Table 2: Cybersecurity Labeling Expectations. Time to Read: 8 minutes He can be reached atjohn.giantsidis@cyberacta.com. Meet our MDR team and get free educational resources on the MDR. Comments on the draft guidance are due on July 7, 2022. List of software anomalies or statement that there are none. Other Clarifications and Changes Overview. These plans should define the steps for identifying and communicating to users regarding vulnerabilities that are discovered after the device is released to market. This should include tracking the percentage of identified vulnerabilities updated/patched (defect density); time from vulnerability identification to when it was updated/patched; time from when an update/patch is available to complete implementation in devices in the field; and averages of these measures. The issue jumped to the headlines again with the 2017 global WannaCry ransomware attack that infected tens of thousands of computers and medical devices, including MRI machines in U.K. hospitals and Bayers Medrad contrast agent injection devices in the U.S.2 The present potential for a Russian cyber-weapon to impact U.S. health care infrastructure remains a possibility, particularly after the NotPetya cyber-weapon hit a global pharmaceutical company during the prior Ukraine conflict and similar weapons are reportedly being deployed during the present war. entity authentication of communication endpoints, whether those endpoints consist of software or hardware, integrity of the execution state of currently running software, and. 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. Manufacturers must document all software components of a device, which may be done through a software bill of materials (SBOM). Safety risk assessment for each known vulnerability. Assessment of anomaly impact on security using a common weakness enumeration (CWE) categorization (such as by AAMI SW91). Implement Roles and Responsibilities: Ensure that everyone inside and outside of the organization involved in the TPLC is prepared to perform their TPLC-related roles and responsibilities throughout the TPLC. Risk controls to address known vulnerabilities . Information Transparency: The information that the FDA expects to be available to customers (labeling). FDA-2021-D-1158 available at https://www.regulations.gov/docket/FDA-2021-D-1158. Premarket Information Supplied: The information that the FDA expects to have available for review in a premarket submission. Part 820 with a new Quality Management System Regulation (QMSR) primarily through incorporating ISO 13485 by reference into the new rule. A high-level description of the device features that protect critical functionality (e.g., backup mode, disabling ports/communications, etc.). The FDA guidance places great emphasis on the process and issuance of a Software Bill of Materials (SBOM) and considers the changes in the SBOM as part of the Design History File (21 CFR 820.30) and Device Master Record (21 820.181). 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. 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. Even after manufacturers obtain clearance or approval for a device and release the device to the market, cybersecurity vulnerabilities may arise, and FDA recommends that manufacturers establish vulnerability management plans to address potential risks as they evolve. 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. After release, cybersecurity testing should be performed at regular intervals (annually) to ensure that potential vulnerabilities are identified prior to being exploited.
The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. View All, Our global consulting team works from 20+ offices on six continents. The draft guidance explains that cybersecurity documentation to be included in a premarket submission will depend on the cybersecurity risks specific to the device that is the subject of the submission. However, the 2022 draft guidance significantly increases the amount of information that must be provided for FDA review. The FDA guidance sets the following expectations about threat modeling: The FDA is clear that to demonstrate compliance with quality system design controls and to support supply chain risk management processes, all software, including that developed by the device manufacturer (proprietary software) and obtained from third parties, should be assessed for cybersecurity risk and that risk should be addressed. Evidence of their boundary analysis and rationale for their boundary assumptions. FDA Regulatory, A description of how the design enables the device to respond when anomalous conditions are detected (i.e., security events) to maintain safety and effectiveness. High-level description of device features that protect critical functionality, such as backup mode, disabling communications, etc. 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. Threat modeling should consider risks from the supply chain (including off-the-shelf software), manufacturing, deployment, interoperation, maintenance/update activities and decommissioning activities. As draft labeling is provided to the FDA during a premarket submission, the FDA will review this. 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. However, there are many differences between the guidance documents as well, some of which are clarifications and some of which are changes. 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. Employ tamper evident seals on device enclosures and their sensitive communication ports to help verify physical integrity. Static and dynamic code analysis, including testing for credentials that are hardcoded, default, easily guessed, and easily compromised. https://www.regulations.gov/docket/FDA-2021-D-1158, https://www.congress.gov/bill/117th-congress/senate-bill/3904/text, https://ec.europa.eu/health/system/files/2022-01/md_cybersecurity_en.pdf, https://www.tga.gov.au/sites/default/files/medical-device-cyber-security-guidance-industry.pdf, https://www.govinfo.gov/app/details/BILLS-117hr7084ih/related, https://csrc.nist.gov/publications/detail/sp/800-218/final, Premarket Notification (510(k)) submissions, Premarket Approval Applications (PMAs) and PMA supplements, Investigational Device Exemption (IDE)/Humanitarian Device Exemption (HDE) submissions. Where appropriate, technical instructions to permit secure network deployment and servicing. 