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7 LONG TITLE
8 General Description:
9 This bill requires certain health care providers to provide certain disclosures when
10 administering a treatment using placental stem cells.
11 Highlighted Provisions:
12 This bill:
13 ▸ defines terms;
14 ▸ requires certain health care providers to provide certain disclosures to a patient
15 when administering a treatment using placental stem cells; and
16 ▸ creates a penalty for failing to provide the disclosures.
17 Money Appropriated in this Bill:
18 None
19 Other Special Clauses:
20 None
21 Utah Code Sections Affected:
22 ENACTS:
23 58-1-512, Utah Code Annotated 1953
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25 Be it enacted by the Legislature of the state of Utah:
26 Section 1. Section 58-1-512 is enacted to read:
27 58-1-512. Stem cell disclosure.
28 (1) As used in this section:
29 (a) "Health care provider" means the same as that term is defined in Section
30 78B-3-403.
31 (b) "Human cells, tissues, or cellular or tissue-based products" has the same meaning
32 as in 21 C.F.R. Sec. 1271.3 as it exists on May 1, 2024.
33 (c) (i) "Stem cell therapy" means a treatment involving the use of afterbirth placental
34 perinatal stem cells or human cells, tissues, or cellular or tissue-based products.
35 (ii) "Stem cell therapy" does not include treatment or research using human cells or
36 tissues that were derived from a fetus or embryo after an abortion.
37 (2) A health care provider whose scope of practice includes the use of stem cell therapy
38 and may perform a stem cell therapy that is not approved by the United States Food and Drug
39 Administration, if the health care provider provides the patient with the following written
40 notice before performing the therapy:
41 "THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health
42 care practitioner performs one or more stem cell therapies that have not yet been approved by
43 the United States Food and Drug Administration. You are encouraged to consult with your
44 primary care provider before undergoing a stem cell therapy."
45 (3) (a) The written notice described in Subsection (2) shall be:
46 (i) on paper that is at least eight and one-half inches by eleven inches; and
47 (ii) written in no less than forty point type.
48 (b) The health care provider shall prominently display the written notice in the entrance
49 and in an area visible to patients in the health care provider's office.
50 (4) (a) A health care provider who is required to provide written notice under
51 Subsection (2) shall obtain a signed consent form before performing the therapy.
52 (b) The consent form shall:
53 (i) be signed by the patient, or, if the patient is legally not competent, the patient's
54 representative; and
55 (ii) state, in language the patient could reasonably be expected to understand:
56 (A) the nature and character of the proposed treatment, including the treatment's United
57 States Food and Drug Administration approval status;
58 (B) the anticipated results of the proposed treatment;
59 (C) the recognized possible alternative forms of treatment; and
60 (D) the recognized serious possible risks, complications, and anticipated benefits
61 involved in the treatment and in the recognized possible alternative forms of treatment,
62 including nontreatment.
63 (5) (a) A health care provider described in Subsection (2) shall include the notice
64 described in Subsection (2) in any advertisement for the stem cell therapy.
65 (b) In a print advertisement, the notice shall be clearly legible, in a font size no smaller
66 than the largest font size used in the advertisement.
67 (c) In any other advertisement, the notice shall be:
68 (i) clearly legible in a font size no smaller than the largest font size used in the
69 advertisement; or
70 (ii) clearly spoken.
71 (6) This section does not apply to:
72 (a) a health care provider who has obtained approval for an investigational new drug or
73 device from the United States Food and Drug Administration for the use of human cells,
74 tissues, or cellular or tissue-based products; or
75 (b) a health care provider who performs a stem cell therapy under an employment or
76 other contract on behalf of an institution certified by any of the following:
77 (i) the Foundation for the Accreditation of Cellular Therapy;
78 (ii) the Blood and Marrow Transplant Clinical Trials Network;
79 (iii) the Association for the Advancement of Blood and Biotherapies; or
80 (iv) an entity with expertise regarding stem cell therapy as determined by the division.
81 (7) A violation of this section is unprofessional conduct.
82 Section 2. Effective date.
83 This bill takes effect on May 1, 2024.