4
Ethics-Oriented Personalized Medicine

In light of the complexity of many medical situations, the uncertainties into which they lead us and the possibility and, indeed, the requirement of ever-better performances, it is becoming increasingly important to support health professionals in practicing their faculty of discernment. Doctors are also becoming aware of those scenarios that they do not know but can only guess. With their growing knowledge, they are forced to constantly ask themselves: What are the consequences of this new knowledge, and how should we act on it? Do doctors have the moral obligation to satisfy all demands that they are technically able to satisfy?

Experience shows us that in order to resolve these situations, which are difficult for both the patients and those around them, doctors need frameworks to help structure the analysis of the situation and to better understand the issues. The quest for discernment is one of the crucial aims of a dialogue-based approach: a demanding approach whose application is more complicated than simply writing a prescription. Perhaps one of the fundamental goals of ethics is that everyone, every day, should be able to create his/her own way of becoming more human [MAL 00].

In this ethical approach, doctors themselves play a privileged role, witnessing and indeed aiding the progress of science simply by doing their jobs every day. It is up to them to determine their own human values as a frame of reference and to define their own ethical behavior so as to achieve true practical wisdom in their therapeutic activities.

4.1. The evolution of society toward an ethical ideal based on information

The detailed description, given earlier, of the path that leads from data to knowledge and thus to practical wisdom seems crucial in developing a complete understanding of how should the theoretical and practical implications of the information gleaned from NICT in society be evaluated. In view of this observation, we can construct a diagram illustrating the relationship between data, information, knowledge and practical wisdom (Figure 4.1). This illustration shows the evolution of society toward an ethical ideal built around information.

Figure 4.1. Evolution of an information society using NICT

Today’s society is an information consumption society, in which focus is given to the epistemological aspect, in which data and information as such predominate. In the medium term, this society is likely to transform into an information communication society, centering on human exchange and sharing. In other words, it should be based on links rather than the information “goods” held by people. This anthropological outlook is crucial for the conversion of information into knowledge. In order to remain faithful to the Hippocratic spirit, we need to learn to better understand and know human beings in the digital environment. Indeed, ICT should serve the concrete needs of both carers and patients, whether in a medical, medico-social or human dimension. However, it is possible for knowledge to be incorrectly handled. For this reason, the achievement of “complex thought” leading to a philosophy of solidarity and non-coercion seems crucial in progressing to the third and final stage – a so-called ethical information society. In and of itself, complex thought feeds into reflexive ethics¹, the purpose of which is to lend “legitimacy” to every practice and every standard. The challenge in today’s world, therefore, is to rehabilitate the “relational person”, by structured networks for cumulative, nonexclusive knowledge exchange. With this goal in mind, we need to develop a controlled ethical framework and new local links based on NICT to create a new art of “living together”.

This thought process is guided by ethical values, which serve as both normative and critical markers. By weaving together pieces of knowledge, it weighs in favor of reliance between humans and turns the knowledge into “practical wisdom” [RIC 90], which is crucial in making an optimal decision. With practical wisdom, duty itself needs to stand the test of prudent, sensible decision-making, in view of each specific situation. According to Edgar Morin [MOR 04], “the principle of non-separation lends itself to solidarity. Thus, complex thought leads to an ethics of responsibility (relatively autonomous subject-recognition) and solidarity (cogent thought). It leads to an ethics of understanding, which is an ethics of pacification of human relations. It shows that the greater the social complexity, the greater are the freedoms and the greater the need for solidarity to ensure the social link”.

In addition, it is noteworthy that this evolution of society also includes the classic three levels of modeling from antiquity, which we can turn into contemporary medical events, namely

• – the “given being”, represented by the epistemological aspect. It is everything that makes up the world to which humans have indirect or partial access through our senses. This can be denoted as Medicine 1.0, of the past, corresponding to a passive attitude;
• – the “perceptible world”, illustrated by the anthropological domain centered on human relations. It represents the world of sensations, and measuring is the only data source that can be used to obtain information about the real world or the given being. It can be illustrated as being Medicine 2.0, of today, with a collaborative approach whereby everybody can produce their own expression on the Internet. This constitutes today’s society, involving an exchange between people – notably via forums and social networks; – the “objective reality”, characterized by philosophical thoughts. It corresponds to a space entirely designed by the human mind. It consists of constructing explanatory models expressing the data gleaned from the perceptible world. This last phase can represent Medicine 3.0, of the future, which involves significant ethical dominance. Primarily, it consists of respecting a deontology and human values so that the virtual can integrate harmoniously with the real. This form of medicine must be independent and respectful of the doctor–patient relationship so as to become the guide for our concerns [ETI 12]. This situation is illustrated by our doctor–patient–IS triangulation (as seen previously), in which the machine becomes intelligent, with the capability to manage and perceive meaningful data. Medicine 3.0, designed with ethics and intelligence, opens the way to the improvement of the caregiving relationship, a return to semiology and the establishment of real-time epidemiology based on dialogue between the doctor and the patient.

In addition, on the basis of our neo-Platonic systemic ethical model, we can establish a new representation of knowledge, integrating different levels of modeling depending on the fields of study. Each field of study corresponds to an area of Medicine (see Figure 4.2).

This pyramidal representation tends toward personalized ethical medicine, assisted by NICT, with the following features:

• – it increases the sense of taking charge of care;
• – it decreases the entropy (degree of disorder) of a healthcare organization.

Our model has shown the final stage of knowledge processing – namely artificial intelligence (AI), where machines can evolve on their own initiative, without human intervention. This step corresponds to the level of the model known as “evolutive virtuality”, in which cybernetics² is based on ethics in the computosphere³, tending toward Medicine 4.0 (see Table 4.1).

Here, we again see the concept of the Internet of Things that Joël de Rosnay called 4.0, which pertains to the capacity of intelligent machines to communicate between themselves, independently of human volition. Now we are entering into the universe of Isaac Asimov⁴, the science-fiction author, who sought to offer a rational view of robots, where one of the fundamental laws is that a machine cannot turn against humans and is merely a possession of its human masters. All the problems caused by robots in Asimov’s universe are actually caused by their creators.

Figure 4.2. Analysis of the knowledge pyramid via ethical modeling

The idea of the computosphere is an interesting idea, because while a numerical solution organizes and always maintains a link with its designers, a computer, on its part, performs computations without the need to report to its designers, because it computes its own evolution.

Table 4.1. Components characterizing the environment surrounding knowledge

	Environment
	Infosphere		Info-ethics	Computosphere
Field of study	Epistemology	Anthropology	Ethics	Cybernetics
Level of modeling	Given being	Perceptible world	Objective reality	Evolutive virtuality
Nature of the knowledge elements	Data/information	Knowledge	Practical wisdom	Artificial intelligence (AI)
Type of Medicine	Medicine 1.0	Medicine 2.0	Medicine 3.0	Medicine 4.0
Time period	Past	Present	Near future	Medium-term future
Nature of the relationship	Man–machine	Man–machine	Inter-human	Inter-machine
Purpose of care management	To do it right	To do it right	To do good	To drive forward its evolution

The computosphere has three informational characteristics, components of technical IS – particularly expert diagnosis-support systems: semantics (the meaning of the information), syntax (the flow of information) and lexicons (the store of information). The semanticist François Rastier [RAS 01], after recapping the positions of Turing and Grice on this subject, proposed six “precepts” conditioning an evolved dialogue system, specifying that they are already used by existing systems:

• – objectivity (use of a knowledge base by the system);
• – textuality (consideration of interventions more than one sentence in length, whether originating from the system or from the user);
• – learning (at least temporary integration of information gleaned from the user’s statements);
• – questioning (request for further details by the system);
• – rectification (suggestion of solutions to the issue posed, when necessary);
• – explanation (explanation, by the system, of a response that it has previously given)

Rastier also suggests that the system must be able to independently create a representation of the user it is dealing with, in order to adapt to that user. For their part, users tend to adapt to the system as soon as they understand the fact that they are dealing with a machine. For the designer, this presents the pragmatic advantage of simplifying certain aspects of the dialogue. With regard to cybernetics, it comprises the set of theories on the control and communication processes and the way in which they are regulated in living creatures, in machines and in sociological and economic systems. Its primary object is the study of the interactions between “governing systems” (or control systems) and “governed systems” (or operational systems), under the aegis of feedback processes. This explains the origin of the term “cybernetics”: it comes from the Greek word kubernesis, which means the action of directing, of governing, in the figurative sense. The organization is active and self-structured, and is dependent and in solidarity with the environment. The organization also reacts on the basis of the information. Information is a stable configuration of symbols, which is both sign and signified. It enables the organization to adapt its behavior at any time by regulation, to transform and to redress a balance so as to preserve an osmotic relationship with the environmental parameters of the infosphere, info-ethics and the computosphere (see Appendix 6).

Thus, the information gives rise to a process of constant adjustment of the organization by channels (the system adapts by accommodation) and codes (the system adapts by assimilation) for communication in relation to a project. In order to represent the organization, Rastier proposes a model comprising a decision-making system, an IS and an operating system.

In addition, this pyramid-shaped illustration involves control filters for each degree of maturation of Medicine and field of study (see Table 4.2):

• – visualization/perception filter and design/establishment filter in epistemology (Medicine 1.0);
• – cartography and use filters in anthropology (Medicine 2.0);
• – effectuation, regulation and legitimization filters in ethics (Medicine 3.0);
• – evolution filter in cybernetics (Medicine 4.0).

On the basis of this view of the evolution of our information society, we have constructed our model of ethical analysis applied to NICT. Note that the idea of using mathematics to describe the “perceptible world” appears to have originated with Pythagoras or his disciples [DIX 03].

