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Introduction
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”), U.S. Department of Justice guidance, as well as applicable industry codes of conduct for our business segments – medical devices and pharmaceutical diagnostics.
GE HealthCare has implemented an appropriately tailored Compliance Program that includes a comprehensive framework of compliance controls with routine audits and monitoring to address business ethics risks throughout our business segments. Our Compliance Program represents our commitment to the highest standards of corporate conduct and integrity. GE HealthCare Board of Directors Audit Committee, in coordination with our Chief Compliance Officer, have responsibility for business ethics issues. GE HealthCare also provides our People Leaders with additional training and resources for managing business ethics.
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 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 a Code of Ethics & Integrity, “The Spirit and The Letter”, “The Global Interactions Policy (GIP) – GE HealthCare global policy on interactions with Healthcare Professionals, Healthcare Institutions, Government Officials and Government Institutions “ (formerly The Lens Policy) as well as various other policies and procedures. The management of ethical marketing promotion is included in the GIP and monitoring program.
The Compliance Program addresses applicable provisions of U.S. federal and state laws and regulations. GE HealthCare certifies annually to adopt the AdvaMed “Code of Ethics on Interactions with Health Care Professionals,” and abides by the PhRMA “Code on Interactions with Health Care Professionals”, as applicable and relevant to our 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.
GE HealthCare has a comprehensive annual Compliance Risk Assessment program with a focus on healthcare specific risks and ethics.
View GE HealthCare's code of conduct, "The Spirit and The Letter," in the following languages:
ENGLISH
ARABIC
BRAZILIAN PORTUGUESE
CHINESE
FINNISH
FRENCH
GERMAN
INDONESIAN
ITALIAN
JAPANESE
KOREAN
NORWEIGAN
POLISH
RUSSIAN
SPANISH
THAI
TURKISH
VIETNAMESE
III. Effective Training and Education
Training and education of all of our colleagues on their legal and ethical obligations under applicable HealthCare laws and GE HealthCare’s policies and Code of Ethics & Integrity are critical components of our Compliance Program. For all relevant GE HealthCare colleagues, 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 colleagues with sufficient knowledge of relevant compliance policies and generally includes questions to assess colleagues understanding of the policies 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 and Channels for Reporting Misconduct
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. For inquiries regarding GE HealthCare’s Compliance Program, call 1-800-437-1171 opt 6.
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.
EU Whistleblower Directive: GE HealthCare is committed to comply with the requirements of the Directive (EU) 2019/1937 of the European Parliament and of the Council 23 October 2019 as transposed into local laws, and provides reporting channels to internal and external whistleblowers to report possible compliance violations, including appropriate standards of protection for persons who raise concerns. To submit a concern, visit the GE HealthCare Open Reporting website.
V. Monitoring and Auditing
GE HealthCare’s Compliance Department and Internal Audit have the responsibility of developing a plan for auditing and monitoring compliance and business ethics risks 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 Internal Audit 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
GE HealthCare’s code of conduct, “The Spirit and The Letter,” provides notice to colleagues, 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 action 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 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.
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