Toward an accelerated adoption of data-driven findings in medicine : Research, skepticism, and the need to speed up public visibility of data-driven findings.

To accelerate the adoption of a new method with a high potential to replace or extend an existing, presumably less accurate, medical scoring system, evaluation should begin days after the new concept is presented publicly, not years or even decades later. Metaphorically speaking, as chameleons capable of quickly changing colors to help their bodies adjust to changes in temperature or light, health-care decision makers should be capable of more quickly evaluating new data-driven insights and tools and should integrate the highest performing ones into national and international care systems. Doing so is essential, because it will truly save the lives of many individuals.

The Ethics of Cloud Computing.

Cloud computing is rapidly gaining traction in business. It offers businesses online services on demand (such as Gmail, iCloud and Salesforce) and allows them to cut costs on hardware and IT support. This is the first paper in business ethics dealing with this new technology. It analyzes the informational duties of hosting companies that own and operate cloud computing datacentres (e.g., Amazon). It considers the cloud services providers leasing 'space in the cloud' from hosting companies (e.g., Dropbox, Salesforce). And it examines the business and private 'clouders' using these services. The first part of the paper argues that hosting companies, services providers and clouders have mutual informational (epistemic) obligations to provide and seek information about relevant issues such as consumer privacy, reliability of services, data mining and data ownership. The concept of interlucency is developed as an epistemic virtue governing ethically effective communication. The second part considers potential forms of government restrictions on or proscriptions against the development and use of cloud computing technology. Referring to the concept of technology neutrality, it argues that interference with hosting companies and cloud services providers is hardly ever necessary or justified. It is argued, too, however, that businesses using cloud services (e.g., banks, law firms, hospitals etc. storing client data in the cloud) will have to follow rather more stringent regulations.

How bioethics principles can aid design of electronic health records to accommodate patient granular control.

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was recently adopted by a team of informaticists who are 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 nonmaleficence 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 discussing 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 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.

Critical theory as an approach to the ethics of information security.

Information security can be of high moral value. It can equally be used for immoral purposes and have undesirable consequences. In this paper we suggest that critical theory can facilitate a better understanding of possible ethical issues and can provide support when finding ways of addressing them. The paper argues that critical theory has intrinsic links to ethics and that it is possible to identify concepts frequently used in critical theory to pinpoint ethical concerns. Using the example of UK electronic medical records the paper demonstrates that a critical lens can highlight issues that traditional ethical theories tend to overlook. These are often linked to collective issues such as social and organisational structures, which philosophical ethics with its typical focus on the individual does not tend to emphasise. The paper suggests that this insight can help in developing ways of researching and innovating responsibly in the area of information security.

Protecting human health and security in digital Europe: how to deal with the "privacy paradox"?

This article is the result of an international research between law and ethics scholars from Universities in France and Switzerland, who have been closely collaborating with technical experts on the design and use of information and communication technologies in the fields of human health and security. The interdisciplinary approach is a unique feature and guarantees important new insights in the social, ethical and legal implications of these technologies for the individual and society as a whole. Its aim is to shed light on the tension between secrecy and transparency in the digital era. A special focus is put from the perspectives of psychology, medical ethics and European law on the contradiction between individuals' motivations for consented processing of personal data and their fears about unknown disclosure, transferal and sharing of personal data via information and communication technologies (named the "privacy paradox"). Potential benefits and harms for the individual and society resulting from the use of computers, mobile phones, the Internet and social media are being discussed. Furthermore, the authors point out the ethical and legal limitations inherent to the processing of personal data in a democratic society governed by the rule of law. Finally, they seek to demonstrate that the impact of information and communication technology use on the individuals' well-being, the latter being closely correlated with a high level of fundamental rights protection in Europe, is a promising feature of the socalled "e-democracy" as a new way to collectively attribute meaning to large-scale online actions, motivations and ideas.

Everyday ethical dilemmas arising with electronic record use in primary care.

The introduction of electronic medical record systems (EMRs) into primary care settings alters work practices, introduces new challenges, and new roles. In the process of integrating an EMR into a primary care setting, clinic staff faced ethical challenges in their everyday work practices resulting from workarounds undertaken to compensate for a poor fit between system design and work practices, issues related to system access, and governance gaps. Examples of these issues are presented, and implications for system design are discussed.

Ethical issues related to computerised family medical histories in sickle cell disease: Inforare.

The Inforare project aims to set up a system for the sharing of clinical and familial data, in order to study how genes are related to the severity of sickle cell disease. While the computerisation of clinical records represents a valuable research goal, an ethical framework is necessary to guarantee patients' protection and their rights in this developing field. Issues relating to patient information during the Inforare study were analysed by the steering committee. Several major concerns were discussed by the committee and formalized in the patients' information letter: educating patients to aid the recruitment of family members, rules of confidentiality and the disclosure of aggregate, individual and unexpected research results. This paper presents the main issues addressed.

