{"id":24750,"date":"2023-07-10T18:12:12","date_gmt":"2023-07-11T01:12:12","guid":{"rendered":"https:\/\/www.privateinternetaccess.com\/blog\/?p=24750"},"modified":"2025-04-16T00:39:18","modified_gmt":"2025-04-16T07:39:18","slug":"medical-device-cybersecurity","status":"publish","type":"post","link":"https:\/\/www.privateinternetaccess.com\/blog\/medical-device-cybersecurity\/","title":{"rendered":"Why Medical Device Cybersecurity Is Essential"},"content":{"rendered":"\n

Everything from wearable and remote devices to the CT, MRI, ultrasound, and X-ray machines you find in hospitals is connected to a network, and anything connected to the internet is vulnerable to cyber attacks \u2014 no exceptions<\/strong>. That includes your smartwatch, and health apps on your smartphone, which contain location and sensitive health information.\u00a0<\/p>\n\n\n\n

Unfortunately, the growing cybersecurity risks for medical devices hasn\u2019t increased healtcare\u2019s attention to security. Many providers have inadequate budgets for development or testing and don\u2019t provide necessary updates to the software, primarily because they never planned for it when first developing the devices and software.<\/p>\n\n\n\n

The healthcare sector isn\u2019t any better, as only 4-7% of the average healthcare facility\u2019s budget is spent on cybersecurity<\/strong>. Most other industries spend up to 15%, including companies in the financial sector. There\u2019s a pressing demand for stronger medical device cybersecurity, and the FDA\u2019s recent addition of Section 524B (Ensuring the Cybersecurity of Devices) to the FD&C Act, reflects this need.<\/p>\n\n\n\n

Read on to discover why cybersecurity is essential for network-connected medical devices<\/strong>, what the government is doing to address the problem, and why your data is at risk.<\/p>\n\n\n\n

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Table of Contents<\/h4>\nWhat Is Medical Device Cybersecurity?<\/a>
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Medical Device Cybersecurity Vulnerabilities<\/a><\/section>\n
CMD Examples, Uses & Risks<\/a><\/section>\nRecent Healthcare Cybersecurity Breaches & Attacks<\/a>
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Diving Deeper \u2014 Other Well-Publicized CMD Security Incidents<\/a><\/section>\nCurrent FDA Medical Device Cybersecurity Standards<\/a>
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FD&C Act, Section 524B \u2014 A Brief Overview of Key Points<\/a><\/section>\n
What the Changes Mean for Healthcare Providers & Manufacturers<\/a><\/section>\n
Do Hospitals & Healthcare Providers Currently Meet FDA Guidelines?<\/a><\/section>\nHow to Protect Your ePHI and PII<\/a>
\nBe Proactive \u2014 Protect Your ePHI and PII<\/a>
\nFAQ<\/a>
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What Is Medical Device Cybersecurity?<\/strong><\/h2>\n\n\n\n

Medical device cybersecurity refers to the steps taken to ensure any medical device connected to a network is protected from cyberthreats<\/strong>, so patient electronic protected health information (ePHI) and personally identifiable information (PII) remain private. This includes all remote and in-house technologies in the healthcare sector<\/strong>, as well as any apps that are part of healthcare services.\u00a0<\/p>\n\n\n\n

The International Medical Device Regulatory Forum provides several ways for medical device manufacturers to improve cybersecurity<\/strong>, urging them to consider the following factors:<\/p>\n\n\n\n

