The FDA and the SOC strive to be as transparent as possible in the operations of the Sentinel System. Nevertheless, each recognizes that some information utilized as part of the Sentinel System must be kept confidential. Confidential Information includes, but is not limited to:
- Protected health information (PHI)
- Information that is proprietary to and maintained as confidential by the Sentinel Collaborating Institutions
- Data, results, and/or communications concerning medical product queries and assessments not yet made public by the FDA
Confidential Information may appear in documents, discussions, responses to surveys, other communications, or queries, and data and may be oral, written, or electronic. In order to facilitate identification of Confidential Information, the FDA and the SOC will endeavor to identify and label documents that may contain Confidential Information as “Confidential.” All Collaborators providing information as part of their participation in Sentinel should also identify and label such documents as “Confidential.” Collaborators may only use Confidential Information obtained in the conduct of Sentinel for the purposes of Sentinel unless approved in writing by the original source of the information. Collaborators may only use individual health information obtained from external sources in the conduct of Sentinel activities for Sentinel’s public health purposes, as described in Data. Collaborators must exercise good judgment and care to avoid unauthorized use or improper disclosure of Confidential Information. The obligation to maintain confidentiality of information discussed in this section continues after the contract period for at least 5-7 years. The FDA and the SOC will provide updates as needed to Collaborators regarding the protection of Confidential Information. All questions concerning confidentiality issues should be addressed to the Administration Division.
Each individual Collaborator who comes in contact with Confidential Information provided by the FDA certifies, by signing the FDA’s Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement, that he or she will not disclose Non-Public or Confidential Information to any unauthorized person. Non-Public or Confidential Information is information not available to the general public. Signed agreements will be kept on file by the SOC until five years after the last participation of the signatory in the Sentinel and will be made available to the FDA upon request.
Uses of Non-Public Information
Non-Public Information shared between the FDA and Collaborators may not be used to solicit or otherwise encourage funding by industry or other organizations or agencies. Collaborators who have received Non-Public Information about a topic may accept engagements in non-FDA supported activities related to that topic if:
- The FDA has not engaged the individual in any capacity to participate in activities on that issue
- The Collaborator does not divulge Non-Public Information previously disclosed to that Collaborator by the FDA
- The Collaborator discloses potential COI, in accordance with the Sentinel conflict of interest policy, prior to or concurrent with any communications with the FDA about any issue concerning the safety of the involved regulated product(s) related to the work done with Sentinel
Sentinel Collaborators are required to keep confidential all communications with the FDA, the SOC, and other Collaborators concerning all Sentinel activities, including but not limited to queries, responses to queries, sequential surveillance and protocol-based assessments, TreeScan analyses, and Patient Episode Profile Retrieval (PEPR) analyses until the FDA determines that such communications are no longer confidential.
All information marked as “confidential” or “proprietary” by Collaborating Institutions, which is shared with or transferred to other Collaborators, the SOC, or the FDA, must be held as confidential and protected from unauthorized use or disclosure. Collaborators, the SOC, and the FDA may not disclose Confidential Information without the prior written consent of the institution that provided the Confidential Information, unless required by law.
All participants in Sentinel, both individuals and institutions, are prohibited from trading on or otherwise benefiting financially from information obtained in the course of or produced as a result of work done under Sentinel that has not yet been made public. This includes Confidential Information generated as a result of Sentinel activities, as well as Confidential Information provided by the FDA and/or Sentinel Collaborating Institutions. Inappropriate use of Confidential Information may constitute insider trading or violate other federal and state laws. Prior to participating in any Sentinel activities, all Sentinel participants must sign the Sentinel Confidentiality Agreement to acknowledge that they are aware of and understand this policy.
Confidential information does not include information that:
- Can be demonstrated to have been in the public domain at the time of disclosure
- Can be demonstrated to have been readily available from another source
- Becomes publicly known not due to any unauthorized act by the Collaborator
- Can be demonstrated to have been independently developed or acquired by the Collaborator