Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy

Background: Smoking in pregnancy remains a public health challenge. Nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, but because women metabolise nicotine and cotinine much faster in pregnancy, it is unclear whether this will be effective for smoking cessation in pregnancy. The NHS Health Technology Assessment Programme (HTA)-funded smoking, nicotine and pregnancy ( SNAP) trial will investigate whether or not nicotine replacement therapy ( NRT) is effective, cost-effective and safe when used for smoking cessation by pregnant women. Methods/Design: Over two years, in 5 trial centres, 1050 pregnant women who are between 12 and 24 weeks pregnant will be randomised as they attend hospital for ante-natal ultrasound scans. Women will receive either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure is biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date ( defined before randomisation and set within two weeks of this) and delivery. At six months after childbirth self-reported maternal smoking status will be ascertained and two years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial will be compared in both groups. Discussion: This trial is designed to ascertain whether or not standard doses of NRT ( as transdermal patches) are effective and safe when used for smoking cessation during pregnancy

The Benefits and Costs of Online Privacy Legislation

Many people are concerned that information about their private life is more readily available and more easily captured on the Internet as compared to offline technologies. Specific concerns include unwanted email, credit card fraud, identity theft, and harassment. This paper analyzes key issues surrounding the protection of online privacy. It makes three important contributions: First, it provides the most comprehensive assessment to date of the estimated benefits and costs of regulating online privacy. Second, it provides the most comprehensive evaluation of legislation and legislative proposals in the U.S. aimed at protecting online privacy. Finally, it offers some policy prescriptions for the regulation of online privacy and suggests areas for future research. After analyzing the current debate on online privacy and assessing the potential costs and benefits of proposed regulations, our specific recommendations concerning the government's involvement in protecting online privacy include the following: The government should fund research that evaluates the effectiveness of existing privacy legislation before considering new regulations. The government should not generally regulate matters of privacy differently based on whether an issue arises online or offline. The government should not require a Web site to provide notification of its privacy policy because the vast majority of commercial U.S.-based Web sites already do so. The government should distinguish between how it regulates the use and dissemination of highly sensitive information, such as certain health records or Social Security numbers, versus more general information, such as consumer name and purchasing habits. The government should not require companies to provide consumers broad access to the personal information that is collected online for marketing purposes because the benefits do not appear to be significant and the costs could be quite high. The government should make it easier for the public to obtain information on online privacy and the tools available for consumers to protect their own privacy. The message of this paper is not that online privacy should be unregulated, but rather that policy makers should think through their options carefully, weighing the likely costs and benefits of each proposal.

Children's Databases - Safety and Privacy

This report describes in detail the policy background, the systems that are being built, the problems with them, and the legal situation in the UK. An appendix looks at Europe, and examines in particular detail how France and Germany have dealt with these issues. Our report concludes with three suggested regulatory action strategies for the Commissioner: one minimal strategy in which he tackles only the clear breaches of the law, one moderate strategy in which he seeks to educate departments and agencies and guide them towards best practice, and finally a vigorous option in which he would seek to bring UK data protection practice in these areas more in line with normal practice in Europe, and indeed with our obligations under European law

Privacy in the Genomic Era

Genome sequencing technology has advanced at a rapid pace and it is now possible to generate highly-detailed genotypes inexpensively. The collection and analysis of such data has the potential to support various applications, including personalized medical services. While the benefits of the genomics revolution are trumpeted by the biomedical community, the increased availability of such data has major implications for personal privacy; notably because the genome has certain essential features, which include (but are not limited to) (i) an association with traits and certain diseases, (ii) identification capability (e.g., forensics), and (iii) revelation of family relationships. Moreover, direct-to-consumer DNA testing increases the likelihood that genome data will be made available in less regulated environments, such as the Internet and for-profit companies. The problem of genome data privacy thus resides at the crossroads of computer science, medicine, and public policy. While the computer scientists have addressed data privacy for various data types, there has been less attention dedicated to genomic data. Thus, the goal of this paper is to provide a systematization of knowledge for the computer science community. In doing so, we address some of the (sometimes erroneous) beliefs of this field and we report on a survey we conducted about genome data privacy with biomedical specialists. Then, after characterizing the genome privacy problem, we review the state-of-the-art regarding privacy attacks on genomic data and strategies for mitigating such attacks, as well as contextualizing these attacks from the perspective of medicine and public policy. This paper concludes with an enumeration of the challenges for genome data privacy and presents a framework to systematize the analysis of threats and the design of countermeasures as the field moves forward