Ethical choice in the medical applications of information theory.

BACKGROUND: Alongside advances in medical information technology (IT), there is mounting physician and patient dissatisfaction with present-day clinical practice. The effect of introducing increasingly complex medical IT on the ethical dimension of the clinical physician's primary task (identified as direct patient care) can be scrutinized through analysis of the EMR software platform. QUESTIONS/PURPOSES: We therefore (1) identify IT changes burdensome to the clinician in performing patient care and which therefore lower quality of care; and (2) suggest methods for clinicians to maintain high quality patient care as IT demands increase. METHODS: Elemental relationships from information theory and physical chemistry are applied to the profit-generating creation and flow of medical information between patients, physicians, administrators, suppliers, and insurers. Ethical implications for patient care and the doctor-patient relationship are drawn in the light of these relationships. WHERE ARE WE NOW?: Little has been accomplished, or even discussed, regarding limiting healthcare IT growth. Quality of patient care is expected to suffer unless physicians carefully scrutinize, refine and occasionally reject portions of the increasing healthcare IT burden being placed upon them. WHERE DO WE NEED TO GO?: Better medicine, simply understood as more effective prevention and treatment of musculoskeletal disease, is our professional goal. We need to establish mechanisms whereby we can limit, control or even reverse IT changes that hinder this goal. Clinicians must confront the negative impact many healthcare IT changes have on patient care. HOW DO WE GET THERE?: Suggestions for maintaining high standards of practice in the face of the new IT burden include: (1) Increasing IT time-awareness. Clinicians should examine actual time spent in clinical versus computer-based activity and implement changes if that ratio is too high. (2) Increasing IT goal awareness. (3) Examine the software creating a medical record to see how much of what it records is there for financial, as opposed to medical reasons. Is the software helping my patient or someone else's bottom line? Is it for talking to colleagues about sick people or to insurance companies?

Practicing preventive ethics, protecting patients: challenges of the electronic health record.

Implementation of guidelines regarding breaches of electronic health information requires an anticipatory stance and physician and patient education regarding security and monitoring measures and methods of redress. Adopting a preventive ethics, rather than a crisis management, model may also increase physician awareness of how the information they choose to include and privilege within the health record may expose patients to added harms if not done mindfully.

Moral and prudential considerations in adopting electronic medical records.

One might argue that beneficence entails a moral obligation for health care providers and systems to adopt electronic medical records (EMR). But this argument is thwarted because EMR systems are currently not required to meet existing standards of care for health care services. Yet using EMR systems may still be prudent if benefits of adoption significantly outweigh burdens. Future moral questions regarding EMR systems will shift from obligations of adoption to that of proper use.

Ethical Use of Electronic Health Record Data and Artificial Intelligence: Recommendations of the Primary Care Informatics Working Group of the International Medical Informatics Association.

OBJECTIVE: To create practical recommendations for the curation of routinely collected health data and artificial intelligence (AI) in primary care with a focus on ensuring their ethical use. METHODS: We defined data curation as the process of management of data throughout its lifecycle to ensure it can be used into the future. We used a literature review and Delphi exercises to capture insights from the Primary Care Informatics Working Group (PCIWG) of the International Medical Informatics Association (IMIA). RESULTS: We created six recommendations: (1) Ensure consent and formal process to govern access and sharing throughout the data life cycle; (2) Sustainable data creation/collection requires trust and permission; (3) Pay attention to Extract-Transform-Load (ETL) processes as they may have unrecognised risks; (4) Integrate data governance and data quality management to support clinical practice in integrated care systems; (5) Recognise the need for new processes to address the ethical issues arising from AI in primary care; (6) Apply an ethical framework mapped to the data life cycle, including an assessment of data quality to achieve effective data curation. CONCLUSIONS: The ethical use of data needs to be integrated within the curation process, hence running throughout the data lifecycle. Current information systems may not fully detect the risks associated with ETL and AI; they need careful scrutiny. With distributed integrated care systems where data are often used remote from documentation, harmonised data quality assessment, management, and governance is important. These recommendations should help maintain trust and connectedness in contemporary information systems and planned developments.

Confidentiality, consent, and caring for the adolescent patient.

PURPOSE OF REVIEW: This study reviews the healthcare-related rationale for providing confidential care to adolescents, as well as the legal framework for the provision of such care. RECENT FINDINGS: Physician assurances of confidentiality increase adolescents' willingness to disclose sensitive health information, but these assurances are rarely given. Physicians may not be aware of legal minor consent guidelines or may be concerned about parental reaction to such confidential discussions. Fortunately, many parents and teens understand the importance of confidential healthcare. Adolescent consent and confidentiality laws vary from state to state, but there are federal guidelines and common law concepts that are applicable throughout the United States. The Health Insurance Portability and Accountability Act Privacy Rule also provides guidelines for confidential care to minors. Future challenges for adolescent confidentiality include ease of access to electronic medical records as well as patient (and/or parent)-controlled health records. SUMMARY: Confidentiality for adolescents has important implications for the quality provision of healthcare for this vulnerable population. Physicians and other healthcare providers must be aware of these health implications, as well as federal policies, common law, and their individual state's laws pertaining to this important topic.