Table 4.2. Structure of knowledge pyramid

Level of knowledge	Nature	Content	Function	Filter
Data: discrete elements	Epistemology	Numbers	Categorize	Visualization and perception (What?)
		Codes	Calculate
		Tables	Collect
		Databases	Measure
			Compile
Information: connected elements	Epistemology	Sentences	Contextualize	Design and establishment (How?)
		Paragraphs	Compare
		Equations	Organize
		Concepts	Converse
		Ideas	Filter
		Questions	Frame
		Simple statements	Rank
Knowledge: organized information	Anthropology	Chapters	Structure	Cartography and usage (Why?)
		Theories	Understand
		Axioms	Interpret
		Conceptual frameworks	Evaluate
		Complex statements	Demolish
Practical wisdom: applied knowledge	Ethics	Books	Protect	Effectuation, regulation and legitimization (What is best?)
		Paradigms	Incarnate
		Systems	Adapt
		Religions/Beliefs	Synthesize
		Philosophies	Apply
		Traditions
		Principles
		Truths
		Schools of thought
Artificial intelligence (AI): evolutive knowledge	Cybernetics	Black box	Changing	Evolution (How can things be made to change?)
		Analysis software	Expressing
		Feedback process	Explaining
		Processing algorithm

In summary, a complex thought links epistemology and anthropology in a loop. Epistemology enables us to design anthropology – an essential condition for a philosophical thought, which is integrated into a loop where each step is necessary for the others, culminating in the creation of ethics. Finally, cybernetics relies on info-ethics in developing AI – the evolutive knowledge of expert diagnosis-support systems. In other words, these four macroscopic stages of society can be illustrated by a microscopic approach to an IS, comprising its design, development, usage and evolution.

Finally, if we apply this model to the economy, we see that, for a long time, we have been in stage 3.0: individuals, society and machine exchange intelligent data (the data are intelligent because they are intelligible). Hence, the markets and certain economic and financial mechanisms are already operating in stage 4.0⁵, and humans have become the pawns of the system.

This should alert us to the fact that if Medicine 3.0 is not centered on the ethics of inter-human relations, which surround NICT and big data in healthcare, then humans will become dependent on Medicine 4.0, where our existences and our fate will be at the mercy of rational medical decisions made by machines. Thus, we need to call on deontology and human behavior to ensure the confidentiality and protection of personal data. With this in mind, we need an ethical charter that covers design, implementation and usage of the personal data. In our view, proper balancing of these medical big data inevitably requires an ethical reflection about the procedures of control and structuring of these metadata to preserve the primacy of confidentiality and trust toward actors in the field of healthcare, and thus help, to a certain extent, to manage the risks and their deviation. This being the case, it is crucial that the processing of these metadata be governed by an ethical charter covering the sharing of personal data in healthcare. Such an ethical framework would help to strengthen public–private partnerships with a view to investing in predictive healthcare, while preserving the security of personal data in trusted networks.

Finally, the use of big data, alongside the medical advances made, marks the passage from traditional curative medicine to preventive medicine tailored to each individual, on the basis of behavioral data. In order to be fully appreciated, this change of medical paradigm needs to be integrated into medical training, to encourage the analysis of these metadata and interdisciplinary exchanges in this domain. This necessitates the raising of the ethical awareness of the scientific community regarding the study, development and use of big data in the field of healthcare.

4.2. The doctor–patient–IS triangulation

Above all, the relationship between a patient and his or her doctor is a human relationship (i.e., intimate) and protected by doctor–patient confidentiality. The patient expresses a need to the doctor, who draws on his or her expertise to establish a diagnosis likely to lead to the resolution of the problem identified. When caring for a patient, the healthcare professionals must take a series of decisions, which finally lead to the therapeutic act. They follow a reasoning process that necessarily involves the notions of knowledge, uncertainty, risk and experience.

In summary, the doctor’s intervention is characterized by two procedures: first “heuristic or investigation-based” approaches, which are intended to uncover an objective truth, and second, the so-called “decisional” approaches, which involve comparing the various possible courses of actions and acting on the choice of the best of those options.

For a long time, it has been claimed that diagnostic investigation by medical imaging tears open a breach in the doctor–patient relationship. In the eyes of some people, it contributes to the “mechanical assimilation of the human body, which ignores the three-dimensionality of that body” [BRE 99]. Its use by practitioners leads to a reductionist, dualist and mechanical view, in keeping with the Cartesian tradition. Today, man–machine communication is an important technological, industrial and social challenge. We use the term “machine”⁶ to denote any device built to serve specific objectives. A machine may be autonomous or may be controlled by an operator. In order to work, it requires an energy source (electricity, fuel, human energy supplied by a crank handle, etc.) [CHA 11]. The patient, for his or her part, may simultaneously be the subject and the object of the medical practice.

The ethical issues surrounding this dual position cannot be dissociated from the realities that accompany the therapeutic act. Thus, the patient is a “subject who navigates between the individual and the social” [MEY 10]. The difficulty is no longer just one of further improving these performances but also of improving the information exchanges with the human user, adapting to the users’ expectations and skills.

In addition, the Internet now forms part of the medical arsenal. Professionals consider this telecommunication tool as an ample and easily accessible reference library. More than half of healthcare professionals use the Internet on a daily basis for their clinical practice, finding a piece of information that they deem generally relevant [LUP 10]. NICT is becoming a complementary tool to the doctor–patient relationship and is likely to become the means of a transformation of that relationship [MÉA 10]. This situation necessitates the growth of a dialogue and human observation between the practitioner and the patient.

Now, linguistics, ethics, cognitive psychology, and social psychology need to be integrated into the computer models, as does computer culture. No longer is the IS merely a set of technological elements; now it represents a way of life, a relational web with personnel who understand and exploit it.

4.2.1. Man–machine interface

Technology is becoming an intermediary that interposes between humans and our environment. In a social and natural context, human relations are being restructured to include technology. The technological world is far from being a counterpoint outside of ourselves but drives us to make progress in our activities, structures our desires and plans, and transforms our relations. We use the term “man–machine interface” to denote the perimeter encapsulating all aspects of the IS that influence the participation of internal and external users in the computerized projects.

It represents all the software and hardware devices that enable a user to communicate with an interactive system. This can be represented by medical decision-support systems (MDSSs)⁷, which are integral parts of this technology. The functional architecture of this IS, therefore, comprises a knowledge base, an inference engine or an execution engine and interfaces to facilitate communication between the IS and the user, the patient’s file, the prescription support system, etc.

To develop this computer tool, which simulates reasoning and the medical approach, it is necessary to create models of medical practice [BEC 01]. MDSSs must be of immediate assistance to doctors, offering them an overview of each case in their daily practice [CLÉ 02]. Hence, that interface includes the design, implementation and evaluation elements of interactive computer systems. The purpose is to encourage understanding between the people and the other elements of a technological system. By nature, the interface deals both with the machine and the human, as it is on the boundary between them. Hence, the study of an IS must be accompanied by a holistic approach integrating the cognitive, social, organization, structural and environmental parameters.

Aristotle said: “the raison d’être of all things lies in their function”, meaning that a thing’s function and purpose justify its existence.

On the basis of this observation, we are led to wonder about the place of the IS in the doctor–patient relationship. In order to answer this question, there are two possible approaches:

On the one hand, we have the techno-centered approach, in which the machine and its possibilities are the focus of all attention. The user thus needs to adapt to the technological tool. This helps us to consider the technology as a simple diagnosis support for health management.

On the other hand, we have the anthropo-centered approach, which places human and their needs at the center. In this case, the machine has to adapt to the users. With this perspective, the technical tool is a shared decision-support tool taking consideration of the requirements and expectations both of the healthcare professional and of the patient.

The advantage of the latter approach is that it serves users’ communicational needs and ways of thinking by uniting with them. This interface must reflect all the human components – even the least rational – that motivate and involve the user in the task at hand. It plays a structuring role for the user, offering comparisons and cultural resistances.

On the basis of our definition and description of the man–machine interface, we feel it is more consistent to speak of it as a mediator between humans who are communicating with one another, an “impedance adaptor” with a machine. The IS is integrated into the actual communication device, becoming one of the partners and participating in the resolution of an action or a problem. It has an entirely separate place in the socialized dialogue between the practitioner and his or her patient.

Contemporary medicine is subject to a new model: “that which involves becoming familiar with large numbers of starting points for the care relationship”, as NICT, and digital and medical imaging technologies are becoming part of medical practice. This anthromorphic approach to the identity of the technological tool lends itself to the idea of “triangulation” of the doctor–patient–IS relationship (see Figure 4.3).

Figure 4.3. Triangulation of the doctor–patient–IS relationship

This new arrangement in the carer–patient relationship is somewhat reminiscent of Hippocrates’ “three Ms rule”, whereby the Malade, the Médecin and the Maladie (the patient, the doctor and the disease) are considered as three non-dissociable entities, no one of which can be discounted. In our triangulation, the disease, which is a part of the overall environment, a background noise in care management, is replaced by the IS. This triangular circulation of medical information, and particular of the digital image, is becoming characteristic of the relationship defining care in radiology [CLÈ 96].

This three-way doctor–patient–IS relationship can be described as follows:

The patient sends data to the IS. Having examined the situation and perceived the patient’s ailments, the computer system displays simplified medical information to the patient. On their part, doctors operate the IS by giving it commands, expressed as signs and actions. In turn, the technical tool sends them complete medical information after analyzing the situation and determining what is required. It is noteworthy that the passage of data from the human mind (that of the patient and that of the doctor) to a transcription in digital form for the IS involves a compression of those data⁸. This phenomenon simply means that the actors have reduced the overall quantity of data into a signal, so as to preserve the usefulness of the transmitted data⁹.

This natural tendency takes place via notes and codes, and by a dropdown menu listing the possible choices that will be taken into account by the IS. This stage is comparable, in analog terms, to a transduction – that is, when a device converts one physical property (energy or a signal) into another [SCO 10]. This being the case, the patient and the doctor can be characterized as being transducers. Consider the example of a loudspeaker, which transforms an electrical signal into sound.

