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Cybersecurity - Could you disclose the risk control measures?

  • 1.  Cybersecurity - Could you disclose the risk control measures?

    This message was posted by a user wishing to remain anonymous
    Posted 01-Feb-2023 08:41
    This message was posted by a user wishing to remain anonymous

    Dear All,

    For the cybersecurity application documents, our engineer insists that it is very risky to disclose the risk control measures in the cybersecurity risk management files.
    They say that revealing it is like openly saying that the key is under the pot at the gate. 

    Could you share your experience?
    What we think of as options are:
    - Accept that disclosure it is unavoidable.
    - Delete the risk control measures column from risk management table. 
       (We don't know what would be happened if the regulator noticed it and it seems like a risky idea to me.)
    - Black out the risk control measures and see what will happens. 
       (In this case, we shall disclose the measures if requested from the regulators.)

    Any advice would be greatly appreciated.
    Thank you in advance for your help.


  • 2.  RE: Cybersecurity - Could you disclose the risk control measures?

    Posted 02-Feb-2023 05:14
    Anon,

    Having worked with cybersecurity medical devices and Software as Medical Device (SaMD) this is a question which gets pondered quite often, including detailing residual risks (and controls) in the product information (Instructions for Use).  It is perfectly acceptable, and should be done, for detailing risk controls within the companies risk management documents.  This also includes providing risk control in risk management documents which are provided to regulators.  Using the analogy it would not be putting the key under the pot at gate, but putting the key to your safe in a cupboard or on a shelf inside your locked and security system house.

    The issue I see and have the discussions with the teams about is disclosing residual risks around cybersecurity and how users identify risks, manage the risks, and actions they could/should take.  This can tread on describing some of the cybersecurity risks associated with the software application or software in a device.  It is important to review this carefully to ensure you are not giving the key to the house and the key to the safe.  I would conclude the risk management information needs to understand the audience this information is being provided or who would be reviewing.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Cybersecurity - Could you disclose the risk control measures?

    This message was posted by a user wishing to remain anonymous
    Posted 06-Feb-2023 08:59
    This message was posted by a user wishing to remain anonymous

    Dear Richard,

    Thank you so much for the detailed explanation.
    However, it was rather difficult and could you kindly advice is my understanding below is correct?

    Does your conclusion below implicate that we need to prepare the documents for internal comprehensive cybersecurity verification validation and the information which could be provided to the customer and reviewer?
    "I would conclude the risk management information needs to understand the audience this information is being provided or who would be reviewing."


  • 4.  RE: Cybersecurity - Could you disclose the risk control measures?

    Posted 06-Feb-2023 15:14
    Hi,

    Risk management table and report is part of the technical documentation owned and maintained by manufacturers and it's for Reviewers eyes. And every risk has to be mitigated, that is the core point of it. Have a diverse team participating in cybersecurity preparedness and response exercises – including clinicians, health care technology management professionals, IT, emergency response, and risk management and facilities staff. Threats and vulnerabilities cannot be eliminated and reducing cybersecurity risks is especially challenging. Vulnerabilities have to be communicated to patient and care givers always keep balanced discussion between risk and benefit, highlight the benefits. The increased use of connected medical devices has led to an increase in cybersecurity vulnerabilities, Regulators are aware of it they help mitigate it. The FDA acts promptly to communicate on cybersecurity vulnerabilities with the public to ensure they are aware of these issues and have the information they need to take appropriate action. Clear, actionable communication is one way to help protect and promote public health, and help ensure that patients, who depend on their medical devices, stay informed and protected.

    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------



  • 5.  RE: Cybersecurity - Could you disclose the risk control measures?

    Posted 07-Feb-2023 05:03
    Hi,

    As Raje as elucidated these documents would be something reviewed internally, could be reviewed by regulatory agencies, but you would want to take care on how this information is conveyed to your customer.  Or putting into any type of public environment might want to review carefully.  Internally it is controlled and information provided to regulatory agencies is usually confidential or can be redacted (such as US FDA).  So my comments were regarding to understand the audience or who would be reviewing as having risk controls might divulge too much information.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 6.  RE: Cybersecurity - Could you disclose the risk control measures?

    This message was posted by a user wishing to remain anonymous
    Posted 08-Feb-2023 09:03
    This message was posted by a user wishing to remain anonymous

    Dear Richard,

    Thanks very much for your further clarification!


  • 7.  RE: Cybersecurity - Could you disclose the risk control measures?

