Anatomical Gifts

Plain English Breakdown

The bill summary does not provide specific details about penalties for violations, leaving some uncertainty in enforcement mechanisms.

Tennessee Genomic Security and End Organ Harvesting Act

This act bans health insurers from covering organ transplants or post-transplant care if the transplant happens in China or uses organs from China, restricts use of certain genetic sequencing equipment made by foreign adversaries, and limits storage of genetic data outside the U.S.

What This Bill Does

• Bans health insurance companies from providing coverage for organ transplants or post-transplant care if the operation is done in China or involves organs from China starting January 1, 2026.
• Prohibits medical and research facilities from using genetic sequencing equipment made by foreign adversaries like China, Cuba, Iran, North Korea, and Russia.
• Requires all genetic data to be stored within the United States unless approved by the health commissioner in writing. Facilities must use strong security measures for this data.

Who It Names or Affects

• Health insurance companies that provide coverage for organ transplants or post-transplant care.
• Medical facilities, research institutions, and other entities storing genetic sequencing data.

Terms To Know

Foreign adversary

A country listed in 15 CFR 791.4, such as China, Cuba, Iran, North Korea, and Russia.

Genetic sequencer

Equipment used to analyze DNA or RNA sequences.

Limits and Unknowns

• The bill does not specify how the health commissioner will designate additional countries with governments that fund forced organ harvesting.
• It is unclear what specific penalties apply if a medical facility fails to remove and replace prohibited genetic sequencing equipment within 180 days.

Official Summary Text

This bill enacts the "Tennessee Genomic Security and End Organ Harvesting Act," which adds the following prohibitions:



For 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, prohibits a health insurer from knowingly providing coverage for a human organ transplant or post-transplant care if (i) the transplant operation is performed in the People's Republic of China or (ii) the human organ to be transplanted was procured by sale or donation originating in the People's Republic of China. The commissioner of health may designate additional countries with governments that fund, sponsor, or otherwise facilitate forced organ harvesting and must provide written notice to the governor when the commissioner designates an additional country. The commissioner must maintain a list of designated countries on the department's public website.



Prohibits a medical facility or research facility from using genetic sequencers, or any operational or research software used for genetic sequencing, produced in or by a nation specified in 15 CFR 791.4 ("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. All genetic sequencers and operational and research software used for genetic sequencers or genetic sequencing devices prohibited under this bill, which are not permanently disabled, must be removed and replaced within 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 this bill. As of the date that this summary was prepared, 15 CFR 791.4 specifies the following nations as foreign adversaries: the People's Republic of China, including the Hong Kong Special Administrative Region (China); the Republic of Cuba (Cuba); the Islamic Republic of Iran (Iran); the Democratic People's Republic of Korea (North Korea); and the Russian Federation (Russia).



Restricts storage of all genetic sequencing data to the geographic location of the United States. Remote access to data storage, other than open data, from outside the United States is prohibited unless approved in writing by the commissioner of health. 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.

As used in this bill, a "medical facility" means a facility for the delivery of health services that (i) receives state funds, including interagency pass through appropriations from the federal
government; (ii) is registered with this state to provide healthcare services in this state; or (iii) conducts research or testing on, with, or relating to genetic sequencing or the human genome.

AUTHORITY OF ATTORNEY GENERAL

This bill authorizes the at
torney general to investigate allegations of violations of this bill. Any person may notify the attorney general of a violation or potential violation. If an employee of an entity accused of a violation notifies the attorney general of a violation or a
p
otential violation, then the employee is afforded all protections as described in present law regarding discharge for refusal to participate in or remain silent about illegal activities or for legal use of an agricultural product.

PENALTIES

On or before
July 1 each year, under the penalties of perjury, this bill requires each medical facility and research institution covered under this bill to certify to the attorney general and the commissioner of health that the facility or institution is compliant wi
t
h this bill. Any medical facility or research institution that violates the storage restrictions described above is subject to a fine of $10,000 for each violation, to be imposed by the commissioner of health. A violation occurs each instance an individ
u
al's genome having undergone genetic sequencing or analysis using a prohibited genetic sequencers or operational and research software is used for genetic sequencers or genetic sequencing.

