Human Factors Standards and the Hard Human Factor Problems: Observations on Medical Usability Standards

With increasing variety and sophistication of computer-based medical devices, and more diverse users and use environments, usability is essential, especially to ensure safety. Usability standards and guidelines play an important role. We reviewed several, focusing on the IEC 62366 and 60601 sets. It is plausible that these standards have reduced risks for patients, but we raise concerns regarding: (1) complex design trade-offs that are not addressed, (2) a focus on user interface design (e.g., making alarms audible) to the detriment of other human factors (e.g., ensuring users actually act upon alarms they hear), and (3) some definitions and scope restrictions that may create “blind spots”. We highlight potential related risks, e.g. that clear directives on “easier to understand” risks, though useful, may preclude mitigating other, more “difficult” ones; but ask to what extent these negative effects can be avoided by standard writers, given objective constraints. Our critique is motivated by current research and incident reports, and considers standards from other domains and countries. It is meant to highlight problems, relevant to designers, standards committees, and human factors researchers, and to trigger discussion about the potential and limits of standards

Reference-dependent preferences in the public and private sectors: A nonlinear perspective

Although existing studies in the strategic management literature examine the importance of reference points in the context of managerial decisions vis-à-vis organizational performance, there is surprisingly little evidence on how reference earnings affect employees' wellbeing and behavior. The present study closes this gap by investigating adaptation dynamics towards reference earnings in the context of employees’ behavioral responses to social comparisons. We argue that a wedge between actual and aspiration-level earnings causes discontent that spurs employees into action to materialize their aspirations. The robustness of such action depends on the size of the wedge in a nonlinear fashion, a hypothesis supported by our findings. Nevertheless, heterogeneity in behavioral responses is evident across the public and private sectors and across gender and educational attainment. Such heterogeneity could be partially attributed to differences in public service motivation among public and private sector employees, to the different weights that employees place on pecuniary vs. non-pecuniary rewards, and whether reference earnings are likely to trigger behavioral responses through a 'jealousy' or through an 'ambition' channel. These findings have implications for the design of strategic human resource management policies to establish reward structures encouraging employees to adopt risk attitudes that are consistent with an overall business strategic plan

Architecture of Environmental Risk Modelling: for a faster and more robust response to natural disasters

Demands on the disaster response capacity of the European Union are likely to increase, as the impacts of disasters continue to grow both in size and frequency. This has resulted in intensive research on issues concerning spatially-explicit information and modelling and their multiple sources of uncertainty. Geospatial support is one of the forms of assistance frequently required by emergency response centres along with hazard forecast and event management assessment. Robust modelling of natural hazards requires dynamic simulations under an array of multiple inputs from different sources. Uncertainty is associated with meteorological forecast and calibration of the model parameters. Software uncertainty also derives from the data transformation models (D-TM) needed for predicting hazard behaviour and its consequences. On the other hand, social contributions have recently been recognized as valuable in raw-data collection and mapping efforts traditionally dominated by professional organizations. Here an architecture overview is proposed for adaptive and robust modelling of natural hazards, following the Semantic Array Programming paradigm to also include the distributed array of social contributors called Citizen Sensor in a semantically-enhanced strategy for D-TM modelling. The modelling architecture proposes a multicriteria approach for assessing the array of potential impacts with qualitative rapid assessment methods based on a Partial Open Loop Feedback Control (POLFC) schema and complementing more traditional and accurate a-posteriori assessment. We discuss the computational aspect of environmental risk modelling using array-based parallel paradigms on High Performance Computing (HPC) platforms, in order for the implications of urgency to be introduced into the systems (Urgent-HPC).Comment: 12 pages, 1 figure, 1 text box, presented at the 3rd Conference of Computational Interdisciplinary Sciences (CCIS 2014), Asuncion, Paragua

Managing Operational Risk in Payment, Clearing, and Settlement Systems

Awareness of operational risk has increased greatly in recent years, both at individual financial institutions and for payment, clearing, and settlement systems (PCSS). PCSS consist of networks of interconnected elements (i.e., central operators, participants, and settlement agents); operational problems at any one of the key elements have the potential to disrupt the system as a whole and negatively affect financial stability. The author describes the key features of systemically important PCSS in Canada and the oversight role of the Bank of Canada with respect to those systems. She also describes one approach that could be used to assess and manage operational risk in Canadian PCSS. This approach relies on a consistent definition of operational risk that can be applied across all elements of a PCSS. It uses a recent methodology adapted from the management of operational risk at individual financial institutions. This methodology, called the loss-distribution approach, assesses risk in terms of the potential outcomes of operational events owing to certain risk factors (such as systems problems, human error, process problems, and external events), their likelihood, and their frequency. Once operational risk databases are developed that record the frequency and severity of operational events, it will be possible to estimate parts of the loss distributions for PCSS. In the meantime, qualitative analysis provided by operations experts associated with the various elements of PCSS will be important for judging the potential impact and frequency of events. In a changing financial environment, it is hoped that this methodology could be used to supplement core aspects of operational risk management, such as sound corporate governance, internal controls, policies and procedures, knowledgeable people, and robust contingency plans.Financial institutions; Payments, clearing and settlements systems

Supreme Court Amicus Brief Regarding Wyeth v. Diana Levine

Prominent in arguments opposing preemption of state tort law liability for alleged inadequacies in prescription drug labeling is the argument that such liability can complement FDA regulation by improving on a regulatory scheme that fails to provide adequate deterrence against the marketing of unsafe or inadequately labeled drugs. The premise of this argument is faulty. Fundamental principles of economics and numerous studies of FDA drug regulation reveal that FDA in fact errs on the side of overregulation of prescription drugs. Product liability litigation focused solely on one side of the prescription drug public health equation leads to further distortions of the drug approval and labeling process and exacerbates FDA's inherent overly cautious approach. Preemption of state tort law where it conflicts with FDA requirements will minimize these distortions and thereby maximize public health.Health and Safety, Other Topics