Prospectively investigating the impact of AI onshared decision-making in post kidney transplant care (PRIMA-AI): protocol for a longitudinal qualitative study among patients, their support persons and treating physicians at a tertiary care centre.

Introduction: As healthcare is shifting from a paternalistic to a patient-centred approach, medical decision making becomes more collaborative involving patients, their support persons (SPs) and physicians. Implementing shared decision-making (SDM) into clinical practice can be challenging and becomes even more complex with the introduction of artificial intelligence (AI) as a potential actant in the communicative network. Although there is more empirical research on patients' and physicians' perceptions of AI, little is known about the impact of AI on SDM.

A Review and Tutorial on Machine Learning-Enabled Radar-Based Biomedical Monitoring.

Radio detection and ranging-based (radar) sensing offers unique opportunities for biomedical monitoring and can help overcome the limitations of currently established solutions. Due to its contactless and unobtrusive measurement principle, it can facilitate the longitudinal recording of human physiology and can help to bridge the gap from laboratory to real-world assessments. However, radar sensors typically yield complex and multidimensional data that are hard to interpret without domain expertise.

Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial.

Background: Patients after kidney transplantation eventually face the risk of graft loss with the concomitant need for dialysis or retransplantation. Choosing the right kidney replacement therapy after graft loss is an important preference-sensitive decision for kidney transplant recipients. However, the rate of conversations about treatment options after kidney graft loss has been shown to be as low as 13% in previous studies.

Palliative care and new technologies. The use of smart sensor technologies and its impact on the Total Care principle.

Background: Palliative care is an integral part of health care, which in term has become increasingly technologized in recent decades. Lately, innovative smart sensors combined with artificial intelligence promise better diagnosis and treatment. But to date, it is unclear: how are palliative care concepts and their underlying assumptions about humans challenged by smart sensor technologies (SST) and how can care benefit from SST?

Aims: The paper aims to identify changes and challenges in palliative care due to the use of SST.

When performance is not enough-A multidisciplinary view on clinical decision support.

Scientific publications about the application of machine learning models in healthcare often focus on improving performance metrics. However, beyond often short-lived improvements, many additional aspects need to be taken into consideration to make sustainable progress. What does it take to implement a clinical decision support system, what makes it usable for the domain experts, and what brings it eventually into practical usage? So far, there has been little research to answer these questions.

"Nothing works without the doctor:" Physicians' perception of clinical decision-making and artificial intelligence.

Introduction: Artificial intelligence-driven decision support systems (AI-DSS) have the potential to help physicians analyze data and facilitate the search for a correct diagnosis or suitable intervention. The potential of such systems is often emphasized. However, implementation in clinical practice deserves continuous attention.

Evaluation of a clinical decision support system for detection of patients at risk after kidney transplantation.

Patient care after kidney transplantation requires integration of complex information to make informed decisions on risk constellations. Many machine learning models have been developed for detecting patient outcomes in the past years. However, performance metrics alone do not determine practical utility.

Transparent human - (non-) transparent technology? The Janus-faced call for transparency in AI-based health care technologies.

The use of Artificial Intelligence and Big Data in health care opens up new opportunities for the measurement of the human. Their application aims not only at gathering more and better data points but also at doing it less invasive. With this change in health care towards its extension to almost all areas of life and its increasing invisibility and opacity, new questions of transparency arise.

Risk-Adjusted Cancer Screening and Prevention (RiskAP): Complementing Screening for Early Disease Detection by a Learning Screening Based on Risk Factors.

Background: Risk-adjusted cancer screening and prevention is a promising and continuously emerging option for improving cancer prevention. It is driven by increasing knowledge of risk factors and the ability to determine them for individual risk prediction. However, there is a knowledge gap between evidence of increased risk and evidence of the effectiveness and efficiency of clinical preventive interventions based on increased risk.

Risk-Adjusted Prevention. Perspectives on the Governance of Entitlements to Benefits in the Case of Genetic (Breast Cancer) Risks.

This article is a revised version of our proposal for the establishment of the legal concept of risk-adjusted prevention in the German healthcare system to regulate access to risk-reduction measures for persons at high and moderate genetic cancer risk (Meier et al. Risikoadaptierte Prävention'. Governance Perspective für Leistungsansprüche bei genetischen (Brustkrebs-)Risiken, Springer, Wiesbaden, 2018).

What is (synthetic) life? basic concepts of life in synthetic biology.

One of the central aims of synthetic biology (SB) is to better understand the mechanisms of life by trying to develop and synthesize new forms and perhaps modes of life. While the question of what is life has occupied mankind for centuries, there is a lack of empirical research examining the basic concepts of life scientists within SB themselves refer to and build on. In order to gain insights into these fundamental concepts, we conducted a qualitative interview study with scientists working in the field of SB.

(Re-)Designing Nature? An Overview and Outlook on the Ethical and Societal Challenges in Synthetic Biology.

