Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
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?	ERROR: type should be string, got " 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

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?

ERROR: type should be string, got " 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