Tennessee 2025-2026 Regular Session

Tennessee House Bill HB0395 Compare Versions

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4		-	$tate of \!rennessee
5		-	PUBLIC CHAPTER NO. 96
6		-	HOUSE BILL NO. 395
7		-	By Representatives Terry, Leatherwood, Reedy, Butler, Hill, Greg Martin, Hawk, Helton
8		-	Haynes
9		-	Substituted for: Senate Bill No. 318
10		-	By Senators Lowe, Rose, Stevens
11		-	AN ACT to amend Tennessee Code Annotated, Title 56 and Title 68, relative to the
12		-	Tennessee Genomic Security and End Organ Harvesting Act.
	1	+
	2	+	SENATE BILL 318
	3	+	By Lowe
	4	+
	5	+	HOUSE BILL 395
	6	+	By Terry
	7	+
	8	+
	9	+	HB0395
	10	+	001203
	11	+	- 1 -
	12	+
	13	+	AN ACT to amend Tennessee Code Annotated, Title 56
	14	+	and Title 68, relative to the Tennessee Genomic
	15	+	Security and End Organ Harvesting Act.
	16	+
13	17		WHEREAS, it is the intent of the General Assembly to ensure that a company
14	18		sanctioned by an adversarial military power does not gain access to genetic information from
15	19		the United States; to combat the heinous practice of forcibly harvesting organs from living
16		-	persons for transplant; to bring awareness concerning the People's Republic of China's state
	20	+	persons for transplant; to bring awareness concerning the People's Republic of China's state-
17	21		sanctioned practice of forced organ harvesting of prisoners of conscience and other vulnerable
18	22		persons; and to prevent residents of this State from unknowingly involving themselves in forced
19	23		organ harvesting; and
20	24		WHEREAS, it is the intent of this State to recognize and fully oppose the heinous
21	25		practice of forced organ harvesting conducted by the People's Republic of China and the
22	26		Chinese Communist Party against prisoners, political dissidents, and other individuals who are
23	27		held and abused in violation of their basic human rights within the People's Republic of China;
24	28		and
25	29		WHEREAS, it is intent of this State to oppose the collection and analysis of genetic
26	30		information for use by the military and surveillance state of the People's Republic of China, and
27	31		to support sanctions imposed by the United States Department of Commerce and Department
28	32		of Defense upon companies engaged in the collection and analysis of genetic information on
29	33		behalf of the military and surveillance state of the People's Republic of China; now, therefore,
30	34		BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
31	35		SECTION 1. Tennessee Code Annotated, Title 68, Chapter 30, is amended by adding
32	36		the following as a new part:
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33	41		68-30-201.
34	42		This part is known and may be cited as the "Tennessee Genomic Security and
35	43		End Organ Harvesting Act."
36	44		68-30-202.
37	45		As used in this part:
38	46		(1) "Company" means a for-profit sole proprietorship, organization,
39	47		association, corporation, partnership, joint venture, limited partnership, limited
40	48		liability partnership, or limited liability company, including a wholly owned
41	49		subsidiary, majority-owned subsidiary, parent company, or affiliate of such
42	50		entities or business associations that exists to make a profit; or a nonprofit
43	51		organization;
44	52		(2) "Domicile" means the country in which:
45	53		(A) A company is registered and the company's headquarters is
46	54		located;
47		-	(B) A majority of a company's affairs are conducted; or ~~HB395~~
	55	+	(B) A majority of a company's affairs are conducted; or
48	56		(C) The majority of a company's ownership shares are held;
49	57		(3) "Forced organ harvesting" means the removal of one (1) or more
50	58		organs from a living person or a person killed for the purpose of removal of one
51	59		(1) or more organs by means of coercion, abduction, deception, fraud, or abuse
52	60		of power or a position of vulnerability;
53	61		(4) "Foreign adversary" means a nation specified in 15 CFR 791.4;
54	62		(5) "Genetic sequencer" means a device or platform used to conduct
55	63		genetic sequencing, resequencing, isolation, or other genetic research;
56	64		(6) "Genetic sequencing" means a method to determine the identity and
57	65		order of nucleotide bases in the human genome;
58		-	(7) "Genomic research facility" means a facility that conducts research on,
59		-	with, or relating to genetic sequencing or the human genome;
60		-	(8) "Health benefit plan" means health insurance coverage as defined in §
61		-	56-7-109;
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	70	+	(7) "Genomic research facility" means a facility which conducts research
	71	+	on, with, or relating to genetic sequencing or the human genome;
	72	+	(8) "Health benefit plan" means health insurance coverage as defined in
	73	+	§ 56-7-109;
62	74		(9) "Health insurer" means a health insurance entity as defined in § 56-7-
63	75		109;
64	76		(10) "Human genome" means deoxyribonucleic acid (DNA) or ribonucleic
65	77		acid (RNA) found in human cells;
66	78		(11) "Medical facility" means a facility for the delivery of health services
67		-	~~that~~:
68		-	(A) Receives state funds, including interagency pass-through
	79	+	which:
	80	+	(A) Receives state funds, including interagency pass through
69	81		appropriations from the federal government;
70		-	(B) Is ~~licensed or~~ registered with this state to provide healthcare
71		-	~~services in~~ this state; or
	82	+	(B) Is registered with this state to provide healthcare services in
	83	+	this state; or
72	84		(C) Conducts research or testing on, with, or relating to genetic
73	85		sequencing or the human genome;
74	86		(12) "Operational and research software" means computer programs
75	87		used for the operation, control, analysis, or other necessary functions of genetic
76	88		sequencing or genetic sequencers; and
77	89		(13) "Software" means a program or routine that is used or intended for
78		-	use to cause one (1) or more computers or pieces of computer-related peripheral
	90	+	use to cause one (1) or more computers or pieces of computer related peripheral
79	91		equipment, or any combination of such equipment, to perform a task, as it relates
80	92		to genetic sequencing or genetic sequencers.
