FDA Rolls Out New Guidelines for Medical Network Device Security
As medical devices become more sophisticated and the Software as a Medical Device (SaMD) business grows in popularity, it is critical to ensure that your medical equipment is cyber-secure. Because of the huge volumes of health information and data, such as patient health, product performance, or data from other devices linked to the same network, the healthcare business has long been a target of cyber assaults. Due to the increase in cyber assaults on medical devices, the FDA (U.S. Food and Drug Administrator) released a Guideline for cybersecurity in medical devices manufacturers on how to secure their devices from assaults. In this blog, we will discuss the importance of cybersecurity, the guidelines of the FDA, and how to protect IoMT (Internet of Medical Things). Understanding the Cyber Threats of Medical Devices Many healthcare assaults utilize phishing and the establishment of persistent threats within networks and devices in order to attack when the potential benefits are greatest. 327 data breaches have been reported since the beginning of 2023. According to research, that statistic has grown more than 104% from 160 breaches as of mid-2022 and shows “no signs of abating.” In 2023, cyberattacks targeted more than 40 million individual patients, representing a 60% rise year on year for the first six months. According to the report, there were five breaches of at least 3 million data each in the first half of 2023, compared to a single breach of 2 million records last year. Healthcare business associates are also in danger, accounting for 14% of all reported breaches and increasing from 22 in mid-2020 to 82 this year. According to the study, this is a 273% increase. Talk to our Cybersecurity Expert to discuss your specific needs and how we can help your business. Schedule a Call FDA Cybersecurity Guidelines for Securing Medical Network Devices While the new guidance is similar in structure and content to the previous version, it adds two new substantive sub-sections to the original security risk management section: A new appendix identifying which specific documentation elements recommended for inclusion in premarket submissions will also apply to IDE submissions, Several cybersecurity term definitions. September 26, 2023: The FDA supports the establishment and use of a “Secure Product Development Framework,” or “SPDF.” This defines as a collection of activities that limit the number and severity of vulnerabilities in products across the device lifecycle. The SPDF is meant to be the core structure which manages cybersecurity risk, and focuses on three main elements: security risk management security architecture cybersecurity testing The guideline also mentions IEC 81001-5-1, a health software reference standard, as a viable framework to explore developing the SPDF. To assist in showing device safety and efficacy, the FDA Cybersecurity Guidance continues to suggest including a security risk management report in a premarket submission. The revised guidance’s modified security risk management section includes two new sub-sections, the first of which is on “Cybersecurity Risk Assessments.” The guideline acknowledges that cybersecurity risks are difficult to foresee and that previous data or modeling cannot estimate and quantify the possibility of an incident occurring. As a result, a cybersecurity risk assessment should concentrate on the exploitability of vulnerabilities existent within a device or system, as well as those that anticipates to exist in the context of use. The FDA recommends that the cybersecurity risk assessment include not only the risks and controls identified in the threat model but also the methods used for scoring such risks before and after mitigation, as well as the associated acceptance criteria, as well as the method for transferring security risks into the safety risk assessment. The risk management section also includes a new section on “Interoperability Considerations,” which addresses cybersecurity concerns that may arise from interoperable functionality. This includes interfaces with other medical devices and accessories and other functions. The guidance states that properly implemented cybersecurity controls will help ensure the safe and effective exchange and use of information. It also advises device manufacturers to assess whether additional security controls beneath common technology and communication protocols such as Bluetooth and network protocols are required to ensure safety and effectiveness. The guidance advises device manufacturers to consider the appropriate cybersecurity risks and controls that associates with interoperability capabilities and ensure they are in the document. According to FDA requirements, all cybersecurity efforts must be well documented and traceable, including records of risk assessments, security controls, testing findings, and mitigation plans. This paperwork must provide useful information for post-market monitoring and risk management. The FDA emphasizes the need to regularly monitor and analyze cybersecurity threats throughout the lifespan of a device. Manufacturers are expected to have mechanisms in place to identify, respond to, and mitigate cybersecurity events in a timely manner, assuring the device’s continuous safety and efficacy. These recommendations define the material necessary for premarket filings, ensuring manufacturers present enough documentation of their cybersecurity risk management strategies. This comprises documentation of risk assessments, security controls, testing findings, and a cybersecurity risk management plan for the device. The FDA is asking for an SBOM (Software Bill of Materials), which is a complete inventory of all software components that utilizes in a medical device, including those generated by the maker and those developed by third parties. An SBOM helps device makers and users discover possible security threats in a timely way, hence facilitating risk management processes. The Mandates of Cybersecurity in Medical Devices FDA Testing, like other aspects of product development, uses to show the efficacy of design controls. While software development and cybersecurity are closely related disciplines, cybersecurity controls necessitate testing that extends beyond standard software verification and validation activities. This is a need in order to demonstrate the effectiveness of the controls in a proper security context. This demonstrates that the device has a reasonable assurance of safety and effectiveness. A manufacturer requires to create and maintain processes for validating the device design. This verification must ensure that the design output satisfies the criteria of the design input. A manufacturer requires to create and maintain processes
