A collection of previously published articles and essays.

The development of an information society and information technologies does not result in positive consequences only. Individuals with criminal intent also find their niche. Information security includes the creation of the input, processing and output processes of protection. The objective of information security is to protect the system of values, to protect and ensure accuracy and integrity and to minimize losses that may be incurred if the information is modified or destroyed. In the development of an information society, the new (...) visible changes in the legislation for the classification of crimes–crimes against computers–altered the concept of electronic crime data and information system security concepts. This article presents a brief analysis on the concept of the change of crimes against security of electronic data and information systems, the legislation analysis, the crimes against security of electronic data systems and information dynamics and its relationship with business factors. (shrink)

PurposeWithin a larger mandate of reviewing the key global trends concerning consumer protection in the electronic commerce (e-commerce) literature, this study aims to study the legal framework concerning e-commerce and consumer protection in the Sultanate of Oman and to analyse the current regulations concerning e-commerce and consumer protection.Design/methodology/approachThis study followed the normative legal research approach and resorted to the desk research process to facilitate content analysis of literature containing consumer protection legislation and regulatory provisions in Oman in particular and (...) the rest of the world in general.FindingsThe study reveals that consumer protection initiatives in Oman are well entrenched for offline transactions, but are relatively new and limited for e-commerce. In spite of the promulgation of consumer protection laws, electronic transaction law and cybercrime law, consumer protection measures for e-commerce in Oman do not address a large number of the global concerns necessary to build consumer confidence and trust in the online environment.Research limitations/implicationsThere is a dearth of information concerning Oman on this topic in the extant literature. The research also witnessed the lack of empirical data on the issue of consumer protection and e-commerce in Oman that offer a detailed database of consumer complaints and associated outcomes.Practical implicationsThe mechanism of consumer protection in electronic transactions is not robust in many countries. Because of the lack of comprehensive and robust legislation, consumers remain vulnerable in the online contractual purchase process. Moving beyond the fragmented legislation, many countries are currently mulling an all-comprehensive e-commerce law, implications of this paper will help the policymakers in identifying the focus areas.Social implicationsConsumer protection is a burning global issue in this era of consumerism. It is important to build consumer trust, transparency and integrity of transactions to reduce the risk and uncertainties of purchase.Originality/valueConsumer protection studies conducted in the context of Oman, hitherto, deal more with data protection and dispute resolution mechanisms, and less with legal provisions, regulations and consumer confidence. The study shares newer insights based on a systematic review of legal and business databases. It is the first study of its kind in the context of Oman and the Middle East in general. (shrink)

Whether due to simplicity or hypocrisy, the question of access to patient data for biomedical research is widely seen in the public discourse only from the angle of patient privacy. At the same time, the desire to live and to live without disability is of much higher value to the patients. This goal can only be achieved by extracting research insight from patient data in addition to working on model organisms, something that is well understood by many patients. (...) Yet, most biomedical researchers working outside of clinics and hospitals are denied access to patient records when, at the same time, clinicians who guard the patient data are not optimally prepared for the data’s analysis. Medical data collection is a time- and cost-intensive process that is most of all tedious, with few elements of intellectual and emotional satisfaction on its own. In this process, clinicians and bioinformaticians, each group with their own interests, have to join forces with the goal to generate medical data sets both from clinical trials and from routinely collected electronic health records that are, as much as possible, free from errors and obvious inconsistencies. The data cleansing effort as we have learned during curation of Singaporean clinical trial data is not a trivial task. The introduction of omics and sophisticated imaging modalities into clinical practice that are only partially interpreted in terms of diagnosis and therapy with today’s level of knowledge warrant the creation of clinical databases with full patient history. This opens up opportunities for re-analyses and cross-trial studies at future time points with more sophisticated analyses of the same data, the collection of which is very expensive. (shrink)

Privacy, Due process and the Computational Turn: The Philosophy of Law Meets the Philosophy of Technology engages with the rapidly developing computational aspects of our world including data mining, behavioural advertising, iGovernment, profiling for intelligence, customer relationship management, smart search engines, personalized news feeds, and so on in order to consider their implications for the assumptions on which our legal framework has been built. The contributions to this volume focus on the issue of privacy, which is often equated with (...) data privacy and data security, location privacy, anonymity, pseudonymity, unobservability, and unlinkability. Here, however, the extent to which predictive and other types of data analytics operate in ways that may or may not violate privacy is rigorously taken up, both technologically and legally, in order to open up new possibilities for considering, and contesting, how we are increasingly being correlated and categorizedin relationship with due process – the right to contest how the profiling systems are categorizing and deciding about us. (shrink)

This chapter addresses the morality of two types of national security electronic surveillance (SIGINT) programs: the analysis of communication “metadata” and dragnet searches for keywords in electronic communication. The chapter develops a standard for assessing coercive government action based on respect for the autonomy of inhabitants of liberal states and argues that both types of SIGINT can potentially meet this standard. That said, the collection of metadata creates opportunities for abuse of power, and so judgments about the trustworthiness (...) and competence of the government engaging in the collection must be made in order to decide whether metadata collection is justified in a particular state. Further, the moral standard proposed has a reflexive element justifying adversary states’ intelligence collection against one another. Therefore, high-tech forms of SIGINT can only be justified at the cost of justifying cruder versions of signals intelligence collection practiced by a state’s less-advanced adversaries. (shrink)

Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role (...) and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs. (shrink)

BackgroundElectronic cigarettes as substitute devices for regular tobacco cigarettes have been increasing in recent times. We investigated neuronal substrates of vaping e-cigs and smoking r-cigs from r-cig smokers.MethodsTwenty-two r-cig smokers made two visits following overnight smoking cessation. Functional magnetic resonance imaging data were acquired while participants watched smoking images. Participants were then allowed to smoke either an e-cig or r-cig until satiated and fMRI data were acquired. Their craving levels and performance on the Montreal Imaging Stress Task and (...) a 3-back alphabet/digit recognition task were obtained and analyzed using two-way repeated-measures analysis of variance. Regions-of-interest were identified by comparing the abstained and satiated conditions. Neuronal activation within ROIs was regressed on the craving and behavioral data separately.ResultsCraving was more substantially reduced by smoking r-cigs than by vaping e-cigs. The response time for the 3-back task was significantly shorter following smoking r-cigs than following vaping e-cigs = 5.3, p = 0.035). Neuronal activations of the right vermis, right caudate, and right superior frontal gyrus were significantly correlated with the RT for the 3-back task only for smoking r-cigs.ConclusionOur findings suggest that insufficient satiety from vaping e-cigs for r-cigs smokers may be insignificant effect on working memory function. (shrink)

BackgroundUse of routinely collected patient data for research and service planning is an explicit policy of the UK National Health Service and UK government. Much clinical information is recorded in free-text letters, reports and notes. These text data are generally lost to research, due to the increased privacy risk compared with structured data. We conducted a citizens’ jury which asked members of the public whether their medical free-text data should be shared for research for public benefit, (...) to inform an ethical policy.MethodsEighteen citizens took part over 3 days. Jurors heard a range of expert presentations as well as arguments for and against sharing free text, and then questioned presenters and deliberated together. They answered a questionnaire on whether and how free text should be shared for research, gave reasons for and against sharing and suggestions for alleviating their concerns.ResultsJurors were in favour of sharing medical data and agreed this would benefit health research, but were more cautious about sharing free-text than structured data. They preferred processing of free text where a computer extracted information at scale. Their concerns were lack of transparency in uses of data, and privacy risks. They suggested keeping patients informed about uses of their data, and giving clear pathways to opt out of data sharing.ConclusionsInformed citizens suggested a transparent culture of research for the public benefit, and continuous improvement of technology to protect patient privacy, to mitigate their concerns regarding privacy risks of using patient text data. (shrink)

Electronic machinic phenomena yield fascinating links with biological processes. Either in the macro-micro-structure of binary encoded information ‐ bytes on media ‐ to the processual flow programs execute on hardware while operating it. Observing micro-electronic worlds akin to living entities: electronic voltages running throughout electronic architectures pipelining data to memory registers; operating systems executing programs on electronic substrates; data flows taking place in machines and in communications protocols within networks. Static art-sci constructs explore (...) and visualize these observations as 2D drawings (Neon Paleolitikos Drawings, 2017‐present) or 3D sculptures (Binary and Biological Sculpture Series, 2018‐present), creatively exposing their inherent rhythmic organization of information, while dynamic installations (Phoenix.Wolfanddotcom.info, Wolfanddotcom, Half-Plant, 2017, Ant Ennae Labyrinths, 2019‐present) propose immersive interference mechanisms that attempt user entanglement in non-human environments. Seven aesthetic case examples are introduced and explored, observing and seeking resonances between micro-granular electronic, biological and hybrid data as source synthesis. This research proposes a look at bio-electronic aggregates on Neon Paleolitikos strata. After the Anthropocene, Neon Paleolitikos is an imaginary epoch dating since the decline of mankind until the zenith of bio-electronic life forms: operational symbioses combined among ruins of silica, transistors, algorithms, cells, plants, animals and electricity. (shrink)

Despite the frequent use of the term systems by academicians and management practitioners, there is little agreement as to what the term really means. Experts in different fields talk about accounting systems, production systems, electronic data processing systems, market systems, financial systems, reward and motivation systems, and so on, but the student of management is confused by the nebulous and, at times, seemingly contradictory terms. This article uses the term Systems Approach as a convenient handle to pull together (...) a few basic ideas about the systems concept. Systems Approach organizes one's thinking to understand more clearly the complexity of a real world phenomenon. It consists of two main parts: (1) Systems Thinking (ST), and (2) Information Technology (IT). ST provides the knowledge for developing a Theory of Systems, such as General Systems Theory and Cybernetics, while IT supplies the tools for testing and improving this theory. The relationship between the two parts is a complementary one. Advances in theory lead to the development of better technology, while improvement in technology makes theory development easier and more reliable. (shrink)

