THIS DECLARATION IS CURRENT AS OF JANUARY 1, 2023
Rapid Medical Inc (“Rapid Medical ” or the “Company”) has adopted a Comprehensive Compliance Program (“Compliance Program”) consistent with guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”). Rapid Medical ’s Compliance Program is intended to provide guidance for Company interactions with healthcare professionals, promote the prevention and resolution of actual or apparent conflicts of interest, ensure compliance with applicable laws and regulations, and provide process for reporting of violations of the Company’s policies relating to the sale and marketing of Rapid Medical ’s products. All Rapid Medical Team Members, officers, directors, and agents must comply with Company policies and procedures as well as all of the laws, rules and regulations of the U.S. and other countries, and the states, counties, cities and other jurisdictions, applicable to the Company’s sale or marketing of its products.
COMPREHENSIVE COMPLIANCE PROGRAM SUMMARY
The OIG advises that an effective compliance program is comprised of seven elements. Rapid Medical Inc has used these seven elements as a basis for its Compliance Program. Fundamental elements of our Compliance Program are summarized below.
Written Policies and Procedures: Rapid Medical Inc has ratified a Code of Ethical Conduct for the Company and has adopted the AdvaMed Code of Ethics on Interactions with Healthcare Professionals as the Company’s primary statement of policies for assuring compliance with applicable laws, regulations and standards governing the marketing and promotion of Rapid Medical Inc ’s products. To the best of its ability and consistent with the OIG’s guidance regarding tailoring compliance programs to the nature of Rapid Medical Inc ’s business as a medical device company, Rapid Medical Inc also has incorporated into its policies and procedures additional requirements of federal and/or state law, e.g., the Massachusetts Marketing Code.
Compliance Leadership: Rapid Medical Inc has designated a Chief Compliance Officer (the “Compliance Officer”). The Compliance Officer is empowered to exercise independent judgment and is responsible for developing, monitoring and otherwise administrating the Compliance Program. The Company also has appointed a Compliance Committee comprised of the Compliance Officer and members of the Company’s senior management to assist the Compliance Officer with review, revision and implementation of the Compliance Program to meet legal and regulatory requirements applicable to the Company.
Education and Training: The Company trains Team Members on the Code of Conduct, on the legal and ethical obligations for Rapid Medical Inc Team Members, and Rapid Medical Inc 's policies and procedures concerning Rapid Medical Inc ’s products.
Communication: Rapid Medical Inc has adopted open-door, confidentiality (to the extent possible) and non-retaliation policies in the event a Team Member is concerned about a potential violation. Team Members may also use the Company’s anonymous Integrity Hotline 1-855-662-7233, Company Code 3534874417
Auditing and Monitoring: The Compliance Officer is responsible for auditing and monitoring compliance with Company policies and procedures.
Enforcement and Appropriate Disciplinary Action: All reported potential violations shall be reported to the Integrity Hotline or forwarded to the Compliance Officer.
Corrective Action Procedures: As needed and on an ongoing basis, the Compliance Officer will assess the need to revise policies, procedures, training, communication or other elements of Rapid Medical Inc’s Compliance Program.
REPORTING OF VIOLATIONS; NO RETALIATION
Any Team Member who suspects a violation of the Company Code of Conduct, financial fraud, or other violations of Company policy should promptly contact the Compliance Officer or Company management. Any Team Member wishing to make an anonymous report regarding suspected illegal behavior or financial fraud of any type may do so by calling one of the Company’s Integrity Hotline, 1-855-662-7233, Company Code 3534874417. The Company will investigate and treat confidentially (to the extent possible) all reported potential violations. All Team Members are expected to cooperate in any internal or external investigations of possible violations of Company policy. The Company will not permit retaliation of any kind by, or on behalf of, the Company or its Team Members against good faith reports or complaints of potential policy violations.
DECLARATION OF COMPLIANCE WITH CALIFORNIA LAW
California Health & Safety Code § 119402 requires certain medical device manufacturers to develop a Comprehensive Compliance Program for interactions with healthcare professionals. Rapid Medical Inc has tailored its Compliance Program to the nature of Rapid Medical Inc’s business as a medical device company. While § 119402 references the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”), Rapid Medical Inc has adopted policies and procedures for compliance which are based on the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, adopted by the Advanced Medical Technology Association (the “AdvaMed Code”) which is similar to the PhRMA Code but is written for medical device companies.
For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, Rapid Medical has established a specific annual aggregate dollar limit of $2,000 on Business Courtesies, promotional materials, or items or activities that Rapid may give or otherwise provide to an individual HCP in California on an annual basis from January 1st to December 31st.
To the best of its knowledge, as of the date of this declaration, Rapid Medical Inc is in compliance with California Health & Safety Code §§ 119402 and the Company’s Compliance Program. Anyone may obtain a copy of this document by calling the toll-free number 1-855-662-7233, Company Code 3534874417.