The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare environment, both in the hospital and at home, comes with the possibility of cyberattacks and intrusions against a compromised connected medical device and the network to which such a device is connected. Install cryptographically authenticated firmware and software updates and do not allow installation where such cryptographic authentication either is absent or fails. This documentation includes threat modeling to identify risks and vulnerabilities across the device system and countermeasures for addressing the risks and vulnerabilities. By John Giantsidis, president, CyberActa, Inc. This includes requirements from internal sources (e.g., the organizations policies, business objectives, and risk management strategy) and external sources (e.g., applicable laws and regulations). Emergo by UL's new human factors tool - provides training, tools, and resources. List of software anomalies or statement that there are none. A list of network ports and other interfaces that are expected to receive and/or send data. Protect the integrity of data necessary to ensure the safety and effectiveness of the device. Meet our MDR team and get free educational resources on the MDR. Plans to communicate vulnerabilities including: Information Transparency Clarifications and Changes Overview. the risk of patient harm due to vulnerability exploitation. Since 2005, the FDA has been striving to enhance medical device cybersecurity, and the latest FDA effort is a draft guidance that expects security throughout the total product life cycle (TPLC). Verify integrity of code while it is being executed on the device. system security objectives and requirements. Although TPLC is mentioned in the 2014 guidance, the detailed expectations were not clear. For example, a device that is not connected to an external network and connects only through a USB interface is lower risk and will require less cybersecurity disclosures, while more complex, network-connected devices carry greater vulnerabilities, requiring more extensive documentation in the premarket submission. This includes certification, Notified Body and consultancy services. The following cybersecurity testing and corresponding objective evidence would be considered the minimum that may support a premarket submission: The FDAs medical device cybersecurity guidance would require that manufacturers devices with software, firmware, or programmable logic, as well as software as a medical device (SaMD), minimize the cybersecurity risks associated with the design, safety, and use of those devices. Premarket submissions should also contain documentation related to each third-party software component, including a SBOM and supporting information such as the components name, version, manufacturer, and end-of-support date and known vulnerabilities associated with the component. Without doubt, this issue will continue to be front-of-mind on Capitol Hill while the Russian attack on the Ukraine continues. Controls for software to maintain integrity from origin to leaving control of manufacturer. To satisfy FDAs Quality System Regulation (QSR), device manufacturers should establish design controls that include software validation and risk analysis procedures. When assessing and addressing the cybersecurity risks associated with devices, the draft guidance recommends that manufacturers consider their devices in the context of the larger medical device system, which includes all of the devices and systemssuch as health care facility networksthat may use or be used with a device. On April 8, 2022, the US Food and Drug Administration published a new draft guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, replacing the 2018 draft guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. It is important to note that this guidance does not replace the following guidance documents at this time: The intent is that when this draft guidance is finalized, it will replace the 2014 cybersecurity guidance. Both the 2014 and the new medical device cybersecurity draft guidance documents indicate that the extent of the requirements necessary for a specific device depends on several factors. define security context, domains, boundaries, and external interfaces of the system. Such information includes, among other things, instructions and product specifications related to cybersecurity controls, detailed diagrams to enable controls to be implemented, lists of network ports and interfaces that send or receive data, guidance on supporting infrastructure requirements, and the SBOM. Threats that the device may be exposed to, and how those threats may be prevented or mitigated. Reuse Existing, Well-Secured Software When Feasible Instead of Duplicating Functionality: Lower the costs of software development, expedite software development, and decrease the likelihood of introducing additional security vulnerabilities into the product by reusing software modules and services that have already had their security posture checked. FDA explains that certain quality system requirements related to cybersecurity will apply to the premarket and post-market stages of the device lifecycle, and applicable requirements may differ depending on the device. Although FDA guidance is