Boston Scientific is committed to acting ethically in dealing with customers, employees, shareholders, partners, suppliers, competitors and the community. One way that we make this happen is through the implementation of our global compliance program.
The primary purpose of our compliance program is to foster and support a culture of integrity at Boston Scientific as well as to prevent, detect and respond to potential violations of applicable laws, regulations and company policies.
Code of Conduct
Personal and corporate integrity has been one of Boston Scientific's guiding principles since the day our company was founded. It enters into everything we do and is a central part of our daily lives.
Our Code of Conduct is about maintaining our good reputation by treating people honestly and with respect, both inside and outside of Boston Scientific. This is fundamental to how we do business.
All Boston Scientific employees around the world are expected to be familiar with and abide by our Code of Conduct.
The Code is also available to you in all of the languages listed below (PDF).
Getting Advice and Reporting Integrity Concerns
Boston Scientific provides a number of resources that employees and others can use to ask a question, obtain guidance, or report a Code of Conduct concern. Boston Scientific strongly encourages
Note: The Advice Line is not designed for reporting product complaints. If you are not a Boston Scientific employee and need to report a product complaint, please call Customer Service at 888-272-1001. Boston Scientific employees, please follow corporate complaint reporting guidelines.
For Asking a Question or Reporting a Concern, see Code of Conduct, page 47.
Boston Scientific does not tolerate any form of retaliation against an individual arising from a good-faith report of a potential violation of our Code of Conduct, a related policy, or of an integrity concern. Retaliation is also prohibited against anyone who participates in an investigation of such a report.
The Advice Line allows anonymous reporting, except where local law restricts it. For additional information about calling the Advice Line, see Code of Conduct, Page 49.
Advice Line Portal
Getting Advice and Reporting
Visit our online Advice Line Portal
Monitoring and Auditing
Interactions with Healthcare Providers
AdvaMed Code of Ethics
U.S. Federal Laws and Regulations
The U.S. Physician Payment Sunshine Act, a provision of the Patient Protection and Affordable Care Act, is a U.S. federal law that requires pharmaceutical, biologic and medical device manufacturers to track and report payments and transfers of value provided to U.S. physicians and teaching hospitals. If a company such as Boston Scientific makes a "payment or transfer of value" to a U.S. physician or teaching hospital (for example, a meal, travel, lodging, etc.), the company must provide information about the interaction to the U.S. government. The U.S. Sunshine Act applies to interactions with U.S. physicians regardless of the country where those interactions occur.
Payments and transfers of value that Boston Scientific must capture and report include expenses such as travel, lodging and meals, consulting payments, royalty payments and licensing fees, research and clinical-trial related expenditures, educational items such as textbooks and journal reprints, training and education expenses, educational and research grants, and charitable donations, among others.
Companies must submit an annual report regarding interactions with U.S. physicians and teaching hospitals to the U.S. federal government, starting in 2014. The government will make this information available to the public annually through a searchable website that will be available by September 30, 2014. Beginning in 2015, the data will be published on June 30. For more information about the Sunshine Act, refer to the presentation created by Boston Scientific’s Global Compliance Program or the AMA website, AdvaMed website and Center for Medicare and Medicaid Services website.
Boston Scientific is committed to acting with integrity in all of our interactions with physicians and other health care providers. We value and look forward to continuing our essential collaboration with health care providers, which allows us to deliver innovative, less-invasive medical devices and procedures for the benefit of patients.
U.S. State Laws and Regulations – California, Massachusetts
Some states, such as California, Massachusetts and Vermont, have imposed limits on how medical device companies can interact with health care providers who are licensed to practice by these states. These state regulations will remain in effect alongside the U.S. Physician Payment Sunshine Act.
California requires device and pharmaceutical manufacturers to post a comprehensive compliance program and provide an annual declaration as to compliance. Access our California Comprehensive Compliance Program and related declaration.
