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November 12, 2019

AdvaMed Unveils Certification Tools For Updated Code of Ethics

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) is launching a suite of tools and resources – including online training, credentialing and certification – to aid implementation of its updated Code of Ethics on Interactions with Health Care Professionals (HCPs) in the U.S. The revised code, which was unveiled in January 2019 and becomes effective on Jan. 1, 2020, reflects evolving legal standards, care delivery models and best practices over the last decade.

“We want compliance professionals at all medtech companies – including small, medium and large-size firms – and all the representatives on the forefront of these businesses, to have all the tools they need to learn about and implement the revised Code,” said Scott Whitaker, president and CEO of AdvaMed. “Offering training, credentialing and certification online is the best way to ensure easy access to the widest possible audience,” Whitaker said.

AdvaMed has joined with HealthStream to launch the RepDirect training and credentialing program for achieving compliance with the new Code. To learn more about RepDirect, click here. Related AdvaMed tools and resources can be accessed here.

“Integrity and common standards are essential for sustainable business success,” said AdvaMed Chairman Kevin Lobo, Chairman and CEO of Stryker. “I encourage any company that cares about ethical business practices to train representatives to this Code.”

“All medtech companies – from start-ups to large multinationals – can benefit from adopting AdvaMed’s strong and comprehensive Code,” said AdvaMed Ethics & Health Care Compliance Board Committee Chairman Ken Reali, president and CEO of Clinical Innovations LLC.

“For start-ups and small companies in particular, which make up the largest share of the medtech industry but that may have limited compliance staff, the online training and other resources AdvaMed has assembled will simplify and accelerate compliance work,” said Christopher White, AdvaMed chief operating officer and general counsel. “We know venture capital investors and acquiring companies carefully weigh ethics and compliance at target companies when considering investment and acquisition decisions. This makes AdvaMed’s role in facilitating ethics and compliance even more essential to maintaining a healthy medtech innovation ecosystem.”

Key changes designed to ensure the AdvaMed Code’s continued effectiveness as the premier foundational document for ethics and compliance across the medtech industry 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.

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.