Note: This is the first in a ten-part series related to Cybersecurity and AI regulatory expectations in the medical product market.
The rapid advancement of technology has revolutionized the healthcare industry, bringing forth innovative medical devices that have improved patient outcomes and overall healthcare delivery. However, with the proliferation and integration of software driven, networked medical devices into the market, concerns regarding cybersecurity vulnerabilities have emerged. Consequently, the Food and Drug Administration (FDA) has recognized the potential risks posed by cyber threats in medical devices and has made significant changes to ensure patient health in the digital age.
The new FDA guidance applies to any and all devices that contain software (including firmware) or programmable logic, as well as software as a medical device (SaMD). Further, this is not limited to networked devices or devices with connection abilities. Any device with software/firmware must have defined procedures and work instructions for end-to-end security: from software development and manufacturer installation, to device end-of-service.
The Evolution of Cybersecurity in Medical Devices
As medical devices have become more connected, the need for robust cybersecurity measures has become increasingly evident. In the past, medical devices were stand-alone or limited to local networks. Recent innovations in healthcare require increased network usage and seamless data exchange between devices and users. In response, manufacturers have introduced connectivity to their devices, exposing them to risks of compromise from malicious attackers.
In response to the evolving landscape of cybersecurity threats, FDA has implemented a proactive approach to ensure the safety and effectiveness of medical devices. The agency has released several cybersecurity guidelines the most recent including the draft guidance – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff, April 08, 2022. The new, draft guidance includes additional design considerations that aim to prevent cybersecurity compromises through out the Total Product Life Cycle (TPLC). This emphasizes the importance for new products to be designed securely and capable of mitigating all cybersecurity risks, including those which may emerge throughout the TPLC.
Cybersecurity is part of device safety and quality system regulations. Before a medical device is brought to market, manufacturers are required to conduct cybersecurity threat analyses, risk management activities, validation processes, and incorporate cybersecurity protocols during the design and development phase. This includes, but is not limited to, identifying threats, vulnerabilities, assets, and impacts to device functionality and user safety. All of which are used to implement design functions and processes that protect the device and the user from cyber threats.
FDA encourages manufacturers to adopt industry standards and best practices, such as encryption, authentication mechanisms, and rapid software validation and deployment to ensure devices remain protected from attacks throughout their lifecycle.
Once a medical device is in use, FDA emphasizes continuous monitoring and timely reporting of cybersecurity issues. Manufacturers are expected to establish effective post-market surveillance systems to promptly identify and respond to potential threats.
Additionally, FDA encourages manufacturers to stay informed on emerging threats and develop effective mitigation strategies to prevent exposure. FDA also promotes design transparency to mitigate security compromises and stop threats before they can cause harm.
MethodSense Provides Cybersecurity Solutions for Your Device
MethodSense is proud to offer tailored solutions for your cybersecurity compliance needs. Our team of experts have ample experience in understanding cybersecurity regulatory expectations, and are here to prepare your device for submission through conducting threat analyses, risk assessments, implementation of cybersecurity controls, and validation processes.
The road through the cybersecurity landscape can be complicated; however, MethodSense makes things easy through established processes and proven techniques that will not only improve your device, but also guide your company through the regulatory gauntlet of the US FDA, EU, UK, Canada and more.