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This Guidance Document provides companies with direction on implementing legitimate, bona fide training and education programs in a way that meets government expectations while ensuring HCPs receive the best, high-quality technical and educational information. In addition, the document expands on existing concepts in the AdvaMed Code (i.e., selecting speakers, identifying attendees, tracking details about programs, providing meals, selecting venue, etc.).

The Guidance Document was initially launched in 2022. It was updated in October 2024, to provide additional guidance related to OIG Advisory Opinion 22-14 on offering Continuing Education programs.

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Lima, Peru – AdvaMed, the Medtech Association, issued the following press release following conclusion of the 2024 Asia-Pacific Economic Cooperation (APEC) Business Ethics for Small- and Medium-Sized Enterprises (SMEs) Forum in Lima, Peru.

“AdvaMed commends APEC’s continued focus on the importance of high-standard business ethics for the medical technology sector, incentivizing ethical business conduct in the public procurement process and continuing advancement of global harmonization of medtech industry codes of ethics,” said Christopher L. White, AdvaMed General Counsel & Chief Policy Officer. “We are delighted that this year’s forum included discussions surrounding government implementation of procurement incentives for enterprises that demonstrate ethical business conduct.”

The 2024 APEC Ethics Forum brought together hundreds of leading health care stakeholders, including the U.S. Department of Commerce and other APEC member economies, medtech associations and their member companies, patient and physician organizations, and others in health-related sectors to align on pivotal strategies for advancing business ethics.

“By focusing on collaborative solutions through collective action, these meetings aim to create a level playing field and advance high standard business ethics critical to patient safety and building trust with the patients we serve,” added AdvaMed’s VP, Assistant General Counsel, Ethics & Compliance Ida Nassar.

“As we move beyond the APEC meetings, government recognition of the value of codes of ethics and rewarding industry adherence to these codes through incentives in public procurement ensures integrity and innovation remain intertwined,” Nassar noted. “We were very pleased to see the 2024 APEC SME Ministerial Statement, which commits to furthering government-to-business interaction by incentivizing ethical business conduct.”  

AdvaMed is encouraged by the APEC Recommendations for Enterprise Integrity in Public Procurement and updates to the UNODC/OECD Resource Guide on State Measures for Strengthening Business Integrity, which include recommendations and guidance for companies and governments, including government implementation of procurement incentives for enterprises that demonstrate ethical business conduct.  

Since 2010, AdvaMed has been honored to help advance the APEC Business Ethics for SMEs Initiative, extending high-standard codes to 31 medical technology associations across 19 economies in the APEC region. These associations collectively represent over 12,000 member enterprises, of which over 10,000 are identified as SMEs. The initiative is also supported by a capacity building platform with an expert team of over 60 members, led by AdvaMed, and advanced in partnership with our many partners, including the U.S. Department of Commerce.

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In the rapidly evolving medical technology sector, ethical business conduct is paramount to patient safety and advancing innovation. Over the years, standards for ethical business conduct have been raised, met, and exceeded thanks in no small part to the relentless drive of many in the medtech industry. The increasing complexity of global trade, however, underscores the need to look forward, strategize, and commit to continued hard work ahead. While the development and implementation of codes of ethics remain vital, these efforts can only go so far when some bad actors refuse to adhere to ethical standards. To tackle future challenges, even the world’s most ethical companies, including medtech companies, need bold action from governments to incentivize ethical business conduct.

AdvaMed is preparing to participate in the upcoming 2024 Business Ethics for APEC SMEs Forum and the 15th Meeting of the Inter-American Coalition for Business Ethics in the Medical Technology Sector from 16-18 September in Lima, Peru. These events will bring together hundreds of leading health care stakeholders, including the U.S. Department of Commerce and other Asia-Pacific Economic Cooperation (APEC) member economies, medtech associations and their member companies, patient and physician organizations, and others in health-related sectors to align on pivotal strategies for advancing business ethics. By focusing on collaborative solutions through collective action, these meetings aim to create a level playing field and ensure that the highest ethical standards are upheld across the industry. Key topics of discussion include incentivizing ethical business conduct in the public procurement process and continuing advancement of global harmonization of medtech industry codes of ethics.

