The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine.

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care.

Ethical Considerations in Electronic Monitoring of the Cognitively Impaired.

Cognitive impairment afflicts an estimated 16 million people in the United States. Wandering is a concerning behavior associated with cognitive impairment, as it may threaten patient safety. The risks posed by wandering place severe burdens on both professional and informal caregivers, as well as law enforcement institutions throughout the United States. As such, location trackers that could reduce this burden have become increasingly prevalent. As with many assistive technologies, the substantial promise of location trackers is counterbalanced by potential pitfalls with respect to loss of privacy and autonomy. This article reviews the ethical issues raised by electronic monitoring of cognitively impaired persons, with the goal of transcending a narrow focus on decisional capacity in favor of a patient-centered framework that is applicable and adjustable at different stages of cognitive decline. Balancing the ethical principles of beneficence and respect in treating cognitively impaired persons goes beyond the necessary step of evaluating decision-making capacity to include partnering with families, caretakers, and cognitively impaired individuals who wander in a collaborative coalition of care. An approach emphasizing the individual needs of patients and caretakers is best suited to finding solutions that implement tracking technologies in ways that both protect and empower the cognitively impaired.

Ethical Questions in Medical Electronic Adherence Monitoring.

Electronic adherence monitors (EAMs) record and report an array of health behaviors, ranging from taking daily medications to wearing medical devices. EAMs are utilized in research worldwide and are being investigated for clinical use. However, there is also growing popular concern about the extent to which electronic devices may be used to monitor individuals, including allegations in the media that EAMs represent a move towards "Big Brother" in medicine. Here, we highlight the unique benefits as well as the potential ethical challenges that electronic adherence monitoring generates. These challenges surround autonomy, privacy and confidentiality, trust, and ancillary care obligations. We describe key questions within each of these domains that warrant further investigation, and present potential solutions to many of the concerns raised.

From intensive care monitoring to personal health monitoring to ambient intelligence.

The historical roots of IT-based monitoring in health care are described. Since the 1970ies monitoring has been spreading to more and more domains of health care and public health. Today one can observe monitoring of persons in many environments and regarding widely different questions. While these monitoring applications have been introduced ethical questions have been raised to balance the possible positive and negative outcomes of the approaches. Today IT-technology is entering many parts of our life - IT eventually became what had been coined already in the last century by IBM as "electronic dust" which one can find in every part of our environment. As most of these "dust-particles" are able to observe something one can also understand this development as a development into ubiquitous monitoring of nearly everything at any time. The foreseen ambient intelligence worlds are also spaces of ambient monitoring. This article describes this historical development. It emphasizes why ethical and data protection questions are an absolute must in most IT activities today.

The PHM-Ethics methodology: interdisciplinary technology assessment of personal health monitoring.

The contribution briefly introduces the PHM Ethics project and the PHM methodology. Within the PHM-Ethics project, a set of tools and modules had been developed that may assist in the evaluation and assessment of new technologies for personal health monitoring, referred to as "PHM methodology" or "PHM toolbox". An overview on this interdisciplinary methodology and its comprising modules is provided, areas of application and intended target groups are indicated.

Ethically sound technology? Guidelines for interactive ethical assessment of personal health monitoring.

Novel care-technologies possess a transformational potential. Future care and support may be provided via monitoring technologies such as smart devices, sensors, actors (robots) and Information and Communication Technologies. Such technologies enable care provision outside traditional care institutions, for instance in the homes of patients. Health monitoring may become "personalized" i.e. tailored to the needs of individual care recipients' but may also alter relations between care providers and care recipents, shape and form the care environment and influence values central to health-care. Starting out from a social constructivist theory of technology, an interactive ethical assessment-model is offered. The suggested model supplements a traditional analysis based on normative ethical theory (top-down approach) with interviews including relevant stakeholders (a bottom-up approach). This method has been piloted by small-scale interviews encircling stakeholder perspectives on three emerging technologies: (1) Careousel, a smart medicine-management device, (2) Robot Giraff, an interactive and mobile communication-device and (3) I-Care, a care-software that combines alarm and register system. By incorporating stakeholder perspectives into the analysis, the interactive ethical assessment model provides a richer understanding of the impact of PHM-technologies on ethical values than a traditional top-down model. If the assessment is conducted before the technology has reached the market - preferably in close interaction with developers and users - ethically sound technologies may be obtained.

PHM-Ethics and ETICA: complementary approaches to ethical assessment.

