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Tennessee General Assembly· SB 318Companion House Bill substituted

Anatomical Gifts - As enacted, enacts the "Tennessee Genomic Security and End Organ Harvesting Act." - Amends TCA Title 56 and Title 68. Companion bill has been assigned Public Chapter Number 96 by the Secretary of State, the official text

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                         $tate of \!rennessee

                           PUBLIC CHAPTER NO. 96

                                                   HOUSE BILL NO. 395

 By Representatives Terry, Leatherwood, Reedy, Butler, Hill, Greg Martin, Hawk, Helton-

                                                             Haynes

                                        Substituted for: Senate Bill No. 318

                                         By Senators Lowe, Rose, Stevens

         AN ACT to amend Tennessee Code Annotated, Title 56 and Title 68, relative to the
Tennessee Genomic Security and End Organ Harvesting Act.

          WHEREAS, it is the intent of the General Assembly to ensure that a company
sanctioned by an adversarial military power does not gain access to genetic information from
the United States; to combat the heinous practice of forcibly harvesting organs from living
persons for transplant; to bring awareness concerning the People's Republic of China's state-
sanctioned practice of forced organ harvesting of prisoners of conscience and other vulnerable
persons; and to prevent residents of this State from unknowingly involving themselves in forced
organ harvesting; and

          WHEREAS, it is the intent of this State to recognize and fully oppose the heinous
practice of forced organ harvesting conducted by the People's Republic of China and the
Chinese Communist Party against prisoners, political dissidents, and other individuals who are
held and abused in violation of their basic human rights within the People's Republic of China;
and

          WHEREAS, it is intent of this State to oppose the collection and analysis of genetic
information for use by the military and surveillance state of the People's Republic of China, and
to support sanctions imposed by the United States Department of Commerce and Department
of Defense upon companies engaged in the collection and analysis of genetic information on
behalf of the military and surveillance state of the People's Republic of China; now, therefore,

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:

          SECTION 1. Tennessee Code Annotated, Title 68, Chapter 30, is amended by adding
the following as a new part:

          68-30-201.

                    This part is known and may be cited as the "Tennessee Genomic Security and
          End Organ Harvesting Act."

           68-30-202.

                    As used in this part:

                              (1) "Company" means a for-profit sole proprietorship, organization,
                    association, corporation, partnership, joint venture, limited partnership, limited
                    liability partnership, or limited liability company, including a wholly owned
                    subsidiary, majority-owned subsidiary, parent company, or affiliate of such
                    entities or business associations that exists to make a profit; or a nonprofit
                    organization;

                               (2) "Domicile" means the country in which:

                                         (A) A company is registered and the company's headquarters is
                               located;

                                         (B) A majority of a company's affairs are conducted; or
HB395

                                        (C) The majority of a company's ownership shares are held;

                              (3) "Forced organ harvesting" means the removal of one (1) or more
                    organs from a living person or a person killed for the purpose of removal of one
                    (1) or more organs by means of coercion, abduction, deception, fraud, or abuse
                    of power or a position of vulnerability;

                              (4) "Foreign adversary" means a nation specified in 15 CFR 791.4;

                              (5) "Genetic sequencer" means a device or platform used to conduct
                    genetic sequencing, resequencing, isolation, or other genetic research;

                              (6) "Genetic sequencing" means a method to determine the identity and
                    order of nucleotide bases in the human genome;

                              (7) "Genomic research facility" means a facility that conducts research on,
                    with, or relating to genetic sequencing or the human genome;

                              (8) "Health benefit plan" means health insurance coverage as defined in §
                    56-7-109;

                               (9) "Health insurer" means a health insurance entity as defined in § 56-7-
                   109;

                               (10) "Human genome" means deoxyribonucleic acid (DNA) or ribonucleic
                    acid (RNA) found in human cells;

                               (11) "Medical facility" means a facility for the delivery of health services
                     that:

                                         (A) Receives state funds, including interagency pass-through
                               appropriations from the federal government;

                                         (B) Is licensed or registered with this state to provide healthcare
                               services in this state; or

                                         (C) Conducts research or testing on, with, or relating to genetic
                               sequencing or the human genome;

                               (12) "Operational and research software" means computer programs
                     used for the operation, control, analysis, or other necessary functions of genetic
                     sequencing or genetic sequencers; and

                               (13) "Software" means a program or routine that is used or intended for
                     use to cause one (1) or more computers or pieces of computer-related peripheral
                     equipment, or any combination of such equipment, to perform a task, as it relates
                     to genetic sequencing or genetic sequencers.

           68-30-203.

                     (a) This part applies to a health benefit plan that is offered, issued, delivered,
           amended, or renewed by a health insurer to take effect on or after January 1, 2026.

                     (b) A health insurer shall not knowingly provide coverage for a human organ
           transplant if:

                               (1) The transplant operation is performed in the People's Republic of
                     China; or

                               (2) The human organ to be transplanted was procured by sale or donation
                     originating in the People's Republic of China.

