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What should be considered when possible? | Hardware-based security solutions |
What should the device and the server mutually authenticate and limit? | the connection is initiated over one or more existing trusted channels |
What can be done with the use o Answer: Strengthen password protections? | null |
What is the use of the acronym CADe for computer-assisted detection known as? | CADe |
What is the name of the clinician who makes the reference standard determination? | clinical truther(s) |
What is the definition of security strength in Appendix 5? | Terminology |
What do cyclic redundancy checks do not provide? | integrity or authentication protections |
What is an authorization scheme used for? | as a defensive measure |
What should be applied to users, system functions, and others? | the principle of least privileges71 |
What is the preferred authentication scheme? | cryptographically proven designs |
What is a medical device programmer capable of? | Near-Field Communications (NFC) |
What is the principle that a security architecture should be designed so that each entity (e.g., user, asset) is granted the minimum system resources and authorizations that the entity needs to perform its function? | least privilege |
What is the name of the device that is not expres? | devices to “deny by default” |
What is one form of denying authorization? | Ignoring requests |
What are the recommendations specifically related to? | selection and implementation of the underlying cryptographic scheme used by a device and the larger system in which it operates |
What do you provide for truthing that relies on the interpretation by a reviewing clinician? | the instructions conveyed to them prior to participating in the truthing process |
What is the expected to be considered cryptographically strong throughout the service life of the device? | cryptographically strong |
What should design a system architecture and implement security controls to prevent? | a situation where the full compromise of any single device can result in the ability to reveal keys for other devices |
What is the NIST FIPS 140-2 Suite B available at? | https://csrc.nist.gov/CSRC/media/projects/cryptographic-module- validation-program/documents/security-policies/140sp2851.pdf |
What can be employed to help meet this objective? | public- key cryptography |
What are many cybersecurity incidents caused, at their root, by the violation of some form of device integrity? | the violation of stored code, stored and operational data, or execution state |
What should be used to Authenticate firmware and software? | signatures, message authentication codes (MACs) |
What is the name of the authentication that is absent or fails in d software updates? | cryptographic authentication |
What is the name of the FDA webpage that provides information regarding UDI? | FDA’s webpage |
What is the definition of “whitelist” in NIST SP 800-128? | NIST SP 800-128 |
What should be verified to ensure that data is not modified in transit or at rest? | integrity of all incoming data |
What is any specific criteria used as part of the truthing process? | any specific criteria |
What is HIDS/HIPS? | Host-based Intrusion Detection/Prevention Systems |
What could lead to patient harm? | disclosure |
What could lead to unauthorized use/abuse of device functionality? | disclosure |
What are these critical capabilities? | Event detection and logging |
What should logs include if possible? | storage capabilities |
What is an example of a security event? | sending requests to unknown entities |
What may secure configurations include? | endpoint protections |
What is recommended to qualify multiple options to support user preferences for different options? | Manufacturers |
What is the NIST SP 800-86 available at? | https: |
What should not be the same as those who participate in the core clinical performance assessment of the CADe device? | ians participating in the truthing process |
What does digital forensics mean? | The application of science to the identification, collection, examination, and analysis, of data while preserving the integrity of the information and maintaining a strict chain of custody for the data |
What should be designed to facilitate the performance of variant analyses such that the same vulnerabilities can be identified across device models and product lines? | Design devices to notify users when malfunctions or anomalous device behavior, including those potentially related to a cybersecurity breach, are detected |
What are cyber-resiliency capabilities important for? | medical devices |
What is the name of the dware-backed trusted execution environments? | dware-backed |
What should be resilient to possible cyber incident scenarios? | network outages, Denial of Service,80 excessive bandwidth usage by other products, disrupted quality of service (QoS),81 and/or excessive jitter82 |
What is the HCIC TF? | null |
What is the HCIC TF Report on Improving Cybersecurity in the Health Care Industry? | Improving Cybersecurity in the Health Care Industry |
What does CNSSI stand for? | Committee on National Security Systems |
What can design devices to anticipate the need for? | software and firmware patches and updates to address future cybersecurity vulnerabilities |
What should consider cybersecurity patches and updates that are independent of regular feature update cycles? | cybersecurity patches and updates |
What should be considered such that third-party company goes out of business or stops supporting a licensed product? | contingency plans |
What is an example of a potential source of Bias in a Ret Submission? | scanned films |
What is the FDA's recommendation for manufacturers to provide detailed information for in Section V.B.2? | views identified in Section V.B.2 |
