Digital therapeutics (DTx) are a subset of digital health which are often coupled with artificial... more Digital therapeutics (DTx) are a subset of digital health which are often coupled with artificial intelligence (A.I.) techniques and machine learning systems. DTx differ from common wellness apps or medication reminder tools in that they require "rigorous" clinical evidence. They are emerging as a new treatment option and are being applied in a variety of areas, including type II diabetes, hypertension, chronic respiratory problems, obesity, insomnia, Alzheimer's disease, various types of dementia or addiction (smoking, alcohol, drugs), anxiety, depression, autism, learning disabilities, and attention deficits. Today, there are roughly 35 to 40 products on the market, 8 of which approved by regulatory agencies. The value of the global DTx market was estimated at USD 1.8 billion in 2018, and it is expected to reach USD 8.9 billion by 2027. Implementing DTx across healthcare systems raises a number of ethical concerns. The present article aims to provide an overview of the main ethical issues pertaining the assessment, implementation, and use of this emerging technology. The final purpose is to support and facilitate an open and transparent deliberation with regard to DTx.
espanolLa contribucion recorre el debate sobre el tema de la etica y la colocacion de los recurso... more espanolLa contribucion recorre el debate sobre el tema de la etica y la colocacion de los recursos en ambito sanitario en los ultimos sesenta anos de publicaciones de la Revista Medicina e Morale. Apelando a algunas fuentes documentales que certifican la insercion de esta tematica entre los objetos de indagacion de la disciplina bioetica, sigue una breve resena de los contenidos de todos los escritos de la Revista en la materia, una discusion de los elementos que la contra distinguen y la indicacion de las perspectivas de publicacion deseables. EnglishThe article deals with the debate on ethics and resource allocation in health care over the past sixty years of the Journal Medicina e Morale publications. The reference to some documental sources certifying the inclusion of this issue among the objects of investigation of bioethics discipline is followed by a brief overview of the contents of all text of the Journal on the subject, a discussion of the elements that mark them and the i...
Objectives: Health Technology Assessment (HTA) is a multidisciplinary process that collect inform... more Objectives: Health Technology Assessment (HTA) is a multidisciplinary process that collect information about medical/economic/organizational/ethical/legal/social issues related to the use of an health technology (HT) in a systematic/transparent/unbiased manner. Its purpose is to support health care decision-makers. From the conception of HTA in the 1970s, it has been argued that the ethical (ETH) domain is a constitutive part of HTA and that value judgments are inherent in the whole HTA process. This contribution is aimed at discussing methodologies, issues and experiences in HTA-ETH domain. Methods: Research query on Pubmed and manual web retrieval on international/national HTA bodies was carried out. Results: HTA-ETH domain aims at analyzing both the ethical questions that a given technology raises when it is put into use/disinvestment as well as ethical issues that the HTA process itself raises. Even though ETH domain is a constitutive part of HTA, ethics has not so frequently been part of HTA reports. Reasons for that are analyzed. Available HTA ethical analyses are worded as an assessment, a list of ethical issues, and/or an appraisal, a moral judgement regarding an HT. A wide range of (up to 43) approaches have been suggested to address HTA-ETH domain. Two further questions are open: standard operative procedures for HTA-ETH domain quality check and the definition of specific core competencies for experts involved. Finally, the experience in HTA-ETH domain of Institute of Bioethics & Medical Humanities (IBioMedH) of Universit\ue0 Cattolica del Sacro Cuore (UCSC), Fondazione Policlinico Universitario \u201cAgostino Gemelli\u201d (FPG), Rome (Italy), from 2005 up to now is showed. Conclusion: HTA-ETH domain is a further expanding field for carrying out healthcare ethical expertise/consultation
Background: From the conception of HTA in the 1970s, it has been argued that ethics is a constitu... more Background: From the conception of HTA in the 1970s, it has been argued that ethics is a constitutive part of HTA. However, integration of ethics (ETH) domain into HTA processes remains challenging for HTA practitioners. The Institute of Bioethics and Medical Humanities (IBioMedH) of the Universit\ue0 Cattolica del Sacro Cuore of Rome has gained 11 years of experience (2008-18) on ETH analyses within HTA processes. Aim of the contribution is: To categorize this experience according to technology, evaluation, and method type, as well as to identify potential issues related to this activity