    This message was posted by a user wishing to remain anonymous
    Posted 07-Feb-2023 10:21
    This message was posted by a user wishing to remain anonymous

    Dear Raje,

    Thank you so much for the advice! 

    I heard from our engineer that the some risk control measures include both the risk and the countermeasure (which should be done by the customer) together. Thus, they think that if there are customers who would not take appropriate action exist, they are exposed to higher risk if the information of risk control measures leaks out. (Yes, we are worrying about countries where even the regulators are not entirely reliable.)

    However, judging from the advice from you and Richard, the situation of the informed customer who doesn't take appropriate action should not be exist. In other words, as a manufacturer, we should provide the enough information to make for our customers to take appropriate measures. 
    It would be highly appreciated if my understanding above contains big mistake.


  • 8.  RE: Cybersecurity - Could you disclose the risk control measures?

    Posted 11-Feb-2023 10:21

    My first question is, "Disclose to whom"? It seems to me there are (at least) two different parties – regulators and users. The answer is different in each case.

    Cast in terms of the NIST post, I infer the cybersecurity risk control measures are a digital fence - a perimeter. The question, then is which aspects of the perimeter to disclose and to whom. My  presumption is that there are two types of controls which I will call obvious and hidden. Obvious controls are "user name + password" and "two point authentication" to prevent unauthorized access. The hidden controls might be something in another layer of your "defense in depth" strategy. The concern, I infer, is that user knowledge of the hidden controls, such as in an IFU, will provide an opportunity for somebody to figure out how to circumvent the control and gain access to the system.

    The NIST post suggests that one cannot prevent unauthorized access – somebody will always figure out how to breach the perimeter and gain access. The zero trust strategy recognizes that the concept of inside and outside the perimeter is not adequate. You need controls inside as well. To quote the post, "Every access request [from inside the perimeter] to a resource must be thoroughly evaluated dynamically and in real time based on access policies in place and current state of credentials, device, application and service, as well as other observable behavior and environmental attributes, before access may be granted."

    One common scenario is a weak-link attack on a device on a network to gain network access. An example might be access to a hospital network through a device with weak cybersecurity controls.

    My recommendation for your device is to make the obvious controls known to the user, but keep the hidden controls hidden. This won't prevent an attack but will make it more difficult. If the attack is on a network, not your device, then the attack will turn to the weak link. Don't let it be your device.

    On your device implement zero trust controls and recommend it for any network to which the user would connect your device.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 9.  RE: Cybersecurity - Could you disclose the risk control measures?

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2023 07:50
    This message was posted by a user wishing to remain anonymous

    Dear Dan,

    Thank you so much for sharing those details. It was very informative to know about what the actual cybersecurity measures are. 

    Our concern now is how much we can share the cybersecurity information with the regulator, which we don't know how much we can trust. 




  • 10.  RE: Cybersecurity - Could you disclose the risk control measures?

    Posted 14-Feb-2023 09:59

    Unfortunately, you need to give the regulator what ever they require. In making the submission, scope your responses narrowly. If the regulator needs more information then it will ask.

    It is not likely that the information will leak from a regulator. However there is a possibility that an attack on a regulator could reveal information; even the US NSA was hacked.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 11.  RE: Cybersecurity - Could you disclose the risk control measures?

    Posted 14-Feb-2023 12:22

    Dan makes a good point with the distinction between regulators and users.  Note that ISO 14971:2019 states that "the manufacturer shall inform users of significant residual risks and shall include the necessary information in the accompanying documentation in order to disclose those residual risks."  Here it is not explicitly necessary for a manufacturer to disclose risk control measures in the accompanying documentation (see clause 3.1 of the standard for a definition); however, where there are risk controls implemented through protective measures or information for safety, care should be given in how to inform the user in order reduce risk effectively. 

    Conversely, risk control option analysis, verification of implementation and effectiveness, as well as evaluation of the residual risk all are checked for compliance "by inspection of the risk management file."  Therefore, it will be necessary to disclose this information within the risk management file for regulators to review.  It is up to the manufacturer's discretion to determine the level of detail provided, but it should be sufficient for the reviewer to determine that the risk controls were appropriate and effective. 

    Admittedly, no system is completely secure nor can all risks be identified and controlled; however, the manufacturer must be compliant to the individual regulations regardless.  If the regulator needs more information, it is likely they will ask for it. 



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    Christopher Erwin
    Scottsdale AZ
    United States
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