We hypothesize that recent uses of the Internet as a public-participation mechanism in the United States fail to overcome the adversarial culture that characterizes the American regulatory process. Although the Internet has the potential to facilitate deliberative processes that could result in more widespread public involvement, greater transparency in government processes, and a more satisfied citizenry, we argue that efforts to implement Internet-based public participation have overlaid existing problematic government processes without fully harnessing the transformative power of information technologies. Public (...) comments submitted in two United States Department of Agriculture rulemaking processes—the National Organic Program’s organic standard and the Forest Service’s Roadless Area Conservation Rule—compose our data. We conclude that the Internet provides an arena for playing out three types of conflicts that have long plagued environmental decision-making processes: conflicts over trust of federal agencies, the use of science, and the role of public values. (shrink)

Big data, big impact -- Values and actions -- Current practices -- Aligning values and actions.

From a speech given at a conference sponsored by the Electronic Funds Transfer Association (EFTA) on "The Puzzle of Data Security and Consumer Privacy," Washington, DC, 16 November 1992. At that time, Dr. Perry was a Consultant in Advisory Services for the Ethics Resource Center.

Emergent technologies are undermining both decisional privacy (intimacy) and informational privacy. Regarding the former consider, e.g., technical intrusions on burglar alarms and telephone calls. Regarding the latter consider how routinely technologies enable intrusion into electronic data processing (EDP) in spite of government efforts to maintain control. These efforts are uneven among nations thus inviting selective choice of a data storage country. Deregulation of telecommunications and assigning operators First Amendment rights invites multiple efforts to profit from preferential treatment (...) of multiple competitors. (shrink)

With the rapid development of sensor technology for automated driving applications, the fusion, analysis, and application of multimodal data have become the main focus of different scenarios, especially in the development of mobile edge computing technology that provides more efficient algorithms for realizing the various application scenarios. In the present paper, the vehicle status and operation data were acquired by vehicle-borne and roadside units of electronic registration identification of motor vehicles. In addition, a motion model and an (...) identification system for the single-vehicle lane-change process were established by mobile edge computing and self-organizing feature mapping. Two scenarios were modeled and tested: lane change with no vehicles in the target lane and lane change with vehicles in the target lane. It was found that the proposed method successfully identified the stochastic parameters in the process of driving trajectory simulation, and the standard deviation between simulation and the measured results obeyed a normal distribution. The proposed methods can provide significant practical information for improving the data processing efficiency in automated driving applications, for solving single-vehicle lane-change applications, and for promoting the formation of a closed loop from sensing to service. (shrink)

Proliferation of data processing and data storage devices in the Internet of Things poses significant privacy risks. At the same time, faster and faster use-cycles and obsolescence of devices with electronic components causes environmental problems. Some of the solutions to the environmental challenges of e-waste include mandatory recycling schemes as well as informal second hand markets. However, the data security and privacy implications of these green policies are as yet badly understood. This paper argues that based (...) on the experience with second hand markets in desktop computers, it is very likely that data that was legitimately collected under the household exception of the Data Protection Directive will “leak” into public spheres. Operators of large recycling schemes may find themselves inadvertently and unknowingly to be data controller for the purpose of Data Protection law, private resale of electronic devices can expose the prior owner to significant privacy risks. (shrink)

The term ‘the artificial’ can only be given a precise meaning in the context of the evolution of computational technology and this in turn can only be fully understood within a cultural setting that includes an epistemological perspective. The argument is illustrated in two case studies from the history of computational machinery: the first calculating machines and the first programmable computers. In the early years of electronic computers, the dominant form of computing was data processing which was a (...) reflection of the dominant philosophy of logical positivism. By contrast, artificial intelligence (AI) adopted an anti-positivist position which left it marginalised until the 1980s when two camps emerged: technical AI which reverted to positivism, and strong AI which reified intelligence. Strong AI's commitment to the computer as a symbol processing machine and its use of models links it to late-modernism. The more directly experiential Virtual Reality (VR) more closely reflects the contemporary cultural climate of postmodernism. It is VR, rather than AI, that is more likely to form the basis of a culture of the artificial. (shrink)

Drawing on Burawoy's framework of “factory regimes” and concepts of power and practice from Foucault and de Certeau, this article depicts a production regime of “familial hegemony” found in a Hong Kong electronics factory. It suggests that the social construction of gender has to be inserted into a theory of production politics if the specific forms and processes of this hegemonic regime are to be explained. In this particular case, ethnographic data capture how an everyday culture of familialism, built (...) around notions of gender norms and behavior, is actively constructed by management and workers to serve their respective interests on the shopfloor. (shrink)

The analysis of data from electronic health records aspires to facilitate healthcare efficiencies and biomedical innovation. There are also ethical, legal and social implications from the handling of sensitive patient information. The paper explores the concerns, expectations and implications of the National Health Service England care.data programme: a national data sharing initiative of linked electronic health records for healthcare and other research purposes. Using Nissenbaum’s contextual integrity of privacy framework through a critical Science and Technology (...) Studies lens, it examines the way technologies and policies are developed to promote sustainability, governance and economic growth as the de facto social values, while reducing privacy to an individualistic preference. The state, acting as a new, central data broker reappropriates public ownership rights and establishes those information flows and transmission principles that facilitate the assetisation of NHS datasets for the knowledge economy. Various actors and processes from other contexts attempt to erode the public healthcare sector and privilege new information recipients. However, such data sharing initiatives in healthcare will be resisted if we continue to focus only on the monetary and scientific values of these datasets and keep ignoring their equally important social and ethical values. (shrink)

