Compliance

Your Integrity. Our Success.

Orthofix is committed to creating an environment of integrity where open, honest communication is encouraged and celebrated. Our company promotes a culture in which employees are comfortable approaching their supervisor or manager if they believe there has been a violation of policy or standards.

 

Our Commitment to Compliance

As a part of the Company’s commitment to compliance, we have instituted a confidential, anonymous reporting system. This resource is hosted by a third-party hotline provider, EthicsPoint, for the submission of reports relating to violations stated in the Company’s Code of Conduct. The hotline is also a​​ source for guidance related to policies, procedures, violations of law and providing positive suggestions and stories.​

​Compliance Hotline: 1.855.603.6985 (Toll-free – 24hr a day – Confidential – You can remain anonymous).

To contact the Compliance Department please email us at:​​ compliance@orthofix.com​​​

Orthofix is a proud supporter of the following global industry groups that promote ethical business interactions and adheres to each organization’s code of conduct.

 

Orthofix is committed to the responsibility and integrity of all employees, stakeholders, and board members. The company works hard to ensure that its teams and distributor partners adhere to applicable laws regarding the use of Orthofix products. Orthofix sales, marketing, education and promotional activities comply with governing laws in each country in which the company conducts business. The Orthofix Code of Conduct contains guidelines for conducting business with the highest standards of ethics and is available in multiple languages by using the following links:

Our Code of Conduct

Orthofix and Compliance

Global Transparency Reporting

Orthofix recognizes its obligation to facilitate ethical interactions with health care professionals (HCPs), which helps ensure that medical decisions are based on the best interests of the patient.  Collaboration between the medical device industry and HCPs improves patient care and advances technology treatment options.  As a global Company, Orthofix is subject to several transparency laws that regulate our interactions with HCPs and require us to report transfers of value to HCPs to ensure that the interactions are beneficial and appropriate.

 

Orthofix supports global transparency reporting for our industry. The purpose of transparency reporting is to help the general public better understand the nature and extent of industry and provider interactions. Orthofix complies with laws and industry code requirements by publicly reporting payments, benefits and transfers of value made to HCPs, health care organizations (HCOs) and health care professionals’ associations.

 

In the United States, there are federal and state transparency laws that require Orthofix to report transfers of value to HCPs.  The federal transparency law (Sunshine Act) requires Orthofix to submit this data through the CMS Open Payments website.  In countries outside the United States, Orthofix participates through the relevant transparency reporting platforms as required by local law or industry code.  Additionally, certain laws require Orthofix to post certifications, as well as, maintain annual transparency data on the company’s website.

 

California State Certification

California Health & Safety Code § 119402 requires pharmaceutical and medical device manufacturers to make publicly available their “Comprehensive Compliance Program” which outlines adherence to applicable federal and state laws and industry standards regulating the marketing and promotion of their products.  Use this link to review Orthofix’s annual written declaration of compliance.

 

Transparency Reporting for Italy:

The Confindustria Dispositivi Medici Code of Ethics, requires all member-companies to disclose transfers of value to HCPs and HCOs. Under this industry Code, Orthofix Italy is required to disclose the names of HCPs and HCOs that have received payments or other transfers of value from Orthofix, and the total amounts of value transferred by the activity type. This can consist of, for instance, an educational grant to an HCO, a consultancy fee to an HCP for speaking or payment for travel. Disclosure reports will be published by June 30th of every year for transfers of value made during the previous calendar year. Use this link to view the most recent transparency report* for Orthofix Italy.

*Data is displayed on an aggregate basis unless we have consent from the HCPs to disclose their data on an individual basis.

 

 

Sunshine Act FAQs

HIPAA FAQs