The Data Capsule for Non-Consumptive Research: Final Report

Digital texts with access and use protections form a unique and fast growing collection of materials. Growing equally quickly is the development of text and data mining algorithms that process large text-based collections for purposes of exploring the content computationally. There is a strong need for research to establish the foundations for secure computational and data technologies that can ensure a non-consumptive environment for use-protected texts such as the copyrighted works in the HathiTrust Digital Library. Developing a secure computation and data environment for non-consumptive research for the HathiTrust Research Center is funded through a grant from the Alfred P. Sloan Foundation. In this research, researchers at HTRC and the University of Michigan are developing a “data capsule framework” that is founded on a principle of “trust but verify”. The project has resulted in a novel experimental framework that permits analytical investigation of a corpus but prohibits data from leaving the capsule. The HTRC Data Capsule is both a system architecture and set of policies that enable computational investigation over the protected content of the HT digital repository that is carried out and controlled directly by a researcher.Alfred P. Sloan Foundatio

Data Leak Detection As a Service: Challenges and Solutions

We describe a network-based data-leak detection (DLD) technique, the main feature of which is that the detection does not require the data owner to reveal the content of the sensitive data. Instead, only a small amount of specialized digests are needed. Our technique – referred to as the fuzzy fingerprint – can be used to detect accidental data leaks due to human errors or application flaws. The privacy-preserving feature of our algorithms minimizes the exposure of sensitive data and enables the data owner to safely delegate the detection to others.We describe how cloud providers can offer their customers data-leak detection as an add-on service with strong privacy guarantees. We perform extensive experimental evaluation on the privacy, efficiency, accuracy and noise tolerance of our techniques. Our evaluation results under various data-leak scenarios and setups show that our method can support accurate detection with very small number of false alarms, even when the presentation of the data has been transformed. It also indicates that the detection accuracy does not degrade when partial digests are used. We further provide a quantifiable method to measure the privacy guarantee offered by our fuzzy fingerprint framework

Implementation of IS Security Standards on Pharmaceutical Manufacturing

This thesis addresses the issue of Information Systems (IS) security in pharmaceutical manufacturing which is closely related to the ISA 99 standard. The ISA 99 'Security for industrial Automation and Control Systems' standard is focused on the work for securing process automation systems from IS security threats. The main thought behind the ISA 99 standard is that a high level of IS security in computerized manufacturing environments cannot be achieved through just one project but needs long-term dedication. Therefore the ISA 99 standard suggests the implementation of an IS security program as the best way to reduce IS security risks to process automation systems and to sustain risk reduction over time. The overall objective of the study was to suggest an IS security program suitable for the pharmaceutical manufacturing at the AstraZeneca manufacturing and supply site in Södertälje, Sweden. The suggested IS security program can briefly be described as a long-term strategy for how to perform IS security activities in the manufacturing at the Södertälje site. The security program defines both technical and organizational requirements and recommendations. According to the ISA 99 standard, working with IS security in the process automation systems environment require both technical, cultural and organizational perspectives. The suggested security program therefore recommends the forming of a special group for working with IS security in the manufacturing within Sweden Operations. This group includes employees from different departments such as IS security, IS/IT, process automation systems managers, engineering, operators and managers in production areas as well as quality assurance personnel. The purpose with the group is to make the IS security work more effective through reducing bureaucracy, increasing communication and sharing of knowledge and business perspectives. The security program also presents IS security policies for the production at the Södertälje site. A security policy is a written document or directive that defines how the organization defines and operates IS security in the process automation systems environment. The security policy ensures both management support and understanding of roles and responsibilities for IS security in the process automation systems environment

Archives and Records

This open access book addresses the protection of privacy and personality rights in public records, records management, historical sources, and archives; and historical and current access to them in a broad international comparative perspective. Considering the question “can archiving pose a security risk to the protection of sensitive data and human rights?”, it analyses data security and presents several significant cases of the misuse of sensitive personal data, such as census data or medical records. It examines archival inflation and the minimisation and reduction of data in public records and archives, including data anonymisation and pseudonymisation, and the risks of deanonymisation and reidentification of persons. The book looks at post-mortem privacy protection, the relationship of the right to know and the right to be forgotten and introduces a specific model of four categories of the right to be forgotten. In its conclusion, the book presents a set of recommendations for archives and records management

PROMISE: first-trimester progesterone therapy in women with a history of unexplained recurrent miscarriages - a randomised, double-blind, placebo-controlled, international multicentre trial and economic evaluation

BACKGROUND AND OBJECTIVES: Progesterone is essential to maintain a healthy pregnancy. Guidance from the Royal College of Obstetricians and Gynaecologists and a Cochrane review called for a definitive trial to test whether or not progesterone therapy in the first trimester could reduce the risk of miscarriage in women with a history of unexplained recurrent miscarriage (RM). The PROMISE trial was conducted to answer this question. A concurrent cost-effectiveness analysis was conducted. DESIGN AND SETTING: A randomised, double-blind, placebo-controlled, international multicentre study, with economic evaluation, conducted in hospital settings across the UK (36 sites) and in the Netherlands (nine sites). PARTICIPANTS AND INTERVENTIONS: Women with unexplained RM (three or more first-trimester losses), aged between 18 and 39 years at randomisation, conceiving naturally and giving informed consent, received either micronised progesterone (Utrogestan(®), Besins Healthcare) at a dose of 400 mg (two vaginal capsules of 200 mg) or placebo vaginal capsules twice daily, administered vaginally from soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) until 12 completed weeks of gestation (or earlier if the pregnancy ended before 12 weeks). MAIN OUTCOME MEASURES: Live birth beyond 24 completed weeks of gestation (primary outcome), clinical pregnancy at 6-8 weeks, ongoing pregnancy at 12 weeks, miscarriage, gestation at delivery, neonatal survival at 28 days of life, congenital abnormalities and resource use. METHODS: Participants were randomised after confirmation of pregnancy. Randomisation was performed online via a secure internet facility. Data were collected on four occasions of outcome assessment after randomisation, up to 28 days after birth. RESULTS: A total of 1568 participants were screened for eligibility. Of the 836 women randomised between 2010 and 2013, 404 received progesterone and 432 received placebo. The baseline data (age, body mass index, maternal ethnicity, smoking status and parity) of the participants were comparable in the two arms of the trial. The follow-up rate to primary outcome was 826 out of 836 (98.8%). The live birth rate in the progesterone group was 65.8% (262/398) and in the placebo group it was 63.3% (271/428), giving a relative risk of 1.04 (95% confidence interval 0.94 to 1.15; p = 0.45). There was no evidence of a significant difference between the groups for any of the secondary outcomes. Economic analysis suggested a favourable incremental cost-effectiveness ratio for decision-making but wide confidence intervals indicated a high level of uncertainty in the health benefits. Additional sensitivity analysis suggested the probability that progesterone would fall within the National Institute for Health and Care Excellence's threshold of £20,000-30,000 per quality-adjusted life-year as between 0.7145 and 0.7341. CONCLUSIONS: There is no evidence that first-trimester progesterone therapy improves outcomes in women with a history of unexplained RM. LIMITATIONS: This study did not explore the effect of treatment with other progesterone preparations or treatment during the luteal phase of the menstrual cycle. FUTURE WORK: Future research could explore the efficacy of progesterone supplementation administered during the luteal phase of the menstrual cycle in women attempting natural conception despite a history of RM. TRIAL REGISTRATION: Current Controlled Trials ISRCTN92644181; EudraCT 2009-011208-42; Research Ethics Committee 09/H1208/44. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 41. See the NIHR Journals Library website for further project information