Data protection and statistics – a dynamic and tension-filled relationship

New statistical methods have been developed for the longer-term storage of microdata. These methods must comply, however, with the fundamental right to informational self-determination and the legal regulations imposed by the Federal Constitutional Court. Thus it is crucial to develop effective and coherent methods for protecting personal data collected for statistical purposes. Recent decisions by the Federal Constitutional Court are likely to result in the outlawing of comprehensive, permanent statistical compilations comprised of microdata from a wide range of sources and updated regularly. However, aside from such comprehensive methods, there are certainly other ways of using microdata that cannot be dismissed from the outset as violating constitutional legal norms. Internet access to statistical microdata is likely to take on increased importance for scientific research in the near future. Yet this would radically change the entire landscape of data protection: the vast amount of additional information now available on the Internet makes it almost impossible to judge whether individuals can be rendered identifiable. In view of this almost unlimited information, individual data can only be offered over the Internet if the absolute anonymity of the data can be guaranteed.Right to informational self-determination, census ruling of December 15, 1983, longer-term storage of microdata, primary statistics, secondary statistics, statistical confidentiality, absolute anonymisation, de facto anonymisation, additional information, pseudonymisation, personal data profiles.

Unilateral Invasions of Privacy

Most people seem to agree that individuals have too little privacy, and most proposals to address that problem focus on ways to give those users more information about, and more control over, how information about them is used. Yet in nearly all cases, information subjects are not the parties who make decisions about how information is collected, used, and disseminated; instead, outsiders make unilateral decisions to collect, use, and disseminate information about others. These potential privacy invaders, acting without input from information subjects, are the parties to whom proposals to protect privacy must be directed. This Article develops a theory of unilateral invasions of privacy rooted in the incentives of potential outside invaders. It first briefly describes the different kinds of information flows that can result in losses of privacy and the private costs and benefits to the participants in these information flows. It argues that in many cases the relevant costs and benefits are those of an outsider deciding whether certain information flows occur. These outside invaders are more likely to act when their own private costs and benefits make particular information flows worthwhile, regardless of the effects on information subjects or on social welfare. And potential privacy invaders are quite sensitive to changes in these costs and benefits, unlike information subjects, for whom transaction costs can overwhelm incentives to make information more or less private. The Article then turns to privacy regulation, arguing that this unilateral-invasion theory sheds light on how effective privacy regulations should be designed. Effective regulations are those that help match the costs and benefits faced by a potential privacy invader with the costs and benefits to society of a given information flow. Law can help do so by raising or lowering the costs or benefits of a privacy invasion, but only after taking account of other costs and benefits faced by the potential privacy invader

Privacy and Accountability in Black-Box Medicine

Black-box medicine—the use of big data and sophisticated machine learning techniques for health-care applications—could be the future of personalized medicine. Black-box medicine promises to make it easier to diagnose rare diseases and conditions, identify the most promising treatments, and allocate scarce resources among different patients. But to succeed, it must overcome two separate, but related, problems: patient privacy and algorithmic accountability. Privacy is a problem because researchers need access to huge amounts of patient health information to generate useful medical predictions. And accountability is a problem because black-box algorithms must be verified by outsiders to ensure they are accurate and unbiased, but this means giving outsiders access to this health information. This article examines the tension between the twin goals of privacy and accountability and develops a framework for balancing that tension. It proposes three pillars for an effective system of privacy-preserving accountability: substantive limitations on the collection, use, and disclosure of patient information; independent gatekeepers regulating information sharing between those developing and verifying black-box algorithms; and information-security requirements to prevent unintentional disclosures of patient information. The article examines and draws on a similar debate in the field of clinical trials, where disclosing information from past trials can lead to new treatments but also threatens patient privacy