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donor directly or indirectly influences the identification or delineation of the specified diseases. the term "affiliate" of any donor includes, without limitation, any employee, agent, officer, shareholder, or contractor (including, without limitation, any wholesaler, distributor, or pharmacy benefits
reports to donors would not contain any information that would enable a donor to correlate the amount or frequency of its donations with the number of patients that use its specialty medications or genetic tests, or the volume of those products or services. requestor would not inform patients or donors...
https://oig.hhs.gov/fraud/docs/advisoryopinions/2010/AdvOpn10-07.pdf
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