La. Admin. Code tit. 48 § V-8511

Current through Register Vol. 50, No. 9, September 20, 2024

Section V-8511 - Release of Information

A. Confidentiality of Published Data

1. Reports published or presented by the Louisiana Tumor Registry shall include aggregate, not case-specific, data.

2. Information that would potentially identify a patient or a health care provider or facility shall not be disclosed, except to treating, diagnosing, and follow-up facilities and providers or qualified investigators currently approved by both the LTR and the LSUHSC Institutional Review Board, in conformity of R.S. 40:1105.8.1

3. When collecting self-reported information from cancer patients, patient privacy will be protected by HIPAA-compliant procedures.

B. Diagnostic, Treatment, and Follow-Up Information. Diagnostic, treatment, and follow-up information about a patient shall be provided, if requested, to a physician or medical facility diagnosing or treating the case. Section 45 CFR 164.506 of the Health Information Portability and Accountability Act (HIPAA) allows such sharing of health information.

C. Collaboration with Federal and State Public Health Agencies and National and International Cancer Surveillance Programs

1. The LTR is authorized to collaborate with the National Cancer Institute, the Centers for Disease Control and Prevention, and other national and international cancer surveillance programs and organizations designated by the LTR, including but not limited to the North American Association of Central Cancer Registries and the International Agency for Research on Cancer, in providing cancer data and participating in cancer studies.

2. In addition, the LTR shall work closely with the LOPH in investigating cancer concerns, evaluating programs, and other cancer-related issues. This includes cooperating in the implementation of the program of cancer investigation and intervention provided for in R.S. 40:1105.8, 1, if sufficient funding is available for this purpose. LOPH requests for case-specific data will require annual approval by the Institutional Review Board of the Louisiana State University Health Sciences Center-New Orleans (LSUHSC-New Orleans). In addition, the LOPH must comply with LTR confidentiality standards, and reports written for public release using registry data must be reviewed by the registry in advance.

3. The use of registry data by LOPH officials and Louisiana Cancer Prevention and Control Programs, who sign an annual agreement to maintain the confidentiality of registry data, shall be considered an in-house activity and shall be processed expeditiously.

D. Requests for Case-Specific LTR Incidence Data. Case-specific data may be released to qualified persons or organizations for the purposes of cancer prevention, control, and research. Such data do not include information collected for special studies or other research projects.

1. The LTR reserves the right to prioritize its responses to data requests.

2. Requests from researchers for case-specific LTR incidence data, including data linkages, must be submitted in writing and shall be reviewed and approved by the LTR Data Release Committee following the established policies of the Louisiana Tumor Registry. A detailed description of the policies and procedures for requesting Registry data can be obtained from the LTR website. These established policies include, but are not limited to, the following requirements:

a. approval from the LSUHSC-New Orleans Institutional Review Board and compliance with the LSUHSC-New Orleans HIPAA research policy as well as approval from the researcher's Institutional Review Board and compliance with that institution's HIPAA research policy;

b. signature of the LTR "agreement to maintain confidentiality of data" by all investigators who will have access to the data, agreeing to adhere to the LTR confidentiality provisions and prohibiting the disclosure of LTR data in any civil, criminal, administrative, or other proceeding;

c. provision of a copy of the complete protocol for the project;

d. completion of all requirements listed in the document on the LTR website;

e. notification of physician, if required, before contacting patients or their next-of-kin;

f. destruction or return of data once the research is completed.

3. LTR Research Committee. The research committee shall be coordinated by the director of the LTR or designee and may include, but not be limited to, the director of the LTR, and a qualified representative from each of the following entities: LSUHSC-New Orleans, OPH, and the Cancer and Lung Trust Fund Board. The committee will verify:

a. that the researchers are able to execute the proposal, in terms of both financial support and professional qualifications;

b. that the study has scientific and ethical merit;

c. that all appropriate confidentiality protections are in place; and

d. that appropriate consent will be obtained.

E. Requests for Aggregate Data

1. Data requested by the Office of Public Health for responding to concerns about threats to public health shall receive priority in determining the order of processing requests.

2. Subject to the provisions of the Public Records Act, R.S. 44:4.1 et seq., other requests for aggregate data shall be processed in the order of their receipt. The registry shall respond to public requests in as timely a manner as resources permit, provided that these requests meet certain requirements in conformity with R.S. 40:3.1(A) and (F) and R.S. 40:1108.8(F) et seq.

3. Those requesting data may be asked to reimburse the LTR for actual costs for compiling and providing data. In no event shall the LTR be obligated to perform original work to create data not currently in existence.

4. According to R.S. 40:1105.8.1. The census tract is the smallest geographic area for which aggregate data may be released, if it does not violate both the suppression rule of the United States Cancer Statistics Program, and HIPAA. LTR may combine years of data to overcome these rules. IRB approval is required when requesting data for smaller geographic areas or areas that are restricted by the aforementioned rules and laws, except for mandated public health investigations. If a data request is denied by the IRB, the IRB shall provide written notice of the reason why to the requestor electronically or via mail.

F. Annual Report. A statistical report shall be prepared and made available on the LTR website. This report will also be submitted to the president of the LSU system, LSUHSC-New Orleans, LSUHSC-Shreveport, the Cancer and Lung Trust Fund Board, participating hospitals, the governor, the speaker of the House of Representatives, the president of the Senate, the Legislative Committees on Health and Welfare, and the governing body of each parish.

1. The LTR shall have a mechanism on its website which individuals may elect to receive notifications and the annual report in electronic form.

La. Admin. Code tit. 48, § V-8511

Promulgated by the Department of Health and Human Resources, Office of Preventive and Public Health Services, LR 13:246 (April 1987), amended by the Louisiana State University Medical Center, Office of the Chancellor, LR 24:1298 (July 1998), amended by the LSU Health Sciences Center, Health Care Services Division, Tumor Registry, LR 30:2839 (December 2004), amended by LSU System, Louisiana State University Health Sciences Center, Louisiana Tumor Registry, LR 35:2789 (December 2009), LR 39:3307 (December 2013), Amended by LR 4473 (1/1/2018).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1105.3(7).