Medical device cybersecurity is a critical aspect of healthcare technology, aimed at protecting medical devices and the networks they operate on from digital threats. As medical devices, ranging from pacemakers to MRI machines, become increasingly interconnected and reliant on internet and network connectivity, they are exposed to potential cybersecurity risks. These risks can include unauthorized access, data breaches, and even remote manipulation of device functions, which could have severe implications for patient safety.
Despite the risks, the benefits of building connected medical devices are so significant, that they usually outweigh them.
Why Connect Medical Devices?
Bringing connectivity to medical devices enables a a huge improvement in the quality of care patients receive and enables diagnosis and treatment that was not previously possible. Some of the benefits of connected medical devices include:
- Real-Time Monitoring – Instead of waiting for a long time before the results are analyzed, connected devices provide real time monitoring capability that can improve lives, log errors and issues
- Device Upgrades – instead of returning to get fixes to issues in devices, a connected medical device can be upgraded conveniently without complicated logistics, reducing time and costs
- User Control – connectivity enables consumers to control and adjust their devices during operation for comfort or other purposes which enhances the therapy provided
- Improved Diagnostics and Monitoring – by capturing data wherever the patient is, doctors can discover problems that other systems can’t find because they didn’t get the information before
Connected medical devices are expected to reach a CAGR of 29.5% by 2028.
What’s Medical Device Cybersecurity?
Medical device cybersecurity refers to the practices, technologies, and policies used to protect medical devices from cyber threats and unauthorized access. As medical devices become increasingly interconnected and reliant on software, they are more vulnerable to cybersecurity risks. These risks can impact patient safety, data privacy, and the overall functioning of the healthcare system.
Some aspects of cybersecurity for medical devices include:
- Data Protection: Ensuring the confidentiality, integrity, and availability of patient data processed or stored by the device. This includes protecting against unauthorized access and data breaches.
- Device Integrity: Securing the device from tampering or unauthorized changes to its software or hardware, which could affect its performance and reliability.
- Compliance and Standards: Adhering to regulatory requirements and industry standards for cybersecurity in medical devices. Regulatory bodies like the U.S. Food and Drug Administration (FDA) provide guidelines and requirements for medical device cybersecurity.
- Risk Management: Continuously assessing, managing, and mitigating cybersecurity risks throughout the device’s lifecycle, from design and development to deployment and decommissioning.
- Incident Response and Recovery: Preparing for and responding to cybersecurity incidents, including having a plan for recovery and maintaining device functionality.
Why are Medical Devices attacked?
Attacks on medical devices stem from a variety of motivations and manifest in different forms, ranging from cyber-attacks to physical tampering. One of the primary reasons for such attacks is financial gain.
Medical devices often contain sensitive patient data, including personal information and health records, which can be valuable for identity theft, fraud, or resale on the black market. By breaching the security of these devices, attackers can access and exploit this data.
Another motivation for attacking medical devices is to disrupt healthcare services, either as a form of protest or to demonstrate the vulnerabilities in the healthcare system. In some cases, these attacks can be politically motivated, with the intent to undermine public trust in healthcare institutions or to cause panic.
Additionally, the increasing reliance on interconnected medical devices and the Internet of Things (IoT) in healthcare has expanded the attack surface, making these devices more vulnerable to hacking. This vulnerability is exacerbated by the fact that many medical devices were not originally designed with robust cybersecurity measures in mind.
Attacks on medical devices can have dire consequences. They can compromise the functionality of critical devices such as pacemakers, insulin pumps, and hospital monitoring systems, potentially putting patients’ lives at risk. This risk is particularly concerning in the case of ransomware attacks, where attackers lock healthcare providers out of their systems and demand payment to restore access. These attacks not only jeopardize patient safety but also disrupt healthcare operations.
Benefits of Securing Medical Devices
Building a secure medical device has a significant number of benefits which go beyond simply complying with regulators and the law.