AdvaMed welcomes the APEC Recommendations for Enterprise Integrity in Public Procurement and updates to the UNODC/OECD Resource Guide on State Measures for Strengthening Business Integrity, which include recommendations/guidance for enterprises/companies and economies/governments, including economy implementation of procurement incentives for enterprises that demonstrate ethical business conduct. The 11th APEC Business Ethics for SMEs Forum will utilize these resources, along with the APEC Kuala Lumpur Principles For Codes of Ethics in the Medical Technology Sector, to focus discussions on the practical application by enterprises and economies to enhance business integrity across the medtech sector, ensuring patient safety and building trust with the patients we serve.

• The APEC Recommendations provides that economies “[i]dentify enterprise integrity provisions within [their] public procurement system that incentivize ethical business conduct before, during, and/or after a public tender is awarded. One example of this provision can include demonstration by enterprises of adherence to a code of ethics, either as a qualification to participate or as an incentive in the tender process.”

• The UNODC/OECD Guide provides that “[t]he simplest form of [the public procurement] incentive is a requirement that companies meet certain minimum good practice standards as a condition for doing business with State agencies in charge of procurement. Mandatory programme requirements based on recognized sector-specific standards, such as codes of ethics, can be an effective way to strengthen business integrity practices, particularly in industries where a large portion of the marketplace consists of public purchasing or reimbursement. Multinational corporations frequently make available good practice guidance and training of key partners in their supply chains, including SMEs and other third-party intermediaries. Governments and industry associations also provide technical assistance to companies on the corporate integrity practices necessary for doing business with State agencies. This assistance takes the form of codes of ethics and guidance, training seminars, model content and other means.”

These resources provide a solid foundation for governments to implement incentives in public procurement for ethical business conduct, encouraging health care companies of all sizes to conduct business ethically. 

• The Inter-American Coalition for Business Ethics in the Medical Technology Sector has also benefited from the APEC and UNODC/OECD resources.  Objectives of the Coalition’s meeting include evaluating strategies for effective advocacy focused on the critical importance of maintaining rigorous ethical standards to ensure patient safety.

As we move beyond September, the collective efforts sparked through these initiatives will evolve with AdvaMed, its members, and global leaders strengthening the medtech sector through a continued commitment to ethical practices in procurement and codes of ethics, ensuring integrity and innovation remain intertwined.

Additional Background

Since 2010, AdvaMed has served as medtech industry lead for the APEC Business Ethics for SMEs Initiative, helping to extend high-standard codes of ethics to 31 medical technology associations across 19 economies in the APEC region. These associations collectively represent over 12,000 enterprises, of which over 10,000 are SMEs. The Business Ethics for SMEs initiative is the largest public- private partnership dedicated to promoting ethical business practices in health-related industries.

To learn more about AdvaMed’s Code of Ethics, click here.

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The AdvaMed Code of Ethics on Interactions with Health Care Professionals in China – the “AdvaMed China Code” or “Code” – serves as a foundational charter for medical technology companies’ compliance programs and encourages the companies to adopt best practices in the ethics unique to their industry.  

AdvaMed has developed revisions to the China Code to reaffirm the medtech industry’s dedication to ethical and compliant partnerships with health care providers in China. The revisions address evolving compliance and legal standards and incorporate additional provisions on risk areas unique to medical technology companies in China. The revised China Code is effective on July 1, 2024. 

The revisions to the text and FAQs: 

• Provide clearer guidance prohibiting all cultural courtesy gifts to HCPs (e.g., gifts for a wedding, birth, anniversary) as well as a complete prohibition on the provision of non-educational branded items to HCPs; 
• Reiterate the important role company representatives play in the clinical setting (i.e., they provide technical support on the safe and effective use of medical technology) and outline the principles that apply to company representatives in the clinical setting; 
• Address virtual interactions, meetings, and programs; 
• Reiterate that interactions with bona fide sub-distributors and sub-dealers should be conducted pursuant to all legal and ethical principles. 

Available in: 

• English 

• 中文 Chinese

Additional resources and implementation tools for the China Code of Ethics can be found here.

Certification and Training 

For resources to develop your own Code of Ethics training program for your staff, please contact Quentin Roemer. 