4.2.2. Data compression

This triangulation shows lossy data compression or perceptual encoding, when that loss of fidelity is acceptable. It is guided by research into the way in which individuals perceive the data in question. Thus, we see that this degradation and reduction of the information is at the heart of an ethical dilemma. Do we or do we not need to voluntarily lose information in order to regulate the doctor–patient–IS triangulation and make it work?

In an attempt to answer this question, we have taken Willard Gibbs’ thermodynamic equation, which was repeated in similar terms by Claude Shannon in his information theory: G = ΔH □ TΔS.

The Gibbs free energy (G) becomes negative when the entropy (S) is high – that is, when there is a high degree of disorder, disinformation, inexactness or loss associated with the transmission of the data to the IS. On the other hand, if we consider James Clerk Maxwell’s model, which uses Gibbs’ figures to establish a three-dimensional model of the thermodynamic surface, with the energy (Z), entropy (X) and volume (Y), the energy decreases if the volume or entropy increases (see Figure 4.4).

On this basis, we can put forward the idea that the Gibbs free energy (G) will be high when the entropy is negative and the volume is small. In other words, in our view, this means that a precise process of transduction (characterized by an effective reduction of the data, filtering only those data that are essential and useful) will contribute to the creation of an ordered system with negative entropy.

Figure 4.4. Maxwell’s three-dimensional model

It is noteworthy that this data compression can be considered as a special case of “data differencing”, which consists of producing a difference between the data of the source and target. In this case, data compression can be represented by the entropy and “data differencing” by the relative entropy.

4.2.3. Flexibility and technical adaptation to the users

In correlation, the doctor and patient are also sensors before and after their data are sent to the IS. Indeed, they gather raw data and transmit them to the IS which, in turn, sends them coded, digitized data. Thus, because of the appropriate intervention of the IS, the oral communication between the healthcare professional and the patient leads to better knowledge of the diagnosis and therefore a shared medical decision arrived at on the basis of human judgments. This last stage is very important in the doctor–patient relationship. It constitutes the moment when the information is of the highest quality in relation to the IS. The information exchanged therefore must lead to a decision that is shared, desired, wanted and based on mutual respect. It requires the presence of two main actors in the therapeutic relationship: first, the doctor, who knows more about treatments and medications, and second, the patient, who is in charge of his or her priorities: only the patient can say what is most important from his or her point of view – particularly in terms of the qualitative and quantitative aspects of life.

In these conditions, we can envisage the presence of alarm signals addressed to the designer of the IS. On the basis of these tracking indicators, the computer scientists can alter the functions of the technological tool in order to adjust the technical actions to the situation at hand. The software designer must, as far as possible, leave the ethical choice to the IS users and, when it is not possible, the ethical hypotheses underlying the algorithms making up those software programs should be made transparent and easy to identify [KRA 11]. With this in mind, the designer must develop an algorithm that is flexible and applicable to the users’ ethical requirements. This may lead to new procedures to go along with the IS. It would be appropriate for doctors using the IS to be given training before using the software, receiving information about the situations in which the algorithm was developed by the designer (choice of transparency) and how the software should be used.

We can look at the example of a type of algorithm used in medical imaging technologies, to precisely represent human and biological structures on a computer in order to improve the prospects of diagnosis or treatment of illnesses. One of the numerous ethical issues raised by these algorithms is the risk of producing false-positive¹⁰ and false-negative results¹¹. Hence, these algorithms include an essential element of judgment of values and therefore an ethical code. Its designer, therefore, needs to find a compromise between minimizing false-positive results or the number of false-negative results¹².

Inevitably, this compromise will be based on a judgment of values. Generally speaking, designers choose a reasonable value for the threshold or setting of the software. The user bases his or her decisions on the results output by the software, constructed using settings based on ethical hypotheses made by the software designer. Thus, it is important that these ethical hypotheses be similar to those that the user him or herself would make.

Hence, the design of an algorithm must enable the user to choose the settings corresponding most closely to his or her circumstances. It is therefore necessary for the designer of the IS to allow the user to specify the ethical parameters that are to be applied. The designer leaves it up to the user to define the default state of the program [STR 08].

Given these observations, we advocate the application of a “semi-active” means of intervention by the IS:

• – the device is engaged automatically after settings have been put in place by the designer and once the doctor using the system has been validated. This is known as a “guard dog” system;
• – the auto-callback device supervises the user’s behavior and actions. This helps prevent prescription errors or redundant investigation and ensures that the protocols in place are respected;
• – the alarm device draws attention to any change in the patient’s situation. For example, it might alert users to abnormal biological values or unusual changes to a physiological parameter [SÉR 04].

In these conditions, four main functions regarding the IS appear crucial in ensuring the harmony of the doctor–patient–IS triangulation:

• – obtaining data via a standardized interface with the environment¹³;
• – using knowledge (provided in the form of professional rules, computational algorithms) from its own knowledge base or from other databases;
• – including an “execution engine” or “inference engine”, capable of using a patient’s data as input and applying rules expressing knowledge to produce interpretations, classifications, recommendations or information requests as output;
• – being able to communicate the result of the application of the rules to the user in the form of alerts, recommendations and reminders, and to the applied environment (prescription system, computerized patient file)¹⁴.

4.2.4. Shared knowledge engineering

The development of an IS must begin with the definition of its objectives, based on an analysis of the user requirements and the specifics of the problems at hand. These objectives depend on the users, their actions and their knowledge. The degree of decision support and the functions required also need to be defined. This IS enables us to gain a complete understanding of the patient’s status with regard to diagnostic or prognostic decision-making. The aim here is to reduce uncertainty as to the patient’s situation. The ultimate goal is to be able to develop a better strategy for taking care of the patient.

In this context, the man–machine interface is a sort of crossroads between the rationality of the IS’ technical actions (illustrated by objective reports transcribed in coded form) and the emotional awareness of the doctor and patient (represented by their impressions and judgments, which are rather subjective)¹⁵. We see a high level of involvement of the patients in regard to elements of the diagnosis, whether that be written reports, additional examinations undergone or medical records.

Because of patients’ deep-seated ambivalence regarding their desire for knowledge, we know that accessing diagnostic elements without accompaniment and support may be problematic for them. Therefore, it seems essential to carry out a prior evaluation of the patients’ knowledge and expectations before stating the information. The ability to adapt one’s discourse on the basis of patients’ emotional expressions also seems to be of fundamental importance [DUT 08]. The increasing appropriation of diagnostic elements by the patients means that the healthcare professional is needed to walk them through everything. On the basis of these considerations, the stressful effects of a technical examination need to be taken into account. It is not enough to merely understand the technical side of things: doctors also need the capacity to establish an attentive relationship with the patient. For instance, radiologists cannot hide behind the highly technical nature of their field of specialty [CLÈ 06]. This need is often touched upon in the existing body of literature, with emphasis being placed identifying a patient’s intellectual level or that of those around him or her, rather than falling into the trap of technical discourse whereby all emotion is buried under excessive rationalization [BOI 06]. Only the practitioner can weave together the diagnostic elements with the specific symptoms of the patient’s condition. In actual fact, it would be counterproductive from the patients’ point of the view to “capitalize” a mass of information about the disease without being able to bring together, organize and single out these elements in connection with the peculiarities of their particular ailment.

Ultimately, this triangulation leads to true engineering of the shared knowledge. It is characterized by a view based on cognitive psychology, the modeling of information-processing devices and the representation of symbolic knowledge with a view to improving medical decision-making. Thus, the IS constitutes a node and a complex relational link between the healthcare actors with emotions, perception and cognition. It represents the “connecting line” in the doctor–patient relationship.

It is therefore on the basis of this new form of organization of healthcare management that the therapeutic action is devised. This interface guides communication on the action and increases the possibility for perception of and action upon the caregiving relationship. It integrates these possibilities and becomes a participant, a partner, in the action. For this reason, for the IS to be pertinent and coherent, it is essential to adapt the evolutionary knowledge and dialogue strategies to the healthcare situation and to the particular users.

Consequently, the ability to understand and visualize the inside of the patient’s body from a technical point of view must be accompanied by an exchange and understanding of the perception, the emotional feelings and the individual identity of the person under care. In our view, the harmony and balance of this three-way relationship necessarily involve this exchange and compromise between the rationalizing technique and the human conscience.

4.3. Ethical use of an information system in healthcare

Both the complexity of an organization’s IS and the organization’s dependence on that system have led to an increase in the number of regulations, good practice guides, protocols and control of that system. Paradoxically, as pointed out by Gérard Ponçon [PON 09]¹⁶, the use contexts of ICT in hospitals are very numerous, varied and, often, complex. Thus, it becomes impossible to regulate everything by procedures and control systems, which would quickly become unworkable. For this reason, it is preferable, and more effective, to make the fundamental resources available to each person who is responsible for carrying out their own duties; they can thus adopt the appropriate behavior and make the correct decision in all working situations that they encounter. These resources actually weaken the system that they are supposed to protect. Thus, it is important to give users the responsibility for making correct use of the system and possibly use active or passive protection devices.

In addition, the ethical policy concerning the use of an IS, as determined by an organization, needs to be specific to that organization, shared by all within it and consistent with the morality and deontology of the disciplines practiced in the hospital. It is a response to the complexity of the IS and to the healthcare establishment’s dependence upon it. Such an ethical code will lend greater importance and consistency to the healthcare professional’s taking responsibility. Medical decision-making, therefore, is part of a multifaceted relational process involving human values and ethical principles. In so-called “simple”, therapeutic situations, it does not seem necessary to consult ethics: deontology, experience and empathy are sufficient, most of the time. Ethics becomes indispensable when the practitioner is faced with conflicting or contrary obligations, when the therapeutic act and the medical decision are not clear-cut, when multiple values and choices are at play simultaneously and when there is confrontation and division. According to Pierre Le Coz [COZ 07], ethics refers to the reflection that arises from the conflict between those values. Following an in-depth study of international literature on bioethics, we can distinguish four universal ethical principles [BEA 01], which are constant from country to country: autonomy, beneficence, non-malfeasance and fairness.

