Steven’s Law

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. 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. 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 (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 (2) Donor-conceived person The term donor-conceived person (3) Donor reproductive tissue The term donor reproductive tissue (4) Recipient The term recipient (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 366 or 369A or

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).