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the (...) beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

Management information system (MIS) professionals have a central role in technology development, determining how technology is used in organizations, and the effects it has on clients and society. MIS stakeholders have expressed concern regarding MIS professional's role in computer crime, and security of electronically stored information. It is recognized that MIS professionals must make decisions based on their professional ethics. The Association for Computing Machinery (ACM) and the Data Processing Management Association (DPMA) have developed codes of ethics to help (...) guide practitioners with ethical professional decision making. In this study, a model was developed from the combined ACM and DPMA codes of ethics and used in the construction of a survey instrument. The survey was conducted using public sector MIS professionals, and findings relative to the influences that codes of ethics, ethical enforcement systems, and membership in professional organizations has on ethical perception were studied. In addition, the influence that ethical obligation to particular constituencies had on respondents' ethical attitudes was also investigated. The study indicated that ethical obligation of public sector MIS professionals is stronger for management and employers than for peers, society, or clients. (shrink)

Plagiarism detection is the process of finding similarities on electronic based documents. Recently, this process is highly required because of the large number of available documents on the internet and the ability to copy and paste the text of relevant documents with simply Control+C and Control+V commands. The proposed solution is to investigate and develop an easy, fast, and multi-language support plagiarism detector with the easy of one click to detect the document plagiarism. This process will be done with (...) the support of intelligent system that can learn, change and adapt to the input document and make a cross-fast search for the content on the local repository and the online repository and link the content of the file with the matching content everywhere found. Furthermore, the supported document type that we will use is word, text and in some cases, the pdf files –where is the text can be extracting from them- and this made possible by using the DLL file from Word application that Microsoft provided on OS. The using of DLL will let us to not constrain on how to get the text from files; and will help us to apply the file on our Delphi project and walk throw our methodology and read the file word by word to grantee the best working scenarios for the calculation. In the result, this process will help in the uprising the documents quality and enhance the writer experience related to his work and will save the copyrights for the official writer of the documents by providing a new alternative tool for plagiarism detection problem for easy and fast use to the concerned Institutions for free. (shrink)

The study aimed to identify the role of administrative procedures and systems in enhancing the performance of the educational institutions in the Islamic University in Gaza. To achieve the research objectives, the researchers used the analytical descriptive approach to collect information. The researchers used the questionnaire distributed to three categories of employees at the Islamic University (senior management, faculty members, their assistants and members of the administrative board). A random sample of 314 employees was selected and 276 questionnaires were retrieved (...) with a recovery rate of 88.1%. The Statistical Analysis Program (SPSS) was used to enter process and analyze data. The results of the research showed a positive role for the administrative procedures and systems in enhancing the performance of the Islamic University from the point of view of the members (senior management, teaching staff and their assistants and the administrative body), where the relative weight of all the paragraphs (73.728%). The analysis of the results revealed that the administrative procedures at the Islamic University in Gaza are used to an acceptable degree. The relative weight of all the paragraphs is 70%. This indicates a relationship between administrative procedures and regulations and the performance of the Islamic University in the Gaza Strip. The study found that there was a good degree of approval from the sample regarding the administrative procedures and their relationship to the job performance. There exist a sufficient degree of powers to the deans and department managers to carry out their tasks, with the use of plans as control tools. And that there are rules and procedures provided for decision-making in the University Council. It also has full powers to manage the university to improve the teaching and learning environment. The researchers also recommended a number of recommendations, including the need to follow up on the procedures and systems of management and update them continuously in the light of changes that may occur and to ensure the existence of a strong system of electronic information systems within the university. There is a need to provide mechanisms for obtaining information about the surrounding external environment, and effective mechanisms to provide managers with the necessary information in a timely manner. The importance of providing channels of communication that enables staff to communicate information about any violations and breaches. The study also recommended the follow-up, review, procedures and administrative systems, and work to modify them in line with the mission of the university and the objectives that the university seeks to reach. (shrink)

This article reviews the debate over electronic data bases and privacy, with an emphasis on the United States since the Privacy Act of 1974. Proposals that have value for the 1990s, both nationally and internationally, are synthesized. Some current controversies are discussed, including some of the reasons for the failure of previous privacy legislation. The way social values affect both statistical and intelligence systems is reviewed, and the debate over organizational necessity and computerization is examined. Some controversial systems (...) and programs are described, along with suggestions designed to move closer to state-of-the-art privacy oversight. (shrink)

