Quality assurance in agile safety-critical systems development

© 2016 IEEE. In this position paper we examine how safety could be assured when increasingly complex systems are developed using agile software development methods. We first discuss the source and nature of complexity in software systems and how a probe - sense - learn approach recommended by the Cynefin Framework is appropriate for designing complex systems and a sense - analyse - learn approach is appropriate for developing a complicated system whose design has been determined. We then examine how quality assurance is incorporated into agile software development before pointing out that those characteristics of a self-managed team that produce so many benefits for software development of complex systems whose solution evolves with problem understanding, are also vulnerable to confirmation bias. This suggests that for safety critical system development, software systems developed by agile teams will need verification and validation by independent parties. We review current quality management practices for medical device software development before discussing how our earlier findings could be adopted into safety critical software quality management

Decreasing Opportunities for Low-Wage Workers: The Role of the Nondiscrimination Law for Employer-Provided Health Insurance

As of 1978, the favorable tax treatment of fringe benefits, including health insurance, has been regulated via a nondiscrimination clause such that low-wage, full-time workers must be offered health insurance (and other benefits) that are offered to higher-wage workers by the firm. Part-time workers may be excluded from coverage, however, creating incentives for firms to hire some types of workers part time to deny them coverage. We hypothesize that firms will hire fewer workers whose relative costs have increased, that is, low-wage workers. These workers will be less likely to work for firms that offer coverage, and those that do will be more likely to work part time without being eligible for the firm’s health insurance benefits. We use the 1988 and 1993 Employee Benefits Supplements to the Current Population Surveys and an employer premium imputation to examine these hypotheses. Both the descriptive and multivariate analysis are consistent with our hypotheses. We predict the probability of working for a firm that offers health insurance to decrease as premiums increase for both high- and low-wage workers. An increase in the premium is also associated with a decrease in the probability of part-time work, but an even greater decrease in the joint probability of part-time work with eligibility for health insurance.

Towards safer medical device software systems: Industry-wide learning from failures and the use of safety-cases to support process compliance

© 2016 IEEE. Software safety is checked today in regulatory audits, which verify software development process compliance to regulatory requirements. Ensuring safety is a critical task in complex life-supporting systems and despite many existing ways of assuring it, unanticipated failure will always be possible. Checking process compliance to required standards ensures the quality of the processes by which software is developed but does not necessarily indicate the quality of the resultant software. Since medical device domain is facing an increasing amount of device recalls due to software failures, our goal is to explore the underlying reasons for this and suggest two improvements within this paper. First, we will introduce complicated and complex systems to illustrate why there will always be unforeseeable and unanticipated situations that could cause the failure of the entire system. We will then describe how medical device software systems are reviewed for compliance and safety today, highlighting the shortcomings in the current methods adopted in the medical device domain and suggest the use of systems thinking. We then propose two improvements to medical device software development where process compliance is supported by safety cases and industry-wide learning from experience

Localization of complement factor H gene expression and protein distribution in the mouse outer retina.

To determine the localization of complement factor H (Cfh) mRNA and its protein in the mouse outer retina.Quantitative real-time PCR (qPCR) was used to determine the expression of Cfh and Cfh-related (Cfhr) transcripts in the RPE/choroid. In situ hybridization (ISH) was performed using the novel RNAscope 2.0 FFPE assay to localize the expression of Cfh mRNA in the mouse outer retina. Immunohistochemistry (IHC) was used to localize Cfh protein expression, and western blots were used to characterize CFH antibodies used for IHC.Cfh and Cfhr2 transcripts were detected in the mouse RPE/choroid using qPCR, while Cfhr1, Cfhr3, and Cfhrc (Gm4788) were not detected. ISH showed abundant Cfh mRNA in the RPE of all mouse strains (C57BL/6, BALB/c, 129/Sv) tested, with the exception of the Cfh(-/-) eye. Surprisingly, the Cfh protein was detected by immunohistochemistry in photoreceptors rather than in RPE cells. The specificity of the CFH antibodies was tested by western blotting. Our CFH antibodies recognized purified mouse Cfh protein, serum Cfh protein in wild-type C57BL/6, BALB/c, and 129/Sv, and showed an absence of the Cfh protein in the serum of Cfh(-/-) mice. Greatly reduced Cfh protein immunohistological signals in the Cfh(-/-) eyes also supported the specificity of the Cfh protein distribution results.Only Cfh and Cfhr2 genes are expressed in the mouse outer retina. Only Cfh mRNA was detected in the RPE, but no protein. We hypothesize that the steady-state concentration of Cfh protein is low in the cells due to secretion, and therefore is below the detection level for IHC

