Related papers: Separating Technological and Clinical Safety Assur…
As wearable health technologies have grown more sophisticated, the distinction between "wellness" and "medical" devices has become increasingly blurred. While some features undergo formal U.S. Food and Drug Administration (FDA) review, many…
Cybersecurity issues in medical devices threaten patient safety and can cause harm if exploited. Standards and regulations therefore require vendors of such devices to provide an assessment of the cybersecurity risks as well as a…
Recent years have witnessed a boom of connected medical devices, which brings security issues in the meantime. Medical imaging devices, an essential part of medical cyber-physical systems, play a vital role in modern hospitals and are often…
There is a growing demand for the use of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare, particularly as clinical decision support systems to assist medical professionals. However, the complexity of many of these…
Implantable Medical Devices (IMD) is a fast pace growing medical field and continues to grow in the foreseeable future. Advancement in science and technology has led to the IMD devices offering advanced medical treatments. Modern IMDs can…
The recent advancements in computing systems and wireless communications have made healthcare systems more efficient than before. Modern healthcare devices can monitor and manage different health conditions of the patients automatically…
Integrated safety and security assurance for complex systems is difficult for many technical and socio-technical reasons such as mismatched processes, inadequate information, differing use of language and philosophies, etc.. Many…
Safety of medical devices and of their interoperation is an unresolved issue causing severe and sometimes deadly accidents for patients with shocking frequency. Formal methods, particularly in support of highly reusable and provably safe…
In the future, AI will increasingly find its way into systems that can potentially cause physical harm to humans. For such safety-critical systems, it must be demonstrated that their residual risk does not exceed what is acceptable. This…
Assurance cases provide an organized and explicit argument for correctness. They can dramatically improve the certification of Scientific Computing Software (SCS). Assurance cases have already been effectively used for safety cases for real…
Machine learning is expected to fuel significant improvements in medical care. To ensure that fundamental principles such as beneficence, respect for human autonomy, prevention of harm, justice, privacy, and transparency are respected,…
The focus of this paper is on wearable technologies which are increasingly being employed in the medical field. From smart watches to smart glasses, from electronic textile to data gloves; several gadgets are playing important roles in…
With increasing complexity of modern-day mobile devices, security of these devices in presence of myriad attacks by an intelligent adversary is becoming a major issue. The vast majority of cell phones still remain unsecured from many…
Assistive technologies increasingly support independence, accessibility, and safety for older adults, people with disabilities, and individuals requiring continuous care. Two major categories are virtual assistive systems and robotic…
Safety assurance is of paramount importance across various domains, including automotive, aerospace, and nuclear energy, where the reliability and acceptability of mission-critical systems are imperative. This assurance is effectively…
Using machine learning in clinical practice poses hard requirements on explainability, reliability, replicability and robustness of these systems. Therefore, developing reliable software for monitoring critically ill patients requires close…
Background: Clinical decision support systems (CDSS) are a category of health information technologies that can assist clinicians to choose optimal treatments. These support systems are based on clinical trials and expert knowledge;…
Clinical systems operate in safety-critical environments and are not intended to function autonomously; however, they are currently designed to replicate clinicians' diagnoses rather than assist them in the diagnostic process. To enable…
The use of embedded software is advancing in modern medical devices, so does its capabilities and complexity. This paradigm shift brings many challenges such as an increased rate of medical device failures due to software faults. In this…
Assurance cases are structured arguments that are commonly used to reason about the safety of a product or service. Currently, there is an ongoing push towards using assurance cases for also cybersecurity, especially in safety-critical…