In May 2021, the UK National Health Service (NHS) proposed a scheme—called General Practice Data for Planning Research (GPDPR)—for sharing patients’ data. Under that system, a patient who does not wish to participate must actively opt out of their data being shared with third parties for research and other purposes. In this paper, we analyse the lessons that can be learned for the responsible and ethical governance of health data from the NHS’ new scheme. More specifically, (...) we explore the extent to which the opt-out within the planned scheme complies with the requirements stemming from the General Data Protection Regulation (GDPR), particularly in relation to the principles of lawfulness and transparency. We then evaluate, from an ethical perspective, this opt-out ‘nudge’ and whether it is sufficiently resistible, reversible, and has appropriate goals. In light of the above, we then propose improvements for the scheme’s legal and ethical acceptability. (shrink)

The editorial introduces issue 21.1 of Technoetic Arts via a critical reflection on the artificial intelligence hype (AI hype) that emerged in 2022. Tracing the history of the critique of Large Language Models, the editorial underscores that there are substantial ethical challenges related to bias in the training data, copyright issues, as well as ecological challenges which the technology industry has consistently downplayed over the years. -/- The editorial highlights the distinction between the current AI technology’s reliance on (...) extensive pre-existing human-generated data for pattern recognition and the performative process inherent in art practice. Patterns of creative output can be replicated without a thorough understanding of underlying concepts. In contrast, the performative process of art practice, as explored through the conceptual frameworks of creativity by Noam Chomsky, Charles Sanders Peirce, and Roger T. Ames and with reference to an earlier publication of the editorial’s author, creates concepts and continually ‘strives to extend itself towards the unknown.’ -/- Following this introductory section, the editorial provides an overview of the ten articles featured in this issue of Technoetic Arts. The first four texts engage with emerging technologies from various perspectives in art and design. The subsequent six articles, part of a special section titled 'Perspectives from Chandigarh,' reflect a quest for meaningful existence within colonial, patriarchal, and biopolitical structures that frame everyday practices of exclusion and oppression. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was adopted recently by a team of informaticists designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially (...) when principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and non-maleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper we show how using ethical principles can help in the design of EHRs by first, explaining how ethical principles can and should be used generally, and then by, discuss how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting further ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest. (shrink)

With the proliferation of networked electronic communication came daunting capabilities to collect, process, combine and store data, resulting in hitherto unseen transformational pressure on the concepts of trust, security and privacy as we know them. The Future Internet will bring about a world where real life will integrate physical and digital life. Technology development for data linking and mining, together with unseen data collection, will lead to unwarranted access to personal data, and hence, privacy intrusion. (...) Trust and identity lie at the basis of many human interactions and transactions, and societies have developed legitimate concern for privacy being essential for freedom and creativity. The burgeoning development of the Information Society, particularly during the past fifteen years, transcended the societal readiness to respond to the transformational change evoked by ICT. We have reached the eleventh hour for the preservation of trust and privacy as elements that can be transposed into our digital future. Europe has been at the forefront in recognizing the importance of privacy protection in relation to digital data, witness the advanced European legislation in this domain. The European Commission recognizes that appropriate measures need to combine technology development with legal means, user awareness and tools supporting data controllers to comply with law in an accountable and transparent way, and that empower users with a controlling stake in managing their personal data. Activities are underway at many levels. European RTD programmes play their role in supporting research in trustworthy ICT, privacy enhancing technologies, privacy-by-design in service layers as well as in networks, enabling technologies such as cryptography, and in generalized frameworks for trust and privacy-protective identity management. (shrink)

With the proliferation of networked electronic communication came daunting capabilities to collect, process, combine and store data, resulting in hitherto unseen transformational pressure on the concepts of trust, security and privacy as we know them. The Future Internet will bring about a world where real life will integrate physical and digital life. Technology development for data linking and mining, together with unseen data collection, will lead to unwarranted access to personal data, and hence, privacy intrusion. (...) Trust and identity lie at the basis of many human interactions and transactions, and societies have developed legitimate concern for privacy being essential for freedom and creativity. The burgeoning development of the Information Society, particularly during the past fifteen years, transcended the societal readiness to respond to the transformational change evoked by ICT. We have reached the eleventh hour for the preservation of trust and privacy as elements that can be transposed into our digital future. Europe has been at the forefront in recognizing the importance of privacy protection in relation to digital data, witness the advanced European legislation in this domain. The European Commission recognizes that appropriate measures need to combine technology development with legal means, user awareness and tools supporting data controllers to comply with law in an accountable and transparent way, and that empower users with a controlling stake in managing their personal data. Activities are underway at many levels. European RTD programmes play their role in supporting research in trustworthy ICT, privacy enhancing technologies, privacy-by-design in service layers as well as in networks, enabling technologies such as cryptography, and in generalized frameworks for trust and privacy-protective identity management. (shrink)

