Department Procedures for Health Data Release

Section 1005 Section 1005.30  Department Procedures for Health Data Release a)         The Department will review all requests for health data to determine whether the request is technically feasible in terms of the ability of the Department to provide the required health data: 1)         From a known data base; and 2)         Under statutes, rules and agreements by which the health data came into the Department's possession. b)         In addition to technical feasibility, the Department will perform an administrative review of all requests for health data as required by laws and regulations specific to the data being requested, based on factors including an assessment of the potential benefit and public health utility to be derived from the proposed analysis as described in 45 CFR 46; the necessity for identifiable health data,  if requested; feasibility of the study design; the applicability of the requested health data to the stated purposes; and the ability of Department staff to provide the requested health data, including an estimation of the staff time and costs involved. c)         All requests for data that are denied will be returned to the applicant within 90 days with a statement containing the reason why the request is being denied. d)         All requests for data that are approved will be processed within 120 days after approval by the Department's IRB and execution of a health data use agreement. e)         Any health data pertaining to fewer than six individual providers at any single identifiable health facility or serving a specified or identifiable geographic area constitutes individual identifiable health data.  This health data shall not be disseminated except pursuant to Section 1005.35(a). f)         The Department and the IRB will each review requests for health data containing direct identifiers and requests for limited health data sets that have not been previously released.  After the review by the Department and the IRB, and upon making the determination that the request is not approved, the person making the request shall be instructed to modify the request. g)         The Department will not approve any release of health data unless all provisions of Section 5 of the Act, this Section, and applicable requirements of 45 CFR 46 have been complied with.