Declaration Under California Health & Safety Code Section 119402
Annual Declaration (January 2020)
Acutus Medical is committed to conducting its business ethically and in compliance with all applicable laws. To the best of its knowledge and based on a good faith understanding of the statutory requirements in the state of California, Acutus Medical declares that it has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections §119400-119402. Accordingly, the Company has established an annual dollar limit of $2,000.00 per individual on items or activities provided to medical or healthcare professionals, as defined under the California Law. Acutus Medical has tailored its Compliance Program to meet the specific needs of the Company and continuously assesses the effectiveness of the Compliance Program. Acutus Medical declares that, based upon its current internal tracking and monitoring systems, the Company is, in all material respects, in compliance with the provisions of its Compliance Program.
For a written copy of the Company’s Compliance Program, please call: 888-202-8151
Last update: 12/1/2019.
OVERVIEW OF THE COMPANY’S COMPREHENSIVE COMPLIANCE PROGRAM
Acutus Medical, Inc. (the “Company”) is committed to maintaining an effective comprehensive compliance program and the highest standards of business conduct, and this comprehensive Compliance Program is a key part of our efforts to ensure these standards are met. The goal of our comprehensive Compliance Program is to help monitor and prevent violations of law or company policy with respect to the marketing of our products. Our Compliance Program complies with California Health and Safety Code § 119402 and reflects our adoption of policies appropriate to our company in the industry, including compliance with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals.
Acutus Compliance Program
The Company has designated a Chief Compliance Officer who is responsible for developing, operating, and monitoring this Compliance Program. The Company has also established a Compliance Committee to advise the Chief Compliance Officer and to assist in the implementation of this Compliance Program. We are committed to ensuring that our Chief Compliance Officer and the Compliance Committee have the support to implement the Compliance Program within the Company as necessary.
2. Written Standards
Our Compliance Program includes comprehensive policies and procedures designed to ensure ethical business practices that meet the requirements of applicable laws as well as the AdvaMed Code of Ethics on Interactions with Health Care Professionals. Our Code of Ethics and Standards of Conduct set forth our ethical and compliance principles that direct our ongoing business operations. Our expectation is that the Company’s management, employees, and agents will act in accordance with the applicable laws and the Company’s compliance policies and procedures.
Our compliance policies and procedures incorporate our fundamental principles and address the potential risk areas for medical device manufacturers, including kickbacks and other forms of illegal remuneration. Our Compliance Program sets forth an annual spending limit of $2,000.00 for certain promotional activities directed toward healthcare professionals. The amount spent on most healthcare professionals will be less than this limit. This limit does not include payments for legitimate professional services rendered by healthcare professionals as allowed by applicable rules.
3. Education and Training
Our Compliance Program includes ongoing education and training of our employees on our Code of Ethics, Standards of Conduct, and Policies and Procedures. New employees receive compliance training as part of their initial training, and the Company provides ongoing compliance training and updates for its existing employees. The Company will regularly review and update its training programs and identify additional areas of compliance training as appropriate.
4. Internal Lines of Communication
Ensuring clear lines of communication between management and employees is a key component of our Compliance Program. Our goal is that all employees know the Company’s compliance reporting policy and report any known or suspected compliance violations without fear of retaliation. The Company’s Compliance Committee is responsible for receiving and investigating complaints related to a compliance matter. Any employee or agent who suspects a violation of the Company’s policies or other wrongdoing is encouraged to report the incident in accordance with the Company’s complaint reporting policy. Such reports may be communicated anonymously through an internal website or by calling the Acutus Compliance Hotline.
5. Auditing and Monitoring
Our Compliance Program includes measures to monitor, audit, and evaluate compliance with the company’s compliance policies and procedures. The nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing will vary according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
6. Disciplinary Procedures
Our Compliance Program includes disciplinary action policies that outline the consequences of violating the law or a company policy. Each situation will be considered on a case-by-case basis. Appropriate disciplinary action, up to and including termination, will be taken against any employee or agent who violates the Company’s policies or applicable laws and regulations. Disciplinary action will also be taken against any manager who intentionally or negligently permits or condones violations of the Company’s policies or applicable laws and regulations.
7. Corrective Action Procedures
The goal of the Compliance Program is to help prevent unlawful and unethical behavior and to identify lapses. This Compliance Program requires the Company to respond promptly to potential violations of law or company policy, take appropriate disciplinary action, evaluate the source of the violation, and implement measures to prevent future violations.