The revised code confirms much of the guidelines in the imoriginal code, which focused on elements of a good faith human services agreement between a company and an HCP. The revised code contains additional guidelines on these elements and deals with licensing agreements for the first time. To avoid violations, companies can pay surgeons and doctors on the basis of hourly rates and/or royalties, which may raise fewer questions than high fixed payments. Companies can also verify and identify all forms of intellectual property acquired by health professionals at the beginning of potential consulting relationships, including not only patentable inventions, but also trade secrets and know-how. Advice agreements should provide that payments are made for all intellectual property rights transferred or used during product development. If a payment to a physician is based exclusively on the transfer of patent rights and there are no patent rights, the payment may be considered unjustified, raising compliance issues under the federal anti-kickback law. Companies can provide grants to conference sponsors to cover the total cost of a conference and provide grants to allow HCPs to participate in conferences as part of the training. This support may include a general grant, but may also include grants for travel, accommodation and fees for HCPs, who will be faculty members at the conference. [xiv] The conference must have a good scientific or pedagogical purpose and the conference sponsor must be independent of the company offering the grant. In addition, the promoter must maintain control over the content of the program, faculty and material. [xv] According to the code, it would not be appropriate for a company to subsidize the costs and costs of an HCP with which it does business. [xvi] With respect to «assessment products,» the revised code allows companies to equip these products free of charge so that «health professionals can evaluate the appropriate use and functionality of the product and determine whether the product should be used, ordered, purchased or recommended in the future.» [lviii] The revised code also distinguishes between single-use/consumable/disposable products and single-use and «multi-use/capital» equipment and provides that «single-use products made available free of charge must not exceed the amount required for an appropriate product evaluation in the current circumstances.» [lix] With respect to multi-use/capital/capital equipment products, the revised code states that products should only be made available for a «timely time» period, that the conditions of the valuation must be established in advance, that companies retain ownership of the products and that a procedure should be in place to «immediately» withdraw the product (s) after the end of the evaluation period, unless the HCP lease or purchase contracts of the product (s) are available.

[lx] While the revised code does not specify whether «assessment and demonstration products» can be billed or billed to third parties, it cautions that «the company should make product-related documents available to the health care professional so that the health care professional can adequately address any reporting obligation for reimbursement purposes.» [lxi] Finally, the revised code states that «assessment and demonstration» of products are not gifts and therefore would not be subject to the gift guidelines in Section IX. [lxii] The following sections examine some of the compliance measures contained in NPs and data protection authorities, as well as the problems that medical device manufacturers may encounter in their attempts to comply with them.