42 U.S.C. § 274L
Section 274l · Stem cell therapeutic outcomes database
Current version, with additions and removals from the July 16, 1998 version.
Current — December 20, 2005
As of July 16, 1998
(a) Establishment of recipient registry
(a) Establishment
The Secretary, acting through the Registry under section 274k of this title (in this section referred to as the “Registry”), shall establish and maintain a scientific registry of information relating to patients who have been recipients of a transplant of bone marrow from a biologically unrelated donor.
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
(b) Information
The scientific registry under subsection (a) of this section shall include information with respect to patients described in subsection (a) of this section, transplant procedures, 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 bone marrow from biologically unrelated donors.
The outcomes database shall include information in a standardized electronic format with respect to patients described in subsection (a) of this section, 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.
(c) Annual report on patient outcomes
(c) Annual report on patient outcomes
The Registry shall annually submit to the Secretary a report concerning patient outcomes with respect to each transplant center. Each such report shall use data collected and maintained by the scientific registry under subsection (a) of this section. Each such report shall in addition include the data required in section 274k(l) of this title (relating to pretransplant costs).
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 title 1 donor registries, and cord blood banks.