Cybersecurity of Medical Devices
The convergence of technologies and the increasing integration of medical devices to computer networks has put vulnerable hardware and software applications to higher cybersecurity risks. With the advent of technology, medical devices play an important role in regulating everything from measuring heartbeat to managing insulin levels and thus, becoming highly vulnerable to hackers. The incorporation of internet by healthcare organizations and consumers has potentially increase the risk even more. Thus, technology can act as a double-edged sword in the healthcare domain, and the cybersecurity is a major issue that must be addressed.
There is recent surge in the ‘crypto-ransomware,’ has impacted hospitals in several countries around the globe. Medical devices firms and healthcare organizations are vulnerable to a variety of cyber threats, including data breach, information exfiltration, and loss of assets, Intellectual Property (IP) abuse, loss of patient information, blackmail, and duress through the exploitation of exfiltrated sensitive data. Also, the COVID-19 outbreak has increase the agile reliance on software solutions by physicians and policymakers to improve patient care. The FDA has recently underlines the life-threatening security issues and one of greatest incident is WannaCry ransomware cyber-attack targeting x-ray machines and MRI systems in the US and 200,000 windows systems in UK. Thus, cybersecurity will become increasingly imperative and spurring focus among regulators and manufacturers.
Regulatory authorities all over the world have established standards and regulations to assist medical device makers in developing safe and secure linked devices. For instance, a risk management system can be built in compliance with ISO 14971:2019, an international risk management standard. Similarly, FDA, EU, and International Medical Device Regulators Forum (IMDRF) has issued guidelines for management of cybersecurity in medical devices.
Despite challenges related to exploitation of network-connected/configured medical devices by malware, the future outlook for this area is quite bright as the regulatory bodies are setting-up the many guidelines for the healthcare companies to safeguard the medical devices.
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