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QUALITY AND SAFETY ASSURANCE OF MEDICAL APPLICATIONS

机译:医疗应用的质量和安全保证

摘要

The present invention relates in a broad aspect to assurance of quality and safety of medical applications determining - or suggesting - diagnosis and/or treatment. In general, such applications are according to the present invention applications which are designed to operate without assistance of a medical adviser in daily use and accordingly these applications must be supervised in some sense in order to be able to guarantee that diagnoses and/or treatments determined by these applications are not determined in a manner that patients are exposed to life threatening treatment due to malfunctioning of these applications. In the general perspective according to the present invention, treatment is suggested based on a diagnosis and a diagnosis is viewed upon as recognition of a pattern. For instance, a diagnosis is the result of recognition of a pattern of antibody substances in a sample taken from the tissue of a patient. Furthermore, the term diagnosis has been given a broad interpretation in the present content so as to include - and/or even be- determination of treatment. The philosophy behind such an approach is that the determination of a treatment is according to the present invention based on determination of a pattern. For instance in case of the prescription of a drug preventing attacks of Multiple Sclerosis, a measured blood sample may be analyzed for patterns of matter in the sample and once a pattern is recognized the treatment assigned to said pattern is the treatment suggested.
机译:本发明在广义上涉及确定或建议诊断和/或治疗的医学应用的质量和安全性的保证。通常,根据本发明,这样的应用是被设计为在日常使用中无需医学顾问的帮助而操作的应用,因此,必须在某种意义上对这些应用进行监督,以便能够保证确定诊断和/或治疗。这些应用程序无法确定患者是否因这些应用程序故障而遭受危及生命的治疗。从本发明的总体观点来看,基于诊断建议治疗,并且将诊断视为对模式的识别。例如,诊断是识别从患者组织获取的样品中抗体物质模式的结果。此外,术语“诊断”在当前内容中已得到广泛的解释,以便包括-和/或什至确定治疗方法。这种方法背后的原理是,根据本发明,基于模式的确定来确定治疗。例如,在开具预防多发性硬化症发作的药物处方的情况下,可以分析被测血样中样品中物质的模式,一旦识别出模式,则建议为该模式指定的治疗。

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