2356-S AMH CODY HICN 010

SHB 2356 - H AMD 951

By Representative Cody

ADOPTED 02/12/2018

    On page 2, line 1, after "(3)" insert "A license holder who is required to provide written notice under subsection (1) of this section must also obtain a signed consent form before performing the therapy.  The consent form must be signed by the patient, or, if the patient is legally not competent, the patient's representative, and must state, in language the patient could reasonably be expected to understand:

    (a) The nature and character of the proposed treatment, including the treatment's 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.

    (4)"

    Renumber the remaining subsections consecutively and correct any internal references accordingly.

    On page 2, line 13, after "(b)" strike "An" and insert "A license holder who performs a stem cell therapy pursuant to an employment or other contract to perform the therapy on behalf of or under the auspices of an"

EFFECT: Requires a license holder that performs a therapy using human cells, tissues, or cellular or tissue-based products that has not been approved by the United States food and drug administration  to obtain the patient's written informed consent before performing the therapy. Clarifies an exception pertaining to institutions to apply to license holders performing therapies pursuant to a contract with such an institution.

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