Both Massachusetts and Vermont require pharmaceutical, biologic and medical device manufacturers to submit an annual report detailing a wide variety of financial interactions with certain physicians and other health care providers licensed by those states. Similar to other pharmaceutical, biologic and medical device manufacturers who do business in those jurisdictions, Boston Scientific may be required by law to report many types of direct and indirect payments and other transfers of value to physicians and other health care providers licensed by those jurisdictions. This generally includes the name of the contracting party, the purpose of the payment, the amount and nature of any payments made, and possibly other information about the payment.
Massachusetts and Vermont also require pharmaceutical, biologic and medical device manufacturers to comply with separate marketing codes of conduct, which regulate how employees of these companies can interact with health care providers licensed by these states. Access more information about the Massachusetts requirements and about the Vermont requirements.
Patient Privacy and HIPAA
We understand that most of our U.S. customers are “Covered Entities” under the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations. As HIPAA Covered Entities, our customers are legally obligated to maintain the privacy of all patient information that they create or receive.
While Boston Scientific is not a HIPAA Covered Entity (except for certain portions of our group health plan), we recognize the impact that HIPAA privacy and security regulations have on our customers. Boston Scientific remains committed to interacting with our customers and their patients as responsible professionals who are dedicated to maintaining the privacy of information that we receive on the job, consistent with applicable law and regulations.
To perform our jobs, Boston Scientific employees may create, develop or receive information about patients' experiences with our medical devices in a variety of situations, including:
- Providing information or technical support for our products
- Interacting with other members of the health care provider team regarding a particular patient’s diagnosis and treatment
- Receiving questions and suggestions about our products and services from patients, nurses, physicians
andother health care providers
- Enrolling patients in clinical trials we sponsor and in our remote monitoring system for certain cardiac rhythm management patients
- Collecting information as required by the FDA and other governmental authorities relating to the quality, safety
andefficacy of our devices
- Collecting, analyzing and re-analyzing our data in a continuous effort to improve the design, quality
andfunction of our devices
- Assisting patients and Covered Entities with receiving pre-authorization from insurance companies for some procedures
We have provided training materials on HIPAA to our sales and marketing teams and expect our employees to respect each customer's explicit and implicit instructions regarding incidental exposure to protected health information while visiting that customer's site.
If you have any questions or concerns, please contact us at HIPAA@bsci.com.
Tax Practices and Responsibility
Commitment to Comply with and follow all Country Tax Laws
Tax Structure and Strategies Oversight by Board
Anti-Corruption & Governance
Policy Statement on Anti-Corruption
Due Diligence of New Channel Business Partners – Corruption and Bribery
Communication of Anti-Corruption Policy to Employees
Training on Anti-Corruption
Corruption Risk Assessments for Company Operations
Procedures to Address Corruption
Compliance with Anti-Corruption Requirements
Conflict Minerals Policy
In August 2012, the Securities and Exchange Commission (SEC) adopted final rules implementing disclosure requirements related to "conflict minerals," as directed by Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010.
The term "conflict minerals" is defined to include tin, tantalum, tungsten and gold (the derivatives of cassiterite, columbite-tantalite, and wolframite) regardless of their country of origin; the U.S. Secretary of State may designate additional minerals in the future.
The final rules are intended in part to bring greater supply chain transparency to the use of such minerals originating from the Democratic Republic of Congo and adjoining countries (covered region) in an effort to help end the violent conflict in the covered region. These rules require companies that file certain reports with the SEC to disclose whether the products they manufacture or contract to manufacture contain "conflict minerals" originating from that region that are "necessary to the functionality or production" of those products.
Boston Scientific is supportive of efforts to enable supply chain transparency and responsible sourcing. We are committed to complying with the new conflict minerals reporting and disclosure requirements. Furthermore, we fully expect our suppliers to undertake reasonable efforts to provide us with pertinent information in a timely manner, and to otherwise support our efforts in complying with these requirements.
To ask questions or to report a concern about Boston Scientific’s Conflict Minerals Policy or Program, please use Boston Scientific’s Advice Line.