117 HR 8307 IH: Steven’s Law U.S. House of Representatives 2022-07-07 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I117th CONGRESS2d SessionH. R. 8307IN THE HOUSE OF REPRESENTATIVESJuly 7, 2022Mr. Jacobs of New York (for himself and Mr. Bacon) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo amend the Public Health Service Act to direct the Secretary of Health and Human Services to require certain medical information related to donors of reproductive tissue be made available to recipients of such tissue and persons conceived using such tissue, and for other purposes.

1.

Short title

This Act may be cited as Steven’s Law.

2.

Reproductive tissue donor information

(a)

In general

The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by inserting after section 369 the following new section:

369A.

Reproductive tissue donor information

(a)

In general

The Secretary shall, by regulation, require that a reproductive tissue bank—(1)collect and verify medical history information from each donor from whom such bank acquires donor reproductive tissue; and(2)make available on request such information to—(A)any recipient of such donor reproductive tissue, including before such recipient purchases or otherwise receives such donor reproductive tissue;(B)the physician of any such recipient; and(C)any donor-conceived person conceived with such donor reproductive tissue if such person has attained eighteen years of age or has the consent of such person’s parent or guardian.(b)

Donor disclosure

Under the regulations issued pursuant to subsection (a), the Secretary shall require a donor to—(1)disclose to a reproductive tissue bank that acquires donor reproductive tissue from such donor—(A)all diagnosed sexually transmitted infectious diseases that the donor has at the time of donation;(B)all diagnosed medical conditions of the donor, including genetic disorders, schizophrenia and other serious mental illnesses (as determined by the Secretary), and intellectual disabilities;(C)any familial medical conditions (as defined by the Secretary) to the extent such donor has knowledge of or should have knowledge of such conditions, including the conditions referred to in subparagraph (B); and(D)the name and contact information of each medical professional who has examined or treated the donor during the 5 years preceding the date of the donation; and(2)provide a waiver of protections of the donor’s medical history and records, including the regulations under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), necessary to authorize such bank to—(A)obtain donor medical records from each medical professional identified under paragraph (1)(D); and(B)disclose the donor’s medical history and records to a recipient, physician, or donor-conceived person in accordance with subsection (a).(c)

Reproductive tissue bank disclosure

Under the regulations issued pursuant to subsection (a), the Secretary shall require a reproductive tissue bank to—(1)provide to a donor from whom reproductive tissue is acquired a statement of the obligations of such donor described in subsection (b) and obtain a signed acknowledgment of such obligations;(2)verify the medical information provided by a donor in accordance with subsection (b) by comparing such information with donor medical records;(3)review donor medical records for risk factors of genetic disorders;(4)except in the case of a donor known to the recipient, remove any individually identifying information, including the donor’s name, address, and other information that may be used to identify such donor, from donor medical records; and(5)in accordance with paragraph (4) and using a standard form prescribed by the Secretary, make available, at no cost, to a recipient, physician, or donor-conceived person in accordance with subsection (a)—(A)the donor’s medical records;(B)a summary of the information included in such records; and(C)any donor medical information that such bank was unable to obtain from donor medical records, including—(i)the type of information unable to be obtained; and(ii)the reason such bank was unable to obtain such information.(d)

Definitions

In this section:(1)

Donor

The term donor means a person who provides donor reproductive tissue for use in an artificial insemination or assisted reproductive procedure performed on recipients other than that person or that person's regular sexual partner, and includes direct and known donors.(2)

Donor-conceived person

The term donor-conceived person means a person purposely conceived through the use of donor reproductive tissue.(3)

Donor reproductive tissue

The term donor reproductive tissue means any tissue, including semen, oocytes, embryos, spermatozoa, or spermatids, from the reproductive tract intended for use in an artificial insemination or assisted reproductive procedure.(4)

Recipient

The term recipient means a person who receives donor reproductive tissue for the purposes of that person conceiving a child.(5)

Reproductive tissue bank

The term reproductive tissue bank—(A)means an entity which acquires, processes, stores, or releases donor reproductive tissue for an insemination implantation site or recipient to use in an artificial insemination or assisted reproductive technology procedure; and(B)includes a semen bank, oocyte donation program, and embryo bank.

.(b)

Rule required

Not later than 180 days after the date of enactment of this Act, the Secretary shall promulgate a final rule to carry out section 369A of the Public Health Service Act, as added by subsection (a).(c)

Conforming amendment

Section 368(a) of the Public Health Service Act is amended by striking 366 or and inserting 366 or 369A or.