Challenges of distributed risk management for medical application platforms

Hatcliff, John; Vasserman, Eugene Y.; Carpenter, Todd; Whillock, Rand

doi:10.1109/ispce.2018.8379270

Cited by 14 publications

(9 citation statements)

References 4 publications

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“…There is a natural knowledge gap between clinicians, administrators, and IT staff, who are expert in their respective fields, but must work together to ensure that formally-written access control policies represent the intent of the facility administrators and the needs of the clinicians. None of the people involved in crafting these requirements and policies may simultaneously have a full understanding of the policy intent and 10 EAI Endorsed Transactions on Security and Safety 08 2019 -05 2020 | Volume 6 | Issue 22 | e2 Alloy [22] ---ACPT [23] Margrave [24] ---SPIN [25] -----ACCOn [26] ----- Figure 8. A brief comparison of the model checking tools we considered.…”

Section: Verification and Validationmentioning

confidence: 99%

“…Simplifying connectivity increases the complexity of resulting "Medical Application Platforms" (MAPs), making them more difficult to understand and manage. Frameworks capable of creating and controlling these "system-of-systems" must be carefully designed to preserve patient safety despite of the increased complexity [10]. Their increased power requires greater assurance that they will not be misused (intentionally or unintentionally) to harm the patient(s) they are treating [1,3,8].…”

Section: Introductionmentioning

confidence: 99%

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Controlled BTG: Toward Flexible Emergency Override in Interoperable Medical Systems

Tasali¹,

Sublett²,

Vasserman³

2020

ICST Transactions on Security and Safety

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INTRODUCTION:In medical cyber-physical systems (mCPS), availability must be prioritized over other security properties, making it challenging to craft least-privilege authorization policies which preserve patient safety and confidentiality even during emergency situations. For example, unauthorized access to device(s) connected to a patient or an app controlling these devices could result in patient harm. Previous work has suggested a virtual version of "Break the Glass" (BTG), an analogy to breaking a physical barrier to access a protected emergency resource such as a fire extinguisher or "crash cart". In healthcare, BTG is used to override access controls and allow for unrestricted access to resources, e.g. Electronic Health Records. After a "BTG event" completes, the actions of all concerned parties are audited to validate the reasons and legitimacy for the override.OBJECTIVES: Medical BTG has largely been treated as an all-or-nothing scenario: either a means to obtain unrestricted access is provided, or BTG is not supported. We show how to handle BTG natively within the ABAC model, maintaining full compatibility with existing access control frameworks, putting BTG in the policy domain rather than requiring framework modifications. This approach also makes BTG more flexible, allowing for fine-grained facility-specific policies, and even automates auditing in many situations, while maintaining the principle of least-privilege. METHODS:We do this by constructing a BTG "meta-policy" which works with existing access control policies by explicitly allowing override when requested. RESULTS:We present a sample BTG policy and formally verify that the resulting combined set of access control policies correctly satisfies the goals of the original policy set and allows expanded access during a BTG event. We show how to use the same verification methods to check new policies, easing the process of crafting least-privilege policies.

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Section: Verification and Validationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Controlled BTG: Toward Flexible Emergency Override in Interoperable Medical Systems

Tasali¹,

Sublett²,

Vasserman³

2020

ICST Transactions on Security and Safety

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“…Interoperable medical systems and their associated components may be developed, operated, and maintained by many different organizations. Such systems may be built using platform concepts designed to facilitate reuse of both platform infrastructure and assurance artifacts when the platform is used to build different systems (Hatcliff et al, 2018). From the managerial perspective, odularity can be seen as a business strategy for efficient design and structuring of complex products, procedures and services with the objective to rationalize the enterprise.…”

Section: Configuration Management and Modularitymentioning

confidence: 99%

“…Following to the overall concept of PLM, the demand is given last but not least by regulatory rules (Hatcliff et al, 2018). For our purpose, a solution which continuously maintains the relationship between PLM and risk management is necessary.…”

Section: Solution Conceptmentioning

confidence: 99%

A Method to Explore Product Risk in Product Lifecycle Management of Configured Products

Castaneda

Ostrosi

Majić

et al. 2020

Proc. Des. Soc.: Des. Conf.

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Today high quality and low product development turnaround time are company-wide priorities. Quality supporting processes such as an effective risk management system shall support continuous business running and meeting the goals of an organization. In this paper, an approach is presented on how to integrate the product risk management in Product Lifecycle Management for configured products by definition of an additional software module and its implementation.

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“…Technical risk management, modularity and PLM are related fields of engineering that can ideally be combined in a process chain and implemented as a technical solution by a software module which works on PDM data. Following to the overall concept of PLM, the demand is given last but not least by regulatory rules [24]. We draw a solution which builds the product risk line based on risk case and supportive information (Figure 3).…”

Section: Solution Conceptmentioning

confidence: 99%

Modular Approach to Technical Risk Management in Product Lifecycle Management

Castaneda¹,

Majić²,

Ostrosi³

et al. 2019

Advances in Transdisciplinary Engineering

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The current trend in product development is toward usage and integration of different advanced technologies which are increasingly embedded in a comprehensive PDM system as a company-wide information back-bone. With such an approach, the transparency is increased and many business processes accelerated. While modularization is a mega-trend, the modular approach is also used to align development processes with the workflows in PDM. The goal of an effective risk management system is to allow continuous business running and achieving the goals of an organization. In order to achieve this, it is necessary, as far as it is possible, to identify and to analyze risks the organization is confronting and to evaluate their effects on the business. In this paper, an approach is presented on how to integrate the technical risk management in Product Lifecycle Management by definition of an additional software module and its implementation.

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Challenges of distributed risk management for medical application platforms

Cited by 14 publications

References 4 publications

Controlled BTG: Toward Flexible Emergency Override in Interoperable Medical Systems

Controlled BTG: Toward Flexible Emergency Override in Interoperable Medical Systems

A Method to Explore Product Risk in Product Lifecycle Management of Configured Products

Modular Approach to Technical Risk Management in Product Lifecycle Management

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