Medical regulation of cognitive enhancement devices: some concerns

The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration.     

Feasibility of Canine Detection of Mass Storage Devices: A Study of Volatile Organic Compounds Emanating from Electronic Devices Using Solid Phase Microextraction

Detection of canines are well‐known to be valuable in the location of contraband, such as explosives or narcotics. More recently, canines have been trained and utilized in the detection of concealed mass storage devices that might contain evidence of illegal activity such as child pornography. To lay the analytical foundation for this detection work, research was carried out to determine the volatile organic compounds associated with mass storage devices (MSD) that could be used by trained canines for detection. Headspace analysis of a variety of electronic devices was performed using solid phase microextraction (SPME) with gas chromatography/mass spectrometry (GC/MS). Analyses found several volatile compounds common to SIM and SD cards, as well as USB drives, including 2‐propenenitrile, styrene, isophorone, hydroxycyclohexyl phenyl ketone, and 2‐furanmethanol, tetrahydro. Results indicated that mass storage devices do have a characteristic odor profile making detection with minimal false alerts feasible for trained canines.     

Electronic signatures and security issues: An empirical study

Security concerns with regard to the use of electronic signatures in the electronic environment seem to represent a potential barrier to their usage. This paper presents an empirical study that examines businesses' perceived security concerns with the use of the electronic signature technology for executing contracts and commercial transactions and whether such issues represent a disincentive for their usage. The findings of the study reveal that there are significant security concerns in the business community with regard to the use of electronic signatures. However, such perceptions seem to be primarily driven by a lack of awareness and understanding. Advising prospective users of electronic signatures about the kind of safeguards that could be put in place to minimise risks associated with their usage can be a useful step towards overcoming their fears and hesitance.     

Muscle contraction during electro-muscular incapacitation: A comparison between square-wave pulses and the TASER(®) X26 Electronic control device

Abstract: Electronic control devices (including the Advanced TASER^® X26 model produced by TASER International) incapacitate individuals by causing muscle contractions. To provide information relevant to development of future potential devices, effects of monophasic square waves with different parameters were compared with those of the X26 electronic control device, using two animal models (frogs and swine). Pulse power, electrical pulse charge, pulse duration, and pulse repetition frequency affected muscle contraction. There was no difference in the charge required, between the square waveform and the X26 waveform, to cause approximately the same muscle‐contraction response (in terms of the strength‐duration curve). Thus, on the basis of these initial studies, the detailed shape of a waveform may not be important in terms of generating electro‐muscular incapacitation. More detailed studies, however, may be required to thoroughly test all potential waveforms to be considered for future use in ECDs.     

The use of orthopedic surgical devices for forensic identification

Surgically implanted devices have become increasingly common in modern skeletal material. Therefore, having the knowledge of the variety of implanted orthopedic devices, their manufacturer, and where to find and how to use identifying numbers in such implants can assist in the identification process when traditional methods are not applicable. Orthopedic device manufacturers are required by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997 to track permanently implanted devices. Manufacturer information on orthopedic devices associates the orthopedic surgeon who implanted the device with the patient. By providing a current list of the most common orthopedic device manufacturers in the U.S.A. and the associated contact information, investigators will have updated tools for the individuation process. Despite numerous complicating factors regarding how device data are tracked, the information presented here can assist forensic professionals with obtaining presumptive and/or positive identifications.     

Regulation of cognitive enhancement devices: commentary

Maslen et al. (2013) have provided us with a comprehensive overview of the current legislation regulating non-clinical cognitive enhancement devices (CEDs) in the European Union and have proposed a specific model whereby CEDs would be regulated in the same way as medical devices. An alternative model would be to require manufacturers to quantify risks only. Irrespective of the purported ‘benefits’ of a product, this would allow the consumer freedom of choice to use the product at their will and allow the periodic review of worthwhile indications and unexpected adverse events. Although this departs from the standard Cochrane-type assessment, it takes into account the facts that (i) the evaluation of clinically used cognitive enhancement techniques may not be as rigorous as one might expect, (ii) variations and case-by-case use might be widespread, and (iii) independent variables of significance and useful endpoints may not be obvious ab initio. We consider cerebrospinal fluid diversion techniques which are widely used clinically to enhance cognition in patients with normal pressure hydrocephalus despite any large-scale clinical studies demonstrating substantial benefit, and the real risks of paralysis and death from these invasive procedures. The risks of CEDs which have been available for some time need to be kept in perspective: are the risks really more than using conventional cognitive enhancement techniques such as imbibing too caffeinated drinks? Furthermore, the loss of Europe as a market for CEDs which do not comply with the proposed regulatory model implies a potential gain in the market for other parts of the world. This could impact on the ability of companies in Europe being able to compete in an evolving market demand for CEDs. Legislation to regulate CEDs should be guided by the principle of ‘do no harm’ and allow for innovation and competition.     

积极应对国际贸易与环境新形势——两个案例的启示

本文通过对金枪鱼案和海虾案的回顾,认为WTO关于国际贸易与环境争端解决有了突破性的进步,我国应该顺应这一形势,采取积极主动的应对措施.     

国内外液态爆炸物安全检查技术和设备的发展

液态爆炸物具有制造简易、不易识别、威力巨大、易于引爆等特点,这些特点增加了液态爆炸物安全检查的难度。液态爆炸物的安全检查分为探测、防护和处置三个环节。针对探测环节,文章综述了国内外主要使用的液态爆炸物探测技术及其特点,介绍了有代表性的技术产品,探讨了液态爆炸物探测技术的发展趋势,最后,对我国液态爆炸物安全检查行业的技术发展提出了几点建议。     

Current state and progress of research on forensic biomechanics in China

Forensic biomechanics gradually has become a significant component of forensic science. Forensic biomechanics is evidence-based science that applies biomechanical principles and methods to forensic practice, which has constituted one of the most potential research areas. In this review, we introduce how finite element techniques can be used to simulate forensic cases, how injury criteria and injury scales can be used to describe injury severity, and how tests of postmortem human subjects and dummy can be used to provide essential validation data. This review also describes research progress and new applications of forensic biomechanics in China.

Key points

• The review shows the main research progress and new applications of forensic biomechanics in China.
• The review introduces eight cases about the application of forensic biomechanics, including the multiple rigid body reconstruction, the finite element applications, study of mechanical properties, traffic crash reconstruction based on multiple techniques and analysis of morphomechanical mechanism about blood dispersal.
• Though forensic biomechanics has a great advantage for the evaluation of injury mechanisms, it still has some uncertainties owing to the uniqueness of the human anatomy, the complexity of biological materials, and the uncertainty of injury-causing circumstances.