SB 55

Enrolled Copy  S.B. 55
1Placental Tissue Amendments
  2026 GENERAL SESSION
  STATE OF UTAH
  Chief Sponsor: Evan J. Vickers
  House Sponsor: Rex P. Shipp
2
3  LONG TITLE
4  General Description:
5      This bill addresses stem cell therapy.
6  Highlighted Provisions:
7      This bill:
8      ▸ imposes a notice requirement on persons who supply or provide human cells, tissues, or
9  cellular or tissue-based products for utilization in stem cell therapy.
10  Money Appropriated in this Bill:
11      None
12  Other Special Clauses:
13      None
14  Utah Code Sections Affected:
15  AMENDS:
16      58-1-512, as enacted by Laws of Utah 2024, Chapter 265
17
18  Be it enacted by the Legislature of the state of Utah:
19Section 1. Section 58-1-512 is amended to read:
2058-1-512 . Stem cell disclosure.
21  (1) As used in this section:
22      (a) "Health care provider" means the same as that term is defined in Section 78B-3-403.
23      (b) "Human cells, tissues, or cellular or tissue-based products" has the same meaning as
24in 21 C.F.R. Sec. 1271.3 as it exists on May 1, 2024.
25      (c)(i) "Stem cell therapy" means a treatment involving the use of afterbirth placental
26perinatal stem cells or human cells, tissues, or cellular or tissue-based products.
27(ii) "Stem cell therapy" does not include treatment or research using human cells or
28tissues that were derived from a fetus or embryo after an abortion.
 S.B. 55  Enrolled Copy
29   (2)(a) A health care provider whose scope of practice includes the use of stem cell therapy may
30perform a stem cell therapy that is not approved by the United States Food and Drug
31Administration, if the health care provider provides the patient with the following written
32notice before performing the therapy:
33"THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health
34care practitioner performs one or more stem cell therapies that have not yet been approved by
35the United States Food and Drug Administration. You are encouraged to consult with your
36primary care provider before undergoing a stem cell therapy."
37(b) A person may supply or provide human cells, tissues, or cellular or tissue-based
38products to a health care provider if:
39(i) the health care provider's scope of practice includes the use of stem cell therapy;
40and
41(ii) prior to supplying or providing the human cells, tissues, or cellular or tissue-based
42products to the health care provider, the health care provider provides to the
43person a written confirmation that the health care provider will provide the notice
44under Subsection (2)(a) to each of the health care provider's patients whose stem
45cell therapy will utilize the human cells, tissues, or cellular or tissue-based
46products.
47   (3)(a) The written notice described in Subsection (2) shall be:
48(i) on paper that is at least eight and one-half inches by eleven inches; and
49(ii) written in no less than forty point type.
50(b) The health care provider shall prominently display the written notice in the entrance
51and in an area visible to patients in the health care provider's office.
52   (4)(a) A health care provider who is required to provide written notice under Subsection
53(2) shall obtain a signed consent form before performing the therapy.
54(b) The consent form shall:
55(i) be signed by the patient, or, if the patient is legally not competent, the patient's
56representative; and
57(ii) state, in language the patient could reasonably be expected to understand:
58(A) the nature and character of the proposed treatment, including the treatment's
59United States Food and Drug Administration approval status;
60(B) the anticipated results of the proposed treatment;
61(C) the recognized possible alternative forms of treatment; and
62(D) the recognized serious possible risks, complications, and anticipated benefits
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 Enrolled Copy  S.B. 55
63involved in the treatment and in the recognized possible alternative forms of
64treatment, including nontreatment.
65  (5)(a) A health care provider described in Subsection (2) shall include the notice
66      described in Subsection (2) in any advertisement for the stem cell therapy.
67      (b) In a print advertisement, the notice shall be clearly legible, in a font size no smaller
68than the largest font size used in the advertisement.
69      (c) In any other advertisement, the notice shall be:
70(i) clearly legible in a font size no smaller than the largest font size used in the
71advertisement; or
72(ii) clearly spoken.
73  (6) This section does not apply to:
74      (a) a health care provider who has obtained approval for an investigational new drug or
75device from the United States Food and Drug Administration for the use of human
76cells, tissues, or cellular or tissue-based products; or
77      (b) a health care provider who performs a stem cell therapy under an employment or
78other contract on behalf of an institution certified by any of the following:
79(i) the Foundation for the Accreditation of Cellular Therapy;
80(ii) the Blood and Marrow Transplant Clinical Trials Network;
81(iii) the Association for the Advancement of Blood and Biotherapies; or
82(iv) an entity with expertise regarding stem cell therapy as determined by the division.
83  (7) A violation of this section is unprofessional conduct.
84Section 2. Effective Date.
85  This bill takes effect on May 6, 2026.
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