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La valutazione etica delle terapie digitali nei processi di Health Technology Assessment (HTA)

The AI-MIND EU funded project aims to develop an artificial intelligence (AI)-based digital tool, which will allow to estimate the risk of people with mild cognitive impairment to develop dementia. To facilitate its implementation in clinical practice, in the project attention is paid to the Health Technology Assessment (HTA) principles, criteria and model. HTA requires to assess clinical, safety, economical, organizational, ethical and legal implications of a given health technology (HT). In the AI-MIND project, first, a group explored the potential impact of the use of an AI on the doctor-patient relationship, then HTA experts identified potentially relevant issues for AI, and finally bioethical experts, trained in HTA, conducted an analysis on the role of explainability, a new ethical issue to take into consideration in an HTA process regarding AI-based HT. A Delphy panel conducted ended in April 2023 allowed to identify HTA issues potentially relevant for AI. 46 qualified experts from mainly provided their feedbacks. The highest level of consensus was reached on the importance of ethical issues, explainability included. Bioethical experts conducted an analysis on the role of explainability for AI-based digital tools for the risk assessment to develop dementia. Both global (information on the model as a whole) and local explainability (information on a specific prediction) were investigated and applied to the specific use case. Attention was dedicated to the designated role in the decision-making process (algorithm-based, -driven, or –determined) of the AI-MIND predicting tool. From the HTA perspective, explainability is increasingly considered crucial for ethical analysis and should be assessed in relation to other aspects such as the design of the technologies, the population target, or the market access. It should be one of the topic to address for building and implementing ethical AI-solutions for early diagnosis of dementia.

Intelligenza artificiale ed HTA: aspetti etici

Health technology assessment (HTA) is multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to implement an informed decision-making process in order to promote an equitable, efficient, and high-quality health system. Ethics has been identified as a key element in HTA because health care is a moral endeavour and potential technology presents complex moral dilemmas, especially with the rise of novel technologies. In evaluating health technologies, ethical aspects must be taken into account such as patients’ privacy and informed consent in terms of (re-)use of their personal sensitive data, alongside with the possibility of unintended consequences (e.g., doing more harm than good: Thalidomide case) and the effects on society in terms of justice and equity, with implications for financial sustainability. Without taking account of the ethical dimension in the process, choices may be made without considering the overall context of implementation, thus, compromising the relevance of decisions and policies, with potentially unintended consequences and/or harmful effects to the health and wellbeing of individuals/patients, to public health, to the environment, and to the society at large. Decision-makers should guarantee that adopted health technologies are meaningful and relevant for the society, with due consideration to their development too, to the extent possible, by also taking ethical aspects into consideration when evaluating health technology. Despite many years of recognising ethics as a foundational part of HTA, studies have shown that the ethical dimension is still not systematically and sufficiently addressed by means of ethical analysis. Furthermore, novel technologies, new types of data, and a paradigm shift in terms of how we generate and synthesize evidence, whilst providing us with unique opportunities in terms of HTA, pose concrete challenges and new (and rev

"Evidence" is a key term in medicine and health services research, including Health Technology Assessment (HTA). Randomized clinical trials (RCTs) have undoubtedly dominated the scene of generating evidence for a long period of time, becoming the hallmark of evidence-based medicine (EBM). However, due to a number of misunderstandings, the lay audience and some researchers have sometimes placed too much trust in RCTs compared to other methods of investigation. One of the principal misunderstandings is to consider RCTs findings as isolated and self-apparent pieces of information. In other words, what has been essentially lacking was the awareness of the value-context of the evidence and, in particular, the value- and theory-ladenness (normativity) of scientific knowledge. This paper aims to emphasize the normativity that exists in the production of scientific knowledge, and in particular in the conduct of RCTs as well as in the performance of HTA. The work is based on some lessons learned from Philosophy of Science and the European project "VALIDATE" (VALues In Doing Assessments of healthcare TEchnologies"). VALIDATE was a three-year EU Erasmus+ strategic partnerships project (2018-2021), in which training in the field of HTA was further optimized by using insights from political science and ethics (in accordance with the recent definition of HTA). Our analysis may reveal useful insights for addressing some challenges that HTA is going to face in the future.

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In line with how ethics has developed for the last three centuries, public health ethics has been widely dominated by a deontological as well as a utilitarian approach. The latter is a version of consequentialism, which states that maximizing utility is the primary goal of the majority of individuals or group action, while, on the other hand, virtue ethics, or at least the appeal to virtues, has been largely marginalized. The aim of this article is twofold. Firstly, we aim to highlight the political and ethical nature of public health interventions, often interpreted and presented as mere scientific enterprises. Secondly, we try to highlight the need to integrate or at least recognize the value of appeal to virtues in public health measures. The analysis will reference the Italian COVID-19 vaccination program as a case study. Initially, we will explore the political and ethical nature of any public health measure, using the implementation of the COVID-19 vaccination program in Italy as an example. Subsequently, we will illustrate the deontological approach to ethics, the utilitarian one, and the virtues one, focusing on the dynamic of the agent’s perspective. Lastly, we will briefly analyze both the Italian COVID-19 vaccination program and the communication campaign that promoted it.

The phenomenon of public opinion is one of the fundamental figures in today’s democratic processes, especially within the context of the increasingly desired deliberative perspective. Even in reference to bioethical issues, parliaments have often to legislate under the pressure of public opinion. Who or what is more precisely “public opinion”? The first aim of this article is cognitive: through a brief historical reconstruction of the concept of “public opinion”, its typification, and an explication of the main theories of its formation, we will try to capture complexity and ambiguity of this concept. Second, we will extrapolate the main features of the modern concept of deliberative democracy. Third, we will briefly analyze the characteristics of information in bioethics. The final aim of the article is to try to draw practical indications for public opinion formation on bioethical issues in the context of journalistic communication, having the deliberative model of democracy as a background.

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Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (ORourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187-90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technologys value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Unions program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the projects website www.validatehta.eu., Funding Agencies|Erasmusthorn Program of the European Union [2018-1-NL01-KA203-038960]

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Objectives To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE. Methods Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results. Results All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines. Conclusions Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as "given"; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging., Funding Agencies|Erasmus+ Programme of the European Union [2018-1-NL01-KA203-038960]

Precariousness of any kind of knowledge and ineradicability of the subject from the scientific speech are two fundamental and - one could say - unquestionable results of the contemporary way of conceiving science. Medicine has struggled a lot to metabolize these steps. With respect to the second aspect, tangible attempts in order to overcome epistemic discrimination of patients are nowadays recognizable; with respect to the first aspect, the nonchalant use of word "evidence", as well as an inaccurate interpretation of the results that the so-called "Evidence-based medicine" (EBM) is able to guarantee, risk to resurrect "myths" of both verificationism and objectivism in science. The pressure which is determined by empowering and disempowering the patient's perspective is arising some issues. The latter are at the basis of some lacerations of our society, such as those that pertain to the restriction of individual freedoms, the green pass obligation, the vaccine obligation, and so on. The aim of the article is to briefly analyze the role of evidence and patient's perspective in medical epistemology. The final aim is to offer some suggestions in order to overcome some of the above issues.

Objectives: To conduct a formative evaluation of applying the VALIDATE approach in practice by 1) assessing how students appreciated the e-learning course, 2) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and 3) what this shows on real-world use of VALIDATE. Methods: Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in HTA practice, followed by semi-structured interviews with interns and supervisors to complement and interpret results. Results: All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively re-defined the HTA problem, based on appreciation of different stakeholders definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines. Conclusions: Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as given ; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O'Rourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187-90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology's value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union's program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project's website www.validatehta.eu.

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