Veni Vidi Dixi: Reliable Wireless Communication with Depth Images

The upcoming industrial revolution requires deployment of critical wireless sensor networks for automation and monitoring purposes. However, the reliability of the wireless communication is rendered unpredictable by mobile elements in the communication environment such as humans or mobile robots which lead to dynamically changing radio environments. Changes in the wireless channel can be monitored with frequent pilot transmission. However, that would stress the battery life of sensors. In this work a new wireless channel estimation technique, Veni Vidi Dixi, VVD, is proposed. VVD leverages the redundant information in depth images obtained from the surveillance cameras in the communication environment and utilizes Convolutional Neural Networks CNNs to map the depth images of the communication environment to complex wireless channel estimations. VVD increases the wireless communication reliability without the need for frequent pilot transmission and with no additional complexity on the receiver. The proposed method is tested by conducting measurements in an indoor environment with a single mobile human. Up to authors best knowledge our work is the first to obtain complex wireless channel estimation from only depth images without any pilot transmission. The collected wireless trace, depth images and codes are publicly available.Comment: Accepted for publication in CoNext 2019 with reproducibility badges. The measurements and the processing codes are available at https://gitlab.lrz.de/lkn_measurements/vvd_measurements for your evaluatio

Transition-ready technologies and expertise from the Chemical and Biological National Security Program at LLNL

HSARPA has initiated a new Bioinformatics and Assay Development solicitation, BIAD2 (BAA 06-01), to address a number of technology gaps and requirements for biodetection (www.hsarpabaa.com). This solicitation will leverage the vast research and development capabilities of the private sector and academia in order to meet the needs of HSARPA and Homeland Security. In order to meet these requirements, this solicitation will: (1) Develop and validate actionable assays for the public and private sector; (2) Develop and validate new assays and novel assay methodologies to enhance existing detection systems and enable future detection platforms; (3) Develop next generation assays which are robust against novel, emerging and engineered threats; (4) Develop novel assays that detect low levels of ribonucleic acid (RNA)-based viral threats in complex backgrounds; (5) Develop novel assays to characterize the viability, degree of virulence or toxicity, and countermeasure resistance of a biological agent; and (6) Develop new bioinformatics tools to support assay development and assay validation The Lawrence Livermore National Laboratory (LLNL) Bioassays and Signature Program (BSP) develops nationally-validated detection and identification assays to cover the full range of biological threat agents, starting from human, animal, and plant pathogens on the Select Agent list. The assays that have been co-developed by the CDC and the BSP are used internationally and represent the gold standard for molecular detection of select agent pathogens for the public health community. They are also used in the DHS environmental monitoring operations such as BioWatch and DHS National Security Special Events support. These reagents have been used to process and analyze more than 5 million samples and have delivered exceptional performance for the end users, with zero false positives since their deployment. Currently, highly-multiplexed nucleic acid assays that represent the ''next-generation'' in BioWatch assays have been developed at LLNL and are in final evaluation at CDC. LLNL is a full partner to the LRN network, as well as a formal LRN member, sanctioned to perform these diagnostics on field samples. The Program has assay extensive experience developing, testing, validating, deploying, and commercializing biodetection assays and instrumentation. The following pages contain additional descriptions of our Program's capabilities. We have a demonstrated track record of established collaborations and look forward to partnering with offerers to the HSARPA BAA to continue to meet the national needs and requirements

Pharmacological And Genetic Reversal Of Age-Dependent Cognitive Deficits Attributable To Decreased Presenilin Function

Alzheimer\u27s disease (AD) is the leading cause of cognitive loss and neurodegeneration in the developed world. Although its genetic and environmental causes are not generally known, familial forms of the disease (FAD) are attributable to mutations in a single copy of the Presenilin (PS) and amyloid precursor protein genes. The dominant inheritance pattern of FAD indicates that it may be attributable to gain or change of function mutations. Studies of FAD-linked forms of presenilin (psn) in model organisms, however, indicate that they are loss of function, leading to the possibility that a reduction in PS activity might contribute to FAD and that proper psn levels are important for maintaining normal cognition throughout life. To explore this issue further, we have tested the effect of reducing psn activity during aging in Drosophila melanogaster males. We have found that flies in which the dosage of psn function is reduced by 50% display age-onset impairments in learning and memory. Treatment with metabotropic glutamate receptor (mGluR) antagonists or lithium during the aging process prevented the onset of these deficits, and treatment of aged flies reversed the age-dependent deficits. Genetic reduction of Drosophila metabotropic glutamate receptor (DmGluRA), the inositol trisphosphate receptor (InsP(3)R), or inositol polyphosphate 1-phosphatase also prevented these age-onset cognitive deficits. These findings suggest that reduced psn activity may contribute to the age-onset cognitive loss observed with FAD. They also indicate that enhanced mGluR signaling and calcium release regulated by InsP(3)R as underlying causes of the age-dependent cognitive phenotypes observed when psn activity is reduced