Refresh of U.S. Industry Code Will Be Effective in 2020

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today announced that its Board of Directors has approved an update of its longstanding Code of Ethics on Interactions with Health Care Professionals (HCPs) in the U.S.

“The updates reflect evolving legal standards, care delivery models and best practices over the last decade – since AdvaMed’s last Code update in 2008 – and are designed to ensure the Code’s continued effectiveness as a premier foundational document for ethics and compliance across the medtech industry,” said AdvaMed President and CEO Scott Whitaker. “These revisions, which also enhance usability and reader-friendliness, reflect our industry’s continued commitment to ethics, integrity and transparency,” Whitaker said.

The revisions will be effective Jan. 1, 2020, to ensure ample time for stakeholder implementation. Key changes include:  new sections guiding education and marketing programs, communication on safe and effective use of medtech, and on providing technical support; expanded provisions on support for third-party educational and other conferences; clarified and expanded definitions of HCPs and “medical technology”; and revisions to provide additional clarity, definition and explanation of existing Code provisions.

“The industry can stand confidently behind these most recent revisions to the AdvaMed Code,” said AdvaMed Chairman Nadim Yared, president and CEO of CVRx. “By clarifying existing provisions, adding new sections to address additional types of HCP interactions, and further developing the Code’s underlying values, the updates anchor the industry in strong compliance principles,” Yared said.

“These updates continue to focus the industry on positive, necessary collaborations with physicians and other HCPs to bring the most effective and innovative care to patients around the world,” added AdvaMed Chair-Elect Kevin Lobo, chairman and CEO of Stryker. “By helping ensure companies continue to focus on ethical business practices, the refreshed Code reinforces the industry’s commitment to delivering expert care and building products that make a difference for health care professionals and patients.”

“AdvaMed’s work with global stakeholders to advance ethical business practices and compliance – including through the Code updates – benefits the entire medical technology ecosystem and patients everywhere,” said AdvaMed Ethics & Health Care Compliance Board Committee Chairman Ken Reali, president and CEO of Clinical Innovations LLC. “All medtech companies – from start-ups to large multinationals – can benefit from adopting AdvaMed’s strong and comprehensive Code.”

To access the updated U.S. Code – along with an overview document and additional information – please click here. 

Additional Background

One of the ways medtech companies serve patients is through beneficial collaborations with HCPs to develop life-changing new products, and to enhance their safe and effective use through appropriate training and education. To ensure these relationships meet the highest ethical standards, they must be conducted in compliance with applicable laws and regulations. However, AdvaMed also works to foster a legal environment that enhances public health through effective industry self-regulation, focusing on socially responsible conduct. That’s where the AdvaMed Code comes in.

The Code clarifies and distinguishes appropriate activity between HCPs and representatives of AdvaMed member companies, and others who adhere to the Code. The U.S. Code has also served as the foundation for other associations’ codes of ethics around the world, and for AdvaMed’s Code of Ethics in China, launched in 2016. AdvaMed’s original U.S. code was implemented in 1993, with subsequent updates effective in 2003 and 2009.