Sec. 379A. STEM CELL THERAPEUTIC OUTCOMES DATABASE

218 words·~1 min read·/statute-compilations/comps-8773/sec-379a

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## SEC. 379A STEM CELL THERAPEUTIC OUTCOMES DATABASE **[**274l**]** ###

(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. ###

(c)Annual Report on Patient Outcomes 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 379 donor registries, and cord blood banks.