GE Healthcare has a comprehensive Compliance Program consistent with the U.S. Department of Health and Human Services Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Guidance”) as well as applicable industry codes of conduct for our two business segments – medical devices and pharmaceutical diagnostics.
GE Healthcare has implemented an appropriately tailored Compliance Program that includes a comprehensive framework of compliance controls throughout our two business segments. Our Compliance Program represents our commitment to the highest standards of corporate conduct and integrity.
The following is an overview of the fundamental elements of our Compliance Program.
I. Compliance Organization
GE Healthcare’s Compliance Program reflects our overall commitment to compliance with U.S. federal and state laws, including the elements specifically implemented to comply with California law. GE Healthcare’s Compliance organization is comprised of the Chief Compliance Officer who heads a team of compliance professionals (the “Compliance Department”). The Chief Compliance Officer is responsible for developing, operating and monitoring the Compliance Program and overseeing the governance of the Compliance Program. GE Healthcare’s Chief Compliance Officer is empowered with appropriate authority to exercise independent judgment and has access to GE HealthCare’s senior management and General Electric Company’s leadership. Supporting the Chief Compliance Officer is a team of compliance professionals who help implement the Compliance Program for GE Healthcare. The team reports to and meets regularly with the Chief Compliance Officer. The Compliance Department reviews and modifies GE Healthcare’s policies and procedures as the business and industry change. The Compliance Department has the authority to recommend and effectuate changes within GE Healthcare as needed.
II. Policies and Procedures
GE Healthcare’s Compliance Program includes General Electric Company’s code of conduct, “The Spirit and The Letter”, GE Healthcare’s “The Lens – GE Healthcare Policy for Compliance Activities in the Health Care Industry”, as well as various other policies and procedures. The Compliance Program addresses applicable provisions of U.S. federal and state laws and regulations and incorporates guidance contained in the AdvaMed “Code of Ethics on Interactions with Health Care Professionals”, and PhRMA Code on Interactions with Health Care Professionals, as applicable and relevant to our two business segments.
GE Healthcare has also established a total annual dollar limit on items of value (including meals), and activities that GE Healthcare may provide to a California-licensed healthcare professional in accordance with Section 119402 of the California Health & Safety Code. The annual limit may be revised by GE Healthcare from time to time.
III. Effective Training and Education
Training and education of our employees on their legal and ethical obligations under applicable healthcare laws and GE Healthcare’s policies are critical components of our Compliance Program. For all relevant GE Healthcare employees, the training program consists of mandatory training and education on applicable healthcare laws and our policies and procedures, with annual refresher courses via online learning modules. The training program is designed to provide employees with sufficient knowledge of relevant compliance policies and generally includes questions to assess employees understanding of the polices and concepts. GE Healthcare also periodically reviews and updates its training programs to identify any potential new areas for training and to ensure the program aligns with GE Healthcare’s compliance policies.
IV. Effective Lines of Communication
A hallmark of GE Healthcare’s Compliance Program is a steadfast commitment to a vibrant, well-publicized and effective open reporting environment. Employees remain GE Healthcare’s first and best line of defense in the early detection of potential compliance issues. GE Healthcare has created and maintains an open line of communication between the Compliance Department and all employees. GE Healthcare expects employees, agents, and vendors who do business with the company to report concerns over possible misconduct, potential conflicts, or known violations of the company’s policies and/or procedures to their supervisors, managers, or to the Compliance Department. GE Healthcare employees may contact the Compliance Department directly through email, mail, phone, or in-person contact/meeting.
GE Healthcare also established a system to receive complaints or for employees to seek information or advice on questions via a compliance hotline. Complaints and questions can be submitted anonymously. We also encourage our employees, officers, and agents to ask questions about any activity where they are unclear about a potential violation or application of our Compliance Program. Questions may be posed through any of the established channels described above. GE Healthcare has also adopted procedures to protect the anonymity of those who raise potential concerns and to protect whistleblowers from retaliation. The company does not permit acts of retaliation or retribution against an employee or officer who in good faith reports a potential, suspected, planned, or actual violation or application of GE Healthcare’s compliance policies and any such actions will be dealt with appropriately.
V. Monitoring and Auditing
GE Healthcare’s Compliance Department and General Electric Company’s Corporate Audit Staff (“Corporate Audit Staff”) have the responsibility of developing a plan for auditing and monitoring compliance with the company’s compliance policies. Through these audits, the Compliance Department can identify potential or existing areas of concern and potential program enhancements which include taking corrective action in an effort to prevent the recurrence of non-compliance as needed. The nature of these audits and reviews, the extent of the audits, and the frequency with which the Compliance Department and the Corporate Audit Staff performs such audits varies due to a variety of factors, including new regulatory requirements, changes in company practices, and other relevant considerations.
VI. Enforcing Standards through Well-Publicized Disciplinary Guidelines
General Electric Company’s code of conduct, “The Spirit and The Letter”, provides notice to employees, including management, and agents that noncompliance with policies and laws will have disciplinary consequences, up to and including termination of employment.
VII. Investigating and Responding to Potential Violations and Implementing Corrective Action Initiatives
GE Healthcare’s Compliance Department thoroughly investigates all reports of non-compliance and/or allegations and suspected cases of misconduct brought to the Compliance Department’s attention.
The Compliance Department oversees the implementation of corrective measures in response to findings of non-compliance, such as retraining, increased monitoring, and disciplinary actions.
GE Healthcare’s Annual Declaration of Compliance for Purposes of California Health & Safety Code §§ 11940-119402
In accordance with California Health & Safety Code sections 119400 and 119402, GE Healthcare believes that it has adopted a compliance program as required by California law that is in accordance with the OIG Guidance, consistent with the PhRMA Code / AdvaMed Code guidelines, and includes an annual limit for certain items and activities given to healthcare professionals covered by this California law. As of the date of the declaration, GE Healthcare believes that it is in compliance with the company’s compliance policies and California requirements in all material respects.
In accordance with GE Healthcare’s understanding of the California statute, this declaration is limited to those activities undertaken by GE Healthcare that are directed to California.
For a copy of GE Healthcare’s Compliance Program and this written declaration of compliance, please call (800) 438-8072 [Updated March 30, 2020.