Healthcare organizations face an unprecedented cybersecurity crisis as medical devices become increasingly connected and vulnerable to cyber attacks. The convergence of life- saving technology with internet connectivity has created a new frontier for cybercriminals, where the stakes extend far beyond financial losses to include patient safety and critical healthcare delivery.
FDA notes that “Cyber-incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care” highlighting the real- world impact of these emerging threats.
The Food and Drug Administration has responded to escalating cybersecurity risks by implementing comprehensive new regulatory requirements for medical device manufacturers.
The Food and Drug Omnibus Reform Act (FDORA), part of the Consolidated Appropriations Act for 2023. This act authorizes the FDA to mandate cybersecurity information in submissions for “Cyber devices” and ensures that manufacturers demonstrate these devices are “cyber secure”.
These requirements represent a fundamental shift from voluntary guidelines to mandatory security standards with enforcement capabilities.
The scope of vulnerable medical devices extends across the entire healthcare ecosystem, from simple monitoring equipment to complex surgical robots. Cyber devices are medical devices incorporating software that, according to the March 2024 FDA update, are network-capable (e.g. can connect to the internet or an intranet) and are thus susceptible to cybersecurity threats.
This broad definition encompasses thousands of device types currently deployed in healthcare facilities worldwide, each representing potential attack vectors for malicious actors.
Medical device cybersecurity challenges are amplified by the unique operational requirements of healthcare environments. Unlike traditional IT systems that can be regularly updated or temporarily taken offline for maintenance, medical devices often require continuous operation to support patient care. This guidance applies broadly to all devices with cybersecurity considerations, including devices that have a software function, contain software or programmable logic, and are network-enabled. Practically, this includes everything from a programmable thermometer to an artificial intelligence-enabled diagnostic device.
Legacy medical devices present particularly acute security challenges due to outdated software, limited update capabilities, and designs that prioritized functionality over security.
Many hospitals operate medical equipment that was deployed years or decades ago, when
cybersecurity was not a primary design consideration. These systems often run outdated operating systems, lack modern security features, and cannot be easily updated without significant costs or operational disruptions.
The regulatory landscape for medical device cybersecurity has evolved rapidly to address these emerging threats. The final guidance also rests on new statutory authority explicitly authorizing FDA to (1) require cybersecurity information in medical device submissions for “cyber devices” and (2) require that manufacturers take certain actions to demonstrate reasonable assurance that such devices and related systems are “cybersecure”. This authority includes enforcement mechanisms that can result in criminal prosecution or injunctive relief against non-compliant manufacturers.
Medical device manufacturers must now demonstrate cybersecurity throughout the entire product lifecycle, from initial design through post-market monitoring and updates. Submit a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures. These requirements ensure that cybersecurity remains a priority throughout the operational life of medical devices rather than just during initial development phases.
The integration of artificial intelligence and machine learning technologies in medical devices creates additional cybersecurity considerations. Recently, the FDA acknowledged that artificial intelligence and machine learning (AI/ML) will play a critical role in medical device development, in part through cross-system integration. AI-enabled medical devices may be particularly vulnerable to adversarial attacks designed to manipulate machine learning algorithms and compromise diagnostic accuracy or treatment recommendations.
Interconnected medical systems amplify cybersecurity risks through network effects that can cascade across healthcare facilities. When medical devices connect to hospital networks, electronic health record systems, and other healthcare infrastructure, compromising one device can provide attackers with access to broader systems containing sensitive patient data or controlling critical medical equipment. This interconnectedness requires comprehensive security architectures that protect both individual devices and the broader healthcare ecosystem.
Supply chain security presents additional challenges for medical device cybersecurity, as devices often incorporate third-party software components with their own vulnerabilities.
Provide a software bill of materials, including commercial, open-source, and off-the-shelf software components. This requirement enables healthcare organizations and regulators to understand the complete software supply chain for medical devices and assess potential risks from third-party components.
Manufacturers must implement secure product development frameworks that integrate cybersecurity considerations from the earliest design phases. The FDA recommends implementing a secure product development framework (SPDF) to address cybersecurity risks. The FDA recommends that, among other things, the SPDF be incorporated at each stage of device development. This approach helps prevent the need to retrofit security features after development completion, which is often more expensive and less effective than security-by-design approaches.
Healthcare organizations face significant operational challenges in implementing comprehensive medical device cybersecurity programs. Many hospitals lack specialized cybersecurity personnel with expertise in medical device security, while budget constraints limit their ability to invest in necessary security technologies and training. Additionally, the clinical staff who operate medical devices may have limited cybersecurity knowledge, creating operational security gaps. Device labeling and user education represent critical components of medical device cybersecurity that directly impact patient safety.
Moreover, the FDA advises that device labeling should include an accurate description of the medical device’s cyber risks, but in a way that is easy to understand to the “average user”. This requirement ensures that healthcare providers understand the cybersecurity risks associated with the medical devices they operate and can take appropriate protective measures.
Post-market surveillance and vulnerability management require ongoing collaboration between manufacturers, healthcare organizations, and regulatory agencies. Medical device manufacturers must establish processes for identifying and addressing cybersecurity vulnerabilities discovered after devices are deployed in clinical settings. The 2016 guidance “Post-market Management of Cybersecurity in Medical Devices” discusses cybersecurity routine updates and patches and describes patching in the context of remediating cybersecurity vulnerabilities.
Emergency preparedness and incident response planning must account for the unique characteristics of medical device cybersecurity incidents. When critical medical equipment is compromised, healthcare organizations must be prepared to maintain patient care using alternative procedures while addressing cybersecurity threats. This requires specialized incident response procedures that prioritize patient safety while enabling effective cybersecurity response.
International cooperation and information sharing are essential for addressing medical device
cybersecurity threats that can affect healthcare systems globally. Cybersecurity vulnerabilities in widely-deployed medical devices can impact healthcare organizations worldwide, making coordinated threat intelligence sharing and response capabilities critical for protecting global healthcare infrastructure.
The future of medical device cybersecurity will likely involve increased automation, enhanced monitoring capabilities, and more sophisticated threat detection systems specifically designed for healthcare environments. As medical devices become more interconnected and incorporate advanced technologies like artificial intelligence, the cybersecurity challenges will continue to evolve, requiring ongoing innovation in both defensive technologies and regulatory frameworks to protect patient safety and healthcare delivery.