Medical devices, especially those of class II and class III, have a potential to significantly harm or even kill a user. The ramifications for such an event would be significant scrutiny and harm for the product’s maker. This is likely to result in criminal and civil penalties as well as product liability lawsuits.
Consumers are constantly evaluating products for safety and security. Products that experience breaches quickly lose consumer trust, impacting sales.
Challenges in Medical Devices Cybersecurity
The cybersecurity of medical devices presents a multitude of challenges, largely due to the unique environment in which they operate and the critical role they play in patient care. Here are several key challenges:
- Complex Lifecycle – as opposed to consumer electronic devices, medical devices can often be refurbished and returned to the manufacturer for analysis, both of which present challenges from a security perspective
- Regulatory requirements – due to the potential impact and the sensitive information contained in these devices, regulations for connected medical devices mean a high bar to successfully launch products including significant R&D, quality, testing and validation efforts
- Sensitive Data – As opposed to other types of devices, medical devices contain sensitive patient information that is valuable and sought after by attackers
- High Impact – Medical devices that provide therapy can be attacked to harm the patient
Regulatory Requirements for Medical Device Security
Regulatory requirements for medical device security are critical components of healthcare compliance, designed to protect patients and ensure the confidentiality, integrity, and availability of medical information. These requirements address the growing threats to medical devices from cyberattacks and other vulnerabilities that can potentially impact patient care.
In the United States, the Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and security of medical devices. The FDA issues guidelines that recommend manufacturers to address cybersecurity throughout the device’s lifecycle. For premarket submissions, the FDA recommends that manufacturers provide documentation to the FDA about the risks identified and controls in place to mitigate those risks. They are also expected to monitor and report on the effectiveness of those controls.
In the European Union, through the European Union Agency for Cybersecurity (ENISA) provides guidelines that support the EU’s cybersecurity strategy. Although ENISA itself does not regulate medical devices, it influences regulations such as the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations have raised the bar for device security, requiring robust risk management and post-market surveillance systems.
These regulatory bodies and their requirements are not static; they evolve in response to emerging threats and technological advances. Compliance with these regulations is not just a legal obligation for device manufacturers but also a crucial factor in the broader effort to protect public health and maintain trust in healthcare systems.
Manufacturers are encouraged to adopt a proactive approach to cybersecurity, anticipating potential vulnerabilities and addressing them before they can be exploited. Beyond just regulatory requirements, there are many reasons to focus on cybersecurity, including:
- Hardware Protection – The security of the device’s hardware is critical in protecting it. This means defending against threats such as firmware extraction and tampering which requires the right combination of silicon and circuit board design to mitigate hardware security. This helps protect the IP and design.
- Firmware Protection – almost all medical devices include software, usually referred to as firmware, that controls the device. Whether the firmware is in the device or if it’s being transferred, it’s critical to make sure it is protected from being accessed. Signed and Encrypted firmware along with proper silicon controls such as secure bootloaders and secure firmware update are critical to prevent the firmware from being accessed by hackers who will reverse engineer it to exploit it. Along with hardware protection, firmware helps protect intellectual property and design.
- Secure Communication and Protocols – Connected medical devices are constantly transferring data wirelessly, which enables attackers to capture it. Securing these communications properly is critical to protecting the data and this requires the right communication systems, protocol and security.
- Access Controls – securing access to the medical device requires proper design while following best practices such as least privilege. Access needs to be evaluated throughout the lifetime of the device including manufacturing, end use, refurbishment and engineering analysis.
- Device Data Security – Medical devices contain significant amount of data, either personally identifiable information (PII) or medical information. Protecting this data is critical from a regulatory and consumer standpoints since it’s some of the most valuable information to attackers
- Cybersecurity attack monitoring – Once a medical device is deployed, it needs to be continually monitored for signs of attacks. This means
References
Internet of Medical Things (IoMT) Market Size & Share Analysis – Growth Trends & Forecasts