not binding, recently proposed legislation could require that premarket submissions include cybersecurity information. View All. identify security-relevant system elements and their interfaces. After release, cybersecurity testing should be performed at regular intervals (annually) to ensure that potential vulnerabilities are identified prior to being exploited. Safety risk assessment for each known vulnerability. Copyright 2022 Ropes & Gray LLP. Software bill of materials (SBOM) including the following information per software component, in a machine readable format: If manufacturer does not have custodial control of third-party source code, a plan of how the third-party software component could be updated or replaced. Ever since the TV show Homeland dramatized a terrorist remotely hacking the Vice Presidents pacemaker in 2012, the need to secure medical devices has captivated the attention of policymakers. The FDA borrows from NIST and introduces a Secure Product Development Framework (SPDF) concept, akin to NISTs Secure Software Development Framework5 and suggests that such integration with product and software development, risk management, and the quality system at large can satisfy cybersecurity QSR. The new draft cybersecurity guidance covers both quality system considerations and the content of premarket submissions (such as 510(k), de novo and premarket approval (PMA) applications), whereas both the 2014 and the 2018 versions of the guidance focused primarily upon the content of premarket submissions. A description of the methods for retention and recovery of device configuration by an authenticated authorized user. With regard to a devices security architecture, FDA recommends that premarket submissions include viewsdiagrams and text explaining the design. Moreover, manufacturers must put in place processes and controls to ensure that their suppliers conform to the manufacturers cybersecurity requirements. Threat modeling documentation shall ultimately demonstrate how the risks assessed and controls implemented for the system address questions of safety and effectiveness. Get the latest articles from Med Device Online delivered to your inbox. The manufacturers process for communicating end of support or end of life. 401(k)/403(b) Plan Litigation Risk Management, Analytics & Behavioral Science Consulting (R&G Insights Lab), E-Discovery, Discovery Strategies & Data Analytics, Executive Compensation & Employee Benefits, Government Enforcement / White Collar Criminal Defense, FDA Proposed Rule Would Harmonize U.S. Quality System Requirements for Medical Devices with International Standard, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Medical Devices Hit by Ransomware for the First Time in US Hospitals, Evolution of Global Real Estate Investment in Life Sciences. Employ tamper evident seals on device enclosures and their sensitive communication ports to help verify physical integrity. Another effort is bipartisan congressional support of the Protecting and Transforming Cyber Health Care Act of 2022 (PATCH Act of 2022),4which, if passed, would revise the existing Federal Food, Drug, and Cosmetic Act. However, the 2022 draft guidance significantly increases the amount of information that must be provided for FDA review. Adequacy of risk controls for threat mitigation. The FDA clarifies that threat modeling should be used to identify security objectives, risks, vulnerabilities and countermeasures. The FDA outlines the following labeling to communicate security information to users: The FDA guidance further expects that manufacturers institute a formal plan for how they will identify and communicate vulnerabilities that are identified after releasing the device to users. As draft labeling is provided to the FDA during a premarket submission, the FDA will review this. Information on securely decommissioning devices by sanitizing the product of sensitive, confidential, and proprietary data and software. entity authentication of communication endpoints, whether those endpoints consist of software or hardware, integrity of the execution state of currently running software, and. Table 2 provides an overview of the information that the FDA specifically expects to be included in premarket submission according to the 2014 and the new 2022 guidance documents. Validate that all data originating from external sources is well-formed and compliant with the expected protocol or specification. This is intended to be an overview only, and does not address all details. Recommended cybersecurity controls, such as anti-malware, firewall use, and password requirements. Assessment of anomaly impact on security using a common weakness enumeration (CWE) categorization (such as by AAMI SW91). John Giantsidis is the president of CyberActa, Inc, a boutique consultancy empowering medical device, digital health, and pharmaceutical companies in their cybersecurity, privacy, data integrity, risk, regulatory compliance, and commercialization endeavors. Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. Device instructions and product specifications related to recommended cybersecurity controls appropriate for the intended use environment (e.g., anti-malware software, use of a firewall, password requirements). Attorney advertising. The draft guidance outlines the type of documentation regarding safety and security risks that manufacturers should include in premarket submissions. Where appropriate, how forensic evidence is captured, including where log files are located, stored, recycled, archived, and consumed by automated analysis software. Prior results do not guarantee a similar outcome. Comments on the draft guidance are due on July 7, 2022. Security risk management report including: % identified vulnerabilities updated / patched (defect density). On April 8, 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance document titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.1 The draft guidance, if finalized, would replace FDAs 2014 final guidance document titled, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which was discussed in a previous Ropes & Gray Alert. US FDA warns of cybersecurity vulnerabilities in Axeda medical device software, FDA resources for medical device companies on 510(k) premarket application review timeframes and communications, FDA finally proposes greater harmonization of US QMS requirements to ISO 13485. A word of caution, however: Any risks transferred to the user should be detailed and considered for inclusion as tasks during usability testing (e.g., human factors testing) to ensure that the user has the capability to take appropriate actions to manage those risks. Create Source Code by Adhering to Secure Coding Practices: Decrease the number of security vulnerabilities in the software and reduce costs by minimizing vulnerabilities introduced during source code creation that meet or exceed organization-defined vulnerability severity criteria. If corrective and preventive actions are identified, these views can be used to help identify impacted functionality and solutions that address the risks. The extent to which security requirements are needed to meet these objectives would depend on: For example, a device would be deemed that it appropriately accounts for authenticity when it evaluates and ensures authenticity for: The expectations for demonstrating Integrity (Code, Data or Execution) provide an illustrative example: The FDA guidance concludes that transparency is critical to ensure safe and effective use and integration of devices and systems and such transparency can be conveyed via both device labels and vulnerability management plans. Learn from our experts through live events. The FDA guidance sets the expectation that the security risk assessment is to focus on exploitability, or the ability to exploit vulnerabilities present within a device and/or system, and the FDA recommends that manufacturers establish a security risk management process that encompasses, at a minimum, design controls, validation of production processes, and corrective and preventive actions to ensure both safety and security risks are adequately addressed. Configure Product to Have Secure Settings by Default: Help improve the security of the product at the time of installation to reduce the likelihood of the product being deployed with weak security settings, putting it at greater risk of compromise. A platform of digital products to improve, simplify and automate RA/QA activities. This, of course, means that there are more areas that the FDA may or may not agree with, which could increase the premarket submission review time or the use of the agencys Q-submission process in an attempt to gain alignment prior to the premarket submission. Procedures for users to download software, including how users will know when software updates are available. The new draft guidance mentions several, including the devices intended use, interfaces, intended connections, environment of use and risk of patient harm from cybersecurity vulnerability exploitation. Penetration testing Identify and characterize security-related issues via tests that focus on discovering and exploiting security vulnerabilities in the product. In addition to the design control requirements (i.e., 21 CFR 820.30(b), 21 CFR 820.30(c), 21 CFR 820.30(d), and 21 CFR 820.30(g)), FDA recommends, under 21 CFR 820.100, manufacturers develop and maintain security architecture view documentation as part of the process for the design, development, and maintenance of the system. How long is the FDA review process for 510(k) medical device submissions? FDA proposes to do this by replacing its Quality System Regulation (QSR) codified at 21 C.F.R. The following security risk management practices are highlighted by the FDA guidance: FDA considers threat modeling foundational and an integral part of security risk management. Postmarket Management of Cybersecurity in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, US FDA Cybersecurity Alert: Risks found in medical device software components. This includes that many of the high-level objectives remain the same, including authenticity, integrity, availability, confidentiality, updatability, cryptography, appropriate authorization, event detection, event logging, and recovery. Information, if known or anticipated, concerning device cybersecurity end of support and end of life. Assess, Prioritize, and Remediate Vulnerabilities: Help ensure that vulnerabilities are remediated in accordance with risk to reduce the window of