Non-Research Use

The department may authorize the disclosure of information contained in vital records and patient abstract files to public agencies administering health, welfare, safety, law enforcement, education, or public assistance programs when deemed in the public interest and not for purposes of commercial solicitation or private gain, otherwise known as non-research activities. Some examples of non-research use would include other state agencies to carry out statutory obligations, public retirement systems, or Missouri school districts for school enrollment projections.

Non-Research Processes

Initial Non-Research Use Information

Statutes, Rules and Regulations Pertaining to Vital Records Data

Missouri state statutes (193.045, 193.245, & 193.255) and the Code of State Regulations (19 CSR 10-10.090 Access to Vital Records) allow for the release of record-level vital records data by the Missouri Department of Health and Senior Services. The statutes listed above only apply to vital events occurring within Missouri’s borders. The records of vital events that occur to Missouri residents in other states are the property of the state where the events take place.

Under section 610.035, RSMo, the department is prohibited from disclosing any Social Security number of a living person unless such disclosure is permitted by federal law, federal regulation or state law. Section 208.120, RSMo prohibits the department from disclosing any information obtained by them in the discharge of their official duties relative to the identity of applicants for or recipients of benefits or the contents of any records (e.g., Medicaid, Food Stamps). Public assistance information can be provided on de-identified records only.

45 C.F.R. Part 160 and Part 164. Vital Records requestors for administrative purposes will only be provided access to the minimum information necessary to achieve their specific administrative requests. Requestors are prohibited from disclosing any information that would identify a person and are also prohibited from the re-release of the data provided.

Statutes, Rules and Regulations Pertaining to Patient Abstract System Data

Missouri state statutes (192.067, 192.665, & 192.667) and the Code of State Regulations (19 CSR 10-33.010 Reporting Patient Abstract Data by Hospitals and Ambulatory Surgical Centers) allow for the release of Patient Abstract System (PAS) data by the Missouri Department of Health and Senior Services. The Department and other public health authorities are authorized to utilize PAS information for epidemiologic studies and for surveillance. The statutes listed above apply to Missouri residents only.

Application Procedures

To request record-level data (whether identified or de-identified) for administrative/non-research projects, a project manager must submit a completed Protocol Application. The application requires detailed information about the project, justification for all data elements requested, and measures to ensure the confidentiality and security of the data. All information must be clear, consistent and specific. General descriptions do not allow accurate assessment of the value of the project or the need for the data items. Release of data from vital records and/or the Patient Abstract System by the Missouri Department of Health and Senior Services is granted to an agency/institution for the sole purpose of the project described in the project application. The applicant will be required to complete and submit an Agreement for Oversight. The Agreement for Oversight requires both the requestor’s signature and the Institutional/Agency Official’s signature with the authority to bind the agency into the agreement (must be two different staff). All persons that will have access to the data must be listed in the application and will be required to sign Confidentiality Pledge prior to being granted access to the project data.

An application will be immediately rejected if it is determined that 1) it does not clearly describe a well-articulated project, 2) the data will be used for commercial or marketing purposes, or private gain, 3) providing the data would overburden the department, or 4) there is reason to believe that confidentiality of the data would be jeopardized by its release.

Project managers interested in obtaining DHSS data should first familiarize themselves with the data sets prior to requesting data (see Data and Surveillance Systems). Only those data elements necessary for the project should be requested. The project manager will be notified of any discrepancy between the list of data elements requested in the application and those determined by DHSS staff to be needed. Vital Records and Patient Abstract Data custodian contact information may be found under the Contact Us link.

Please Note:

The data provided are to be used solely for the non-research/administrative purposes described in the application. Use of these data for research studies is prohibited and will require a separate application for research protocols. For additional information on research use requirements see the Research Data Release Policies, Procedures, and Guidelines.

We suggest submitting a completed application at least two to three months prior to when data will be needed. Project applications are reviewed on an ‘as time permits’ basis between other priority projects. The complexity of the requested data sets and the number of priority projects may impact the response time. Please plan accordingly.

Regardless of the duration of the project, approval is only for one year at a time. Annual review is required for each project for as long as Department data are held.

Review Process

A primary reviewer is assigned to each application to conduct a preliminary review and to correspond with the applicant if the information provided is unclear or incomplete. If insufficient documentation is presented to determine approval, additional information will be requested to clarify the application. The primary reviewer will be reviewing issues such as the purpose of the request, the appropriateness of requested data, ensuring provisions for maintaining confidentiality and security protections are adequate, and the availability of department resources to fill the request.

Once the primary reviewer completes the review, a recommendation is provided to either the State Registrar and/or PAS Authority or their designee, as needed, to approve or deny the application. You will be notified in writing of the final decision. If your project application is approved, you will receive a Scope of Work (Project Estimate/Quote) outlining the requested files for your review/approval. Once the signed Scope of Work has been received back, the records/files will be prepared on the basis of your application in accordance with Missouri statutes, rules and regulations. If your request is denied, you will be notified of the reasons within 60 days of the denial.