Accessibility versus confidentiality of information in the emergency department.

INTRODUCTION: In the emergency department (ED), clinicians can benefit greatly from having access to information at the point of care. It has been suggested that using computerised information systems could improve the accessibility of information. However, making information accessible, while maintaining confidentiality, is one of the main challenges of implementing information systems. This article presents the ED staff perspectives about the accessibility and confidentiality of information in the ED. METHOD: The authors undertook a qualitative study in March-April 2007. Data were collected using in-depth semi-structured interviews with the ED staff of an ED located in Northern England. In total, 34 interviews were conducted and transcribed verbatim. Data were analysed using framework analysis. RESULTS: The results showed that the ED staff had role-based access to the current information systems, and these systems met only a small part of their information needs. As a result, different sources were used to get access to the needed information. Although the ED staff believed that improving the accessibility of information could be helpful in emergency care services, there were concerns about the confidentiality of information. The confidentiality of information could be threatened--for example, by sharing passwords, misusing patient information or by unauthorised staff having access to patient information. CONCLUSION: To design a system, the accessibility and confidentiality of information should be addressed in parallel. A balance between these two is needed, as the failure of each of these may negatively influence the use of the system.

Primary healthcare research network: the Belgian ResoPrim recommendations.

Dedicated primary care research networks aim to gather and analyse data collected from general practioners' (GPs) electronic health records (EHRs). ResoPrim (2003-2008) was a Belgian multidisciplinary research project which was set up to provide recommendations for facilitating the organisation and management of these primary care research networks, assessing and improving opportunities for researchers working with available data from EHRs, and stimulating the involvement of GPs in such networks. This paper provides a short description of Resoprim's global methodology (which included 2 pilot phases involving 64 GPs and 6 different software systems), followed by the project's final recommendations.

Ethical concerns in the use of electronic medical records.

The use of electronic medical record systems raises important ethical concerns about patient privacy and confidentiality, medical errors, expectations of structured data entry by clinicians, documentation integrity, and provider-patient interaction. Clinicians and health care organizations need to define best practices and policies in the use of EMR systems to improve quality and maintain clinician efficiency without compromising patient welfare and safety.

Introduction to the mining of clinical data.

The increasing volume of medical data online, including laboratory data, represents a substantial resource that can provide a foundation for improved understanding of disease presentation, response to therapy, and health care delivery processes. Data mining supports these goals by providing a set of techniques designed to discover similarities and relationships between data elements in large data sets. Currently, medical data have several characteristics that increase the difficulty of applying these techniques, although there have been notable medical data mining successes. Future developments in integrated medical data repositories, standardized data representation, and guidelines for the appropriate research use of medical data will decrease the barriers to mining projects.

Considering something 'ELSE': ethical, legal and socio-economic factors in medical imaging and medical informatics.

The focus on the use of existing and new technologies to facilitate advances in medical imaging and medical informatics (MIMI) is often directed to the technical capabilities and possibilities that these technologies bring. The technologies, though, in acting as a mediating agent alter the dynamics and context of information delivery in subtle ways. While these changes bring benefits in more efficient information transfer and offer the potential of better healthcare, they also disrupt traditional processes and practices which have been formulated for a different setting. The governance processes that underpin core ethical principles, such as patient confidentiality and informed consent, may no longer be appropriate in a new technological context. Therefore, in addition to discussing new methodologies, techniques and applications, there is need for a discussion of ethical, legal and socio-economic (ELSE) issues surrounding the use and application of technologies in MIMI. Consideration of these issues is especially important for the area of medical informatics which after all exists to support patients, healthcare practitioners and inform science. This paper brings to light some important ethical, legal and socio-economic issues related to MIMI with the aim of furthering an interdisciplinary approach to the increasing use of Information and Communication Technologies (ICT) in healthcare.

Ethical aspects of future health care: globalisation of markets and differentiation of societies - ethical challenges.

The shift in health care to an aggregate corporate and distributed model dominated by electronic methods of diagnosis, record-keeping and communication spanning jurisdictional boundaries raises technical, social and paradigmatic issues. The technical issues concern the material natures of the tools, devices, procedures and protocols; the social issues gravitate around abstract matters like individual rights and models of responsibility within a corporate setting and accountability in inter-jurisdictional contexts; the paradigmatic issues centre in the question of how the rights and duties of traditional and direct health care translate into the mediated context of the globally expanded corporate model of eHealth and telemedicine. The present discussion presents a brief overview of the issues and sketches some of their implications for the evolution of contemporary health care.