opportunity for attackers. On February 23, 2022, FDA published its long-awaited proposed rule to harmonize its regulations governing current good manufacturing practices (cGMP) for medical devices with ISO 13485:2016, the international consensus standard for device quality management systems (QMS) used by regulatory authorities in many countries throughout the world. The guidance discusses five security objectives that manufacturers should take into account when designing devices: authenticity, including data integrity; authorization; availability; confidentiality; and secure and timely updateability and patchability. Data, Privacy & Cybersecurity. A description of systematic procedures for users to download version-identifiable manufacturer-authorized software and firmware, including a description of how users will know when software is available. Table 2: Cybersecurity Labeling Expectations. Premarket Information Supplied Clarifications and Changes Overview. Please note that this document is not intended to provide complete information needed to address cybersecurity, but is focused on differences. The draft guidance explains that failure to have adequate cybersecurity controls can cause a device to be misbranded. Diagrams that allow cybersecurity controls to be implemented. Configure the Compilation, Interpreter, and Build Processes to Improve Executable Security: Decrease the number of security vulnerabilities in the software and reduce costs by eliminating vulnerabilities before testing occurs. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. The latest industry news and insights from our global team. From a high-level standpoint, the objective remains the same: to ensure that the device is, and remains, safe and effective for its intended use. As with past guidance, but with further clarifications, the 2022 guidance covers software and firmware or programmable logic, including software as a medical device (SaMD), regardless of whether it is connected to a broader environment. A high-level description of the device features that protect critical functionality (e.g., backup mode, disabling ports/communications, etc.). Review all code that handles the parsing of external data using automated (e.g., static and dynamic analyses) and manual (i.e., code review) methods. The FDA further summarizes that cybersecurity controls require testing beyond standard software verification and validation activities to demonstrate the effectiveness of the controls in a proper security context to therefore demonstrate that the device has a reasonable assurance of safety and effectiveness. For devices with cybersecurity risks, FDA also believes that informing users of security information through labeling may be an important part of QSR design controls to help mitigate cybersecurity risks and help ensure the continued safety and effectiveness of the device. Consistent with Executive Order 14028 (issued after the SolarWinds attack involving a nation-state injecting malicious code into a secure compiling process), FDA also recommends that a device manufacturer prepare a Software Bill of Materials (SBOM) describing the various software components used by the device, including off-the-shelf and other software manufactured by third parties, that can be used by FDA as well as device users to understand a devices cybersecurity controls. An analysis of the entire system is expected, to understand the full environment and context in which the device is expected to operate, and the security architecture is to include a consideration of system-level risks, including but not limited to risks related to the supply chain (e.g., to ensure the device remains free of malware or vulnerabilities inherited from upstream dependencies such as third-party software, among others), design, production, and deployment (i.e., into a connected/networked environment). Review the Product Design to Verify Compliance with Security Requirements and Risk Information: Help ensure that the product will meet the security requirements and satisfactorily address the identified risk information. Infrastructure requirements, such as minimum networking requirements and supported encryption interfaces. While the prospects for this bill being enacted are uncertain at the present time, there is clearly a trend toward increasing cybersecurity expectations for medical device manufacturers. A Software Bill of Materials (SBOM) in a format for users to effectively manage their assets, to understand the potential impact of identified vulnerabilities to the device (and the connected system), and to deploy countermeasures to maintain the devices safety and effectiveness. List of ports and interfaces expected to receive and/or send data, along with approved destination endpoints. Unceremoniously tucked as Division Y into the H.R. 2471 Consolidated Appropriations Act, 2022, the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA) will require covered entitiesorganizations in certain critical infrastructure sectorsto report substantial cybersecurity incidents to the Department of Homeland Security within 72 hours after the organization reasonably believes the cyber-incident has occurred. Description of backup and restore features. Manufacturers would have to generate and maintain