The chapter undertakes a comparison of different approaches to the ethical assessment of novel technologies by looking at two recent research projects. ETICA was a FP7 sister project to PHM-Ethics, responsible for identification and ethical evaluation of information and communication technologies emerging in the next 10-15 years. The aims, methods, outcomes and recommendations of ETICA are compared to those of PHM-Ethics, with identification of linkages and similar findings. A relationship is identified between the two projects, in which the assessment methodologies developed in the projects are shown to operate at separate, but complementary levels. ETICA sought to reform EU ethics governance for emerging ICTs. The outcomes of PHM-Ethics are analyzed within the policy recommendations of ETICA, which demonstrate how the PHM-Ethics toolbox can contribute to ethics governance reform and context-sensitive ethical assessment of the sort called for by ETICA.

Development of a personal health monitoring system--the IT-systems industry view.

The Development and Implementation of PHM systems require a different approach than typical application development processes. Based on a practical example it is described how ethical and legal aspects will be considered during the development process. The result is a cohesion and adoption of different methods with defined interaction points to reiterate the solution design by legal and ethical aspects.

Ethicted (evaluation process model to improve personalised ICT services for independent living and active ageing)--future scenario.

ICT innovations are constantly developed, and there is no lack of elderly customers, as the number of the elderly is dramatically increasing. Elderly are willing to use ICT to increase their own safety and social activity, but they need trust on the reliability, accessibility and other ethical aspects of ICT including the maintenance of privacy and self-determination. Ethical standards for ICT are usually not considered. "Ethicted" characterizes an ICT service or product as ethically evaluated. As a standardized procedure, it will not only increase the acceptability of ICT, but also provide services for ICT developers. In the future scenario, ICT under development should be evaluated by using a process model that is specifically built to find the lacks in ethical aspects. The model would then be tested by end-users, the formal and informal care givers, to receive direct feedback for redeveloping solutions. As final outcomes, there should be standards for ICT in elderly care and a service for ICT developers to utilize the evaluation model. This future scenario work included partners from 6 EU member countries. The combination of academic research and industrial/commercial interest of ICT developers should and can bring new value to assistive ICT for elderly care.

Naturalistic observation of health-relevant social processes: the electronically activated recorder methodology in psychosomatics.

This article introduces a novel observational ambulatory monitoring method called the electronically activated recorder (EAR). The EAR is a digital audio recorder that runs on a handheld computer and periodically and unobtrusively records snippets of ambient sounds from participants' momentary environments. In tracking moment-to-moment ambient sounds, it yields acoustic logs of people's days as they naturally unfold. In sampling only a fraction of the time, it protects participants' privacy and makes large observational studies feasible. As a naturalistic observation method, it provides an observer's account of daily life and is optimized for the objective assessment of audible aspects of social environments, behaviors, and interactions (e.g., habitual preferences for social settings, idiosyncratic interaction styles, subtle emotional expressions). This article discusses the EAR method conceptually and methodologically, reviews prior research with it, and identifies three concrete ways in which it can enrich psychosomatic research. Specifically, it can (a) calibrate psychosocial effects on health against frequencies of real-world behavior; (b) provide ecological observational measures of health-related social processes that are independent of self-report; and (c) help with the assessment of subtle and habitual social behaviors that evade self-report but have important health implications. An important avenue for future research lies in merging traditional self-report-based ambulatory monitoring methods with observational approaches such as the EAR to allow for the simultaneous yet methodologically independent assessment of inner, experiential aspects (e.g., loneliness) and outer, observable aspects (e.g., social isolation) of real-world social processes to reveal their unique effects on health.

Reducing the harmful effects of alcohol misuse: the ethics of sobriety testing in criminal justice.

Alcohol use and abuse play a major role in both crime and negative health outcomes in Scotland. This paper provides a description and ethical and legal analyses of a novel remote alcohol monitoring scheme for offenders which seeks to reduce alcohol-related harm to both the criminal and the public. It emerges that the prospective benefits of this scheme to health and public order vastly outweigh any potential harms.

[Facing the challenges of ubiquitous computing in the health care sector]. / Herausforderungen durch ubiquitäres Computing im Gesundheitsbereich.

The steady progress of microelectronics, communications and information technology will enable the realisation of the vision for "ubiquitous computing" where the Internet extends into the real world embracing everyday objects. The necessary technical basis is already in place. Due to their diminishing size, constantly falling price and declining energy consumption, processors, communications modules and sensors are being increasingly integrated into everyday objects today. This development is opening up huge opportunities for both the economy and individuals. In the present paper we discuss possible applications, but also technical, social and economic barriers to a wide-spread use of ubiquitous computing in the health care sector.

