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ItemSoftware as a Medical Device (SaMD): Useful or Useless Term?( 2021-01-05)Software as a medical device is a relatively new and expanding field in which patient safety must be a key concern. Regulation and standards regarding software as a medical device (subsequently referred to as “SaMD”) must incorporate all components that could potentially influence SaMD, both in its development and implementation. However, SaMD has been varyingly defined by organisations and individuals within the literature, therefore there is no clear boundary as to what is or is not SaMD, consequently, no clear definition of SaMD exists. Without a clear definition it therefore becomes impossible to create standards to regulate SaMD. Ultimately, this results in increased risks to patient safety. The purpose of this study was to identify SaMD concepts through a Scoping Review to establish the boundaries of SaMD. This has significant impact on new technology applications to support healthcare monitoring and healthcare service delivery. This will ultimately affect how new technology can be regulated in healthcare and will impact innovation and design in this field.
ItemSoftware Architectures and Efficient Data Sharing for Promoting Continuous Drug Re-purposing( 2021-01-05)The proposed layered and component based architectural style enables data sharing and accessibility of computational software components across problem domains in Biomedical Science. However, it also opens door to translational informatics, which bridges the gap between knowledge generated in biomedical science and clinical practices. Software applications generated from such an architectural style, are able to support continues drug repurposing. They exploit the semantic which exists, and is available across biomedical problem domains, between drug chemical compounds, their biological targets, particularly unintentional targets and drug therapeutic effects. The excerpt from the proposed software architectures has already been deployed in computationally light-weight software applications which based drug repurposing on reasoning upon collected available semantic. However a full scale implementation of the ideas of data sharing across the spectrum of biomedical research and disciplines, would require some changes in the way therapeutic drugs are discovered, tested and approved.
ItemHealth in the Era of the Internet of Things: A Domain-Specific Modelling Language( 2021-01-05)Based on the cultural, social and technological development of the last hundred years, the pursuit of health driven by primal instincts has been transformed in most areas worldwide into a quasi de facto standard. But this security is deceptive. Not only the global developments of the last few months, but also creeping factors such as demographic change or the steadily growing world population are putting increasing pressure on the healthcare system. Today, more and more health care systems based on continuous demand for medical resources are increasingly reaching their limits. Technologies such as the Internet of Things are not a panacea, but offer great potential for increasing the flexibility and efficiency of healthcare systems. However, the development of such IoT-based healthcare systems requires a holistic understanding of the information technology as well as the domain itself. Against this background, the paper presents a domain- specific modelling language for IoT-based healthcare systems