When we apply these four fundamental principles in the doctor–patient–IS triangulation, we see that:

• – in keeping with the principle of autonomy, the healthcare professional must be capable of understanding, reasoning, making independent choices and involving the patient in the taking of the medical decision;
• – in keeping with the principle of beneficence, the doctor and the IS must contribute to producing good for the care receiver. With this in mind, it is necessary to put in place training and awareness-raising programs to ensure the best possible use is made of the system and to adopt the best savoir-faire in relation to the doctor;
• – in keeping with the principle of non-malfeasance, the user of the IS must focus fully on his or her tasks to avoid any risks of causing harm to the patient. This essentially involves avoiding unnecessary harm or suffering for the patient;
• – in keeping with the principle of fairness, the hospital practitioner must carry out the same actions with the same level of attention, determination and concentration, whoever the patient is. The objective is to share equivalent available resources (time, energy, attention, money, etc.) between all the patients.

Thus, the ethics of using the IS must be shared between all the actors within the structure and must conform to the deontology and professional moral code in force in that establishment. That code of ethics brings consistency to the level of responsibility borne by the healthcare professionals, who can no longer hide behind the checks and formal protocols enacted by the system. They must be able to exercise responsibility in order to do their job as freely as possible, and make reports a posteriori without apprehension. This being the case, the design and use of an IS must conform to three “levels of organizational requirements” in a healthcare establishment:

• – the first corresponds to the shared conviction that an IS, above all, is a social cohesion tool associated with shared concerns among all the actors within the healthcare structure;
• – the second constitutes a true democratic debate, based on the transparency of its content, trust and mutual respect between all the actors involved;
• – the third represents the conviction that everyone has a shared obligation – which transcends their respective professional ambitions – to build a structure and a patient-centered system in which quality of care, respect for others and consideration for the patients’ needs and wishes are constantly present.

With this in mind, the framework needs to be founded on the four universal ethical principles, which are closely associated with a person’s professional conscience, whether that person is a user of information or is in charge of its evolution. The objective is to ensure the quality of the healthcare received by the patient. Finally, the shared medical decision must take account not only of the patients’ motivations (emotional, financial, etc.) but also of a certain balance between the well-being of the patient and the good of the society.

In a social and natural context, human relations are being restructured, with the inclusion of technology. The technological world is far from being a counterpoint outside of ourselves but drives us to make progress in our activities, structures our desires and plans, and transforms our relations. Thus, ICT is becoming an intermediary that interposes between humans and our environment. It is therefore from the basis of this new healthcare organization, centered on a doctor–patient–IS triangular partnership, that the therapeutic action is devised. This interface guides communication on the action and increases the possibility for perception of and action on the caregiving relationship. It integrates these possibilities and becomes a participant, a partner, in the action. For this reason, for the IS to be pertinent and coherent, it is essential to adapt the evolutionary knowledge and dialogue strategies to the healthcare situation and to the particular users. Thus, the ethics attached to human emotions constitutes one of the major issues in the shared medical decision. The ability to understand and visualize the inside of the patient’s body from a technical point of view must be accompanied by an exchange and understanding of the perception, the emotional feelings and the individual identity of the person under care. In our view, the harmony and balance of this three-way relationship necessarily involve this exchange and compromise between the rationalizing technique and the human conscience.

In addition, the use of the IS has repercussions for all of the actors involved in hospital life: the staff, the patient, the families and the publishers of the IS. This means that the designers of the IS must reflect on multisectorial issues, such as standards, norms, rules and procedures, good practice guides, protocols, the significant judicial implications¹⁷ and the interrelations between the day-to-day use of the IS, in the various working contexts and management thereof.

In conclusion, to develop an IS, it is essential to involve multidisciplinary groups, functioning as an “ad hoc-racy” – that is, an organizational configuration that, in the context of unstable and complex environments, involves pluridisciplinary, specialist and cross-cutting skills, to perform specific tasks [MIN 89]. Therefore, the crucial step is to identify the ethical objectives and the place of the IS in relation to the doctor and the patient within the healthcare organization.

Thus, the ethics of use of an IS is a response to the complexity of the IS and to the dependence of the healthcare establishment on it. That code of ethics brings greater importance and consistency to the level of responsibility borne by the healthcare professional. The ethical policy needs to be specific to that healthcare structure, shared by all within it and consistent with the morality and deontology of the disciplines practiced in the hospital. According to Jacques Lucas, the main objective of setting up an IS within a healthcare structure must be not only to serve the patient, by taking account of his or her concerns but also to “facilitate equality of professional practices by integrating the needs of the healthcare professionals” [LUC 13], whose involvement is fundamentally crucial to the operation of the system. The users cannot hide behind the checks and formal protocols enacted by the system. They must be able to exercise responsibility in order to do their job as freely as possible and make reports a posteriori without apprehension. The practitioner realizes that the use of the IS brings with it a responsibility to other people and thinks about the ethical purpose of the decisions and actions taken using this tool. With this in mind, the framework needs to be founded upon a number of universal ethical principles, which are closely associated with a person’s professional conscience, whether that person is a user of information or is in charge of its evolution.

Healthcare professionals who, in order to discharge their duties to the fullest extent possible, enter the data from patient files into the computer system themselves (rather than delegating the task), therefore, expect excellent user-friendliness from the system¹⁸, an easily grasped user interface (i.e., which does not require any prior training), the ability to access a patient’s data quickly and reliably (in emergencies or tense situations), and completely transparent management of the data and of the users (secure messaging) [HER 07]. Such a framework of use necessitates the definition of the conditions of perennity and development of the IS, the inventorying of the risks, issues and dangers with which the tool may have to deal, the construction of a system of values specific to the IS and its users, and the deduction of norms and rules of behavior for the use of the system. Given this observation, it become crucially important for the healthcare professionals:

• – not to hide behind the checks and formal protocols enacted by the system;
• – to be able to exercise responsibility and do their job properly without reservation;
• – to be able to give reports after the fact, without any problems;
• – draw on their professional conscience, which is based on the four fundamental ethical principles:
  • - autonomy: the user must be capable of comprehension; the patients must be able to be involved in their own care,
  • - beneficence: it is important to provide functionally operative services; to develop the best savoir-faire and take measures that are beneficial for the quality of the care,
  • - non-malfeasance: presence of an emergency access device; negligent use may cause harm to the patients,
  • - fairness: the healthcare structure must be fair toward the healthcare professional to whom it entrusts an activity¹⁹; the user must operate with the same degree of determination irrespective of who the patient is (here we see the concept of equity).

Ultimately, an IS is designed to be used whenever it may serve the users’ needs. The definition of such systems is based on a precise knowledge of what they do and of the diversity of the situations in which they exist.

4.4. Ethics-oriented personalized medicine

Any medical action must be based on a clear, precise goal that determines the patients’ moral and social needs in relation to their situation and to the context. This goal gives rise to a strategy and recommendations to serve these healthcare requirements. It evolves, depending on the appropriate strategy. Only by very closely re-examining the human condition, our expectations, choices and fate can we effectively support medical practice and ensure that the patient’s dignity is respected, offering fair healthcare. The purpose of a medical action is the “why” – the meaning – as opposed to the “how” – the mechanisms or functions that the action involves. It is taken as a piece of evidence when we resolve to do something or to obtain a result. This evidence enables us to interpret someone else’s observed action as “finished:” what does that person want to do? What is the meaning behind his or her act? We can observe purpose not only in the actions of a person but also in the behavior or structure of an organism – even the organism that is believed to be insentient – if we see a certain adaptation of means to an end. Where do our ethical concerns come from? How are we to make the distinction between right and wrong in a medical decision? Such questions help us to examine purpose. Goals do not only govern human activities, they are also the basis for orders, recruiting human efforts to achieve those goals. Therefore, they also define states, duties attached to these states and the qualities or virtues required to successfully fulfill those duties. Questions such as these lead us to re-think medical practice, considering that the performance of a medical action must be based on ethics-oriented personalized medicine, which is founded on modeling, appropriate management and self-evaluation of medical practice.

4.4.1. Value of management

The French healthcare system and the professionals who keep it running all day are embroiled in a “maelstrom” of reforms, which is profoundly altering their ways of working, their beliefs and, perhaps, their guiding values. It might even be said that change is the norm, and stability is the exception. In this context, executives’ discomfort (real or imagined) is little spoken of and is almost never expressed formally. In the view of the management, evolution is about looking at not only the new ways of organizing the workload but also the relationship that everyone has with the work.

What role is played by evolution in organizations in the full throes of new governance and based on much-maligned managerial models? Does conventional participative management still make sense in healthcare structures? What is the true goal of the medical activities? Questions like these often remain unanswered, for lack of well-founded institutional reflections on the subject of management [COU 06].

Our bibliographical studies on the subject have shown that the establishment of a strategy based on a working method cannot work without the involvement of an advisor and effective framing to guide the people involved in the process. The consultant constructs “a relationship which requires trust on both sides” [PED 04]. The position of this ethical management is as a sort of intermediary – a “halfway:” between the individual and the action, between the person’s interaction and the implementation of the action, and between professional life and personal life. Its action is, therefore, significantly important for the actors in the doctor–patient relationship, because it is primarily oriented toward the aim and meaning of a medical action. This inevitably involves a good command and sharing of the information that is circulating.

Hence, the consultant helps optimize the hospital practitioner’s predisposition for change, individual performance and organization [PED 04]. The aim of this human supervision is not to look for the “why” of things but rather to optimize the consequences and effects of the actions. However, the ethics lies primarily in the intention behind the acts – the goal they serve.

Therefore, healthcare structures need to use management methods and concrete resources, which are accessible at all levels of the organization, appropriate at the decision level to achieve overall performance. This enables us to construct and optimally operate the information system, based on structure, reflections and dialogue between the decision-makers at the different levels of control. These healthcare organizations need to implement reactive mechanisms of collective learning from their own mistakes and proactive mechanisms of risk control. This inevitably involves a good command and sharing of the information that is circulating. Healthcare establishments thus need, day by day, to weave multiple connections, interactions, interrelations, synergies, affluences, confluences, innumerable and varied influences, guided by a managerial strategy hinging on collective performance, giving meaning and purpose (see Table 4.3).