This structured literature analysis aims to map the current, emerging, and predicted future of synthetic biology (SB) by putting the focus on the implied conceptual, societal, and ethical challenges. The central objective of the analysis is to provide an initial systematization of the ethical and socio-scientific debate on SB by structuring and categorizing widely discussed issues within the debate in recent years. Starting with the quest for possible definitions, issues of biosafety and biosecurity are emphasized.

Primer on an ethics of AI-based decision support systems in the clinic.

Making good decisions in extremely complex and difficult processes and situations has always been both a key task as well as a challenge in the clinic and has led to a large amount of clinical, legal and ethical routines, protocols and reflections in order to guarantee fair, participatory and up-to-date pathways for clinical decision-making. Nevertheless, the complexity of processes and physical phenomena, time as well as economic constraints and not least further endeavours as well as achievements in medicine and healthcare continuously raise the need to evaluate and to improve clinical decision-making. This article scrutinises if and how clinical decision-making processes are challenged by the rise of so-called artificial intelligence-driven decision support systems (AI-DSS).

The budgetary impact of genetic testing for hereditary breast cancer for the statutory health insurance.

Potential opportunities and challenges of predictive genetic risk classification of healthy persons are currently discussed. However, the budgetary impact of rising demand is uncertain. This project aims to evaluate budgetary consequences of predictive genetic risk classification for statutory health insurance in Germany.

Images of synthetic life: Mapping the use and function of metaphors in the public discourse on synthetic biology.

Synthetic biology is currently one of the most frequently addressed emerging biotechnologies. Developments within this field receive a great deal of attention in media coverage, in which they are frequently illustrated by certain forms of metaphorical speech. Although it can be assumed that societal perceptions and evaluations of emerging biotechnologies are shaped by media coverage and its transported images, there is a lack of empirical research examining the reporting on synthetic biology as well as the use and function of metaphors within media articles.

MaxSynBio: Avenues Towards Creating Cells from the Bottom Up.

A large German research consortium mainly within the Max Planck Society ("MaxSynBio") was formed to investigate living systems from a fundamental perspective. The research program of MaxSynBio relies solely on the bottom-up approach to synthetic biology. MaxSynBio focuses on the detailed analysis and understanding of essential processes of life through modular reconstitution in minimal synthetic systems.

Mind the gaps! Towards an ethical framework for genome editing.

The use of CRISPR/Cas genome editing in agriculture and medicine develops in a state of vagueness regarding regulation, trust and responsible research. The precautionary principle could provide a way for handling these uncertainties when developing safe and socially acceptable applications. [Image: see text]

[Entitlement to prophylactic treatment in cases of genetic predisposition for breast cancer : Interdisciplinary perspectives].

Genetic tests can detect the predisposition to various diseases. The demand for gene diagnostics and corresponding prophylactic measures is increasing steadily. In the German healthcare system, however, legal uncertainties exist as to whether a mere risk of disease is reason enough to bear the costs for prophylactic measures.

['Healthy sick' or: How Genetic Risks Lever the Disease Concept of the Healthcare System].

Currently it is not clear, whether and which specific prophylactic measures the healthcare system should provide as a standard offer for persons with genetic risks. Furthermore, there is no theoretical model for transparent regulation in this context. In the concrete case of BRCA1/2 carriers, the consequences of these defects become obvious: requests for medical measures are subjected to decision-making procedures of health insurance companies that are not wholly transparent.

Ways Out of the Patenting Prohibition? Human Parthenogenetic and Induced Pluripotent Stem Cells.

According to the judgement of the European Court of Justice in 2014, human parthenogenetic stem cells are excluded from the patenting prohibition of procedures based on hESC by the European Biopatent Directive, because human parthenotes are not human embryos. This article is based on the thesis that in light of the technological advances in the field of stem cell research, the attribution of the term 'human embryo' to certain entities on a descriptive level as well as the attribution of a normative protection status to certain entities based on the criterion of totipotency, are becoming increasingly unclear. The example of human parthenotes in particular demonstrates that totipotency is not at all a necessary condition for the attribution of the term 'human embryo'.

"I bet you won't": The science-society wager on gene editing techniques.

By proposing a moratorium on human germ line editing using CRISPR, scientists have entered an all‐or‐nothing wager with public opinion. A better approach would be to convene a rational and broad discussion of the fair and ethical application and regulation of gene editing and other new technologies. [Image: see text]

Safe and Sound? Scientists' Understandings of Public Engagement in Emerging Biotechnologies.

Science communication is a widely debated issue, particularly in the field of biotechnology. However, the views on the interface between science and society held by scientists who work in the field of emerging biotechnologies are currently insufficiently explored. Therefore filling this gap is one of the urgent desiderata in the further development of a dialogue-oriented model of science-public interaction.

The synthetic biology puzzle: a qualitative study on public reflections towards a governance framework.

Synthetic biology is currently one of the most debated emerging biotechnologies. The societal assessment of this technology is primarily based on contributions by scientists and policy makers, who focus mainly on technical challenges and possible risks. While public dialogue is given, it is yet rather limited.