81	93		68-30-203.
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82	98		(a) This part applies to a health benefit plan that is offered, issued, delivered,
83	99		amended, or renewed by a health insurer to take effect on or after January 1, 2026.
84	100		(b) A health insurer shall not knowingly provide coverage for a human organ
85		-	transplant if:
	101	+	transplant or post-transplant care if:
86	102		(1) The transplant operation is performed in the People's Republic of
87	103		China; or
88		-	(2) The human organ to be transplanted was procured by sale or ~~donation~~
89		-	originating in the People's Republic of China.
	104	+	(2) The human organ to be transplanted was procured by sale or
	105	+	donation originating in the People's Republic of China.
90	106		(c) The commissioner of health may designate additional countries with
91	107		governments that fund, sponsor, or otherwise facilitate forced organ harvesting and shall
92	108		provide written notice to the governor when the commissioner of health designates an
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94	109		additional country. The commissioner shall maintain a list of designated countries on the
95	110		department's public website.
96	111		68-30-204.
97	112		(a) A medical facility or research facility shall not use genetic sequencers, or any
98	113		operational or research software used for genetic sequencing, produced in or by a
99	114		foreign adversary, a state-owned enterprise of a foreign adversary, a company domiciled
100	115		within a foreign adversary, or a subsidiary or affiliate that is owned or controlled by a
101	116		company domiciled within a foreign adversary.
102	117		(b) All genetic sequencers and operational and research software used for
103	118		genetic sequencers or genetic sequencing devices prohibited under subsection (a),
104	119		which are not permanently disabled, must be removed and replaced within one hundred
105	120		eighty (180) days after the effective date of this act with genetic sequencers and
106	121		operational and research software used for genetic sequencers or genetic sequencing in
107	122		compliance with this section.
108		-	(c) A medical facility or research facility is not required to investigate any
109		-	individual component of genetic sequencing equipment or software to be in compliance
110		-	with this section.
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111	127		68-30-205.
112		-	(a) ~~A medical facility or research facility shall not store~~ genetic sequencing data
113		-	~~within a foreign adversary.~~ The ~~medical facility or research facility shall not allow~~ remote
114		-	~~access to genetic sequencing data storage within its direction or control~~, ~~other than open~~
115		-	~~data, to a foreign adversary, unless approved in writing by the commissioner~~ of health.
	128	+	(a) Storage of all genetic sequencing data is restricted to the geographic location
	129	+	of the United States. Remote access to data storage, other than open data, from
	130	+	outside the United States, is prohibited unless approved in writing by the commissioner
	131	+	of health.
116	132		(b) Medical facilities, research institutions, and other companies and entities
117	133		storing genetic sequencing data, including through contracts with third-party data
118	134		storage companies, must ensure the security of genetic sequencing data using
119	135		reasonable encryption methods, restrictions on access, and other cybersecurity best
120	136		practices.
121	137		68-30-206.
122		-	(a)
123		-	(1) On or before July 1 each year, under the penalties of perjury, each
124		-	medical facility and research institution covered under this part shall certify to the
125		-	commissioner of health that the facility or institution is compliant with this part.
126		-	(2) On or before July 1 each year, under the penalties of perjury, each
127		-	licensed health facility covered under this part shall certify to the health facilities
128		-	commission that the licensed health facility is compliant with this part.
	138	+	(a) On or before July 1 each year, under the penalties of perjury, each medical
	139	+	facility and research institution covered under this part shall certify to the attorney
	140	+	general and reporter and the commissioner of health that the facility or institution is
	141	+	compliant with this part.