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). Sarah Fitzgerald, RAC is Senior Consultant, Quality and Regulatory Affairs at Emergo by UL. Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. Security risk management report including: % identified vulnerabilities updated / patched (defect density). FDA proposes to do this by replacing its Quality System Regulation (QSR) codified at 21 C.F.R. 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. All devices within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act), whether or not they require a premarket submission. FDA recommends that manufacturers include cybersecurity information in device labeling and provides a list of specific types of information that labeling should contain. any other appropriate parts of the system where a manufacturers threat model and/or risk analyses reveal the need for it. Assess, Prioritize, and Remediate Vulnerabilities: Help ensure that vulnerabilities are remediated in accordance with risk to reduce the window of opportunity for attackers. 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. Implement and Maintain Secure Environments for Product Development: Ensure that all components of the environments for product development are strongly protected from internal and external threats to prevent compromises of the environments or the product being developed or maintained within them. This includes certification, Notified Body and consultancy services. Controls for software to maintain integrity from origin to leaving control of manufacturer. Risk controls from each assessment should be assessed to ensure that they do not inadvertently introduce or change risks to the other, in alignment with AAMI TIR57. List of ports and interfaces expected to receive and/or send data, along with approved destination endpoints. 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. Validate that all data originating from external sources is well-formed and compliant with the expected protocol or specification. identify system risks and mitigations as well as inform the pre- and post-mitigation risks considered as part of the security risk assessment, state any assumptions about the system or environment of use (e.g., hospital networks are inherently hostile; therefore, manufacturers are recommended to assume that an adversary controls the network with the ability to alter, drop, and replay packets), and, capture cybersecurity risks introduced throughout. The FDAs draft guidance on medical device cybersecurity provides insight on how the agency is going to apply the existing regulatory requirements. Evidence of testing that demonstrates effective risk control measures according to the threat models provided in the system, use case, and call-flow views. While the SPDF recommendation is far more specific than anything recommended in FDAs 2014 guidance, FDA acknowledges that manufacturers also may satisfy the QSR using other approaches, provided they meet the QSRs requirements. 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. Ensure that the authenticity of software, firmware, and configuration are validated prior to execution, e.g., allow-listing based on digital signatures. A machine-readable SBOM, available on a continuous basis such as an online portal. 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).
Further, as the FDA wishes to review more information in the appropriate premarket submission, additional justification will be expected from applicants in premarket submissions. A description of the secure configuration of shipped devices, a discussion of the risk trade-offs that might have been made about hardening options implemented by the device manufacturer, and instructions for user-configurable changes. Total Product Lifecycle (TPLC) Approach Clarifications and Changes Overview. The draft guidance recommends that device manufacturers satisfy the QSR by establishing a Secure Product Development Framework (SPDF), which is a set of processes designed to reduce the number and severity of product vulnerabilities throughout all aspects of the product life cycle. The draft guidance reiterates FDAs prior position that stakeholders throughout the medical device system, including health care facilities, patients, providers, and manufacturers, share responsibility for medical device security. 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. FDA also outlines in the draft guidance the types of cybersecurity testing that premarket submissions should contain, which includes threat mitigation testing, vulnerability testing, and penetration testing. Information on securely decommissioning devices by sanitizing the product of sensitive, confidential, and proprietary data and software. A description of how forensic evidence is captured, including but not limited to any log files kept for a security event. Boundary analysis and rationale for boundary assumptions. He holds a Bachelor of Science degree from Clark University, a Juris Doctor from the University of New Hampshire, and a Master of Engineering in cybersecurity policy and compliance from The George Washington University. 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. Any industry-accepted formats of SBOMs can be used, provided that the following information is included: FDA outlines that manufacturers are responsible for identifying cybersecurity risks in their devices and the systems in which they expect those devices to operate and implementing the appropriate controls to mitigate those risks. 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. 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. Unceremoniously tucked as Division Y into the H.R. View All, Exemptions and GUDID deadline extensions for several Class I devices, Helpful guidance for medical device manufacturers, Resources and tools tailored to medical device professionals. 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. Without doubt, this issue will continue to be front-of-mind on Capitol Hill while the Russian attack on the Ukraine continues. Get the latest articles from Med Device Online delivered to your inbox. 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. 