Recently, big data analytics have gained significant attention in healthcare industry due to generation of massive quantities of data in various forms such as electronic health records, sensors, medical imaging, and pharmaceutical details. However, the data gathered from various sources are intrinsically uncertain owing to noise, incompleteness, and inconsistency. The analysis of such huge data necessitates advanced analytical techniques using machine learning and computational intelligence for effective decision making. To handle data uncertainty in healthcare (...) sector, this article presents a novel metaheuristic rough set-based feature selection with rule-based medical data classification technique on MapReduce framework. The proposed MRSFS-RMDC technique designs a butterfly optimization algorithm for minimal rough set selection. In addition, Hadoop MapReduce is applied to process massive quantity of data. Moreover, a rule-based classification approach named Repeated Incremental Pruning for Error Reduction is used with the inclusion of a set of conditional rules. The RIPPER will scale in a linear way with the number of training records utilized and is suitable to build models with data uncertainty. The proposed MRSFS-RMDC technique is validated using benchmark dataset and the results are inspected under varying aspects. The experimental results highlighted the supremacy of the MRSFS-RMDC technique over the recent state of art methods in terms of different performance measures. The proposed methodology has achieved a higher F-score of 96.49%. (shrink)

This paper presents the Obstetric and Neonatal Ontology (OntONeo). This ontology has been created to provide a consensus representation of salient electronic health record (EHR) data and to serve interoperability of the associated data and information systems. More generally, it will serve interoperability of clinical and translational data, for example deriving from genomics disciplines and from clinical trials. Interoperability of EHR data is important to ensuring continuity of care during the prenatal and postnatal periods for (...) both mother and child. As a strategy to advance such interoperability we use an approach based on ontological realism and on the ontology development principles of the Open Biomedical Ontologies Foundry, including reuse of reference ontologies wherever possible. We describe the structure and coverage domain of OntONeo and the process of creating and maintaining the ontology. (shrink)

Science is at present passing through a credibility crisis*. One could almost say a moral crisis. As a matter of fact we are standing at a turning point in the relationship between science and society, a turning point marked by the change from a social evolution characterized by high productivity and growth, into an evolution which might lead humanity to a new balance between individuality and collectivity.At the beginning of the 20th century and during its second half the scientific world (...) had suffered the impact of two significant revolutions: first of physics and then of biology. The basic discoveries in the field of physics led to applications in realms of energy, transportation, communication, electricity, electronics, and data processing. (shrink)

Mendelian Inheritance in Man, a computerized catalogue of human genetic disorders authored and maintained by cardiologist and medical genetics pioneer Victor A. McKusick, played a major part in demarcating between a novel biomedical science and the eugenic projects of racial betterment which existed prior to its emergence. Nonetheless, it built upon prior efforts to systematize genetic knowledge tied to individuals and institutions invested in eugenics. By unpacking the process of digitizing a homespun cataloguing project and charting its development into an (...) online database, this article aims to illuminate how the institution-building efforts of one individual created an ‘information order’ for accessing genetic information that tacitly shaped the norms and priorities of the field toward the pursuit of specific genes associated with discernible genetic disorders. This was not by design, but rather arose through negotiation with the catalogue's users; it accommodated further changes as biomedical research displaced the Mendelian paradigm. While great effort was expended toward making sequence data available to investigators during the Human Genome Project, MIM was largely taken for granted as a ‘legacy system’, McKusick's own labour of love. Drawing on recent histories of biomedical data, the article suggests that the bibliographical work of curation and translation is a central feature of value production in the life sciences meriting attention in its own right. (shrink)

BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by (...) REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits. (shrink)

Because of difficulty processing the electronic medical record data of patients with cerebrovascular disease, there is little mature recognition technology capable of identifying the named entity of cerebrovascular disease. Excellent research results have been achieved in the field of named entity recognition, but there are several problems in the pre processing of Chinese named entities that have multiple meanings, of which neglecting the combination of contextual information is one. Therefore, to extract five categories of key entity information for (...) diseases, symptoms, body parts, medical examinations, and treatment in electronic medical records, this paper proposes the use of a BERT-BiGRU-CRF named entity recognition method, which is applied to the field of cerebrovascular diseases. The BERT layer first converts the electronic medical record text into a low-dimensional vector, then uses this vector as the input to the BiGRU layer to capture contextual features, and finally uses conditional random fields to capture the dependency between adjacent tags. The experimental results show that the F1 score of the model reaches 90.38%. (shrink)

This chapter provides an analysis of the long process of introducing an electronic identity for online authentication in Germany. This process is described as a multi-facet innovation, involving actors from different policy fields shifting over time. The eID process started in the late ‘90s in the context of eGovernment and eCommerce with the legislation on e-signatures, which were supposed to allow for online authentication of citizens. When after 5 years it was recognized that this was not the case, a (...) new digital ID card, which had meanwhile been announced, was chosen as token for the eID. This process was dominated by the concerns for visual inspection and border control, including the storage of digital fingerprints. Under the leadership of the Ministry of the Interior (BMI) and technical guidance of the Federal Agency for Information Security (BSI), technical specifications have to a large extent been adopted from the electronic passport, which had been smoothly introduced 2 years before. However, in the legislative process some concern regarding digital fingerprints on the eID card was raised and led to an opt-in solution. In 2009, a bill on the new ID card was passed which regulates the eID function for online authentication as well. This is characterized as a radical innovation by introducing a double-sided, mutual authentication of the citizen and the service provider and implementing the principle of proportionality regarding the access of service providers to data on the chip. At the time of writing, field tests are conducted. Roll-out of the new eID card is to start in November 2010. Therefore no figures about adoption can be provided here. (shrink)

