Utah 2025 Regular Session

Utah Senate Bill SB0275 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	02-13 09:56 S.B. 275
2	2	1
3	3	Placental Tissue Amendments
4	4	2025 GENERAL SESSION
5	5	STATE OF UTAH
6	6	Chief Sponsor: Evan J. Vickers
7	7	House Sponsor:
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10	10	3
11	11	LONG TITLE
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13	13	General Description:
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15	15	This bill addresses stem cell therapy.
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17	17	Highlighted Provisions:
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19	19	This bill:
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21	21	▸ imposes a notice requirement on persons who supply or provide human cells, tissues, or
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23	23	cellular or tissue-based products for utilization in stem cell therapy; and
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25	25	▸ makes technical changes.
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27	27	Money Appropriated in this Bill:
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29	29	None
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31	31	Other Special Clauses:
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33	33	None
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35	35	Utah Code Sections Affected:
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37	37	AMENDS:
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39	39	58-1-512, as enacted by Laws of Utah 2024, Chapter 265
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43	43	Be it enacted by the Legislature of the state of Utah:
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45	45	Section 1. Section 58-1-512 is amended to read:
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47	47	58-1-512 . Stem cell disclosure.
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49	49	(1) As used in this section:
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51	51	(a) "Health care provider" means the same as that term is defined in Section 78B-3-403.
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53	53	(b) "Human cells, tissues, or cellular or tissue-based products" has the same meaning as
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55	55	in 21 C.F.R. Sec. 1271.3 as it exists on May 1, 2024.
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57	57	(c)(i) "Stem cell therapy" means a treatment involving the use of afterbirth placental
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59	59	perinatal stem cells or human cells, tissues, or cellular or tissue-based products.
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61	61	(ii) "Stem cell therapy" does not include treatment or research using human cells or
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63	63	tissues that were derived from a fetus or embryo after an abortion.
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65	65	(2)(a) A health care provider whose scope of practice includes the use of stem cell therapy may
66	66	S.B. 275 S.B. 275 02-13 09:56
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68	68	perform a stem cell therapy that is not approved by the United States Food and Drug
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70	70	Administration, if the health care provider provides the patient with the following written
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72	72	notice before performing the therapy:
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74	74	"THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health
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76	76	care practitioner performs one or more stem cell therapies that have not yet been approved by
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78	78	the United States Food and Drug Administration. You are encouraged to consult with your
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80	80	primary care provider before undergoing a stem cell therapy."
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82	82	(b) A person may supply or provide human cells, tissues, or cellular or tissue-based
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84	84	products to a health care provider if:
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86	86	(i) the health care provider's scope of practice includes the use of stem cell therapy;
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88	88	and
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90	90	(ii) prior to supplying or providing the human cells, tissues, or cellular or tissue-based
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92	92	products to the health care provider, the health care provider provides to the
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94	94	person a written confirmation that the health care provider will provide the notice
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96	96	under Subsection (2)(a) to each of the health care provider's patients whose stem
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98	98	cell therapy will utilize the human cells, tissues, or cellular or tissue-based
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100	100	products.
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102	102	(3)(a) The written notice described in Subsection (2) shall be:
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104	104	(i) on paper that is at least eight and one-half inches by eleven inches; and
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106	106	(ii) written in no less than forty point type.
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108	108	(b) The health care provider shall prominently display the written notice in the entrance
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110	110	and in an area visible to patients in the health care provider's office.
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112	112	(4)(a) A health care provider who is required to provide written notice under Subsection
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114	114	(2) shall obtain a signed consent form before performing the therapy.
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116	116	(b) The consent form shall:
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118	118	(i) be signed by the patient, or, if the patient is legally not competent, the patient's
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120	120	representative; and
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122	122	(ii) state, in language the patient could reasonably be expected to understand:
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124	124	(A) the nature and character of the proposed treatment, including the treatment's
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126	126	United States Food and Drug Administration approval status;
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128	128	(B) the anticipated results of the proposed treatment;
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130	130	(C) the recognized possible alternative forms of treatment; and
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132	132	(D) the recognized serious possible risks, complications, and anticipated benefits
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134	134	involved in the treatment and in the recognized possible alternative forms of
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137	137	treatment, including nontreatment.
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139	139	(5)(a) A health care provider described in Subsection (2) shall include the notice
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141	141	described in Subsection (2) in any advertisement for the stem cell therapy.
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143	143	(b) In a print advertisement, the notice shall be clearly legible, in a font size no smaller
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145	145	than the largest font size used in the advertisement.
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147	147	(c) In any other advertisement, the notice shall be:
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149	149	(i) clearly legible in a font size no smaller than the largest font size used in the
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151	151	advertisement; or
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153	153	(ii) clearly spoken.
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155	155	(6) This section does not apply to:
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157	157	(a) a health care provider who has obtained approval for an investigational new drug or
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159	159	device from the United States Food and Drug Administration for the use of human
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161	161	cells, tissues, or cellular or tissue-based products; or
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163	163	(b) a health care provider who performs a stem cell therapy under an employment or
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165	165	other contract on behalf of an institution certified by any of the following:
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167	167	(i) the Foundation for the Accreditation of Cellular Therapy;
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169	169	(ii) the Blood and Marrow Transplant Clinical Trials Network;
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171	171	(iii) the Association for the Advancement of Blood and Biotherapies; or
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173	173	(iv) an entity with expertise regarding stem cell therapy as determined by the division.
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175	175	(7) A violation of this section is unprofessional conduct.
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177	177	Section 2. Effective Date.
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179	179	This bill takes effect on May 7, 2025.
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