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. This website uses cookies to ensure you get the best experience on our website. Cybersecurity should continue to be considered throughout the TPLC of the device, with updates made to relevant documentation as appropriate. 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. the type of cybersecurity vulnerabilities present, the exploitability of the vulnerabilities, and. How long is the FDA review process for 510(k) medical device submissions? This recommendation also could create a potential liability trap as hacking techniques evolve, but devices cannot be re-engineered without undue cost and risk. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. the intended and actual environment of use. Moreover, manufacturers must put in place processes and controls to ensure that their suppliers conform to the manufacturers cybersecurity requirements. Provide a Mechanism for Verifying Product Release Integrity: Help product/software acquirers ensure that the product/software they acquire is legitimate and has not been tampered with. Method for retention and recovery of device configuration. Adequacy of risk controls for threat mitigation. The FDA considers it important to provide a user with adequate labeling to appropriately use a medical device and communicate risks. However, like the 2014 guidance, this guidance does not provide clear recommendations on how to evaluate the extent of requirements necessary for different devices, meaning that a manufacturer is going to have to justify what they consider necessary on an individual device basis. US FDA formally proposes aligning Quality System Regulations with ISO 13485, US FDA's latest medical device cybersecurity guidance: Key differences from previous versions. 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. This could increase burdens, therefore, for both industry and the FDA. More generally, on March 15, 2022, President Biden signed into law significant new federal data breach reporting legislation that will likely expand data breach notice requirements far beyond personal data. Information about device cybersecurity end of support or end of life, including that risk is likely to increase. 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. the risk of patient harm due to vulnerability exploitation. Significantly, the widespread publication of this information would also potentially provide attackers with detailed information about vulnerabilities that could be exploited, requiring the exercise of considerable care in the development of such labeling. Although FDA guidance is not binding, recently proposed legislation could require that premarket submissions include cybersecurity information. Premarket Information Supplied Clarifications and Changes Overview. A description of the methods for retention and recovery of device configuration by an authenticated authorized user. 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. The new guidance generally aligns with the International Medical Device Regulators Forum (IMDRF) 2020 guidance Principles and Practices for Medical Device Cybersecurity.. Practices: View All. Recommended cybersecurity controls, such as anti-malware, firewall use, and password requirements. Instructions on how to respond upon detection of a cybersecurity vulnerability or incident. 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 plan is to be in unison with risk management processes under 21 CFR 820.30(g) and corrective and preventive action processes in accordance with 21 CFR 820.100. The FDA clarifies that threat modeling should be used to identify security objectives, risks, vulnerabilities and countermeasures. Test Executable Code to Identify Vulnerabilities and Verify Compliance with Security Requirements: Help identify vulnerabilities so that they can be corrected before the product is released in order to prevent exploitation. The following principles may be considered the fundamental practices that the FDA had in mind regarding SPDF: The FDA guidance sets the expectation that devices must meet the security objectives of authenticity, integrity, authorization, availability, confidentiality, and secure and timely updatability and patchability. Vulnerability testing Evidence on the testing of: Abuse case, malformed and unexpected inputs, Closed box testing of known vulnerability scanning, Software composition analysis of binary executable files. Learn from our experts through live events. identify security-relevant system elements and their interfaces. A list of network ports and other interfaces that are expected to receive and/or send data. Digital Health, Security risk assessment for each known vulnerability. Plans to communicate vulnerabilities including: Information Transparency Clarifications and Changes Overview. 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. Design Product to Meet Security Requirements and Mitigate Security Risks: Identify and evaluate the security requirements for the product; determine what security risks the software is likely to face during operation and how the softwares design and architecture should mitigate those risks; and justify any cases where risk-based analysis indicates that security requirements should be relaxed or waived. the software level of support provided through monitoring and maintenance from the software component manufacturer, the software components end-of-support date, and. A platform of digital products to improve, simplify and automate RA/QA activities. the devices intended use and indications for use. The manufacturers process for communicating end of support or end of life. The FDA has required certain labeling be present, as described in the 2014 final guidance. If the device remains in service following the end of support, the manufacturer should have a preestablished and pre-communicated process for transferring the risks highlighting that the cybersecurity risks for end users can be expected to increase over time. No mention is made as to whether such testing could justified as being partial, suggesting that the FDA expects full cybersecurity-related testing to be conducted annually. 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. May 11, 2022 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. Description of backup and restore features. Attorney advertising. 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.
Sitemap 20