VSDAttachment J7.docx

Attachment J.7 Safeguards for Individuals and Establishments Against Invasions of Privacy (308(d) Assurance of Confidentiality for VSD Contractors/Subcontractors)

In accordance with Section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)), the contractor is required to give an assurance of confidentiality and to provide for safeguards to assure that confidentiality is maintained.

To provide this assurance and these safeguards in performance of the contract, the contractor and subcontractor shall:

1. Be bound by the following assurance:

Assurance of Confidentiality

In accordance with Section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)), no potentially identifiable information obtained in the course of this activity may be disclosed to anyone other than authorized staff of CDC or others noted in the Assurance of Confidentiality statement unless such establishment or individual has consented to additional disclosures.

2. Maintain the following safeguards to assure that this confidentiality is protected by the contractor/subcontractor’s employees and to provide for the physical security of the records:

a. After having read the above assurance of confidentiality, each employee of the contractor/subcontractor participating in this project is to sign the following pledge of confidentiality:

I have carefully read and understand the CDC assurance, which pertains to the confidential nature of all records to be handled in regard to these studies. As an employee of the contractor/subcontractor I understand that I am prohibited by law from disclosing any such confidential information, which has been obtained under the terms of this contract/subcontract to anyone other than authorized staff of CDC.

b. To preclude observation of confidential information by persons not employed on the project, the contractor/subcontractor shall maintain all confidential records that identify individuals or establishments or from which individuals or establishments could be identified under lock and key.

Specifically, at each site where these items are processed or maintained, all confidential records that will permit identification of individuals or establishments are to be kept in locked containers when not in use by the contractor’s/subcontractor’s employees. The keys or means of access to these containers are to be held by a limited number of the contractor/subcontractor’s staff at each site. When confidential records are being used in a room, admittance to the room is to be restricted to employees pledged to confidentiality and employed on this project. If at any time the contractor/subcontractor’s employees are absent from the room, it is to be locked.

c. The contractor/subcontractor and his professional staff will take steps to insure that the intent of the pledge of confidentiality is enforced at all times through appropriate qualifications standards for all personnel working on this project and through adequate training and periodic follow-up procedures.

d. That no information collected under the authority of Section 306 of the Public Health Service Act (42 U.S.C. 242k) and provided for this VSD contract may be used for any purpose other than the purpose for which it was supplied, and such information may not be published or released in other form if the particular individual or establishment supplying the information or described in it is identifiable to anyone other than authorized staff of CDC, unless such establishment or individual has consented to such release.

3. Release no information from the data obtained or used under this contract/subcontract to any person except authorized staff of CDC.

(Typed/printed Name)

(Signature)

(Date)