State of California Comprehensive Compliance Program

State of California Comprehensive Compliance Program 

Conducting our business with integrity and maintaining the highest ethical standards are fundamental in all that we do.  Adopted in accordance with California law, this Comprehensive Compliance Program holds Insulet Corporation (“Insulet” or “Company”) to the highest ethical standards and responsible decision-making in its interactions with healthcare professionals.  The Compliance Program is designed to prevent and detect violations of compliance standards, Company policy and applicable law.  

Written Standards 

Insulet has adopted a Code of Business Conduct and Ethics, and has adopted policies incorporating the AdvaMed Code of Ethics on Interacting with U.S. Health Care Professionals and parallel codes adopted by affiliated organizations in other countries where the Company operates, based upon the cornerstone values of education, integrity, respect, responsibility, and transparency, legal requirements and applicable guidance including industry guidance and guidance from the U.S. Department of Health & Human Services Office of Inspector General.  

In response to California Health & Safety Code §§119400 et seq., Insulet has established a $1,500-per-calendar-year limit for certain promotional materials, items and/or promotional activities directed toward individual medical and healthcare professionals in California.  

Compliance Officer and Compliance Committee 

Insulet has appointed a Compliance Officer who is responsible for enforcing and overseeing the organization’s compliance with government laws and regulations.  In addition, Insulet has designated a Compliance Committee to provide compliance oversight to support the Compliance Officer. The Compliance Officer and/ his/her designee(s) conduct and/or monitor investigations into alleged violations of law and/or Company policies or procedures, including the Company’s Code of Conduct and the Policy. As a result of these investigations, Insulet determines appropriate corrective, preventive and/or disciplinary actions to be taken and monitors to ensure that such actions are taken. 


Training & Education 

Insulet recognizes that training and education are essential parts of an effective compliance program. Employees who interact directly or indirectly with healthcare professionals are given training on the AdvaMed Code of Ethics.  Additional ethics and compliance education and training is also provided on an ongoing basis as required by an individual’s job responsibilities and by changes in the laws and Company policies and procedures. Training records are maintained in accordance with Company policy. 

Violations of the Compliance Program 

Employees, customers, suppliers, and others are encouraged to contact the Compliance Officer with questions or concerns. Insulet has established a confidential Compliance and Ethics hotline and online portal that can be used to anonymously report violations or express concerns regarding compliance.  Information regarding reporting violations or concerns can be found on our website and in the Company’s Code of Conduct. 

Corrective or Preventive Action 

Insulet’s Comprehensive Compliance Program is designed to prevent and detect conduct that may be inconsistent with the requirements of the Policy, regulations, or applicable law.  Insulet takes reasonable and appropriate action to address any improper conduct promptly and responsibly with corrective action including, but not limited to, appropriate disciplinary measures. Insulet will assess whether violations of the Compliance Program are a result of gaps in policies, practices, training, internal controls, or individual acts, and will take action to prevent future violations. 

Monitoring and Review 

The Compliance Officer and/or the Compliance Officer’s designee(s), with support from the Compliance Committee, will monitor the implementation and administration of the Compliance Program, including monitoring the activities of sales and marketing personnel.  This oversight will include a review of Insulet’s operations, to identify new and emerging risk factors for the Company in its relationships with Healthcare Professionals. The Compliance Officer and/or his designee(s) will report on a regular basis to the Nominating, Governance and Risk Committee of the Board of Directors and to the Compliance Committee as to the status of the Compliance Program, including its implementation and an assessment of its effectiveness and areas that may need improvement. 

Copies Of Compliance Program 

Copies of this Compliance Program, and the Code of Conduct, can be obtained by calling Insulet’s toll-free number at 1-800-591-3455

February 1, 2022