There has been an explosion of technology-enabled scientific insight into the basic biology of the causes of adverse events. This has been driven, in part, by the development of the various "omics" tools (e.g., genomics, proteomics, and metabolomics) and associated bioinformatics platforms. Meanwhile, for decades, changes in preclinical testing protocols and guidelines have been limited. Precli...

Modern vehicles consist of many interconnected, software-based IT components which are tested very carefully for correct functional behavior to avoid safety problems, e.g. that the brakes suddenly stop working. However, in contrast to safety testing systematic testing against potential security gaps is not yet a common procedure within the automotive domain. This however could eventually enable...

The direct-to-consumer (DTC) medical industry (i.e., medical testing and treatment outside of physician oversight) is growing rapidly as the Internet becomes more accessible globally. As several studies have highlighted, this industry offers unproven medical testing, provides testing for unapproved indications, and uses suspect advertising claims (1–5 ). Furthermore, given the prevalence of ill...

The use of software in safety-critical medical applications permits sophisticated functionality that would otherwise not be achievable. However, it is very difficult to ensure that software in these systems is dependable. In particular all software development techniques have limitations, and none can provide any guarantee of overall software dependability. Given this shortcoming, the approach ...