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Welcome to our resource hub for the AdvaMed Code of Ethics on Interactions with Health Care Professionals in China. The “AdvaMed China Code” or “Code” serves as a foundational charter for medical technology companies’ compliance programs and encourages the companies to adopt best practices in the ethics unique to their industry.   Below, you will find a range of downloadable resources designed to support companies in aligning with these standards. Access and explore these tools to further your understanding and implementation of the Code.

Download Resources in English:

• AdvaMed China Code Guidance on Educational Items and Prohibition of Gifts
• AdvaMed China Code – Training Slides
• AdvaMed China Code Crosswalk

Download Resources in Chinese

• AdvaMed China Code Guidance on Educational Items and Prohibition of Gifts
• AdvaMed China Code – Training Slides

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AdvaMed offers members compliance education and ethical guidance for interactions with healthcare professionals through the HealthStream-powered AdvaMed Code of Ethics. Demo this important tool during this webinar.

Game-Changing Compliance Education for Healthcare Professionals: Healthstream Webinar

February 20, 2025
10:00 AM – 11:00 AM

RSVP

Overview

1. Overview
2. Agenda
3. Speakers

Game-Changing Compliance Education for Healthcare Professionals: Healthstream Webinar

February 20, 2025
10:00 AM – 11:00 AM

RSVP

Our 2024 Compliance Bootcamp has officially concluded but join our mailing list to receive updates on the 2025 program.

This event is perfect for those who have recently taken on compliance responsibilities, are currently revamping an existing program, or just want a quick refresher. The carefully curated program will provide you with a comprehensive understanding of the current compliance framework; practical, hands-on approaches for addressing challenges and hurdles; and methods for effectively managing compliance within a medical technology company. Ensure your team is up to speed on compliance issues and secure your spot for this event!

Learning Objectives

• How to build and maintain an effective compliance program, as well as implement best practices.
• Group breakout sessions and interactive discussions of relevant hypothetical case studies.
• An in-depth look at major risk areas and compliance challenges and the ways to mitigate those risks.
• A holistic breakdown of the fundamentals of compliance.

This event is in partnership with:

2024 Agenda

The full Compliance Bootcamp agenda is below. You can also download a copy of it here.

DAY ONE – Tuesday, September 10th

Start Time	Topic/Details All Sessions Will Be Interactive Throughout
8:00 am	Breakfast
8:30 am	Introduction Faculty Bios Program Overview Attendees’ Goals for This Program/Polling AdvaMed Intro
9:00 am	The Amorphous Power of Culture Impact of Culture on Compliance Pressure Points that Can Affect (and Change?) Culture
9:45 am	The Foundation of Your Compliance Program Relevant Laws, Rules and Guidance Converting the Required Elements of an Effective Compliance Program into a Structure The Tools and Environment to Manage Risk Motivating Senior Management and Educating the Board
10:45 am	Break
11:00 am	What Interests The Government These Days Recent Government Enforcement Actions & Areas of Focus Lessons Learned and Their Relevance to Your Business New Developments
12:00 pm	Lunch
1:00 pm	Compliance Deep Dive: Identifying and Mitigating Ongoing and Emerging Risk Areas Inside and Outside the United States Identifying High Risk Areas Addressing and Mitigating Risks Locally and Globally   Considerations related to Interactions with HCPs and Other Health Care Entities; Managing Third-Party Distributors; Data Privacy; Other Compliance Challenges
3:00 pm	Break
3:15 pm	Interactive Break Out Session Present hypothetical scenarios and consider application of the AdvaMed Code and other compliance considerations Conducting a compliance risk assessment
5:15 pm	Review of Day One/Plan for Day Two
5:30 pm	Adjourn Day One
5:30 pm	Program Reception – AdvaMed Rooftop 1301 Pennsylvania Avenue NW Suite 400, Washington, DC 20004

