With the increasing use of technology in healthcare, medical devices are becoming more connected than ever. From pacemakers to insulin pumps and heart-lung machines to portable MRIs, these devices are essential for the health and well-being of millions of patients. However, as the number of connected medical devices grows, so do the potential security vulnerabilities. This is why cybersecurity and medical devices have become a critical concern for healthcare professionals, patients, and regulatory agencies such as the Food and Drug Administration (FDA).
Unauthorized access, tampering, and information leakage are potential cybersecurity threats to medical devices. However, security measures can add their own risk and should not impede the function and availability of the device to patients.
Technology integration in healthcare has greatly benefited patients and healthcare professionals alike, but it has also presented new cybersecurity challenges. The FDA and other regulatory agencies are working to ensure that medical device manufacturers take the necessary steps to protect patients from cybersecurity threats. It’s a delicate balance that requires a comprehensive approach to assess and mitigate cybersecurity risks while ensuring patient safety and access to essential medical devices.
Common Medical Device Cybersecurity Threats
There are several common types of medical device cybersecurity threats:
Unauthorized access occurs when an attacker gains access to a medical device without the proper permissions or credentials. This can include physical access to the device and remote access via a network or the internet.
Tampering refers to any unauthorized modification or alteration of a medical device’s functionality. These modifications can include physically altering the device, such as changing the hardware or firmware.
Information leakage occurs when sensitive information, such as patient data, is inadvertently or maliciously disclosed. These disclosures can include data stored on the device and transmitted to or from the device.
Denial of service occurs when a medical device is intentionally or unintentionally made unavailable. This can include physical denial of service, such as by physically destroying a device, and logical denial of service, such as by overwhelming the device with traffic.
Designing for Cybersecurity and Medical Devices
Medical devices have a higher bar than typical electronic devices. A medical device affected by a cybersecurity problem may have the issues of any electronic device, but it also may affect the treatment causing harm or death.
Manufacturers are responsible for the safety of all people that come in contact with their devices. There are specific laws, regulations, and standards that call out the responsibilities and actions required.
When designing a new medical device, manufacturers must take into account the specific cybersecurity risks associated with the device and its intended usage. Devices connected to a local network or the internet each require their own risk-based assessment and implementation of methods to mitigate potential threats.
The manufacturer must take a comprehensive approach to cybersecurity and ensure appropriate mitigations are used for all potential risks.
Risk management is a key aspect of medical device development. Cybersecurity is an increasing part of this process. This process involves identifying and evaluating potential risks and implementing controls to mitigate or eliminate those risks. Implementing encryption, authentication protocols, and regularly updating software to address known vulnerabilities are some of the ways to mitigate cybersecurity risks.
The particular hardware, where it is used, who has access, and other factors will impact the risk and design choices for mitigations. Failure to scale mitigations to risks increases cost and the chance that mitigations will not work, will be hard to maintain, and reduce ease of use of the product.
The FDA and ISO 13485
The FDA has been working closely with manufacturers and healthcare providers to develop best practices for medical device cybersecurity. These include guidance for securing medical devices and recommendations for handling security vulnerabilities when discovered.
The FDA recognizes that cybersecurity risks are unique and require active participation from all parties involved with medical devices to ensure effective cybersecurity measures and controls. The 2022 draft guidance emphasizes transparency by requiring manufacturers to supply technical information, such as manuals, to assist healthcare providers in managing device security and promptly patching the devices as necessary.
ISO 13485 is based on the quality management principles of ISO 9001 but has additional requirements specific to the medical device industry. These include requirements for regulatory compliance, risk management, and post-market surveillance.
Specifically, ISO 13485 requires manufacturers to implement a risk management process to identify and evaluate the risks associated with medical devices. This process should take into account the entire lifecycle of the medical device, from design and development to production, distribution, installation, servicing, and final disposition.
Plan Ahead for the Future of Cybersecurity and Medical Devices
The safety and well-being of those who use medical devices and the advancement of healthcare depend on the future of cybersecurity and medical devices. With the growing number of connected medical devices and the increasing sophistication of cyber-attacks, all stakeholders must work together to ensure that patients are protected. The FDA, manufacturers, healthcare providers, and security agencies must continue collaborating to develop and implement best practices for medical device cybersecurity.
Working with an ISO 13485-certified EMS provider with an in-house design team will ensure your products are designed with proper risk management processes. To determine the most appropriate type of electromechanical design elements for a device, we can work with you to weigh the design implications of different types of components and security measures against the potential benefits of those measures in terms of improved security and compliance with regulators’ expectations.
Nortech Systems is an ISO 13485-certified firm providing comprehensive design solutions to address these issues. By working together, we can create a future where patients can trust that their medical devices are safe, secure, and always working for their benefit. Contact us for more information.