Table 4.3. Strategic deployment: giving meaning and goals

Types of measures	Methods	Questions
Vision	–	What does the organization want to become?
Mission		What is the legitimacy of the organization?
Values		What are the organization’s principles of behavior and decision?
Medium-term strategic avenues	Balanced scorecard	What are the medium-term strategic approaches and are they consistent?
Main strategic priorities		What are the strategic priorities that must be borne in mind by everyone?
Process objectives	Hoshin	What are the annual performance- and progress-related objectives of the processes?
Team objectives	Objective conventions	What are the collective objectives and targets, mainly determined by the leadership?
Individual objectives	Yearly interview	What are the singular objectives or the contribution of each individual to the objectives of the teams?

We can take the example of the implementation of an IS in a healthcare structure where, according to Avis 91 of the CCNE²⁰, its success depends on what is put into it, in terms of human resources and the security of the application, which is proportional to the number of qualified people. Hence, it appears crucial that users should have sufficient training time. Users “internal” to the healthcare establishment must be guided by the IS designers and managers involved in the implementation of the chosen system, so as to properly understand the way it works and how it should be used. Thus, if computer scientists are available to help the healthcare workers who need to train the other members of staff at the healthcare establishment, it would help to adjust mentalities in favor of the most efficient IS tools. The surest way of encouraging healthcare professionals to trust these new technologies would be to allow them to undergo progressive training. This would help users to anticipate the ways to deal with technical anomalies and understand the complexity of the circuit.

This necessitates the creation of:

• – training/action groups (initial/continuous), classes, workshops and practice groups devoted to the proper use of the IS;
• – learning reviews.

4.4.2. Ethical management

Medical communication should contribute to the finding of a relational balance favoring teamwork and staff training to improve the patients’ care. In these conditions of relational balance and harmony, individual morality goes hand in hand with collective reasoning in an attempt to solve ethical questions in medicine. In the view of Jean Abbad [ABB 01], social communication is crucially important for the prosperity, development and affirmation of every medical organization marked by a system of values, standards and achievements. For this reason, in order to interpret people’s behavior in a communication situation, we need to try and understand the meaning that those people attach to their action. This meaning is the product of an interaction between the fact of communicating and all of the elements that make up the medical context. Various parameters are involved, including the physical and sensory environment, the spatial organization, the temporal data, the standards, processes of positioning of individuals and of identity expression, and the need for “relational quality”. Thus, through this complex combination of these procedural criteria making up a system, the doctor and patient give meaning to their way of communicating and acting with one another. Increasingly, medical decision-making raises difficult ethical issues. It is a field of research that is expanding rapidly, drawing on not only ethics and fundamental knowledge but also practice and experience [LLO 04].

Generally, the majority of medical decisions does not require pronounced ethical reflection but is based more on savoir-faire, respect for the deontological code, the concretization of protocols and best-professional-practices recommendations, as well as the practitioner’s technological skill. Ethical decision-making is highly complex and requires prudence and experience. Ethics comes into play when the healthcare professionals are faced with choices where their values or socially accepted values come into conflict with one another. In other words, ethics is the reflection that arises from friction between our values. Medical decision-making, therefore, is part of a multifaceted relational device. Medical action is based on the practitioners’ capacity for reasoning and their ability to make decisions in spite of the fact that the medical data may be tainted with uncertainty – particularly when NICT is used. This uncertainty may arise from multiple sources: there is the possibility for error in the data entry or ambiguity of the representation of the existing knowledge and so on.

NICT alters the distribution circuit, the responsibilities and the value chain in the medical domain [SIL 09]. Despite the fact that this new technology helps reach the correct diagnosis, we see a dehumanization of the healthcare relationship, which is already rather cold and unnerving for those who are not used to it. Could it be that everything is reduced to the provision of “processes” – that is, procedures – to the detriment of professional conscience, creativity, instinct and occasional inventiveness to make better use of the existing resources? Does technology fog or replace the doctor–patient relationship? All these questions lead us to wonder whether, in fact, the very idea of progress undermines the philosophy of healthcare which, since the days of Hippocrates, has been based on face-to-face meeting – the one-on-one conference between the patient and the doctor?

In these conditions, uncertainty becomes the ethical driving force behind the medical decision, with an absolute necessity of moral vigilance. Ethics as a discipline must remain rational, open and accessible to all the actors in the human and medical sciences and users in the field of healthcare. This leads us to ask the question: which ethical values could be accepted by everyone?

Finally, we can make the recommendation to base an organization’s approach on the establishment of a cell of technical, medical, organizational and economic experts to oversee the installation and operation of the IS. This “functioning cell” [CHA 06] can include users and staff involved in the more general management of activities between the different departments services. The missions of this team might be as follows:

• – assessment of the initial needs;
• – management of the objectives of the adopted strategy;
• – definition of the technical specifications;
• – installation of the tool and user training;
• – monitoring and evaluation of activity on the IS;
• – provision of encouragement within the IS;
• – provision of decision analysis support;
• – provision of consensus- and discussion-based conflict resolution;
• – provision of participation in the quality approach and responsibility promotion;
• – consideration of the viewpoint of the various actors;
• – establishment of an activity indicator and evaluation criteria;
• – development of a collective culture and team cohesion with shared values.

In our view, one of the solutions inevitably requires an effort toward awareness-raising and educating the healthcare professionals and users.

4.5. Tool for the establishment and constant improvement of information systems for ethical practice in hospitals

In order to facilitate the work and the homogeneity of internal management for ethical performance in hospitals for the IS, we offer this guide to the creation of a “dashboard” system tailored to the requirements of healthcare establishments for the establishment and continuous improvement of the IS. This guide proposes an approach and provides tools that can be put into practice directly. This “starter kit” shows that there is plenty of opportunity to improve hospitals’ ethical performance for IS. It could constitute an avenue to be pursued in the future as a continuous improvement tool. This tool is sufficiently flexible to be easily adapted to the specific needs of each situation.

The objectives of the dashboard system are to:

• – monitor the policy of a hospital’s ethical performance for the IS;
• – monitor the quality of the IS between the different departments within the hospital;
• – analyze the shortfalls and causes of breakdowns;
• – raise any necessary alarms to prevent malfunctions;
• – facilitate the reviewing of the actions under way, at a glance;
• – provide a support tool to the IS’ ethical assurance and management system.

This starter kit comprises two main parts:

• – first, a discussion of the construction of the dashboards stricto sensu, which will inform the content of the coming presentation of the dashboard tool;
• – second, a presentation of the methodology by which to implement and use these evolutionary management dashboards.

4.5.1. Construction of the dashboards

On the basis of foreign initiatives and our extensive conceptual research, we propose a model of the construction of dashboards to better visualize the ethical situation of the IS in a healthcare establishment. On the basis of the research seen earlier, we see a plan of action for this hospital management based on an approach of interlocking three mutually complementary dashboards linking the different hierarchical levels of the healthcare establishment:

• – the so-called “strategic” (visualization) dashboard (DB1), to deal with the issues of the IS’ ethical performance. DB1 is fed by ethical process indicators (namely, the 40 items on questionnaire Q1 in the study);
• – the “tactical” (intervention) dashboard (DB2), to establish concrete actions on the ethical performance of the IS. DB 2 is fed by ethical guidance indicators (the 80 actions/recommendations listed in the study);
• – the “operational” (control) dashboard (DB3), to monitor whether or not the prescribed actions for the IS are put into practice. DB 3 works by the integration of the ethical reporting indicators (the 80 items on questionnaire Q2 in the study) (see Table 4.4)