Acoustic emission technique is a common approach to identify the damage of the refractories; however, there is a complex problem since there are as many as fifteen involved parameters, which calls for effective data processing and classification algorithms to reduce the level of complexity. In this paper, experiments involving three-point bending tests of refractories were conducted and AE signals were collected. A new data processing method of merging the similar parameters in the description of the damage and reducing (...) the dimension was developed. By means of the principle component analysis for dimension reduction, the fifteen related parameters can be reduced to two parameters. The parameters were the linear combinations of the fifteen original parameters and taken as the indexes for damage classification. Based on the proposed approach, the Gaussian mixture model was integrated with the Bayesian information criterion to group the AE signals into two damage categories, which accounted for 99% of all damage. Electronic microscope scanning of the refractories verified the two types of damage. (shrink)

As an EU state, Lithuania has become an active member of the eEurope 2005 initiative, implementing the goals set forth in the strategic plan for the development of information society in Lithuania. Information technologies introduced into various areas of life open up new, more convenient opportunities to receive services and information. The modernization of state management becomes an integral factor for ensuring continuous social development. The objective of this paper is to study practical aspects of the application of specialized knowledge (...) in the investigation of crimes on electronic data and information systems security and to offer some recommendations for the investigation and prevention of such crimes. This article is the first of a two part study. In the next article, the authors intend to present aspects of prevention in crimes against electronic data and information systems security. The authors used statistical data, results of a survey of experts—investigators of crimes on electronic data and information system security, experts of information technology (IT) forensics. (shrink)

The Umayyad State is widely criticized in the West as well as in its own region. Actually, this is normal situation. Because Hijaz Arabs who had no state experience, built a multinational state in short period of time. Yet, this caused serious matters. The fundamental point of the criticism is the payment of tax, also called jizya, which is taken from residents (mawālī) of Khorasan and Transoxania. However, in most studies on this subject, it is understood that the jizya taken (...) from mawālī is combined jizya and kharja, which is different type of tax. Although mawālī was tested for whether it passes religious criteria in critic periods or not, this situation did not last throughout the entire Umayyad history. It was continued for fifteen and twenty years. In this period, it was understood that the jizya tax taken from the mawālī, was caused by the unlawful practices of some regional governors, most of them were non-Muslim local tax officials and all their purpose was to collect the amount of combined jizya. It cannot be said that the Umayyad caliphs officially ordered written instructions in order to take the conceptual sense from the mawālī part. But some Khorasan governors, who detected that taxes were decreasing, blinked at the collection of the jizya from the mawālī.Summary: The tax policies of a state are of great importance for the political, social, and economic stability. A regular tax system minimizes the problems that the state mechanism might face. The establishment of a fair and just tax scheme is undoubtedly possible with a deep-rooted state experience. It is known that the Umayyad state which is the subject of this research has no state experience. Furthermore, ruling to the area which is on 13 million square kilometers and reaching to Kashgar in the East and to South France in the West and governing this multinational structure who are living on these regions, put the Umayyad government in a very difficult condition. With the vast borders and the stoppage of the conquests, some political, social and economic problems were experienced and these problems deeply affected the government. The groups which had argued with Shiites and Khārijites because of some various reasons led the country into collapsing. It is also known that many plague epidemics in the region of Damascus affected the society in a negative way, changing the capital and changing some of the border cities in favor of the Eastern Roman Empire.All these negativities certainly shaken the Umayyad state economically. It is understood from the data that the instability and political uncertainties in the country led to a decrease in the tax rates. For example, the Umayyad caliph ‘Abd al-Malik İbn Marwān period, only half of the tax was collected at the time of Hazrat ‘Umar could be collected. It can be said that the public who avoided the general policies of the state avoided giving tax, in other words, the tax evasion. Also, the increasing migration from village to city and due to that, the vacancy of tribute tax collected land, failure to obtain expected yield because of rent fights on fertile lands, and conversion process in non-Muslim community are included in other reasons of reduction of taxes.In the Umayyad period, the issue of taking the jizya from the mawālī can be considered in this context. We do not have an independent work or research article on how this practice was initiated, how it was and how it was taken from mawālī, and how it was a state policy, and how long it was sustained. The studies that touch on this subject are far from being holistic. Even in the main sources it is seen that the concepts of kharāj and jizya are not fully understood and therefore used interchangeably. This may be considered normal for the first period in which the concepts are not in place. However, in the following centuries, the works that were copyrighted and, except for a few, instead of understanding and explaining this confusion, chose to use the word jizya from these two words which can be used interchangeably in texts. Therefore, this approach has led to the widespread conviction that the Umayyad state has taken jizya from the mawālī in the conceptual sense.Al-Ḥajjāj ibn Yūsuf is claimed to have started the application of taken jizya from mawālī. However, Haccac aimed to provide the regularity of both agricultural products and the kharāj which is taken from farmers because of the status of the soil by sending Sawad villagers who migrated to the big cities and became Muslims by changing their religions. The status of the lands seized was decisive in taxation. According to this, the conquest and the territorial lands were taxed differently, but in some cases the same tax (kharāj) was taken. Non-Muslims who living in the territory of conquest were demanded jizya per capita. The jizya and kharāj tax collected from this category can be expressed as “joint jizya”. Regardless of whether the person is a Muslim or not, the fact that he was demanded from him due to the status of the land was interpreted by some researchers as juristic. However, in times of political instability, it is also a fact that mawālī is demanding jury in addition to the tribute tax. The point that is misunderstood or interpreted is that this practice was carried out throughout the entire Umayyad territory and the history. When examined, this distorted tax concept is actually concentrated in the area of Transoxania. Although some attempts were made to take the jizya from the mawālī to the country, the Umayyad caliphs have not allowed it. The practice of taking the jizya from the mawālī is actually followed by the killing Qutayba ibn Muslim al-Bāhilī (d. 96/715). This started political instability in the Transoxania and continued by some Khurāsān governors. These governors act according to the provocations of the Turkish governors and tax collectors of the region in order to be able to send their taxes completely. They claimed that the region in the region was not a sincere Muslim and, they continued to take the jizya from them.It can be said that jizya is not demanded as it is taken from non-Muslims in the common meaning from mawālī. Because any Umayyad caliph wrote no written instructions regarding this issue in the sources. It is understood that until the caliphate of ‘Umar b. ‘Abd al-‘Azîz, the Umayyad caliphs were not even aware of this distorted tax policy in the area of Transoxania. To put it once again, this practice was initiated by some Khurāsān governors with the concern that tax revenues might decrease. However, it should not be forgotten that this unfair practice after 96/715 is limited to certain governors. For example, during the tenure of Naṣr b. Seyyâr, the last governor of Khurāsān (120-131 / 738-748), the jizya tax was completely removed from the mawālī. Another activity that shows this action is regional and that was ordered by some governors of Khurāsān. Therefore, this practice does not reflect the Umayyad state policy. This is also apparent in the fact that the Shiites, Kharijites, and those who carried out the Abbasid Revolution for thirty-two years, did not make an anti-Umayyad propaganda with provoking the slave by the way of wrong application. (shrink)