What is another method used to describe the architecture of a medical device? | call-flow views |
What should architecture views provide specific protocol details of? | communication pathways between parts of the medical device system |
What is the most important asset that gineers and reviewers should be able to cross? | intermediate assets |
What is a security-relevant analysis? | the ability to construct and follow a detailed trace for important communication paths |
What should be included in Detailed diagrams and supporting explanatory text that identify all medical device system assets? | Device hardware |
What are some nonbinding recommendations for nonbinding recommendations? | Applications, hardware, and/or other supporting assets that directly interact with the targeted device |
What is an example of a communication path when there is at least one intermediate asset? | an app |
What is the name of the access control model for every asset? | privileges |
What is the purpose of an “handoff” sequence? | how is their integrity/authenticity assured |
What can often be minimized or at least mitigated through good study design? | sources of statistical bias |
What is the name of the strength indicators in a cryptographic method? | key bit length |
What are some examples of verification credentials? | certificates, asymmetric keys, or shared keys |
What is generated, stored, configured, transferred, and maintained? | password, key |
What is another assurance of security properties? | verification of session identifiers |
What is the need to balance innovation and security in designs especially during clinical trials? | FDA |
What does 21 CFR 812.25 require manufacturers to provide as a part of their IDE application? | an investigational plan |
What is included in the 21 CFR 812.25(c), (d)? | updateability/patchability views |
What does not preclude the possibility of future cybersecurity questions or concerns being raised during review of a subsequent marketing application? | approval of an IDE based on the documentation recommended above |
What is the term for the time when a device is submitted for marketing authorization? | Cybersecurity improvements will likely be needed between the time of clinical trials and when the device is submitted for marketing authorization |
What is recommended for all premarket submissions for devices with potential cybersecurity risks? | each type of documentation identified throughout the guidance |
What is Statistical analysis of diagnostic performance based on? | subjects verified for presence or absence of the condition of interest by the reference standard |
What is the purpose of the table? | to summarize the specific documentation elements identified throughout the guidance for premarket submissions |
What is the table in the table that represents one possible way to organize the recommended information? | This table |
What is the only view that a SaMD product will likely need to have for each of the global system? | multi-patient harm |
What is the most common use of a premarket document? | clinical use cases |
What is the type of Premarket Guidance Section(s) IDE Submission* Submission Documentation? | null |
What is not specifically recommended Assessment? | Unresolved Section V.A.5 |
What is the name of the section that could be helpful to submit? | Architecture Views Section V.B. |
What is the name of the section that is not specifically recommended Labeling Section VI.A.? | Section V.C. |
What does “recommended” refer to? | the elements of an IDE submission FDA discusses in Appendix 3 of this document |
What process should a manufacturer use to make a recommendation? | FDA Q-submission process |
What is introduced when subjects selected for study are not representative of the intended use population? | Selection bias |
What is anything that has value to an individual or an organization? | Asset |
What is the right or a permission that is granted to a system entity to access a system resource? | Authorization |
What defines the security boundary for an information system? | Boundary Analysis |
What is the 89 definition adapted from? | CNSSI 4009-2015 Committee on National Security Systems (CNSS) Glossary |
What is a safeguard or countermeasure deployed, in lieu of, or in the absence of controls designed in by a device manufacturer? | Nonbinding Recommendations Compensating Controls |
What is Configuration? | the possible conditions, parameters, and specifications with which a device or system component can be described or arranged |
What is the process of preventing unauthorized access, modification, misuse or denial of use? | Cybersecurity |
What is the process that includes proper identification, authorization for disposition, and sanitization of the equipment, as well as removal of Patient Health Information (PHI) or software, or both? | null |
What is the purpose of a system asset? | a specified intended use |
What is the NIST guide for Security-Focused Configuration Management of Information Systems called? | NIST SP 800-128 Rev. 4 |
What may eliminate or mitigate selection bias? | Random or consecutive sampling of subjects |
What is the form called that conceals the data’s original meaning? | ciphertext |
What is the software program or set of instructions programmed on the flash read-only memory of a hardware device? | Firmware |
What is the practice of reducing a system's vulnerability by reducing its attack surface? | Hardening |
What is the lifecycle of a medical device? | all phases in the life of a medical device |
What is a “repair job” for a piece of programming also known as? | a “fix” |
What is provided to manage and track the installation of patches? | a special program |
What is the term for use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior? | Reasonably foreseeable misuse |