We are dependent on sophisticated information technology for our products and infrastructure. As a result of technology initiatives, expanding and evolving privacy and cybersecurity laws, changes in our system platforms and the ongoing integration of business acquisitions, we have been consolidating and integrating the number of systems we operate and have upgraded and expanded our information systems and cybersecurity capabilities. In addition, some of our products and services incorporate software or information technology that collects data regarding patients and patient therapy, and some software and other products we provide to customers connect to our and third-party systems for maintenance and other purposes. We also have outsourced elements of our operations to third parties (including suppliers, customers and other business partners), and, as a result, we manage a number of third parties who may now or could in the future have access to our confidential information, including, but not limited to, intellectual property, proprietary business information and personal information of patients, team members and customers (collectively “Confidential Information”).
Our information systems, and those of third parties with whom we contract, require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace with continuing changes in information technology, evolving systems and regulatory standards, changing threats and vulnerabilities, and the increasing need to protect data including patient, customer and Confidential Information. In addition, given their size and complexity, these systems are vulnerable to service interruptions and to security breaches from inadvertent or intentional actions by our employees, third-party suppliers and/or business partners, and from cyber-attacks by malicious third parties attempting to gain unauthorized access to our products, systems or Confidential Information. Our use of artificial intelligence and machine learning in our infrastructure and products exposes us to new threats, risks and uncertainties, including with respect to changing laws and regulations regarding the use of such technologies.
Like other large multi-national corporations, we regularly experience cyber attacks, and we expect to continue to be subject to such attacks. These attacks may include phishing, state-sponsored cyber attacks, industrial espionage, insider threats, computer denial-of-service attacks, computer viruses, ransomware and other malware, payment fraud or other cyber incidents. Evolving artificial intelligence and machine learning continue to improve the capabilities of cyber attackers. In addition, as a result of our adoption of remote work arrangements in many positions, a significant number of our employees who are able to work remotely are doing so, and malicious cyber actors may increase efforts targeting remote workers, which exposes us to additional cybersecurity risks. Our cybersecurity program, incident response efforts, business continuity procedures and disaster recovery planning may not be sufficient for all eventualities. If we fail to maintain or protect our information systems and data integrity effectively, we could:
suffer a loss of access to or alteration of all or a portion of our Confidential Information;
suffer a loss of access to or alteration of all or a portion of our Confidential Information;
have difficulty meeting our compliance requirements, including with respect to data retention and reporting, QMS, quality reporting or other requirements;
have difficulty meeting our compliance requirements, including with respect to data retention and reporting, QMS, quality reporting or other requirements;
have difficulty developing new or enhanced products;
have difficulty developing new or enhanced products;
lose existing customers, suppliers and business partners;
lose existing customers, suppliers and business partners;
have difficulty attracting new customers;
have difficulty attracting new customers;
have problems in determining product cost estimates and establishing appropriate pricing;
have problems in determining product cost estimates and establishing appropriate pricing;
suffer outages or disruptions in our operations, supply chain, products and/or services, including our ZBEdgeTM ecosystem;
suffer outages or disruptions in our operations, supply chain, products and/or services, including our ZBEdgeTM ecosystem;
have difficulty preventing, detecting, and controlling fraud;
have difficulty preventing, detecting, and controlling fraud;
have disputes with customers, physicians, other healthcare professionals and payors for our products;
have disputes with customers, physicians, other healthcare professionals and payors for our products;
have regulatory sanctions or penalties imposed;
have regulatory sanctions or penalties imposed;
incur increased operating expenses;
incur increased operating expenses;
be subject to issues with product functionality that may result in a loss of data, risk to patient safety, field actions and/or product recalls;
be subject to issues with product functionality that may result in a loss of data, risk to patient safety, field actions and/or product recalls;
incur expenses or lose revenues as a result of a data privacy breach; or
incur expenses or lose revenues as a result of a data privacy breach; or
suffer other adverse consequences.
suffer other adverse consequences.
We will continue to dedicate significant resources to protect against unauthorized access to our systems and work with government authorities to detect and reduce the risk of future cyber incidents; however, cyber-attacks are becoming more sophisticated, frequent and adaptive. Therefore, despite our efforts, we cannot assure that cybersecurity incidents or data breaches will not occur or that technology or information system issues will not arise in the future. Any significant breakdown, intrusion, breach, interruption, corruption or destruction of these systems could have a material adverse effect on our business and reputation and could materially adversely affect our results of operations and financial condition.