88R13807 JES-F
	By: Johnson	S.B. No. 1544

Statutes affected:
Introduced: ()

	A BILL TO BE ENTITLED
	AN ACT
	relating to the use of an individual's genetic data by certain
	genetic testing companies for commercial purposes; authorizing a
	civil penalty.
	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
	SECTION 1.  Subtitle A, Title 11, Business & Commerce Code,
	is amended by adding Chapter 503A to read as follows:
	CHAPTER 503A. DIRECT-TO-INDIVIDUAL GENETIC TESTING COMPANIES
	Sec. 503A.001.  DEFINITIONS. In this chapter:
	(1)  "Biological sample" means a material part of the
	human body, or a discharge or derivative part of the body, including
	tissue, blood, urine, or saliva that is known to contain DNA.
	(2)  "Deidentified data" means data not reasonably
	linked to and that cannot reasonably be used to infer information
	about an identifiable individual.
	(3)  "Direct-to-individual genetic testing company"
	means an entity that:
	(A)  offers genetic testing products or services
	directly to individuals; or
	(B)  collects, uses, or analyzes genetic data that
	results from a direct-to-individual genetic testing product or
	service and that an individual provides to the entity.
	(4)  "DNA" means deoxyribonucleic acid.
	(5)  "Express consent" means an individual's
	affirmative response to a clear and meaningful notice regarding the
	collection, use, or disclosure of genetic data for a specific
	purpose.
	(6)  "Genetic data" means any data, regardless of
	format, concerning an individual's genetic characteristics. The
	term:
	(A)  includes:
	(i)  raw sequence data derived from
	sequencing all or a portion of an individual's extracted DNA;
	(ii)  genotypic and phenotypic information
	obtained from analyzing an individual's raw sequence data; and
	(iii)  health information regarding the
	health conditions that an individual self-reports to a company and
	that the company:
	(a)  uses for scientific research or
	product development; and
	(b)  analyzes in connection with the
	individual's raw sequence data; and
	(B)  does not include deidentified data.
	(7)  "Genetic testing" means a laboratory test of an
	individual's complete DNA, regions of DNA, chromosomes, genes, or
	gene products to determine the presence of the individual's genetic
	characteristics.
	(8)  "Person" means an individual, partnership,
	corporation, association, business, or business trust or the legal
	representative of an organization.
	Sec. 503A.002.  APPLICABILITY. (a) This chapter applies to
	a direct-to-individual genetic testing company that:
	(1)  offers its products or services to individuals who
	are residents of this state; or
	(2)  collects, uses, or analyzes genetic data that
	results from the company's products or services and was provided to
	the company by an individual who is a resident of this state.
	(b)  This chapter does not apply to:
	(1)  an entity only when they are engaged in
	collecting, using, or analyzing genetic data or biological samples
	in the context of research, as defined by 45 C.F.R. Section 164.501,
	that is conducted in accordance with:
	(A)  the federal policy for the protection of
	human subjects (45 C.F.R. Part 46);
	(B)  the good clinical practice guidelines issued
	by the International Council for Harmonisation of Technical
	Requirements for Pharmaceuticals for Human Use (ICH); or