technical measures to ensure that the data
19   cannot be associated with a particular consumer;
20       (ii) Public commitment by the company to maintain and use data in
21   deidentified form and not to attempt to reidentify data; and
22       (iii) Legally enforceable contractual obligations that prohibit
23   any recipients of the data from attempting to reidentify the data.
24       (7) "Genetic testing" means any laboratory test of a consumer's
25   complete DNA, regions of DNA, chromosomes, genes, or gene products to
26   determine the presence of the genetic characteristics in a consumer
27   or a consumer's offspring.

28       NEW SECTION.      Sec. 2.      (1) To safeguard the privacy,
29   confidentiality, security, and integrity of a consumer's genetic
30   data, a direct-to-consumer genetic testing company shall:
31       (a) Provide clear and complete information regarding the
32   company's policies and procedures for collection, use, or disclosure
33   of genetic data by making available to a consumer:
34       (i) A high-level privacy policy overview that includes basic,
35   essential information about the company's collection, use, or
36   disclosure of genetic data; and
37       (ii) A prominent, publicly available, and easy to read privacy
38   notice that includes, at a minimum, information about the company's


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 1   data    collection,  consent,  use,   access,   disclosure,  transfer,
 2   security, and retention and deletion practices;
 3       (b) Obtain a consumer's consent for collection, use, or
 4   disclosure of the consumer's genetic data including, at a minimum:
 5        (i) Initial express consent that clearly describes the uses of
 6   the genetic data collected through the genetic testing product or
 7   services purchased by the consumer, and specifies who has access to
 8   test results and how the genetic data may be shared;
 9        (ii) Separate express consent for transferring or disclosing the
10   consumer's genetic data to third parties other than vendors and
11   services providers, or for using genetic data beyond the primary
12   purpose of the purchased genetic testing product or service and
13   inherent contextual uses;
14        (iii) Informed consent in compliance with the federal policy for
15   the protection of human research subjects, 45 C.F.R. Sec. 46 (2019),
16   when the consumer's genetic data is transferred or disclosed to third
17   parties for research purposes or when research is done under the
18   control   of  the   company  for   the  purpose   of  publication  or
19   generalizable knowledge; and
20       (iv) Express consent for marketing to a consumer based on the
21   consumer's genetic data or the consumer having ordered or purchased a
22   genetic testing product or service;
23       (c) Require valid legal process for disclosing genetic data to
24   law enforcement without a consumer's express consent;
25       (d) Develop, implement, and maintain a comprehensive security
26   program to protect a consumer's genetic data against unauthorized or
27   inappropriate access, disclosure, or use; and
28       (e) Provide a process for a consumer to:
29       (i) Access the consumer's genetic data;
30       (ii) Correct or amend inaccurate genetic data or other personal
31   information in the consumer's account;
32       (iii) Specify how long the consumer's genetic data and biological
33   sample may be retained by the company;
34       (iv) Delete the consumer's account and genetic data; and
35       (v) Request and obtain the destruction of the consumer's
36   biological sample.
37       (2) Notwithstanding any other provisions in this section, a
38   direct-to-consumer genetic testing company may not disclose a
39   consumer's genetic data to any entity offering health insurance or
40   life insurance, or to any employer of the consumer.
                                     p. 3                          HB 2485
 1       NEW SECTION.    Sec. 3.     (1) The legislature finds that the
 2   practices covered by this chapter are matters vitally affecting the
 3   public interest for the purpose of applying the consumer protection
 4   act, chapter 19.86 RCW. A violation of this chapter is not reasonable
 5   in relation to the development and preservation of business and is an
 6   unfair or deceptive act in trade or commerce and an unfair method of
 7   competition for the purpose of applying the consumer protection act,
 8   chapter 19.86 RCW.
 9       (2) The attorney general may bring an action in the name of the
10   state, or as parens patriae on behalf of persons residing in the
11   state, to enforce this chapter. In any action brought by the attorney
12   general to enforce this chapter, a violation of this chapter is
13   subject to a civil penalty of two thousand five hundred dollars for
14   each violation of this chapter.
15       (3) A consumer prevailing in an action under this chapter may
16   recover actual damages, but not less than statutory damages of two
17   thousand five hundred dollars per violation.
18       (4) A court must award costs and reasonable attorneys' fees to a
19   plaintiff who prevails in an action under this chapter.


20       NEW SECTION.     Sec. 4.    Sections 1   through   3   of   this   act
21   constitute a new chapter in Title 19 RCW.

                                  --- END ---




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