LivaNova is committed to enabling access to our products. We work with reimbursement and health technology agencies to ensure sustained and affordable access to LivaNova products for patients, and we partner with industry groups around the world to support policies that enable access. One area of focus is on solutions for resource-limited providers of care and accelerating access for patients who are distant from care facilities, for example, via remote monitoring.
LivaNova is committed to interacting with healthcare providers in an ethical and responsible manner, and with the patients’ best interests in mind. In addition to compliance with applicable international and domestic laws and regulations where our products are developed and commercialized, we have established mandatory policies, procedures, and guidance that all employees and third parties, as applicable, must follow when interacting with healthcare professionals and other customers.
- Our employees are trained on responsible marketing and advertising practices.
- Our sales and marketing employees receive training on LivaNova's compliance procedures at their annual sales meeting and additional trainings any time an update is made to standard operating procedures.
- Audits and monitoring ensure compliance with internal policies, procedures, guidance applicable laws and regulations related to marketing and advertising practices.
All LivaNova collateral materials, including scientific medical information, used for training, education, marketing and promotion of, LivaNova products are subject to LivaNova’s Global Collateral Materials Review Procedure. Designees from appropriate departments are trained on the applicable processes for collateral material review and approval of content to create content that is consistent with our product labelling.
Information Security & Privacy
We endeavor to bring the latest technology to our products in a safe and secure manner. In doing so, we strive to integrate both privacy and information security into our products and services. LivaNova is subject to various local and international laws that protect the privacy and confidentiality of certain patient health information, including patient medical records, and that restricts the use and disclosure of patient health information. We work to comply with various privacy standards and to adapt our business processes to ensure that the safety of our products and patients’ information remain at the core of what we do.
We have dedicated resources and processes to help prevent, detect, and respond to cyber threats. Our information security team, led by the Chief Information Security Officer (CISO), manages our Information Security Management System (ISMS) with the objective of strengthening our cyber resiliency. Our ISMS strengthening plans consider leading industry standards, such as the NIST cybersecurity framework, ISO 27001, COSO, and other security controls to apply across our business.
On a quarterly basis, the CISO presents key security metrics to various governing bodies internal to LivaNova, including but not limited to the Audit and Compliance Committee and Company management. We maintain a structured cyber incident response program and strive to continually improve our cyber resiliency strategy, including performing periodic simulation exercises for our security responders. We routinely engage third-party experts to assess our IT infrastructure and the strength of our security program to identify and remediate potential vulnerabilities, in addition to deploying security tools with 24/7 monitoring.
We publish our security and acceptable use policies on our company intranet and require annual certification alongside our Code of Conduct. We conduct frequent security awareness initiatives to keep our employees and contract workers abreast of the evolving security challenges, and we provide communication avenues for all our employees and contract workers to report security incidents through our global IT help desk.