DAY TWO – Wednesday, September 11^th

Start Time	Topic/Details All Sessions Will Be Interactive Throughout
8:00 am	Breakfast
8:30 am	Recap of Day 1 and Interactive Q&A
9:00 am	Managing Promotional, Medical, Corporate & Investor Communications (including Social Media): What You Can/Should/Shouldn’t Say to Whom Regulatory Requirements for Promotion Recent Developments: FDA and FTC Enforcement Key Considerations for Scientific Exchange Disease Awareness and Corporate Communications Social Media and Considerations with Use of “Influencers”
10:00 am	Industry Panel – Healthcare Compliance and All Its Glory in the Medical Device Business This session will involve current in-house Compliance Officers and AdvaMed compliance leaders who will discuss the multifaceted considerations associated with managing and mitigating health care compliance risks in today’s medical device industry.
11:30 am	AdvaMed Update Patrick Fogarty, Deputy General Counsel and Senior Vice President, Legal, AdvaMed Ida Nassar, Vice President, Assistant General Counsel, Compliance & Ethics, Legal, AdvaMed
12:15 pm	Lunch Break
12:45 pm	Hot Topics
1:45 pm	Closing Discussion, Q&A and Wrap-up Any Remaining (Burning) Questions So What Are You Going to Do When You Get Back to Work?
2:00 pm	Adjourn Day Two

2024 Speakers

Michelle D. Axelrod, J.D. Managing Principal of Porzio, Bromberg & Newman.

Michelle D. Axelrod is the Managing Principal of Porzio, Bromberg & Newman’s New England office. Michelle has over 25 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel. Michelle primarily counsels pharmaceutical, medical device, and biotech clients on legal and compliance issues related to product commercialization and related sales, marketing, and reimbursement activities. Michelle reviews promotional
content and medical communications, advises on fraud and abuse matters and related issues, provides direction regarding field and account management, and supports clients’ compliance initiatives, including the development of policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews commercial and government contracts, including discount and rebate agreements with health plans/PBMs, retail/specialty pharmacies, GPOs, wholesalers, and other healthcare entities. In addition, she handles distribution agreements and other fee-for-service consulting and service arrangements common in the life sciences industry.

Alfred R. Brunetti, Principal, Porzio, Bromberg & Newman.

Alfred R. Brunetti is a seasoned counselor who guides clients through the increasingly complex matrix of data privacy and
security laws, regulations and guidance impacting business across all industries. Fred combines his in-depth knowledge of
existing and emerging privacy laws and best practices with his extensive nationwide litigation and compliance experience to
regularly advise clients, both large and small, on all manner of data privacy issues relating to the collection, processing and
management of personal information throughout its life cycle.

He leads the firm’s Data Privacy Practice Group and is certified by the International Association of Privacy Professionals
(IAPP) as both a Certified Information Privacy Professional in the laws of the United States (CIPP/US), a designation
evidencing information privacy expertise with advanced concentration in domestic private sector laws, and a Certified
Information Privacy Manager (CIPM), a designation evidencing expertise in the creation and management of a
comprehensive privacy program.

Fred began his legal career as a law clerk for the Hon. Elaine L. Davis, P.J. Crim., in Hudson County, NJ, and then as an
assistant prosecutor in the Union County Prosecutor’s Office in Elizabeth, NJ. He is a graduate of Seton Hall University and
Seton Hall University School of Law, where he was an award-winning member of the Interscholastic Moot Court Board.

Pat Fogarty, Esq., Deputy General Counsel, Senior Vice President of Legal, AdvaMed

Pat Fogarty is the Deputy General Counsel & Senior VP of Legal at the Advanced Medical Technology Association (AdvaMed). AdvaMed advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies that save and improve lives. In addition to providing in-house legal counsel to the organization, Pat leads AdvaMed’s litigation reform legal policy work and related stakeholder outreach, which are emerging priorities for medtech innovators and patients who rely on FDA’s safety determinations. He also manages the association’s amicus curiae program, including filing multiple briefs on a myriad of issues in U.S. federal and state courts. Pat holds a B.A. from Virginia Tech and a J.D. from the Syracuse University College of Law. He is admitted to the District of Columbia Bar.

Masha Goodman-Khan, Senior Director of Compliance and Legal Operations, Vericel

Masha Goodman-Khan is the Senior Director of Compliance and Legal Operations at Vericel Corporation.  She possesses over a decade of experience guiding biopharmaceutical and medical technology organizations in the area of healthcare and regulatory compliance, as well as healthcare law and policy.  Masha holds a Bachelor of Science in Biological Sciences from Georgia State University and a Master of Science in Jurisprudence (M.S.J) in Pharmaceutical and Medical Device Law & Compliance and Hospital and Health Policy from Seton Hall University School of Law.