evidence regarding the quality management systems and risk management frameworks used to manage medical device cybersecurity to demonstrate compliance. Security risk management should be part of a manufacturers quality system. That is FDAs expectation and further elucidates that the process for performing security risk management is a distinct process from performing safety risk management as described in ISO 14971:2019. In recognition of the increased potential and evolving nature of cybersecurity threats, FDAs draft guidance expands on its 2014 recommendations by providing more details about how device manufacturers should integrate cybersecurity considerations into their quality systems and what cybersecurity information should be included in premarket submissions (PMAs, 510(k)s, de novo classification requests, PDPs, HDEs, and IDEs) to demonstrate a reasonable assurance of safety and effectiveness. A description of backup and restore features and procedures to restore authenticated configurations. Technical instructions to permit secure network deployment and servicing, and instructions for users on how to respond upon detection of a cybersecurity vulnerability or incident. the presence and functionality of its electronic data interfaces. Ropes & Gray will continue to monitor developments in this area. Review and/or Analyze Human-Readable Code to Identify Vulnerabilities and Verify Compliance with Security Requirements: Help identify vulnerabilities so that they can be corrected before the software is released to prevent exploitation. Sufficiently detailed diagrams for users that allow recommended cybersecurity controls to be implemented. All rights reserved. First, it is important to understand that the scope of FDAs guidance is exceptionally broad and covers devices that contain software (including firmware) or programmable logic, as well as SaaMD, and would be expected for: The FDA guidance establishes six broad expectations and introduces the newly minted concept of a Secure Product Development Framework (SPDF), which encompasses all aspects of a products life cycle, including development, release, support, and decommission to satisfy Quality System Regulations (QSR) in 21 CFR Part 820: The FDA guidance sets the nexus between a reasonable assurance of safety and effectiveness for devices with cybersecurity risks and the expectation that such cybersecurity risks are governed by the QSR. Define and Use Criteria for Product Security Checks: Help ensure that the product resulting from the TPLC meets the organizations expectations by defining and using criteria for checking the products security during development. The FDA clarifies that security risk management is distinct from safety risk management (ISO 14971), as it focuses on exploitability. Part 820 with a new Quality Management System Regulation (QMSR) primarily through incorporating ISO 13485 by reference into the new rule. The FDA considers cybersecurity to potentially have an effect on the safety and/or effectiveness of a device, and has required information be provided in a premarket submission in order to evaluate the device, as described in the 2014 final guidance. Verify authentication tags (e.g., signatures, message authentication codes [MACs]) of software/firmware content, version numbers, and other metadata. If this control is not available, a plan of how the third-party software component could be updated or replaced must be established. Other Clarifications and Changes Overview. FDA Regulatory, The guidance lists elements that vulnerability communication plans should include, such as personnel responsible; periodic testing; update processes; and communication plans for remediation efforts, patches, and updates to customers. This website uses cookies to ensure you get the best experience on our website. Disable or otherwise restrict unauthorized access to all test and debug ports (e.g., JTAG, UART) prior to delivering products. View All, Our global consulting team works from 20+ offices on six continents. This is intended to emphasize the importance of designing devices security and in a manner that cybersecurity risks can be mitigated throughout the total product lifecycle (TPLC), with a recommendation of using a secure product development framework (SPDF). First, a device without adequate cybersecurity controls may be misbranded under section 502(f) of the Federal Food, Drug and Cosmetic Act (FDCA) if the devices labeling does not contain adequate directions for use. The FDA guidance relies on the existing regulatory framework of 21 CFR 820.30(b), (c), and (d) for the expectation that design processes, design requirements, and acceptance criteria for the security architecture of the device holistically address the cybersecurity considerations for the device and the system in which the device operates. any other appropriate parts of the system where a manufacturers threat model and/or risk analyses reveal the need for it. Log file descriptions should include how and where the log file is located, stored, recycled, archived, and how it could be consumed by automated analysis software. These plans should define the steps for identifying and communicating to users regarding vulnerabilities that are discovered after the device is released to market.