                     (c) The commissioner of health may designate additional countries with
           governments that fund, sponsor, or otherwise facilitate forced organ harvesting and shall
           provide written notice to the governor when the commissioner of health designates an

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          additional country. The commissioner shall maintain a list of designated countries on the
          department's public website.

          68-30-204.

                    (a) A medical facility or research facility shall not use genetic sequencers, or any
          operational or research software used for genetic sequencing, produced in or by a
          foreign adversary, a state-owned enterprise of a foreign adversary, a company domiciled
          within a foreign adversary, or a subsidiary or affiliate that is owned or controlled by a
          company domiciled within a foreign adversary.

                    (b) All genetic sequencers and operational and research software used for
          genetic sequencers or genetic sequencing devices prohibited under subsection (a),
          which are not permanently disabled, must be removed and replaced within one hundred
          eighty (180) days after the effective date of this act with genetic sequencers and
          operational and research software used for genetic sequencers or genetic sequencing in
          compliance with this section.

                    (c) A medical facility or research facility is not required to investigate any
          individual component of genetic sequencing equipment or software to be in compliance
          with this section.

          68-30-205.

                    (a) A medical facility or research facility shall not store genetic sequencing data
          within a foreign adversary. The medical facility or research facility shall not allow remote
          access to genetic sequencing data storage within its direction or control, other than open
          data, to a foreign adversary, unless approved in writing by the commissioner of health.

                    (b) Medical facilities, research institutions, and other companies and entities
          storing genetic sequencing data, including through contracts with third-party data
          storage companies, must ensure the security of genetic sequencing data using
          reasonable encryption methods, restrictions on access, and other cybersecurity best
           practices.

           68-30-206.

                     (a)

                               (1) On or before July 1 each year, under the penalties of perjury, each
                     medical facility and research institution covered under this part shall certify to the
                     commissioner of health that the facility or institution is compliant with this part.

                               (2) On or before July 1 each year, under the penalties of perjury, each
                     licensed health facility covered under this part shall certify to the health facilities
                     commission that the licensed health facility is compliant with this part.

                      (b)

                                (1)

                                         (A) Any medical facility or research institution that violates § 68-
                               30-204(a) is subject to a fine of ten thousand dollars ($10,000) for each
                               violation, to be imposed by the commissioner of health.

                                         (B) Any licensed health facility that violates § 68-30-204(a) is
                               subject to a fine of ten thousand dollars ($10,000) for each violation, to be
                               imposed by the health facilities commission.

                               (2) For the purposes of subdivision (b)(1), a violation occurs each
                     instance an individual's genome having undergone genetic sequencing or
                     analysis using prohibited genetic sequencers or operational and research
                     software is used for genetic sequencers or genetic sequencing.

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HB395

                    (c) A health benefit plan that knowingly provides coverage for an organ transplant
          prohibited by this part is subject to a fine of one hundred thousand dollars ($100,000) for
          each violation, to be imposed by the commissioner of commerce and insurance.

                    (d) An entity that knowingly stores genetic sequencing data outside of the United
          States as prohibited in § 68-30-205 is subject to a fine of ten thousand dollars ($10,000)
          for each violation, to be imposed by the commissioner of health.
          68-30-207.

                    (a) If a person is a patient or research subject of an entity that is found guilty of a
          violation of § 68-30-204, and that person's genetic information was used in the violation,
          then the person is entitled to recover statutory damages of not less than five thousand
          dollars ($5,000) for each unique use of the person's genomic information.

                    (b) If a person is a patient or research subject of an entity that is found guilty of a
          violation of § 68-30-205, and that person's genetic information was used in the violation,
          then the person is entitled to recover statutory damages of not less than five thousand
          dollars ($5,000) for each unique use of the person's genomic information.
          68-11-208.

                    (a) The health facilities commission is authorized to investigate allegations of
          violations of this part.

                     (b) Any person may notify the health facilities commission of a violation or
          potential violation of this part.

                     (c) The health facilities commission shall take no further action on a complaint if
          the health facilities commission must obtain authorization to enter a facility from the
           Center for Medicare and Medicaid Services (CMS) and CMS denies the authorization to
          enter.

                     (d) If an employee of an entity accused of a violation notifies the health facilities
           commission of a violation or a potential violation, then the employee is afforded all
           protections as described in§ 50-1-304.
           SECTION 2. If any provision of this act or its application to any person or circumstance
 is held invalid, then the invalidity does not affect other provisions or applications of the act that
 can be given effect without the invalid provision or application, and to that end, the provisions of
 this act are severable.
           SECTION 3. This act takes effect January 1, 2026, the public welfare requiring it.

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         HOUSE BILL NO. 395

PASSED:  March 17, 2025

                              CAMERON SEXTON, SPEAKER
                              HOUSE OF REPRESENTATIVES

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                              ~            RANDY.1W-I■-• ·~-- I

                                 SPEAKER OF THE SENATE

cir- APPROVED this ;;);8tfl.. day of M<Ar  2025

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BILL LEE, GOVERNOR
Every fact on this page links to its source, starting with the official bill record.