Volume 3, Issue 1 - Ethical, Legal and Technological Aspects of Health Information Management

The rate of any biomarker discovery is highly influenced by the costs associated with obtaining the relevant genetic, genomic, and clinical data. Currently, to identify a human genetic or genomic biomarker, a clinical researcher must identify a set of transplant recipients that either has been or can be clinically phenotyped, and then obtain samples from patients that can be subjected to gene expression and proteomic analysis. This process of obtaining a clinical cohort by matching donors to recipients is usually time-consuming and expensive. It is further time constrained by patient's signed written consent which has a use-by date.Biomarker database systems can play a pivotal role in establishing mechanisms that enable clinical researchers to access clinically derived genetic and co-variate data in a secure, privacy-aware, de-identified and auditable manner. They can also establish mechanisms and audit trails that monitor the movement of research data across institutions due to their custodial responsibilities to protect patient privacy.In this paper, we prototype the concept of a de-identified centralized biomarker repository that empowers principal investigators and researchers to access multiple data sources needed for the conduct of genomic, proteomic interpretation and computational experiments. The repository takes the form of a research data mart such that the enrolled patients' clinical and treatment history can be tracked during pre and post transplant phases. We demonstrate how technology and information engineering design principles help to implement a de-identification schema for patients to protect patient privacy and prevent unauthorized data access.

New advances in genomics changed the research landscape significantly in the last few years. The power and significance of already existing tissue collections is enhanced by their growing size, and all over the world national projects aim to connect with each other at the international level, calling for integrated and common regulations in the transnational research field. The post genomics era faces problems that are partially different from those within the classical bioethical framework. The challenge is to find new ways to deal with regulations in order to facilitate research without frustrating personal rights. Informed Consent has been the center of this wide debate. We propose a model for rethinking consent in an open-time/open-goal framework suitable to genomics research. Consensus becomes more than a single legal step and goes more in the direction of a participated governance mechanism, a circular open process of communication which the IC sheet signature is just one instance of. This approach provides a governance framework based on different levels of consensus and participation that already contains mechanisms to resolve conflicts between different instances and to protect both the interest of research and the rights of participants.

In this paper I consider the recent review of the discrimination law of England and Wales. The Discrimination Law Review published its final report, "Framework for a Fairer Future," in 2008. The report advocated a complete overhaul of the discrimination law in England and Wales, creating a single duty to promote equality. Although many of the consultees had argued that genetic discrimination should be included in the grounds of discrimination, the Discrimination Law Review team and the government have since decided to exclude it from the proposed Single Equality Bill. In this paper I analyse the reasons given for this decision, and argue that this was a missed opportunity to deal with a problem which will only get worse in the future.

July 2008 saw a conclusion to a case which began with a request to the Common Services Agency for the Scottish Health Service (hereinafter ‘the CSA') under the Freedom of Information (Scotland) Act 2002 (hereinafter ‘FOISA') and culminated in a hearing in front of the House of Lords as Court of Appeal. The outcome, however, can be considered both a triumph and a failure for data protection law.This paper analyzes the House of Lords decision to determine whether the judgment has provided more legal clarity in an area in which guidance is still very much required.

Ethical questions about information and communications technologies (ICT) have been debated since World War II. Western democracies have had more than 50 years of experience in addressing and organising the ethical, social and legal aspects (ESLA) of scientific and technological developments. However, this expertise, tradition and experience are not enough to manage the most urgent ethical and social issues and contemporary challenges involving ICT. A systematic and institutional organisation of social values in the context of modern ICT tools is needed.This paper focuses on four major areas: (i) developing a specific approach to ethical issues raised by ICT; (ii) describing in more detail the age-related digital divide in Europe; (iii) identifying technology trends and emerging challenges; and (iv) defining the legal framework for inclusion of senior citizens in the digital society. The paper then concludes with a summary of its key points on the basis of which it makes three proposals as a contribution to efforts aimed at overcoming the exclusion of senior citizens from today's Information Society.

Living in an economically developed country means being blessed and burdened with unprecedented access to information. We struggle to absorb and evaluate a cacophonic flow of information and are largely overwhelmed. Because that flow is unlikely to ebb, we are challenged to devise strategies to differentiate and manage the information. Yet we do not have the reliably stable world views that guided our ancestors and have not forged successor views that provide reliable criteria by which to evaluate the information thrust upon us.This paper's statement of the difficulties of evaluating information in the modern world is not an argument against facts. Nor is it a derivative argument against technology that is implicated in a casual explanation for the rapid turnover of facts. It is instead a caution about the difficulties of securing a firm grasp on the relevant facts when new facts, reduced to bloodless data points, steadily press upon us and facts, new and old, are routinely spun to promote an agenda.A noteworthy consideration in the devising of strategies to cope with this unsteady wonderland of facts is the recognition that the rapid evolution of technologies may predispose us to discard information before it is appropriately evaluated. Immersion in a technology-rich culture may inculcate habits that dull our evaluative capacities and mechanically displace information that has not been recently applied without regard to the quality (perhaps the timelessness) of the information. We need to structure our mental filters and cultural dispositions to accommodate the volume and manipulation of facts in order to assure that the timeless facts are not expunged by neglect or disuse.

In this paper I propose that the special duty of care present in the doctor-patient relationship is passed along the chain of professionals involved in modern healthcare. A chain of duty arises from knowledge of intended use and requires a system of trust between patient, doctor and non-clinical professionals. The first part of the paper introduces the concepts of duty of care and the requirement for trustworthiness in medical ethics, and extends these, via chains of duty and chains of trust, to non-clinical professions. The second part demonstrates the application of this in one field of information management in healthcare: decision support systems.

This special issue is concerned with the evolving ethical and legal issues associated with the use of different types of information in health and health care by a wide range of stakeholders. The stakeholders include but are not restricted to practicing clinicians, researchers, managers, policy makers and last but hopefully not least patients and the public.