§1105.8.1. Louisiana Tumor Registry; research committee; disclosure of registry data

            A. The Louisiana Tumor Registry, referred to hereafter in this Section as the "tumor registry", shall provide diagnostic, treatment, and follow-up information concerning a patient, if requested, to a physician or medical facility diagnosing or treating the case as authorized pursuant to 45 CFR 164.506.

            B.(1) The tumor registry shall collaborate with the National Cancer Institute, the United States Centers for Disease Control and Prevention, the North American Association of Central Cancer Registries, the International Agency for Research on Cancer, and any other national or international cancer surveillance program it may designate in providing cancer data and participating in cancer studies.

            (2) The tumor registry shall cooperate with the office of public health of the Louisiana Department of Health, referred to hereafter in this Section as the "office of public health", in evaluating programs and investigating cancer concerns and other cancer-related issues through activities including, without limitation, cooperating with the office of public health in implementing the program of cancer investigation and intervention provided for in R.S. 40:5.12. Because the tumor registry data are an integral part of national and state cancer prevention and control programs, the use of registry data by office of public health officials and registry-designated national cancer surveillance programs shall be considered an in-house activity and shall be processed expeditiously.

            (3) Requests by the office of public health for case-specific data shall require annual approval by the institutional review board of the Louisiana State University Health Sciences Center-New Orleans, referred to hereafter in this Section as the "LSUHSC-New Orleans". Additionally, the office of public health shall comply with all applicable confidentiality standards of the tumor registry.

            C.(1) Subject to the limitations of Subsection F of this Section, the tumor registry shall release case-specific data to persons or organizations for the purposes of cancer prevention, control, and research in accordance with Paragraph (2) of this Subsection. However, no such data shall include information collected for special studies or other research projects. The tumor registry shall have and shall reserve the right to prioritize its responses to data requests.

            (2) Requests from persons or organizations for case-specific tumor registry incidence data, including data linkages, shall be submitted in writing and shall be reviewed and approved by the tumor registry research committee following the established policies of the registry. These policies shall require, without limitation, all of the following:

            (a) Approval from the LSUHSC-New Orleans institutional review board and compliance with the LSUHSC-New Orleans HIPAA research policy.

            (b) Approval from the researcher's institutional review board and compliance with that institution's HIPAA research policy.

            (c) Execution of the tumor registry's form entitled "Agreement to Maintain Confidentiality of Data", or any successor form, by each investigator who will have access to the data indicating agreement by the investigator to adhere to the tumor registry confidentiality provisions and prohibiting the disclosure of tumor registry data in any civil, criminal, administrative, or other proceeding.

            (d) Provision of a copy of the complete protocol for the project.

            (e) Completion of all requirements provided in the document entitled "Louisiana Tumor Registry: Researchers' Requests for Data", or any successor document.

            (f) Prior to contacting a patient or his next of kin, notification to the patient's physician, if required.

            (g) Destruction or return of data once the research is completed.

            (3) If a request for data submitted in accordance with the provisions of this Subsection is denied by the LSUHSC-New Orleans institutional review board, the institutional review board shall provide to the requestor notice in writing of the reason for the denial electronically or by postal mail.

            D.(1) The director of the tumor registry or his designee shall coordinate the research committee of the tumor registry. The research committee shall include, without limitation, the following members:

            (a) The director of the tumor registry.

            (b) A qualified representative selected from each of the following entities:

            (i) The LSUHSC-New Orleans.

            (ii) The office of public health.

            (iii) The Louisiana Cancer Advisory Board.

            (2) The research committee shall verify that the researchers are able to execute the proposal, in terms of both financial support and professional qualifications; that the study has scientific and ethical merit; and that the researchers will obtain appropriate consent.

            E.(1) In determining the order of processing requests for data, the tumor registry shall give priority to requests for data from the office of public health for use in responding to concerns about threats to the public health.

            (2) Subject to the provisions of the Public Records Law, R.S. 44:1 et seq., the tumor registry shall process requests for aggregate data other than those provided for in Paragraph (1) of this Subsection in the order of receipt. The tumor registry shall respond to any public request in a timely manner, as resources permit, if the request meets the applicable requirements of R.S. 40:3.1 and 1105.8.

            (3) The tumor registry may assess a charge to a requestor of data for actual costs of compiling and providing the data, and may require payment before proceeding to fulfill the data request.

            (4) The tumor registry shall not be required in any instance to perform original work to create data not currently in existence.

            F.(1) The tumor registry shall not release data in cases in which such data would disclose the identity of any person to whom the data relate and thus violate the requirements of the Health Insurance Portability and Accountability Act relating to uses and disclosure of protected health information (45 CFR 164.514). In such situations, the tumor registry may combine more years of cancer data together at the census tract level or suppress the data according to the suppression rule of the United States Cancer Statistics program.

            (2) In considering for approval or denial a request for aggregate data, the research committee of the tumor registry shall determine whether the request complies with applicable state and federal laws relating to privacy of health information. If the research committee finds that disclosure of data in response to the request would violate any such law, then the committee shall collaborate with the requestor to revise the request in order to preclude such violation.

            (3) In collaborating with a requestor as provided in Paragraph (2) of this Subsection, the research committee shall employ methods for de-identifying case-specific data as defined by the United States Centers for Disease Control and Prevention and any other de-identification or statistical methods for disclosure protection.

            (4) The research committee of the tumor registry shall not deny any request for aggregate data for any reason that is unrelated to compliance with state or federal privacy laws.

            G. The tumor registry shall annually prepare a statistical report concerning cancer rates and counts which includes data at the census tract level and shall submit the report to the office of the president for inclusion with the annual cancer report required by R.S. 40:1105.10. The tumor registry shall also provide the statistical report required by this Subsection to the Louisiana State University Health Sciences Center at New Orleans, the Louisiana State University Health Sciences Center at Shreveport, the Louisiana Cancer Advisory Board, and each participating hospital.

            Acts 2017, No. 373, §1; Acts 2018, No. 206, §4; Acts 2024, No. 404, §1, eff. May 28, 2024.