Ida Nassar, Esq., Vice President, Assistant General Counsel, Ethics & Compliance, AdvaMed

Ms. Nassar manages AdvaMed’s ethics and compliance policy working groups on the AdvaMed Code, federal and state anti-kickback statutes, the Physician Self-Referral (Stark) Law, Sunshine Implementation, False Claims Act, and other health care laws and regulations applicable to medical device innovators and manufacturers. Ms. Nassar also handles AdvaMed’s global legal policy working groups, which seek to establish common global standards for anti­ corruption and business integrity and secure procurement, regulatory, and enforcement incentives that reward compliance. Prior to AdvaMed, Ms. Nassar was a Senior Attorney within the Drug Enforcement Administration’s Office of Chief Counsel where she handled enforcement actions under the Controlled Substances Act as well as defensive litigation matters for the department. She also served as Trial Attorney for the U.S. Department of Justice, managing commercial and torts litigation (including vaccine litigation). Ida also practiced for several years with the Hollingsworth law firm managing life sciences products liability litigation.

Jennifer Romanski, J.D., Principal, Porzio, Bromberg & Newman

Ms. Romanski, chair of the firm’s Life Sciences Legal, Regulatory, and Compliance Practice Group, has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, advertising and promotion activities, medical publication planning, interactions with healthcare practitioners, grants and continuing medical education programs, FDA enforcement activity, and sample accountability and PDMA requirements. She worked for many years in Porzio’s Key Client program where she served as part of the in-house legal team for various pharmaceutical companies several days a week. She has also served as acting compliance director at a large pharmaceutical company, where she was involved in over twenty compliance reviews and investigations.

Daniel Spicehandler, VP, Compliance- Commercial Divisions, Stryker Corporation

Dan Spicehandler is currently the vice president for Compliance Commercial Divisions at Stryker, a leading international medical device and technology company. He is responsible for leading a team of compliance officers who support the commercial divisions at Stryker through a proactive, principles and risk-based program.

His career has involved multiple operational and leadership positions across the medtech, biotech, and pharmaceutical industries. Prior to Stryker, he served as the U.S. compliance officer for Sanofi Pasteur; led the monitoring, auditing, policy, and risk team at Novo Nordisk Inc.; and served as the director of compliance for Meda Pharmaceuticals (acquired by Mylan). His career has involved both compliance and legal positions, and he has also served as in-house counsel at both Novo Nordisk and Meda. Dan’s experience at both large multinational organizations under monitorships for Corporate Integrity Agreements and REMS programs and smaller U.S.-based companies have helped him to understand the importance of developing compliance programs designed to fit the needs of the business and adapt to the changing expectations of regulators.

Prior experience also includes work as a consultant in developing compliance programs with Polaris Management Partners (now IQVIA) and as a lawyer with the firm of Reed Smith LLP. He is a graduate of Fordham University School of Law, where he serves as an alumnus on its Advisory Board for Compliance Programs, and Union College in Schenectady, New York.

Alessandra Spina, VP and Deputy GC, Chief Compliance Officer – Healthcare Compliance –Terumo Americas

Alessandra  is a business oriented legal and compliance professional with over twenty years of diverse operational, transactional, and healthcare compliance experience in world-leading medical device and consumer electronics corporations. She has a proven record of success managing large-scale projects, global commercial transactions, and strategic development of anti-bribery/anti-corruption corporate compliance programs in the Americas, EMEA, and Asia Pacific.

Alessandra joined Terumo in 2016, serving the organization in legal and compliance roles of increasing responsibilities: as of 2019 Alessandra served as Terumo Americas Holding Deputy Chief Compliance Officer and the designated Chief Compliance Officer for MicroVention and Terumo Medical. In 2024 Alessandra was appointed as Chief Compliance Officer for Terumo Americas and continued to enhance the ABAC compliance program and bring alignment across all Terumo companies while fostering the company’s ethical culture.

Alessandra is an attorney admitted in New York State and in Italy (inactive). She holds an LL.M. in Corporate Compliance from Fordham University School of Law in New York City.