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  • How the device interacts with other devices and networks<\/strong>, how it communicates with devices supporting less secure methods of communication, and how to prevent unauthorized access and modification during data transfer.<\/li>\n\n\n\n
  • How the device could interfere with other devices and networks<\/strong>, if it may cause the software to lag or work improperly, if it\u2019s cross-compatible with other devices, and whether custom-made devices (CMDs) may cause network disruption.\u00a0<\/li>\n\n\n\n
  • Whether the level of encryption and other security measures for data storage and transfer are adequate, and if confidentiality risk control measures are required<\/strong>.<\/li>\n\n\n\n
  • Any risks affecting device integrity<\/strong>, including evaluating system-level architecture to determine if all obligatory design features are present alongside anti-malware controls.<\/li>\n\n\n\n
  • Methods of user access control and how to securely assign user roles and privileges<\/strong>.<\/li>\n\n\n\n
  • How to communicate information about regular updates, how software and hardware will be updated,<\/strong> requirements for conducting updates, and code verification for connection authenticity, as well as any other control measures in place.<\/li>\n<\/ul>\n\n\n\n

    <\/p>\n\n\n\n

    Medical Device Cybersecurity Vulnerabilities<\/strong><\/h3>\n\n\n\n

    The biggest concern with any form of medical device is the large quantities of ePHI and PII they collect and store daily. Add poor cybersecurity to the mix and medical devices are prime targets for malware attacks, data theft, and device hijacking<\/strong>.\u00a0<\/p>\n\n\n\n

    It isn\u2019t just the new medical gadgets that are vulnerable \u2014 the FBI has increased concerns over legacy devices, as they pose some of the worst risks. Legacy software, protocols, and hardware are often outdated as medical firms don\u2019t put much focus on upgrades or on cybersecurity of any kind<\/strong>. An overall lack of security makes older devices like insulin pumps a prime target for cybercriminals and results in deadly consequences.\u00a0<\/p>\n\n\n\n

    Medical devices are constrained by ethical, budgetary, and regulatory factors<\/strong>, including compliance with regulations in the US, EU, China, Australia and the UK to enter medical devices into the market.\u00a0<\/p>\n\n\n\n


    Legislation surrounding medical device cybersecurity also varies from one region to another. For example, the European Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Device Regulation (IVDR) define multiple cybersecurity regulations under \u2018\u2019general safety and performance requirements\u2019. The US Food and Drug Administration (FDA) offers guidance documents explaining how manufacturers can meet all necessary cybersecurity requirements for medical devices.<\/p>\n\n\n\n

    While CMDs give patients more freedom in terms of where and when medical treatments and monitoring can happen, they raise<\/strong> serious concerns over the privacy challenges associated with transmitting large amounts of patient information<\/strong>. Several laws are in place to help safeguard patient data including the EU\u2019s General Data Protection Regulation (GDPR), the US\u2019s FD&C Act Section 524B, and the UK\u2019s Data Protection Act 18 (DPA18).<\/p>\n\n\n\n

    Violating any of the above regulations can be incredibly expensive<\/strong>, not to mention the damage it does to the manufacturer or healthcare facility\u2019s reputation. Penalties can range from millions in fines and damages to patent refusals. Despite this, many CMD manufacturers still don\u2019t take cybersecurity seriously<\/strong> during and after device development.\u00a0<\/p>\n\n\n\n

    Unauthorized access<\/strong> is also a major concern <\/strong>as it can have more severe consequences than data theft. Attacks on CMDs can put a patient in danger and even cause fatalities. Without proper management, cybersecurity incidents can easily result in unintentional device malfunctions or delay necessary treatments.\u00a0<\/p>\n\n\n\n

    Other key areas of neglect include establishing product security incident report teams<\/strong>, providing timely updates and patches to devices, and post-development cybersecurity planning. Providing updates and patches in a timely manner<\/strong> ties into the lack of ownership and responsibility for legacy and non-legacy CMDs within healthcare institutions. Similarly, a small budget can influence the adequacy of pre and post-development planning, ultimately leaving devices more vulnerable to threats.<\/p>\n\n\n\n

    This gross oversight means cybercriminals view healthcare providers, and the medical industry in general, as easy targets. So, exactly how much ePHI and PII do you put at risk using a CMD<\/strong>? Let\u2019s take a look at the various types of CMDs and the cybersecurity risks accompanying them.<\/p>\n\n\n\n