Title: Steven’s Law
Policy area: Health

Summary:
Steven's Law
This bill establishes requirements for collecting and disclosing the medical history of reproductive tissue donors.
Through regulations, the Department of Health and Human Services (HHS) must require reproductive tissue banks to collect, verify, and disclose certain information about a donor's medical history. As part of the regulations, HHS must (1) set out the medical information that a donor must disclose to a tissue bank, including familial medical conditions and the contact information of a medical professional who has examined the donor; and (2) require donors to waive privacy and other protections that limit disclosure of personal health information.
A tissue bank must provide, at no cost, the donor's medical information to the recipient of the donor tissue, the recipient's physician, or a person conceived using the donor tissue (if that person is either 18 years of age or older or has the consent of a parent or guardian).

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8307 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8307

   To 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              July 7, 2022

   Mr. Jacobs of New York (for himself and Mr. Bacon) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as ``Steven's Law''.

SEC. 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:

``SEC. 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''.
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