This bill provides that a health benefit plan that knowingly prov
ides coverage for an organ transplant or post-transplant care prohibited by this bill is subject to a fine of $100,000 for each violation, to be imposed by the commissioner of commerce and insurance. An entity that knowingly stores genetic sequencing dat
a
outside of the United States as prohibited in this bill is subject to a fine of $10,000 for each violation, to be imposed by the commissioner of health.

This bill provides that, if a person is a patient or research subject of an entity that is found
guilty of a violation of this bill, and that person's genetic information was used in the violation, then the person is entitled to recover statutory damages of not less than $5,000 for each unique use of the person's genomic information. Additionally, i
f
a person is a patient or research subject of an entity that is found guilty of a violation of this bill, and that person's genetic information was used in the violation, then the person is entitled to recover statutory damages of not less than $5,000 for

each unique use of the person's genomic information.

ON MARCH 10, 2025, THE HOUSE ADOPTED AMENDMENT #1 AND PASSED HOUSE BILL 395, AS AMENDED.

AMENDMENT #1 makes the following revisions:



Clarifies that the definition of "medical facility" includes a facility that is licensed with this state to provide healthcare services in this state, as well as meets other criteria.



Removes the prohibition against a health insurer knowingly providing coverage for post-transplant care if (i) the transplant operation is performed in the People's Republic of China; or (ii) the human organ to be transplanted was procured by sale or donation originating in the People's Republic of China.



Adds that 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 the bill.



Revises the provision relative to the storage of genetic sequencing data to, instead, prohibit a medical facility or research facility (i) from storing genetic sequencing data within a foreign adversary and (ii) from allowing 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.



Removes the requirement that each medical facility and research institution certify to the attorney general that the facility or institution is compliant with the bill.



Adds that, on or before July 1 each year, under the penalties of perjury, each licensed health facility covered under the bill must certify to the health facilities commission that the licensed health facility is compliant with the bill.



Adds that any licensed health facility that violates the provisions of the bill relative to genetic sequencers and related software is subject to a fine of $10,000 for each violation, to be imposed by the health facilities commission.



Removes the authority of the attorney general to investigate allegations of violations of the bill and, instead, authorizes the health facilities commission to so investigate. Any person may notify the health facilities commission of a violation or potential violation of the bill.



Requires the health facilities commission to 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.



Adds that, 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 law relative to illegal discharge for refusal to participate in or remain silent about illegal activities or for legal use of agricultural products.

ON MARCH 10, 2025, THE SENATE ADOPTED AMENDMENT #2 AND PASSED SENATE BILL 318, AS AMENDED.

AMENDMENT #2 makes the same changes that were made by House Amendment #1.

ON MARCH 17, 2025, THE SENATE RECONSIDERED ITS ACTIONS IN PASSING
SENATE BILL 318, LIFTED THE TABLING MOTION, SUBSTITUTED HOUSE BILL 395 FOR SENATE BILL 318, AND PASSED HOUSE BILL 395.

Current Bill Text

SENATE BILL 318
By Lowe

HOUSE BILL 395
By Terry

HB0395
001203
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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:

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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
(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;

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(7) "Genomic research facility" means a facility which 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
which:
(A) Receives state funds, including interagency pass through
appropriations from the federal government;
(B) Is 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.

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(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 or post-transplant care 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
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.

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68-30-205.
(a) Storage of all genetic sequencing data is restricted to the geographic location
of the United States. Remote access to data storage, other than open data, from
outside the United States, is prohibited 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) 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 attorney
general and reporter and the commissioner of health that the facility or institution is
compliant with this part.
(b)
(1) 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.
(2) For the purposes of subdivision (b)(1), a violation occurs each
instance an individual's genome having undergone genetic sequencing or
analysis using a prohibited genetic sequencers or operational and research
software is used for genetic sequencers or genetic sequencing.
(c) A health benefit plan that knowingly provides coverage for an organ
transplant or post-transplant care prohibited by this part is subject to a fine of one

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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)
(1) The attorney general and reporter is authorized to investigate
allegations of violations of this part.
(2) Any person may notify the attorney general and reporter of a violation
or potential violation of this part.
(b) If an employee of an entity accused of a violation notifies the attorney
general and reporter of a violation or a potential violation, then the employee is afforded
all protections as described in § 50-1-304.
(c) 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.
(d) 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.
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

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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.