Prior to joining Terumo, she served as EMEA Legal Counsel for Zimmer Biomet based in Switzerland, and as Acting General Counsel Samsung Electronics based in Italy.

Christopher L. White, General Counsel, Chief Policy Officer, and Secretary, AdvaMed

Mr. White serves as the Association’s Chief Legal Officer and AdvaMed’s Chief Policy Officer, leading the Association’s work to develop and promote policy positions enhancing patient access to medical technology worldwide. Mr. White also leads the Association’s strategic planning activities and investor relations matters. In March 2020, Mr. White was appointed the organization’s COVID-19 Action Team Leader, leading all COVID-19-related initiatives and policy. Additionally, he guided the organization to fully remote functioning upon the onset of the pandemic.

He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is a frequent speaker on health law and policy issues, and posts health policy blogs on his Linkedln page.

Prior to AdvaMed, Mr. White was a partner with the global law firm Morgan Lewis; and he began his health law legal career with the firm Drinker Biddle. Mr. White is a graduate of Wake Forest University, where he studied electron microscopy and cell biology, and Catholic University Law School.

The post MedTech Compliance Bootcamp appeared first on AdvaMed.

The AdvaMed Code of Ethics provides medical technology companies with guidance on ethical interactions and relationships with health care professionals, based on the cornerstone values of innovation, education, integrity, respect, responsibility, and transparency. A company that adopts the Code is strongly encouraged to submit to AdvaMed a biennial certification stating that the company has adopted the Code and has implemented an effective compliance program.

AdvaMed has developed revisions to the code to address evolving compliance and legal standards, account for innovative value-based care arrangements, and incorporate additional provisions on risk areas specific to medical technology companies. Revisions and updates to the Code went into effect on June 1, 2023.

The revisions include:

• guidance on innovative business models;
• information on recent value-based safe harbor modernizations
• a framework of best practices for companies when hosting company-conducted training and educational programs

Available in:

• English
• Spanish
• Portuguese

Blog / Investor Relations / Legal

Managing Your Life Sciences Portfolio: False Claims Act Risk for Private Investors and How AdvaMed Can Help

In recent years, private investors have been subject to increased government enforcement scrutiny under the False Claims Act. Given investors’ vital role in medtech, AdvaMed developed tools and resources to help investors and portfolio companies adopt best compliance practices and manage risk.

Certification and Training

For resources to develop your own Code of Ethics training program for your staff, please contact John Bryan. We are also pleased to offer a fully-developed and interactive Code of Ethics training course through HealthStream. Review your options below.

For Members

Members can participate in the Code of Ethics certification program, affirming that their organization has agreed to abide by the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

For All Medtech Companies

Compliance Contact Information

The following AdvaMed member companies have submitted valid certifications to the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

The following non-member companies have submitted valid certifications to the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

The post AdvaMed Code of Ethics appeared first on AdvaMed.

“Here at J&J MedTech, the AdvaMed Code of Ethics serves as a valuable resource for interactions with healthcare professionals and stakeholders. The AdvaMed Code provides a framework for our collective commitment to integrity and transparency, and builds trust and credibility within the industry. Aligned to our Johnson & Johnson Credo, ethical practices and patient safety are our top priority.” 

Ashley McEvoy, Executive Vice President and Worldwide Chairman, MedTech, Johnson & Johnson | Chair, AdvaMed Board of Directors 

  “Developing and sustaining the AdvaMed Code of Ethics is one of AdvaMed’s most meaningful achievements during my 20+ years on the AdvaMed Board. The Code represents the medtech’s industry commitment to serve patients based on the cornerstone values of innovation, education, integrity, respect, responsibility, and transparency.”

Michael A. Mussallem, Chairman and Chief Executive Officer, Edwards Lifesciences

This April, AdvaMed celebrated the 30^th anniversary of its Code of Ethics on Interactions with Health Care Professionals (the Code). For three decades now, the Code has guided the medical technology industry and improved medical innovation by establishing ethical parameters for interactions between medtech innovators and health care professionals. The ultimate beneficiaries of Code adherence, as with all medtech work, are patients. The Code reinforces integrity in medical decision-making, reassuring patients that the medtech used in their care is always in their best interests. 

