42 U.S.C. § 274l — Stem cell therapeutic outcomes database

submitted 82 years ago by Pub. L. 105-196 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 209 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Secretary must create a database tracking outcomes for stem cell transplant patients. It records diagnosis, procedures, results, and follow-up. Transplant centers must report yearly, and some data becomes public to help research and inform patients.

(a) Establishment: The Secretary must set up and keep, by contract, a scientific database about patients who received a stem cell therapeutics product — such as bone marrow or cord blood — from a donor. (b) Information: The database must include, in a standardized electronic format, information about these patients, their diagnosis, the transplant procedures used, the results, and long-term follow-up. It can include anything else the Secretary thinks appropriate. The purpose is to keep evaluating the scientific and clinical status of transplants from donors of stem cell products. (c) Annual report on patient outcomes: The Secretary must require the entity holding the contract for the database to submit a yearly report to the Secretary on patient outcomes for each transplant center, based on the data the entity has collected and maintained. (d) Publicly available data: The database must make relevant scientific information — without anything that would identify an individual patient — available to the public, as summaries and data sets. This is meant to encourage medical research and to inform transplant programs, physicians, patients, entities holding contracts under section 274k, donor registries, and cord blood banks.

the actual law source: uscode.house.gov ↗public domain

(a) Establishment

The Secretary shall by contract establish and maintain a scientific database of information relating to patients who have been recipients of a stem cell therapeutics product (including bone marrow, cord blood, or other such product) from a donor.

(b) Information

The outcomes database shall include information in a standardized electronic format with respect to patients described in subsection (a), diagnosis, transplant procedures, results, long-term follow-up, and such other information as the Secretary determines to be appropriate, to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving recipients of a stem cell therapeutics product from a donor.

The Secretary shall require the entity awarded a contract under this section to submit to the Secretary an annual report concerning patient outcomes with respect to each transplant center, based on data collected and maintained by the entity pursuant to this section.

(d) Publicly available data

The outcomes database shall make relevant scientific information not containing individually identifiable information available to the public in the form of summaries and data sets to encourage medical research and to provide information to transplant programs, physicians, patients, entities awarded a contract under section 274k of this title1 donor registries, and cord blood banks.

Source credit: (July 1, 1944, ch. 373, title III, § 379A, as added Pub. L. 105–196, § 3, July 16, 1998, 112 Stat. 635; amended Pub. L. 109–129, § 3(b), Dec. 20, 2005, 119 Stat. 2561.)

history & why it existsrecord from the source credit

1944Enacted · Pub. L. 105-196 · 112 Stat. 635
2005Amended · Pub. L. 109-129 · 119 Stat. 2561

A history note hasn’t been published yet. The record shows enactment by Pub. L. 105-196 on 1944-07-01.

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