HIPAA - Advisory 3: Preceptorships for Vendors

FACULTY ADVISORY 3 (Nov. 18, 2005)

PRECEPTORSHIPS FOR VENDORS

This communication provides guidance regarding preceptorship programs conducted for vendor representatives. The HIPAA Privacy Rule requires that patient privacy and the confidentiality of protected health information ("PHI") are maintained when interacting with vendor (device, pharmaceutical, etc.) representatives. As a reminder, PHI is any information that identifies or could lead to the identification of a patient and may reveal something about that patient's health status.

A previous advisory (Faculty Advisory 2: Vendor Representatives) provided guidance regarding the presence of vendor representatives where PHI is being discussed or patients are accessible (i.e. patient rooms, treatment areas).

Vendor preceptorship programs involve compensation from industry in exchange for, among other things, the opportunity to accompany physicians while they interact with patients or perform clinical procedures. One stated purpose of this interaction is for industry representatives to become informed about disease states and courses of treatment to further product development. Such programs are therefore limited to vendor scientists or research and development personnel. These preceptorships are not meant to provide sales and marketing representatives access to physicians in order to influence clinical or business decisions.

Such vendor preceptorship programs may foster the advancement of medical research. However, it is imperative that we balance the desire to exchange knowledge with our commitment to protect the confidentiality of patient information. Therefore, the following guidelines have been established.

Before industry visitors are allowed to participate in preceptorship programs at the University of Chicago Medical Center, the following guidelines must be met.

A vendor preceptorship program can only be sponsored by BSD faculty members.
Faculty members wishing to sponsor vendor preceptorship programs should view the Forms section of this web site or contact Bob Gross, HIPAA Program Director, at 4-3987 to obtain a Preceptorship Proposal Form and a Preceptorship Confidentiality Agreement.
The following documents should be submitted to the HIPAA Program Manager for review:

Completed Preceptorship Proposal Form.
A written contract between involved parties describing the services and activities related to the preceptorship program and any compensation provided. Such a contract will contain provisions relevant to the HIPAA Privacy and Security Rules.
Signed Confidentiality Agreement for the industry visitor(s) participating in the preceptorship program.

The sponsoring faculty member will be notified whether the preceptorship program has been approved within five (5) business days of receiving the Form. A program's approval by the HIPAA Program Office does not imply that the program is compliant with other Medical Center policies. For example, in order for vendor representatives to be present in the operating rooms, all requirements of Policy A02-24, PC50 (Visitors to the Operating/Recovery Rooms) must be followed.

If the proposed arrangement is new, or there is any question about its potential approval, a draft preliminary contract may be reviewed with the HIPAA Program Manager. Please make these guidelines available to your faculty and staff that may be involved in such activities. If you have questions regarding these guidelines, please contact Bob Gross at 4-3987.

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