A Living, Global Gold Standard for the Innovations Patients Need 

Because medtech is continuously evolving, the Code is a living document, updated and refreshed in pace with the rapid development of the medical technologies deployed for patients. One recent revision applies to medtech innovators as “solutions providers,” working as partners with health care providers in achieving positive patient outcomes, rather than “vendors and suppliers.” Another recent update reflects the industry’s commitment to improve health equity, inclusion, and diversity, and extends the Code’s ethical expectations to investors.  

Executive Commitment to Guide Ethical Decision-making 

AdvaMed and its board of medtech CEOs are committed to making agile, seamless updates because of the clear principles and values framework underlying the Code. The framework also enables medtech innovators to address unexpected circumstances not contemplated by regulations or captured in the Code, responding ethically in new situations.  This approach served industry and patients well during the pandemic. 

Since its inception, the Code has ensured that interactions between medtech companies and health care professionals not only comply with all applicable laws and regulations but also:   

1. support conflict-free medical decision-making in the best interests of patients;
2. maintain appropriate transparency to instill public confidence and trust. 

The Cornerstone Values Underlying the Code: 

• Innovation — Advance the development of safe and effective medical technology to improve and save lives. 
• Education — Deliver high-quality training and education to help ensure that health care professionals safely and effectively use medical technology. 
• Integrity — Conduct interactions with integrity at all times and avoid real or perceived conflicts of interest.  
• Respect — Respect the independent clinical judgment of health care professionals.  
• Responsibility — Promote socially and ethically responsible business practices that protect patients, their rights, and their safety. 
• Transparency — Interact with health care professionals fairly, openly, and transparently. 

Under Our Code, Patients Come First, Every Time

The Code reflects the unique nature of medtech in that collaboration and interaction between medtech creators and providers is critical to innovation, and the work requires the highest ethical standards and integrity because patients come first. The guidance shapes the conduct of the research and development that is necessary for medtech invention and the demonstrated effectiveness and safety of new medtech before reaching patients. The guidance also includes training and briefings for physicians using new medical devices, again to ensure patient benefit and safety are at the forefront.   

Because the AdvaMed Code sets a universal ethical standard and offers a guidance model that works, it’s known as the global gold standard for the medical technology industry’s collaboration with health care professionals. Hundreds of companies have already adopted the Code, and thousands of industry professionals have become Code-certified so they can correctly adhere to these important principles. 

As we look forward to the next 30 years, continuing to uplift the principles and practical considerations set forth in AdvaMed’s Code of Ethics will ensure medical innovation can continue to benefit patients for generations to come.  

Learn about Code of Ethics certification and training. 

“As innovators in medical technology, we have a great responsibility to the patients we serve, and it is important that we operate in a way that honors their expectation that we deliver high-quality lifesaving and life-sustaining innovations. It also means that along the path of developing and delivering these innovations, we engage with partners in an honest and trustworthy way. The Code of Ethics is a living document that is our compass in ensuring that we are engaging responsibly with all, whether that is employees, patients, customers, communities, governments, shareholders or others.” 

— Michael A. Mussallem, Chairman and Chief Executive Officer, Edwards Lifesciences

The post The AdvaMed Code of Ethics: Protecting and Driving Innovation for 30 Years appeared first on AdvaMed.

The Advanced Medical Technology Association’s Deputy General Counsel and Senior, VP of Legal, Pat Fogarty, joined Jack Kalavritinos, host of Capital Forum, and Jonathan Turner, Global Head of Compliance, Privacy and Governance, Zoll Medical, to discuss the recent revisions the AdvaMed Code.

The longstanding Code provides important guidance to medical technology companies, and with these revisions, AdvaMed and its members reaffirm their commitment to ethical and compliant interactions and collaborations with HCPs, while also ensuring that the Code reflects the evolving legal, regulatory, and health care landscape.

The revised Code, which went into effect on June 1, 2022, includes updates concerning value-based or outcomes-based health care arrangements, consistent with the recent value-based safe harbor modernizations under the federal Anti-Kickback Statute, as well as revisions and FAQs in response to the OIG’s 2020 Special Fraud Alert on Speaker Programs.

For more information about the AdvaMed Code of Ethics click here.

Watch the full Capital Forum episode with Fogarty and Turner here.

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