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Would the proposed modifications to the Privacy Rule have any impact on marketing conducted by covered entities and their business associates?

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Would the proposed modifications to the Privacy Rule have any impact on marketing conducted by covered entities and their business associates?

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Yes. The proposed modifications implement and attempt to clarify a number of changes effected by the HITECH Act that limit permissible marketing communications without written authorization. Specifically, the proposed modifications would change the definition of “marketing” under the Rule as follows: (1) revise the exceptions to marketing to better distinguish the exceptions for treatment communications from those communications made for health care operations; (2) add a definition of “financial remuneration” [to mean direct or indirect payment from or on behalf of a third party whose product or service is being described, and to exclude any direct or indirect payment for the treatment of an individual]; (3) provide that health care operations communications for which financial remuneration is received are marketing and require individual authorization; (4) provide that written treatment communications for which financial remuneration is received are subject to certain notice and opt o

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