{"id":14907,"date":"2020-09-14T19:54:32","date_gmt":"2020-09-14T14:24:32","guid":{"rendered":"https:\/\/coforge.site\/cigniti\/blog\/?p=14907"},"modified":"2021-02-02T01:38:38","modified_gmt":"2021-02-01T20:08:38","slug":"medical-devices-cybersecurity-testing","status":"publish","type":"post","link":"https:\/\/coforge.site\/cigniti\/blog\/medical-devices-cybersecurity-testing\/","title":{"rendered":"The most effective solution for cybersecurity issues in medical devices"},"content":{"rendered":"

Amidst the growing healthcare connectivity with widespread adoption of medical IoT devices and Software as a Medical Device (SaMD), cyberattacks and patient privacy concerns are also on a rise.<\/span>\u00a0<\/span><\/p>\n

During the pandemic, the healthcare industry has taken some immediate and urgent measures to address the lack of sufficient resources and hastily adopted telehealth and other digital solutions for offering patient care.<\/span>\u00a0<\/span><\/p>\n

Remote medical devices and Software as a Medical Device have proven to be a boon as healthcare institutions were struggling with a severe lack of equipment as well as professionals.<\/span>\u00a0<\/span><\/p>\n

However, as more and more patients adopt smart medical devices as pacemakers, insulin pumps, cardiac implants, or other vital monitoring systems, they are also being exposed to potential cyberattacks.<\/span>\u00a0<\/span><\/p>\n

Axel Wirth, Chief\u00a0<\/span>Security Strategist at MedCrypt said in an interview with\u00a0<\/span>MedTech Intelligence<\/span><\/a>, \u201c<\/span>Security is not purely a technical or engineering issue. Cybersecurity has to become a business objective. An organization must realize strategically how important cybersecurity is and that they need to build a culture of security into development processes from the concept of a new device to it being transferred into manufacturing and eventually shipped to a customer. That entire lifecycle of the device needs to embrace security. It\u2019s a technical topic but it\u2019s not just a technical problem\u2014it\u2019s a business challenge that needs to be looked at as a business problem.<\/span>\u201d<\/span>\u00a0<\/span><\/p>\n

The cybersecurity threat on medical devices is real and here, demanding immediate attention from those concerned.\u00a0<\/span>Let us understand how the cybersecurity issues can be solved effectively<\/span>\u00a0with\u00a0<\/span>medical devices testing<\/span><\/a>\u00a0and security testing.<\/span>\u00a0<\/span><\/p>\n

The state of medical devices cybersecurity<\/span><\/b>\u00a0<\/span><\/p>\n

Earlier this year, the U.S.\u00a0<\/span>Food\u00a0<\/span>and<\/span>\u00a0Drug Administration<\/span><\/a>\u00a0informed patients, providers, and manufacturers about potential cybersecurity vulnerabilities in certain medical devices using Bluetooth Low Energy.\u00a0<\/span>\u00a0<\/span><\/p>\n

Known as \u2018SweynTooth\u2019, the vulnerabilities upon exploitation may allow<\/span>\u00a0an unauthorized user to wirelessly crash the device, stop it from working, or access device functions normally only available to the authorized user.<\/span>\u00a0<\/span><\/p>\n

Suzanne Schwartz, deputy director of the Office of Strategic Partnerships and Technology Innovation in the FDA\u2019s Center for\u00a0<\/span>Devices and Radiological Health commented \u2013<\/span>\u00a0<\/span><\/p>\n

\u201c<\/span>Medical devices are becoming increasingly connected, and connected devices have inherent risks, which make them vulnerable to security breaches. These breaches potentially impact the safety and effectiveness of the device and, if not remedied, may lead to patient harm<\/span>.\u00a0<\/span>The FDA recommends that medical device manufacturers stay alert for cybersecurity vulnerabilities and proactively address them by participating in coordinated disclosure of vulnerabilities as well as providing mitigation strategies. An essential part of the FDA\u2019s strategy is working with manufacturers, health care delivery organizations, security researchers, other government agencies and patients to address cybersecurity concerns that affect medical devices in order to keep patients safe.\u201d<\/span>\u00a0<\/span><\/p>\n

Have a look at these alarming statistics pertaining to medical devices security status:<\/span>\u00a0<\/span><\/p>\n