Families' and professional caregivers' views of using advanced technology to track people with dementia.

in this study we examined the ethical aspects of the use of the Global Positioning Systems (GPS) to track people with dementia. The findings are based on qualitative data gathered from focus groups of family and professional caregivers. The most important theme was the need to balance patients' need for safety with the need to preserve their autonomy and privacy. The main potential benefit of the use of GPS was related to the peace of mind of the caregivers themselves. The findings also suggest that caregivers' views change according to the locus of responsibility of the caregivers for the safety of people with dementia. The caregivers give preference to patients' safety more than autonomy when they are responsible for the patients. When the patients are under the responsibility of other caregivers, they give preference to patients' autonomy more than their safety. Overall, the variety and the depth of the views of different stakeholders toward the use of electronic tracking for people with dementia presented in this article provide a meaningful contribution to the ethical debate on this topic.

Mobile-centric ambient intelligence in health- and homecare-anticipating ethical and legal challenges.

Ambient Intelligence provides the potential for vast and varied applications, bringing with it both promise and peril. The development of Ambient Intelligence applications poses a number of ethical and legal concerns. Mobile devices are increasingly evolving into tools to orientate in and interact with the environment, thus introducing a user-centric approach to Ambient Intelligence. The MINAmI (Micro-Nano integrated platform for transverse Ambient Intelligence applications) FP6 research project aims at creating core technologies for mobile device based Ambient Intelligence services. In this paper we assess five scenarios that demonstrate forthcoming MINAmI-based applications focusing on healthcare, assistive technology, homecare, and everyday life in general. A legal and ethical analysis of the scenarios is conducted, which reveals various conflicting interests. The paper concludes with some thoughts on drafting ethical guidelines for Ambient Intelligence applications.

Ethical perspectives on emerging assistive technologies: insights from focus groups with stakeholders in long-term care facilities.

ASSISTIVE TECHNOLOGIES ARE RELATIVELY novel tools for research and daily care in long-term care (LTC) facilities that are faced with the burgeoning of the older adult population and dwindling staffing resources. The degree to which stakeholders in LTC facilities are receptive to the use of these technologies is poorly understood. Eighteen semi-structured focus groups and one interview were conducted with relevant groups of stakeholders at seven LTC facilities in southwestern Pennsylvania. Common themes identified across all focus groups centered on concerns for privacy, autonomy, cost, and safety associated with implementation of novel technologies. The relative importance of each theme varied by stakeholder group as well as the perceived severity of cognitive and/or physical disability. Our findings suggest that ethical issues are critical to acceptance of novel technologies by their end users, and that stakeholder groups are interdependent and require shared communication about the acceptance of these emerging technologies.

Telenursing and home healthcare. the many facets of technology.

Telenursing was instituted as an effective mode for providing care to patients geographically distant from healthcare providers. Using telecommunications and information technology, nursing care is provided remotely to individuals. Nurses recognize the value of telecare and telehomecare as essential components of telenursing that give patients easy access to high-quality care and eliminate costs and difficulties associated with travel to healthcare facilities. Patient satisfaction with telenursing is related to prompt quality care from professional nurses. Telenursing continues to grow as a valuable method for providing nursing care, especially in home healthcare.

New solutions for personalised health management: citizens' needs, healthcare changes, and market perspectives round table debate.

The aim with the round table was to give additional inputs and views to the specific technology oriented presentations focusing on issues dealing with the need, patients' view, the use and the business opportunities relating to wearable eHealth systems for personalised health management. Wearable eHealth systems for personalised health management are targeting citizens, patients at health risks and patients enrolled in open care or home care for monitoring, treatment or follow up. The developments so far show promises for these group categories, and in addition, could support developments in health care organisations and systems. However, the ethical issues and data privacy nature have to be seriously taken into account. The market is not yet developed, and this is the situation both in Europe and in the US. To be able to give the customers solid product information a standardised test bed for new equipment and services might speed up the market development. In the round table discussion it was highlighted that one has to differ between needs and demands. Needs are related to the prevalence of the diseases, the health risks, etc. Demands are more related to market developments and customers' willingness to pay for the new products and services. Further, technical interoperability was seen as a fundamental prerequisite for market acceptance. As wearable eHealth systems for personalised health management differ completely from traditional way of deliver healthcare, new reimbursement systems have to be developed and implemented.