The Advanced Medical Technology Association (AdvaMed) has revised its U.S. Code of Ethics for Interactions with Health Care Professionals, with updates that take effect January 1, 2020. Until then, the current AdvaMed Code remains in effect.

AdvaMed is a trade association with members that include companies producing medical devices, diagnostic products and health information systems. The AdvaMed Code is intended to provide guidance to AdvaMed members regarding ethical business practices and responsible industry conduct. Although the AdvaMed Code was initially published to provide guidance to its members, it is available online and has been used by others within the medical technology and health care industries as well. According to AdvaMed, the revisions are intended to increase user-friendliness, address the evolving nature of interactions with health care professionals, provide greater clarity, and include examples that are more current. In connection with these changes, medical technology and health care organizations may want to review their policies to determine whether any updates should be made in light of AdvaMed’s new guidance.

The revised AdvaMed Code contains new sections and updates including, among others, its recommendations for:

  • communicating unapproved/uncleared uses of medical technology and identifying information as off-label;
  • principles for company representatives providing technical support in clinical settings (e.g., transparency that individual is acting on behalf of the company, patient privacy, non-interference with clinical decision making);
  • providing evaluation products, including recommendations concerning the terms of evaluation arrangements;
  • controls for consignment product arrangements;
  • the provision of meals, travel expenses, and appropriate meeting venues;
  • consulting agreements, including clarifications to language discussing “legitimate need” and developing a fair market value methodology; and
  • parameters for company-conducted programs, including training and education, and other business meetings.

In addition, the revised AdvaMed Code contains a comprehensive section on grants, donations and commercial sponsorships that merges the existing sections relating to third-party educational, charitable and research programs, addressing among other things:

  • research grants, including an expansion and clarification of recommended requirements for support of independent grant requests;
  • educational grants, focusing on organizer accreditation standards, permissible uses of grant fund, and the evaluation process;
  • commercial sponsorship, to include a prohibition on passing along any benefit received for financial support (for example, a round of golf) to health care professionals;
  • satellite symposia, including recommendations on whether companies can host these symposia and pay travel costs for health care professionals; and
  • charitable donations, expanding and clarifying the parameters of appropriate donations by medical device companies.