129	142		(b)
130		-	(1)
131		-	(A) Any medical facility or research institution that violates § 68-
132		-	30-204( a) is subject to a fine of ten thousand dollars ($10,000) for each
133		-	violation, to be imposed by the commissioner of health.
134		-	(B) Any licensed health facility that violates § 68-30-204(a) is
135		-	subject to a fine of ten thousand dollars ($10,000) for each violation, to be
136		-	imposed by the health facilities commission.
	143	+	(1) Any medical facility or research institution that violates § 68-30-204(a)
	144	+	is subject to a fine of ten thousand dollars ($10,000) for each violation, to be
	145	+	imposed by the commissioner of health.
137	146		(2) For the purposes of subdivision (b)(1), a violation occurs each
138	147		instance an individual's genome having undergone genetic sequencing or
139		-	analysis using prohibited genetic sequencers or operational and research
	148	+	analysis using a prohibited genetic sequencers or operational and research
140	149		software is used for genetic sequencers or genetic sequencing.
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142		-	(c) A health benefit plan that knowingly provides coverage for an organ transplant
143		-	prohibited by this part is subject to a fine of one hundred thousand dollars ($100,000) for
144		-	each violation, to be imposed by the commissioner of commerce and insurance.
	150	+	(c) A health benefit plan that knowingly provides coverage for an organ
	151	+	transplant or post-transplant care prohibited by this part is subject to a fine of one
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	156	+	hundred thousand dollars ($100,000) for each violation, to be imposed by the
	157	+	commissioner of commerce and insurance.
145	158		(d) An entity that knowingly stores genetic sequencing data outside of the United
146	159		States as prohibited in § 68-30-205 is subject to a fine of ten thousand dollars ($10,000)
147	160		for each violation, to be imposed by the commissioner of health.
148	161		68-30-207.
149		-	(a) If a person is a patient or research subject of an entity that is found guilty of a
	162	+	(a)
	163	+	(1) The attorney general and reporter is authorized to investigate
	164	+	allegations of violations of this part.
	165	+	(2) Any person may notify the attorney general and reporter of a violation
	166	+	or potential violation of this part.
	167	+	(b) If an employee of an entity accused of a violation notifies the attorney
	168	+	general and reporter of a violation or a potential violation, then the employee is afforded
	169	+	all protections as described in § 50-1-304.
	170	+	(c) If a person is a patient or research subject of an entity that is found guilty of a
150	171		violation of § 68-30-204, and that person's genetic information was used in the violation,
151	172		then the person is entitled to recover statutory damages of not less than five thousand
152	173		dollars ($5,000) for each unique use of the person's genomic information.
153		-	(b) If a person is a patient or research subject of an entity that is found guilty of a
	174	+	(d) If a person is a patient or research subject of an entity that is found guilty of a
154	175		violation of § 68-30-205, and that person's genetic information was used in the violation,
155	176		then the person is entitled to recover statutory damages of not less than five thousand
156	177		dollars ($5,000) for each unique use of the person's genomic information.
157		-	68-11-208.
158		-	(a) The health facilities commission is authorized to investigate allegations of
159		-	violations of this part.
160		-	(b) Any person may notify the health facilities commission of a violation or
161		-	potential violation of this part.
162		-	(c) The health facilities commission shall take no further action on a complaint if
163		-	the health facilities commission must obtain authorization to enter a facility from the
164		-	Center for Medicare and Medicaid Services (CMS) and CMS denies the authorization to
165		-	enter.
166		-	(d) If an employee of an entity accused of a violation notifies the health facilities
167		-	commission of a violation or a potential violation, then the employee is afforded all
168		-	protections as described in§ 50-1-304.
169	178		SECTION 2. If any provision of this act or its application to any person or circumstance
170	179		is held invalid, then the invalidity does not affect other provisions or applications of the act that
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171	184		can be given effect without the invalid provision or application, and to that end, the provisions of
172	185		this act are severable.
173	186		SECTION 3. This act takes effect January 1, 2026, the public welfare requiring it.
174		-	4 HOUSE BILL NO. 395
175		-	PASSED: March 17, 2025
176		-	t:2
177		-	CAMERON SEXTON, SPEAKER
178		-	HOUSE OF REPRESENTATIVES
179		-	~ Y1 .. ~~\_ ... _
180		-	. WI
181		-	.. ----. , .. ,,.,
182		-	~ RANDY1- ■-• ·~--I
183		-	SPEAKER OF THE SENATE
184		-	APPROVED this ;;);8tfl.. day of M<Ar cir- 2025
185		-	.~lµ;
186		-	BILL LEE, GOVERNOR