Table 4.4. Structure and composition of the three dashboards

Dashboard	“Strategic” – visualization (DB1)	“Tactical” – intervention (DB2)	“Operational” – control (DB3)
Indicator	Ethical “process”	Ethical “piloting”	Ethical “reporting”
Ethical principle	Ethical purpose	Regulatory action	Action checklist
B1	Supporting medical decision-making by the healthcare professional	Integrating good-practice protocols into the computer system	Are the professional good-practice protocols integrated into your establishment’s computer system?
		Establishing an appropriate management protocol, accompanied by an established decision-making process	Has the number of medical mistakes been decreasing since your IS was installed?
B2	Promoting quality, organization, management and planning of the patient’s care	Using management methods and concrete resources, which are accessible at all levels of the organization, appropriate at the decision level to achieve overall performance	Does your IS help improve the qualitative performance of your patient care?
		Establishing a detailed project methodology around the IS	Since your IS was installed, have you noticed an improvement in the internal means of quality management of the medical information given to the patient?
B3	Working for the good of the patient	Creating a patient-satisfaction questionnaire concerning your IS	Have you often received compliments from your patients or from patients’ associations regarding the quality of your IS?
		Defining the objectives of the IS on the basis of an analysis of the users’ needs and of the characteristics of the problems posed	After quality of care, are cost management and productivity among the main aims of your IS?
B4	Sharing common, transparent and accessible information	Developing an interface for the exchange and sharing of information between doctor and patient, hinging on the IS	Does your IS have a sharing platform where patients can access medical information pertaining to themselves?
		Listing the patients’ needs in terms of the nature, quality and quantity of medical information shared by the IS	Is the sharing and pooling of medical information about the patient the main purpose of your IS?
B5	Ensuring quality and choice of the information transmitted	Carrying out a patient-satisfaction survey about the choice and quality of the information shared	Have you carried out a patient-satisfaction survey about the choice and quality of the information distributed?
		Establishing a 24/7 on-call system	Does your IS include a monitoring device to check that the information it is transferring is not erroneous or deteriorated by usage
B6	Improving the continuity of the care given	Being able to communicate the result of the application of rules (to the patient’s data) to the user, in the form of alerts, recommendations, reminders, etc. and to the application environment (prescription system, computerized patient file, etc.)	Is your IS capable of keeping patients informed (within a fairly short timeframe) of their medical results, via their doctor?
		Covering a larger range of action than that which is delimited by the premises of the organization	Does your IS facilitate exchanges and communication between doctors and other healthcare providers?
B7	Supporting the monitoring of all the healthcare activities	Installing the Intranet within the healthcare structure	Within your healthcare structure, is the medical information easily transferable from one department to another via your internal connection or network?
		Designating and choosing the data exchanged to aid inter-departmental exchanges	Does your system have good transversality between the different healthcare activities?
B8	Helping the Health Ministry to serve healthcare users’ expectations and cancer treatment	Installing a system to export activity data to the State or its subsidiaries (regional health authorities)	Does your IS send the State and the Ministry the necessary information to determine the political objectives and the strategy to be implemented to serve the needs of all the healthcare actors?
		Installing a system for exporting epidemiological data and public health data, for use by the State or its subsidiaries (regional health authorities)	Does your IS send the medical information to the State or its subsidiaries so that they can plan changes to the national healthcare system?
B9	Providing legal legitimacy and information processing	Identifying the ethical and medical issues involved in the IS in relation with the patients’ rights	In your view, does your IS confer legitimacy of the right to information for the patient?
		Enforcing the “ethical charter” regarding the handling of patients’ medical information	In your view, does your IS confer legitimacy of the information processing for the patient?
B10	Establishing a duty of security, integrity, traceability and protection of medical data	Identifying and understanding the potential hacking threats	Have you properly identified all the stakes and the risks relating to the security of the data sent via your IS (e.g., deterioration, loss, theft, identity theft)?
		Having a rigorous, evolving security policy	Have you fully applied all the available methods and tools to secure data exchanges, such as identification, authentication, encryption, electronic signature, certification, technical specifications of the computer system and the backup systems?
J1	Evaluating performances and identifying those areas where action is required, listing the points of weakness	Making structural and organizational changes to go along with the implementation of the IS	Have you made structural changes or new actions within your structure, after analyzing data provided by the IS?
		Installing an automated tool that has an alarm function in case of the malfunction of the IS	Does your IS have a standby device that alerts the manager when an abnormal situation or activity occurs?
J2	Running the healthcare structure efficiently while keeping costs under control	Being aware of all the equipment installed for the IS so as to be able to develop a management strategy centered around it	Have you applied a management policy for your establishment on the basis of your existing IS?
		Controlling the processes implemented for the IS from a hierarchical point of view	Does your IS exert a significant impact on the “decisional” departments for the direction of your establishment?
J3	Facilitating epidemiological or statistical analysis (SAE – annual healthcare establishment review in France)	Gathering, identifying and (statistically) analyzing the information about facts that are relevant for healthcare	Are the medical data that feed into your IS used for statistical studies?
		Evaluating healthcare intervention and publishing the results of that evaluation in a public health report	Have the medical data that feed into your IS been used for epidemiological studies?
J4	Improving and strengthening interactivity with the actors outside the healthcare structure	Appointing an external liaison officer to support the management and transmission of knowledge and usage of the IS	Has your IS saved you time in your contact or exchanges with a healthcare actor outside the establishment?
		Setting up awareness-raising days	Since your IS has been operating, have you had more regular contact with the other healthcare actors on a daily basis?
J5	Making healthcare actors more available	Integrating the IS into the actual communication device so that it becomes one of the partners and participates in the resolution of an action (doctor–patient–IS triangulation)	Has your computer system enabled the healthcare professionals to have more frequent and more regular contact with their patients?
		Developing social communication, which is crucially important for the prosperity, development and affirmation of every medical organization	Do you believe your IS has helped improve the availability of the healthcare actors in your structure?
J6	Facilitating access to medical information for all users: reduction of social inequality	Finding out the legal, social, deontological, institutional and governmental standards and constraints	Does your IS contribute to correction of the social inequalities in terms of access to medical information among your patients?
		Applying the legal, social, deontological, institutional and governmental standards and constraints	Does your IS have precise regulations about the nature of professional status among your staff and the possibility of accessing certain medical information?
J7	Respecting the same rule of access to and distribution of information regardless of the patient’s profile or status	Constructing a set of technical specifications, including the way in which medical information is to be distributed via the IS	Does your IS have precise regulations about the way in which medical information is distributed?
		Putting forward an ethically acceptable framework based on the criteria of acquisition and accessibility of medical information for the patient	Have you received comments from healthcare users regarding unfairness in the acquisition of medical information?
J8	Distributing the advantages and disadvantages of such a tool equitably in the healthcare professional’s workload	Establishing a computer system that is appropriate for, and coherence with, the organization of healthcare	Have you distributed the workload of the healthcare personnel on the basis of their IS user profiles?
		Identifying the impact of the IS on the healthcare professionals’ daily workload	Have you drawn up a breakdown of the advantages and disadvantages of using the IS in terms of their daily workload?
J9	Sharing the same information and the same medical decision support for all the healthcare professionals involved in the patient’s healthcare circuit within the structure	Listing the people affected by the IS, their duties, their objectives and the degree of their access to medical information	Does your IS transmit the same information to all the healthcare professionals involved in the patient’s healthcare circuit within your structure?
		Identifying the different possible options in terms of interventions on the IS for the healthcare professional	Does your IS represent the same decision-support tool for all the healthcare professionals involved in the patient’s healthcare circuit within your structure?
J10	Developing and sharing information that is precise and is appropriate for everyone	Constructing a technical solution for the IS that is comprehensible, useful and usable from the point of view of the user	Is the information output by your IS clearly understood by your patients?
		Raising the patient’s awareness and explaining the information transmitted by the IS to him or her	Do your patients complain about the inaccuracy of the information divulged by your IS?
A1	Putting the patient back at the center of the decision-making process by providing him or her with more complete medical information, more quickly	Involving the patient in the medical decision-making process	Since your IS has been operating, have your patients had more of an influence on the medical decisions that affect them?
		Using the IS to transmit the maximum amount of concise information that is essential for the patient	In your view, does your IS provide patients with fuller and more reactive information?
A2	Ensuring the patient consents and sticks to the plan	Explaining to the patients the nature of the use that is made of their personal medical data	Are your patients aware of the nature of the use that is made of their medical data?
		Explaining to the patient the form in which his or her medical data will be constructed, distributed and stored	Do your patients know the form in which their medical data will be constructed, distributed and stored?
A3	Respecting private life, the right to medical secrecy and confidentiality	Inserting settings into the IS that are able to conceal the patient’s identity	Does your IS have settings to mask the patient’s identity for which the medical information is associated?
		Identifying and masking the personal information relating to the patient integrated into the IS, which is not absolutely crucial for adequate healthcare	Does your IS handle information relating to your patients’ private life that you deem indispensable in order for that system to work?
A4	Respecting the right to prior information, rectification and opposition	Inserting settings into the IS, which enable the patient to rectify and/or challenge the medical data that have been posted	Is your IS fully compliant with the law on “ICT and Freedom”?
		Providing prior information to the patient about the way in which the system is used in healthcare	Does your IS respect your patients’ right to prior information?
A5	Reducing the asymmetry of information between the doctor and the patient: establishing a better balance in the doctor–patient relationship	Explaining to patients their rights concerning access to their personal medical information	Does your healthcare establishment clearly explain to the patients the rules concerning access to data pertaining to their health (see France’s law of 4 August 2002; patient information; direct access to the medical file; shared medical information)?
		Obtaining data via a standard interface, adapted to suit its user (doctor or patient)	Do you think your IS helps reduce the informational imbalance between the doctor and the patient?
A6	Increasing transversality of services within the healthcare structure	Establishing a training plan that allows the management team and supervisors to constructing a common language surrounding the IS	Does your IS have good computer integration and functional interoperability?
		Employing a coordinator/organizer, who is indispensable in preserving cohesion and overall credibility of the system	In your view, does an IS enhance cooperation with the other applications and computerized devices used in the different departments?
A7	Establishing an individual and/or collective use of the medical information	Conducting learning reviews as regard the individual usage of the IS by the healthcare professionals	Is your IS subject to individual usage?
		Using multidisciplinary working groups for support (such groups help bring team members together and promote adhesion) as far as possible	Is your IS subject to collective usage?
A8	Adapting the use of the medical information to suit the organization of the healthcare structure	Setting up training programs and awareness-raising programs to ensure the best possible use of the system and to promote the adoption of the best savoir-faire	Has your establishment agreed to devote a financial and/or human effort in the evolution of the IS?
		Establishing a cell of experts in the technical, medical, organizational and economic fields to oversee the installation and operation of the IS	Does your IS have good flexibility of implementation within your structure?
A9	Adapting a technology to the knowledge and savoir-faire of the healthcare professional	Establishing training/action groups (initial/continuous), classes, workshops and practice groups dedicated to the proper use of the IS	Have you received requests for training from your staff to better grasp and understand the tool?
		Putting in place reactive mechanisms of collective learning about errors and management of the risk of errors linked to the IS	Within your structure, have you noticed mistakes in the way your staff use the IS?
A10	Establishing a management/piloting policy concerning the use of medical information	Drawing up an informational guideline to the IS, based on the existing document	Has your organization undertaken the writing of guidelines for the use of the IS?
		Establishing a working methodology accompanied by an advisor and effective management for the people involved	When your IS was installed, was there a real policy of monitoring the change in order to adapt your establishment to the new modes of information management?
NM1	Obeying the legislative regulation of medical data	Integrating homogeneous technological solutions with references respecting all regulations in force (DICOM, HL7, etc.)	Does your IS obey all the regulations in force (DICOM and HL7) regarding medical data?
		Creating an IS that is flexible, adaptable and evolves over time	Does your IS have the ability to evolve on the basis of the adjustments imposed by the legislation in force?
NM2	Respecting the rules concerning storage, hosting and distribution established by the CNIL (France’s National Commission on ICT and Freedom) or similar authorities	Applying the rules on storage and hosting established by the CNIL	Does your IS obey the rules concerning storage and hosting as enacted by the CNIL?
		Applying the rules on the dissemination of medical information established by the CNIL	Does your IS obey the rules concerning the distribution of medical information as enacted by the CNIL?
NM3	Maximizing the use of medical information: ethical quality of medical decision	Convincing the relevant authorities (heads of department, hospital practitioners) of the usefulness of the IS in order to achieve a dynamic	Does your IS contribute to the advancement of organizational efficiency in the use of the medical information?
		Setting up patronage and oversight systems in relation to the use of the IS	Have you adapted the organization of your structure to improve the use of the medical information?
NM4	Developing an organization oriented toward collective performance	Establishing a supervisory board for the IS	In your view, does your IS support the strategic objectives defined in the overall ambition of your structure?
		Installing the IS at the heart of the space making up the departments involved in the particular branch of healthcare in question	Has your IS contributed to the development of actions involving all of the staff at your structure?
NM5	Minimizing or eliminating harm done to patients because of incorrect information	Using reliable knowledge (professional rules, computational algorithms) drawn from the organization’s own knowledge base or any of a large number of other known databases	Have you been the subject of a lawsuit brought by a healthcare user because of erroneous medical information given to him or her?
		Putting supervision and monitoring tools in place	Has your IS helped you to avoid or reduce harm done to your patients because of improper distribution of the medical information?
NM6	Ensuring that the resources used do not exceed what is necessary to achieve the desired objectives	Using planning techniques (Pert, Gantt, Precedence Diagram Method, MPM, etc.)	In your view, are the resources used appropriate for the desired objectives for your IS?
		Carrying out a retrospective study regarding the evolution of the resources put in place in relation to the objectives initially envisaged	Have you carried out a retrospective study regarding the evolution of the resources mobilized in relation to the objectives initially envisaged?
NM7	Reducing unnecessary or misjudged risks	Identifying and ranking all the issues and risks associated with the IS	Does your establishment have an analysis of the issues and ranked risks for the IS?
		Setting up an oversight committee for the IS	Has your establishment developed a policy of prevention and precaution regarding to the possible consequences of the operation of your IS?
NM8	Ensuring the reliability of the medical data collection and its permanence	Having internal resource people present to regularly monitor the IS	Does your IS have a system to check the quality of the stored medical data?
		Having a backup system and a continuity plan for the IS	Does your IS have a maintenance system that keeps it operational 24/7?
NM9	Ensuring the technical relevance and human appropriateness of the IS	Performing an analysis by establishing links between the relevant facts and the ethical frameworks linked to the IS and oriented toward the patient	Are the main objectives of your IS primarily oriented toward the patient’s interest?
		Mirroring the architecture of the IS with the organization of the healthcare put in place	Is the computer system consistent in its construction and technical assembly?
NM10	Making the whole collective responsible for the conduct of the healthcare user	Making patients aware of their responsibility and their role in the healthcare system	Do you believe that your IS gives the healthcare user more responsibility toward the collective?
		Having the patient take part in the medical decision-making process by way of better access and explanation of the information provided by the IS	In your view, is one of the aims of your IS to increase the patients’ own responsibility by offering them greater independence in the making of the medical decision?

