Abstract

ABSTRACT Introduction Many cardiac devices, such as implantable cardioverter-defibrillators (ICD) and pacemakers (PPM), often involve a remote connection to allow for data transfer and accessibility from the device to the medical clinic. These devices are vulnerable to cybersecurity threats and data breach. Areas covered The FDA, device manufacturers and professional cardiology societies work in conjunction to assess and evaluate potential areas of weakness in medical devices and formulate software update improvements to strengthen patient safety. We undertook a literature review focusing on the history, progression, and improvements in monitoring of cybersecurity vulnerabilities surrounding cardiovascular medical devices. Expert opinion Cardiac device cybersecurity will continue to evolve and progress as more research is conducted on potential areas of vulnerabilities. The standard procedure as of now is for multiple perspectives from the FDA, professional organizations, device manufacturers, physicians, and patients to review and analyze the effectiveness of cybersecurity safeguards for these devices. We believe this practice will continue as it equally involves all stakeholders in relation to the manufacturing, distribution, and use of these devices. As information technology capabilities expand, safer and secure medical devices and cardiac technology to prevent the threat of hacking will continue to expand and improve.

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