Abstract. Unsecure computational environments threaten many nancial cryptography implementations, and other sensitive computation. High-performance secure coprocessors can address these threats. However, using this technology for practical security solutions requires overcoming numerous technical and business obstacles. These obstacles motivate building a high-performance secure coprocessor that balances security with easy third-party programmability|but these obstacles also provide many design challenges. This paper discusses some of issues we faced when attempting to build such a device.
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The Caernarvon operating system was developed to demonstrate that a high assurance system for smart cards was technically feasible and commercially viable. The entire system has been designed to be evaluated under the Common Criteria at EAL7, the highest defined level of assurance. Historically, smart card processors have not supported the hardware protection features necessary to separate the OS from the applications, and one application from another. The Caernarvon OS has taken advantage of the first smart card processors with such features to be the first smart card OS to provide this kind of protection. Even when compared with conventional systems where the hardware protection is routine, the Caernarvon OS is noteworthy, because of the EAL7 assurance. This approach facilitated implementation of a formally specified, mandatory security policy providing multi-level security (MLS) suitable for both government agencies and commercial users. The mandatory security policy requires effective authentication of its users that is independent of applications. For this reason, the Caernarvon OS also contains a privacy-preserving, two-way authentication protocol integrated with the Mandatory Security Policy. The Caernarvon OS includes a strong cryptographic library that has been separately certified under the Common Criteria at EAL5+ for use with other systems. The Caernarvon OS implements a secure method for downloading trusted and untrusted application software and data in the field, with the assumption that all applications are potentially hostile. While the initial platform for the operating system was smart cards, the design could also be used in other embedded devices, such as USB tokens, PDAs, cell phones, etc.
Background As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology. Methods The trial (internal pilot) paused in March 2020, re-opened in July 2020, and is currently recruiting in 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made to WILL processes and surveyed sites for their views of these changes (20 sites, videoconference). Results Despite 88% of sites favouring an electronic investigator site file (ISF), information technology requirements and clinical trial unit (CTU) operating procedures mandated the ongoing use of paper ISFs; site start-up delays resulted from restricted access to the CTU. Site initiation visits (SIVs) were conducted remotely; 50% of sites preferred remote SIVs and 44% felt that it was trial-dependent, while few preferred SIVs in-person as standard procedure. The Central team felt remote SIVs provided scheduling and attendance flexibility (for sites and trial staff), the option of recording discussions for missing or future staff, improved efficiency by having multiple sites attend, and time and cost savings; the negative impact on rapport-building and interaction was partially mitigated over time with more familiarity with technology and new ways-of-working. Two methods of remote consent were developed and used by 30/37 sites and for 54/156 recruits. Most (86%) sites using remote consenting felt it improved recruitment. For remote data monitoring (5 sites), advantages were primarily for the monitor (e.g. flexibility, no time constraints, reduced cost), and disadvantages primarily for the sites (e.g. document and access preparation, attendance at a follow-up meeting), but 81% of sites desired having the option of remote monitoring post-pandemic. Conclusions COVID adaptations to WILL trial processes improved the flexibility of trial delivery, for Central and site staff, and participants. Flexibility to use these strategies should be retained post-pandemic. Trial registration ISRCTN77258279. Registered on 05 December 2018.
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