Placental Tissue Amendments

3
58-1-512
0
Placental Tissue Amendments
2026 GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Evan J. Vickers
House Sponsor: Rex P. Shipp
LONG TITLE
General Description:
This bill addresses stem cell therapy.
Highlighted Provisions:
This bill:
imposes a notice requirement on persons who supply or provide human cells, tissues, or
cellular or tissue-based products for utilization in stem cell therapy.
Money Appropriated in this Bill:
None
Other Special Clauses:
None
Utah Code Sections Affected:
AMENDS:
58-1-512
, as enacted by Laws of Utah 2024, Chapter 265
Be it enacted by the Legislature of the state of Utah:
Section 1. Section
58-1-512
is amended to read:
58-1-512
. Stem cell disclosure.
(1)
As used in this section:
(a)
"Health care provider" means the same as that term is defined in Section
78B-3-403
.
(b)
"Human cells, tissues, or cellular or tissue-based products" has the same meaning as
in 21 C.F.R. Sec. 1271.3 as it exists on May 1, 2024.
(c)
(i)
"Stem cell therapy" means a treatment involving the use of afterbirth placental
perinatal stem cells or human cells, tissues, or cellular or tissue-based products.
(ii)
"Stem cell therapy" does not include treatment or research using human cells or
tissues that were derived from a fetus or embryo after an abortion.
(2)
(a)
A health care provider whose scope of practice includes the use of stem cell therapy may
perform a stem cell therapy that is not approved by the United States Food and Drug
Administration, if the health care provider provides the patient with the following written
notice before performing the therapy:
"THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health
care practitioner performs one or more stem cell therapies that have not yet been approved by
the United States Food and Drug Administration. You are encouraged to consult with your
primary care provider before undergoing a stem cell therapy."
(b)
A person may supply or provide human cells, tissues, or cellular or tissue-based
products to a health care provider if:
(i)
the health care provider's scope of practice includes the use of stem cell therapy;
and
(ii)
prior to supplying or providing the human cells, tissues, or cellular or tissue-based
products to the health care provider, the health care provider provides to the
person a written confirmation that the health care provider will provide the notice
under Subsection
(2)(a)
to each of the health care provider's patients whose stem
cell therapy will utilize the human cells, tissues, or cellular or tissue-based
products.
(3)
(a)
The written notice described in Subsection
(2)
shall be:
(i)
on paper that is at least eight and one-half inches by eleven inches; and
(ii)
written in no less than forty point type.
(b)
The health care provider shall prominently display the written notice in the entrance
and in an area visible to patients in the health care provider's office.
(4)
(a)
A health care provider who is required to provide written notice under Subsection
(2)
shall obtain a signed consent form before performing the therapy.
(b)
The consent form shall:
(i)
be signed by the patient, or, if the patient is legally not competent, the patient's
representative; and
(ii)
state, in language the patient could reasonably be expected to understand:
(A)
the nature and character of the proposed treatment, including the treatment's
United States Food and Drug Administration approval status;
(B)
the anticipated results of the proposed treatment;
(C)
the recognized possible alternative forms of treatment; and
(D)
the recognized serious possible risks, complications, and anticipated benefits
involved in the treatment and in the recognized possible alternative forms of
treatment, including nontreatment.
(5)
(a)
A health care provider described in Subsection
(2)
shall include the notice
described in Subsection
(2)
in any advertisement for the stem cell therapy.
(b)
In a print advertisement, the notice shall be clearly legible, in a font size no smaller
than the largest font size used in the advertisement.
(c)
In any other advertisement, the notice shall be:
(i)
clearly legible in a font size no smaller than the largest font size used in the
advertisement; or
(ii)
clearly spoken.
(6)
This section does not apply to:
(a)
a health care provider who has obtained approval for an investigational new drug or
device from the United States Food and Drug Administration for the use of human
cells, tissues, or cellular or tissue-based products; or
(b)
a health care provider who performs a stem cell therapy under an employment or
other contract on behalf of an institution certified by any of the following:
(i)
the Foundation for the Accreditation of Cellular Therapy;
(ii)
the Blood and Marrow Transplant Clinical Trials Network;
(iii)
the Association for the Advancement of Blood and Biotherapies; or
(iv)
an entity with expertise regarding stem cell therapy as determined by the division.
(7)
A violation of this section is unprofessional conduct.
Section 2.
Effective Date.
This bill takes effect on
May 6, 2026
.
2-27-26 8:58 AM