Astute Medical, Inc. (“Astute” or the “Company”) is committed to maintaining the highest standards of corporate conduct and ethics. Accordingly, Astute has adopted this Comprehensive Compliance Program (“CCP”) in connection with California Health and Safety Code § 119402.
The Company developed the CCP in accordance with the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”). The CCP is designed to meet the requirements relevant to a medical device manufacturer. The medical device industry has established the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (the “AdvaMed Code”), which is substantially equivalent to the PhRMA Code reference in California Health & Safety Code § 119402, but reflects the unique interactions between medical technology companies and healthcare professionals. Accordingly, our CCP includes policies for compliance with the current AdvaMed Code of Ethics on Interactions with Health Care Professionals. As the OIG Guidance acknowledges, the implementation of such a compliance program cannot guarantee that improper employee conduct will be entirely eliminated. However, it is our expectation that any Astute employee who interacts with patients or Health Care Professionals meet high ethical standards, and that those interactions are conducted with appropriate transparency and in compliance with applicable laws, regulations and government guidance.
The elements of Astute’s CCP are described below:
Written Policies and Procedures, Training, and Auditing
Astute’s written policies and procedures (including, but not limited to, the Corporate Code of Ethics Policy and the California/Connecticut/Nevada State Specific Advertising and Promotion Policy) outline the ethical and compliance principles that guide the Company’s daily operations. The Company maintains a program for the periodic training of relevant personnel on these policies and procedures. Astute reviews and updates its training programs and identifies additional areas for training on an “as needed” basis. Astute has also adopted procedures to monitor, audit and evaluate compliance against these policies and procedures.
Communication Regarding Compliance Matters
The Company’s Compliance, Environmental Health and Safety Manager acts as the Corporate Compliance Officer and has ultimate responsibility for overseeing the compliance program; however, every team member has a responsibility to identify and report any potential compliance violations in a timely fashion. This CCP, certain Company policies, regular compliance training and other means of communication are designed to assist all team members when seeking answers to questions or reporting potential violations of law, regulation or policy. If a team member has knowledge of an illegal or unethical activity, he or she should seek counsel from a supervisor, any member of senior management, the Human Resources Department and/or the Corporate Compliance Officer. It is a violation of Company policy for any team member to be retaliated against in any way for asking questions or voicing concerns in good faith.
To assist with the Company’s compliance efforts, Astute has convened a Local Compliance Team. The Local Compliance Team is comprised of the Corporate Compliance Officer and the Vice President of Clinical and Regulatory Affairs. This team works with members of senior management and, if necessary, outside counsel to identify and manage areas of risk and areas of focus for the Company.
Responding to Potential Violations / Corrective Actions
All reports of alleged violations are investigated by the Company. If the results of an investigation indicate that corrective action is required, the Company will decide the appropriate steps to take, including team member discipline, dismissal and possible legal proceedings. Although each situation is considered on a case-by-case basis, the Company undertakes appropriate disciplinary action in an effort to address inappropriate conduct and deter future violations.
As of 5/17/19, to the best of the Company’s knowledge, Astute is in compliance with this compliance program and the provisions of the California Health and Safety Code § 119402, in all material respects.
A copy of this document may be obtained by calling 855-317-2788.~