Approval Criteria

Projects must meet the following specific standards and criteria:

contribute to public health practice;
not use Department resources unreasonably and unnecessarily;
be conducted ethically and with integrity;
be in compliance with state and federal statutes and regulations, including confidentiality provisions; and
be consistent with Department policy.

Fee Schedule

In an effort to recover the service cost incurred for staff time and other expenses involved in data delivery, the Department will charge fees for their data and services based on the Fee Schedule. Fees are assessed for preparation of data based on programming time and materials. Payment is required before data files can be released.

Application Submissions

All applicants must complete, sign, date, and submit the Non-Research Protocol Application, Agreement for Oversight, and Confidentiality Pledge(s). If data files are requested, a completed Data Element Checklist is also required for each data set being requested. Combined checklist will be rejected.

Completed packets should be mailed to the Project Coordinator at the address listed under Contact us. Electronic submission of applications with all applicable signatures is acceptable. When scanning, please scan in black and white only. Please do not scan black and white documents in color (default) due to size limitations.

Annual Review

Approved applications/continuations for use of Missouri vital records and/or patient abstract system data are valid for one year at a time, regardless of the duration of the project. A completed Request for Review Form and an Agreement for Oversight must be submitted to the Project Coordinator at least 20 calendar days prior to the current approval expiration date. The Agreement for Oversight requires both the requestor’s signature and the Agency/Institutional Official’s signature with the authority to bind the agency into the agreement (must be two different staff). The Department will attempt to email a reminder notice to the Project Manager on file prior to the current approval expiration date; however, it is the responsibility of the project manager to ensure that annual review materials are submitted whether or not a reminder is received.

A project must be reviewed annually as long as the project is ongoing and DHSS-provided data are retained. Projects in the data analysis phase are considered ongoing. A Request for Review Form includes the following:

Project Summary: Provide a summary of all project activities since the last approval was granted. Continuous progress is essential for continued department support and extension approval. If you have not made any progress, plans should be developed and reported addressing how you will overcome the barriers hindering progress, or continuation may be denied and Department support withdrawn.
Supporting Documents (when applicable): Copies of any presentations, reports, and/or articles not previously submitted for DHSS review.
Project Modification (when applicable): An explanation of any proposed changes to the protocol or changes to the projected end date.
Project Personnel (when applicable): Report any new staff assigned to the project since the last approval was granted, who have access to the DHSS-provided data. All new staff members must sign a Confidentiality Pledge prior to being granted access to DHSS data. It is the responsibility of the project manager to ensure that all staff are aware of and adhere to the confidentiality and security procedures.

Amendment

Any changes to a project or personnel require the submission of an amendment request to the Project Coordinator. Proposed project changes must be reviewed and approved by the Department before being implemented. In the rare event that changes to the project must be made without the prior approval, in order to protect subject safety and welfare, the Project Coordinator must be notified as soon as possible after the changes have been made. Please use the Request for Review form to submit any amendments.

Completed Projects/Disposition of Data

When projects are completed, project managers must submit the following documents:

A completed/signed Request for Review closing out the project.
Copies of reports, citations and/or articles developed from the project not previously submitted.
An original signed/notarized Affidavit of Data Disposal.

Termination/Failure to Comply

If the DHSS receives a credible report or evidence that unauthorized release of data or other breach of confidentiality has occurred, the Department will investigate whether such has occurred and whether the project should be suspended. Project Managers are responsible for notifying any consumer whose confidential information the project staff breaches. However, the project manager MUST also notify the DHSS if the project staff has a breach of confidentiality involving data that was provided to the Project Manager by DHSS.

The Department will require that all data and information provided by the DHSS to the Project Manager be destroyed if the DHSS determines one or more of the following have occurred:

data have been released to unauthorized persons;
the identity of a person, patient, physician, or provider has been revealed to a person not listed as project staff on the approved project application;
data are being used in an unapproved manner.

Per 192.067(5), RSMo, “any department of health and senior services employee, public health authority or coinvestigator of a study who knowingly releases information which violates the provisions of this section shall be guilty of a class A misdemeanor and, upon conviction, shall be punished as provided by law.”

The attorney general shall have exclusive authority to bring an action to obtain actual damages for a willful and knowing violation of 407.1500(1), RSMo and may seek a civil penalty not to exceed one hundred fifty thousand dollars per breach of the security of the system or series of breaches of a similar nature that are discovered in a single investigation.

Failure to comply with the annual review or close out process could result in the immediate withdrawal of DHSS approval of the project. In the event of DHSS withdraws approval, the Department will require that all data provided by the DHSS to the project manager be destroyed.

The Department reserves the right to deny the release of future DHSS data files to the Project Manager for other projects for any breach of the terms of the project application, confidentiality requirements, and/or the failure to comply with the annual review or close out process.