4.5.1.1. Strategic dashboard (visualization)

The strategic dashboard (visualization) enables us to obtain a precise idea of the situation in time and space of the IS’ ethical performance. It comprises:

• – 4 ethical dimensions corresponding to the 4 ethical principles: beneficence, autonomy, non-malfeasance and fairness;
• – 40 ethical process indicators, represented by the 40 ethical justifications.

4.5.1.1.1. Representation

• – For an ethical principle:

Table 4.5. Representation of the strategic dashboard – visualization. For a color version of the table, see www.iste.co.uk/beranger/ethics.com

4.5.1.1.2. Operation

The tables are reviewed every month or every trimester²¹. If the observation and the tendency are coded “orange” or “red” for a given indicator, then we need to fill in the integral “tactical” dashboard governing intervention for that indicator.

NB: Green = score of 3/3; orange = score 2/3; red = score 1/3 or 0/3

4.5.1.1.3. Explanations of color coding

The criteria are characterized by four indissociable elements for general visualization of the ethical situation of the IS:

• – The observation: indicates the current measured value of the indicator in relation to the set objective.

Color coding – Green: The set objectives have been achieved.

The situation is consistent with the prediction and expectations.

Orange:	The objectives have only partly been achieved.
	The difficulties have been identified and are in the
	process of being resolved.
	The situation needs to be discussed at a meeting.
Red:	The objectives have not been achieved.
	The negative points need to be dealt with at a
	meeting.

• – The tendency: shows the indicator’s short- and medium-term evolution. Color coding – Green: The predictable evolution is favorable/satisfactory.

Orange:	The predictable evolution is uncertain.
	The difficulties need to be projected.
	This needs to be discussed at a meeting.
Red:	The predictable evolution is unfavorable.
	The indicator’s measured value is seriously lowered.
	This needs to be dealt with at a meeting.

• – The comment: it takes the form of a written evaluation. It analyzes the seriousness/urgency (or lack thereof) of the actions taken and/or to be taken to achieve the objectives.

Color coding – Red:	When the observation is “orange” or “red”?
	When the tendency is “orange” or “red”?

This needs to be dealt with at a meeting.

It is interesting to construct a graphic representation such as a radar plot or a spider web graph of this dashboard.

4.5.1.2. Tactical dashboard (intervention)

The “tactical” dashboard (intervention) enables us to establish a plan of action based on piloting indicators of the real-world environmental parameters (REPs) in order to put strategies in place that are specific to the shortfalling sector. It comprises:

• – 2 ethical “piloting” indicators, associated with 1 ethical “process” indicator;
• – 80 ethical “piloting” indicators, representing 80 actions from our recommendations.

4.5.1.2.1. Representation

• – For an ethical “process” indicator:

Table 4.6. Representation of the “tactical” dashboard – intervention. For a color version of the table, see www.iste.co.uk/beranger/ethics.com

4.5.1.2.2. Operation

We create as many “tactical” dashboards as there are ethical “process” indicators with an alarm signal (“orange” or “red”) for the observation and tendency. These dashboards are reviewed monthly.

The ethical piloting indicators are strategic indicators that can be used to monitor the proper implementation of the strategy.

NB: Green = score of 3/3; orange = score 2/3; red = score 1/3 or 0/3

4.5.1.2.3. Explanations of color coding

Color coding – Green:	The strategy has been properly implemented.
Orange:	The strategy has not yet been totally implemented.
Red:	There are major problems with the implementation of the strategy.

4.5.1.3. “Operational” dashboard (control)

The “operational” dashboard (control) enables us to monitor the proper implementation and the impact of these various strategies for daily life at the hospital. The aim is to send back information to the Directorate General so that they can follow the evolution of the situation and make the right decisions. It comprises:

• – as many ethical “reporting” indicators as there are ethical “piloting” indicators;
• – 80 ethical “reporting” indicators representing the result of checks representative of the strategy;
• – indicators that are necessary to visualize the impact of the strategy and the evolution of the IS after the implementation of the REP strategies.

Note that if the 40 process indicators have an “orange” or “red” signal, then we would have 40 “tactical” dashboards and 40 “operational” dashboards associated therewith.

4.5.1.3.1. Representation

• – For an ethical process indicator:

Table 4.7. Representation of operational dashboard – control. For a color version of the table, see www.iste.co.uk/beranger/ethics.com

4.5.1.3.2. Operation

We construct as many “operational” dashboards as there are “tactical” dashboards per ethical “process” indicator with an alert signal in the observation and tendency categories: “orange” or “red”. These dashboards are read monthly.

NB: Green = score of 3/3; orange = score 2/3; red = score 1/3 or 0/3

4.5.1.3.3. Explanations of color coding

Color coding – Green:	The target has been fully achieved.
Orange:	The target has not yet been totally achieved.
Red:	The target has not been achieved.
	The strategy does not produce the predicted effect.
	Reflect on how the strategy in question should be modified.
	This must be dealt with at a meeting.
White:	The data for these indicators have not yet been linked and transmitted.
Boxed:	Strategically criticable

4.5.2. Methodology of implementation and use

The method of implementation and use is divided into four successive steps, spread out over the course of a year (see Table 4.8).

This iterative approach means we can ensure that the dashboards are consistent with the strategic objectives and the evolutions for the IS within the hospital.

Table 4.8. Intrahospital coordination and strategic planning

4.5.2.1. Step 1: Implementation of the project “Hospital Dashboard”

Implementation consists of identifying and mobilizing the actors to make up working groups:

• – a “usage” group, defining the need for dashboards on the basis of the functional needs identified;
• – a “technical” group, validating the feasibility of the dashboards and their relevance in relation to the technical realities of the IS;
• – a “piloting” group, handling the costs and recurrent expenses associated with the dashboards in the production phase;
• – an “operating” group, ensuring that the dashboards and procedures can be operated easily both in terms of their constitution and of their use.

It is crucial to analyze and describe the cycles or phases of prediction and planning, if they are present, because this sets the pace for the unit’s activity, within the organization. This analysis is important because, in part, it conditions the design of the dashboards from the following three angles:

• – Anticipation: The dashboards may contain information and indicators that, when the time comes, can illuminate the choices, orientations and compromises, which are necessarily involved in all processes of prediction and planning of the IS.
• – Schedule: The prediction and planning procedures are a succession of steps, after each of which, specific tasks need to be performed or specific documents need to be drawn up. The procedures can be assimilated to projects and can be managed as such.
• – Monitoring and control: The function of prediction and planning leads us to specify objectives over time and allocate the available resources. By analyzing these cycles of prediction and planning, we shall be able to more precisely what needs to be monitored and when it is best to perform these checks on the IS.