Co-authored by a Computer Scientist and a Digital Humanist, this article examines the challenges faced by cultural heritage institutions in the digital age, which have led to the closure of the vast majority of born-digital archival collections. It focuses particularly on cultural organizations such as libraries, museums and archives, used by historians, literary scholars and other Humanities scholars. Most born-digital records held by cultural organizations are inaccessible due to privacy, copyright, commercial and technical issues. Even when born-digital data (...) are publicly available, users often need to physically travel to repositories such as the British Library or the Bibliothèque Nationale de France to consult web pages. Provided with enough sample data from which to learn and train their models, AI, and more specifically machine learning algorithms, offer the opportunity to improve and ease the access to digital archives by learning to perform complex human tasks. These vary from providing intelligent support for searching the archives to automate tedious and time-consuming tasks. In this article, we focus on sensitivity review as a practical solution to unlock digital archives that would allow archival institutions to make non-sensitive information available. This promise to make archives more accessible does not come free of warnings for potential pitfalls and risks: inherent errors, "black box" approaches that make the algorithm inscrutable, and risks related to bias, fake, or partial information. Our central argument is that AI can deliver its promise to make digital archival collections more accessible, but it also creates new challenges - particularly in terms of ethics. In the conclusion, we insist on the importance of fairness, accountability and transparency in the process of making digital archives more accessible. (shrink)

This book provides an overview of computer techniques and tools — especially from artificial intelligence (AI) — for handling legal evidence, police intelligence, crime analysis or detection, and forensic testing, with a sustained discussion of methods for the modelling of reasoning and forming an opinion about the evidence, methods for the modelling of argumentation, and computational approaches to dealing with legal, or any, narratives. By the 2000s, the modelling of reasoning on legal evidence has emerged as a significant area within (...) the well-established field of AI & Law. An overview such as this one has never been attempted before. It offers a panoramic view of topics, techniques and tools. It is more than a survey, as topic after topic, the reader can get a closer view of approaches and techniques. One aim is to introduce practitioners of AI to the modelling legal evidence. Another aim is to introduce legal professionals, as well as the more technically oriented among law enforcement professionals, or researchers in police science, to information technology resources from which their own respective field stands to benefit. Computer scientists must not blunder into design choices resulting in tools objectionable for legal professionals, so it is important to be aware of ongoing controversies. A survey is provided of argumentation tools or methods for reasoning about the evidence. Another class of tools considered here is intended to assist in organisational aspects of managing of the evidence. Moreover, tools appropriate for crime detection, intelligence, and investigation include tools based on link analysis and data mining. Concepts and techniques are introduced, along with case studies. So are areas in the forensic sciences. Special chapters are devoted to VIRTOPSY (a procedure for legal medicine) and FLINTS (a tool for the police). This is both an introductory book (possibly a textbook), and a reference for specialists from various quarters. (shrink)