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.
Article highlights
Cardiac devices are prone to cyberattacks as they often involve remote monitoring or connection to transfer data from the home device programmer to the physician’s clinic.
During the data transferring period, areas of weaknesses include a lack of data encryption and presence of bugs.
Over the years, governing bodies like the FDA as well as professional cardiology organizations have worked together with device manufacturers and patients to improve the safety and efficacy of their devices.
These efforts allow patients and providers to be more knowledgeable about what medical devices should be given and future software updates patients should be aware of.
As efforts continue, the field will evolve to have safer and more secure medical devices and cardiac technology to prevent the threat of hacking and make patients feel at ease while receiving life-saving treatment from their devices.
Declaration of intrest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.