4.5.2.1.1. Recommendations

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• – Bring together all the actors in the healthcare establishments around the same program.
• – Make all the hospital actors share a vision of the strategic objectives of management.
• – Establish a connection between the strategy and the piloting system, with strategic alignment of the indicators, and adaptation to the new orientations or new projects.
• – Assign responsibilities to everyone – in other words, determine who is to review the data and who is to take action.
• – Involve the executives, managers and medical staff more directly in the quality management and in the program, bringing them in for the data collection process and the use of the dashboard.
• – Use the most appropriate means of communication and awareness-raising.
• – Provide training to the hospital staff regarding the collection, analysis and usage of the data used in the dashboard.
• – Demonstrate the performance of the dashboard and share it at all levels of the organization: information dissemination.

The learning of the performance is “collective” and takes place over an extended period of time.

For these two reasons, the “socio-organizational” piloting practices play an essential role in the effectiveness of the system.

• – The organizational development is more useful in “educational” arrangements to facilitate practices when the functioning of a team is more important than ever.
• – The piloting system must be carefully linked with human resource management – in particular, with the evaluation of individual performances and the organization’s incentive system (remunerations, career management, recognition of merits with a financial bonus).
• – On average, this stage typically lasts approximately 2 months.

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4.5.2.2. Step 2: Usage of the hospital dashboards

This step consists of publishing and exploiting the dashboards in accordance with the projected review periods. Thus, it entails:

• – gathering the constitutive data:
  • - collation,
  • - processing,
  • - calculation of the indicators;
• – using the dashboards in the decision-making process.

4.5.2.2.1. Recommendations

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• – Maintain a constant view and monitor the evolution of the indicators.
• – Provide raw data (unadjusted) so that clinicians and managers can conduct an analysis for their own ends.
• – Be sure of the integrity of the data, and therefore, be extremely rigorous regarding the quality of the data used.
• – Use familiar mechanisms for the display of terminology and data.
• – Respect the periodicity of reading of each dashboard.
• – Provide a report card for the organization each month.
• – On average, this stage typically lasts approximately 6 months.

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4.5.2.3. Step 3: Modes of coordination and working in concert

The life of the unit is punctuated by a certain number of meetings where points are raised, and we examine the problems that have arisen, the advancement of the projects, any new facts, etc. Usually, these meetings are teamwork sessions at which the situations are discussed and evaluated, and in general, decisions tend to be made. In order to be effective, these meetings require preparation. There again, the piloting system and the dashboards are appropriate instruments. The production of the dashboards can be finalized on the meeting schedules. Thus, it is essential to take stock and to analyze the scheduled meetings in which the actors participate. This reflection highlights two aspects:

• – the information and key data necessary for each type of team meeting and coordination meeting (content of dashboards);
• – the frequency and schedule for construction of the dashboards.

4.5.2.3.1. Recommendations

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• – Establish management of the study before, during and after the execution.
• – Consider having the head of each dashboard clearly date and sign the document when it has been read, so as to preserve the traceability of the viewing by level.
• – Do not include, on a weekly dashboard, any indicators or information pertaining to objectives or functions that are only checked and monitored on a monthly basis.
• – Publish the dashboards in the departments concerned.
• – Communicate them to the units or collaborators of level L-1.
• – Collect the dashboards from the collaborators.
• – Discuss the impact of that tool on daily life at the hospital.
• – Information is political: the hospitals must also carefully consider the potential consequences of disseminating the information and be prepared to react in case of inappropriate use.
• – First allow the healthcare establishment and its staff to familiarize themselves with the dashboard before publishing their data.
• – On average, this stage typically lasts approximately 2 months.

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4.5.2.4. Step 4: Evolution of hospital dashboards

By monitoring the dashboards, we are able to see whether they need to be altered, on the basis of the following situations:

• – poor quality of the indicators (ergonomics, consistency, relevance, etc.);
• – evolution of the hospital context for the IS;
• – evolution of the objectives of the hospital ethical performance for the IS;
• – inappropriacy of the indicators in relation to the strategic objectives;
• – change of the addressees depending on the hospital department in question.

4.5.2.4.1. Recommendations

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• – The visual representation of the indicators needs to be simple and communicative.
• For that information to be truly meaningful, it is desirable to simultaneously present:
  • - the initial value of the objective,
  • - the result attained and the gap between that result and the objective,
  • - the evolution of the results over time.
• – Check that the parameters both internal and external to the hospital have not changed since the dashboard was set up.
• – Develop reflection and self-evaluation regarding the process put in place.
• – On average, this stage typically lasts approximately 2 months.

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4.5.2.5. Reflection of the hospital organogram

The hospital’s policy is handed down from the top to the bottom. Meanwhile, the indicators are communicated from the bottom upward. In these conditions, the medical information about the ethics of the IS represented by the dashboards (DBs) must be transmitted in such a way as to fully respect the hierarchy within the hospital. Thus, we see that DBs 1 and 2 are filled in by the doctors, nurses and secretaries in each department. They send back the information to the head of each medical department, who sends the summary of the results of DBs 1 and 2, using the “reporting” DB 3, to the doctor from the medical information department (MID) (see Figure 4.5).

The path of events is as follows:

• – When the ethical process indicator (DB1) is orange or red, the person in charge of picking up the alert signals must mention that indicator in a meeting with the managing decision-making team so that they can make the appropriate decisions to remedy the situation by establishing a piloting plan of action.
• – When the ethical piloting indicator (DB2) for a particular sector is orange or red, the head of department must conduct a meeting with the staff in that department to reflect together on the implementation and resolving of that deficient strategy.

Figure 4.5. Use of dashboards in the hospital organogram

• – When the ethical reporting indicator (DB3) for such a strategy is red (i.e., when the target is less than 95% of the way to being achieved), the staff in that department must mention that indicator in a meeting with the head of the department and the doctor from the MID, who will feed back the information to the managing decision-making team, so that they can decide on a change of strategy.
• – After compilation of all the reports of DB3, the quality directorate will feed back the information to the administrative board or directly to the head of the hospital.

4.5.2.5.1. Recommendations

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• – The plan of action and the ethical objectives for the IS obey a top–down vertical movement in terms of the hierarchy.
• – The implementation of the indicators in a hospital department first requires a decision from the head of department, followed by an action of awareness-raising and training of the hospital team.
• – The indicators must allow for information widely distributed to those people whom it affects. It must be communicated to those people in an accessible form.
• – A diagnostic of the IS’ existing situation is necessary to establish the initial objectives.
• – The hospital’s internal communication must be based on a strong policy of displaying the ethical quality indicators devoted to the IS Therefore, those indicators must periodically be distributed using simple tools such as graphs, plots and tables, which are easily interpretable for any reader.
• – Learning must be oriented toward action and collective performance.
• – The socio-organizational piloting practices play an essential role in the effectiveness of the internal management of such a program.
• – The process must function in such a way that individual learning comes together and coagulates into collective learning – organizational learning, so to speak.
• – This feeding back of information from the dashboards to the board of directors rises through the ranks of the hierarchy from the bottom up.
• – The management receives concise and precise reports on the ethics of the IS.

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1 Hence, ethics is eternally bound “to remain vigilant in its quest for legitimization, and led to mobilize its reflexive capacity in reference to values” [HÖF 91].

2 Science of self-regulating systems, where the focus is not so much on the components themselves as on the ways in which they interact, and above all, their overall behavior is considered. It is a model of the relationship between the elements of a system, by studying information and the principles of interaction.

3 A set of digitized data constituting an information universe and a communication medium, pertaining to the interconnection of computers. It constitutes the support for the informational interconnection between machines.

4 “I, Robot” is a compilation of nine science-fiction short stories written by Isaac Asimov, first published by Gnome Press in 1950.

5 The course taken by oil tankers depends on the trend of the price of crude oil, which is, in part, determined by projections made by computer programs about the cost per barrel.

6 Here, we use the term “machine” in the broadest sense.

7 MDSSs are “computer applications whose purpose is to provide clinicians, at the appropriate place and time, with the information describing a patient’s clinical situation, as well as any knowledge appropriate to the situation, correctly filtered and presented, in order to improve the quality of care and patients’ health” [LOB 07].

8 In computer science and information theory, data compression, source coding or reduction of the bitrate is the process of encrypting the information using fewer bits than are used in the original representation. The design of data compression systems involves finding a balance between different factors, including the compression rate, the distortion caused (if we are dealing with a lossy compression system), and the computational resources needed to compress and decompress the data. We use the term “lossless” to speak of compression algorithms that use statistical redundancy to represent the sender’s data more concisely, without any errors.

9 The theoretical context of lossy compression is given by the bitrate-distortion theory. These fields of study were essentially founded by Claude Shannon. The theory of encryption is also linked. The idea of data compression is very strongly linked to statistical inference.

10 The algorithm triggers a counting system (counting of cells, symptoms of a disease, etc.) in a digital environment that is not really there.

11 The algorithm is unable to identify a structure in the image that actually exists.

12 The algorithm designer has to deal with a decision-making process that, in many respects, is similar to that encountered by people who design other technological artifacts. This implies that the value judgments built into an algorithm are similar to those involved in the design processes.

13 Entered by the user, or harvesting of information from a patient file or another application, or information provided directly by the external application invoking the IS.

14 Ideally, the user needs to be able to go on to use the output to advise on a suitable course of action or enter the required data without having to change the working environment.

15 We see a trio with the IS designer when adjustments and evolutions need to be applied to the computer device.

16 Sector head at the Direction Informatique et Réseau (Computer and Networking Directorate) – AP-HM (Public Hospital Service in Marseilles, France).

17 Data conservation, hosting, authentication, identification, etc.

18 Cohesion of the order of data entry with the carrying out of medical examination: the writing of initial specifications for the application proves to be a necessary and helpful exercise.

19 The “right to be wrong”, depending on his or her skills and abilities.

20 Avis 91 of the Conseil Consultatif National d’Ethique (CCNE – National Ethical Consultation Council): note on the ethical problems posed by the computerization of hospital prescriptions and patient files.

21 Depending on the total duration of the strategic process, the nature of the indicator, the need for reactivity, feasibility and the internal organization of the plan of action.