This workshop will deepen understanding the role of Hospital Based HTA on the decision making; pa... more This workshop will deepen understanding the role of Hospital Based HTA on the decision making; participants will learn the steps for developing an assessment in hospital-based context and tools to perform a rapid assessment; it will be presented the implementation process of its recommendations. For each section there is an analysis of the impact of the pandemic. The coronavirus pandemic has changed the global scenario regarding healthcare and the use of tools such as HB-HTA. Operational processes have become much faster and there has been a greater need for information on technologies for diagnosing and treating COVID. Which of these had a rationale, some potential evidence, which impact on the organization and which costs. All questions to which the Hospital Based HTA was asked to give answers that required its reorganization both of a methodological and operational type. The workshop aims to illustrate these changes resulting from real experiences lived in different parts of the globe. 1. Main role of HB-HTA \u2013 functions 2. Has HB-HTA role changed as a consequence of the pandemic? 3. Steps for a HB-HTA, relying on AdHopHtA 4. Rapid Assessment? Criteria 4.a. Assessment of clinical outcomes, evidence level and safety 4.b. Assessment with real world HTA 4.c. Assessment of patient perception 4.d. Assessment of economic consequences 4.e. Assessment of organizational consequences 4.f. Assessment of other potential aspects: Strategical, legal, ethical etc. 4.g. How to ensure the quality of HB HTA? 5. Implementation process of the HB-HTA recommendations into the hospital decision making. Impact of pandemic 6. Discussion and closing \u2022 To give the participants: - an understanding of how HB HTA can be organized, produced and implemented at hospitals as the basis for decisions on investment in new health technologies - skills to produce high quality HB HTAs on their hospitals on the basis of the evidence from the AdHopHTA project. \u2022 To show potentials of HB-HTA to push for value-based innovations in hospitals \u2022 To discuss examples of HB HTAs including assessments of innovative, digital health technologies produced within hospitals. \u2022 To share the challenges and strategies to implement and carry out HB-HTA in the pandemic contex
Tra gli strumenti che si sono maggiormente diffusi, negli ultimi anni, nel contesto del governo d... more Tra gli strumenti che si sono maggiormente diffusi, negli ultimi anni, nel contesto del governo dell\u2019innovazione tecnologica, vi \ue8 senza dubbio l\u2019Health Technology Assessment (HTA). Si tratta di una particolare attivit\ue0 di ricerca di sistematica valutazione multidisciplinare delle conseguenze assistenziali (cliniche e organizzative), economiche, giuridiche, sociali ed etiche provocate in modo diretto e indiretto, nel breve e nel lungo periodo, dalle tecnologie sanitarie esistenti e da quelle di nuova introduzione. In particolare, il domain etico nell\u2019HTA ha come obiettivo fondamentale quello di analizzare le questioni etiche sollevate dal potenziale impiego o non impiego di una determinata tecnologia sanitaria, come pure dal processo stesso di HTA. Obiettivo del contributo \ue8 quello di presentare le caratteristiche fondamentali di questa che pu\uf2 essere considerata come una diversa forma di consulenza etica in ambito sanitario, con una breve ricostruzione di alcune questioni presenti nel dibattito a esse connesso, e con l\u2019esplicitazione di alcune notazioni su somiglianze e differenze tra le due attivit\ue0
Il chiarimento del rapporto tra economia ed etica svolto lungo un asse cronologico suggerisce com... more Il chiarimento del rapporto tra economia ed etica svolto lungo un asse cronologico suggerisce come le idee, risalenti alla cultura positivista e neo economica volta al recupero della sola efficienza e intesa come “avalutativa”, rappresentino un modo obsoleto di concepirla e siano a oggi tendenzialmente superate. Il contributo mostra, in particolare, come a partire dagli anni ’60 del XX secolo inizi a farsi strada anche in economia (in corrispondenza di un ridimensionamento della “legge di Hume” in ambito filosofico e della conseguente apertura delle scienze sociali all’etica) l’idea della necessità di una sua apertura all’etica e di una maggiore considerazione delle istanze relative all’equità. Da qui l’auspicio, che l’articolo esprime, di una maggiore apertura dell’economia sanitaria ai discorsi etici e l’invito a una sua più stretta collaborazione con la bioetica. Una maggiore considerazione da parte dell’economia sanitaria dei consistenti contributi che, fin dal suo momento costitutivo, la bioetica ha prodotto sul tema dell’”etica dell’allocazione delle risorse scarse in sanità” faciliterebbe, infatti, l’individuazione in materia distributiva di un punto di convergenza (un trade-off) tra le istanze economiche e quelle etiche, rappresentato dal valore-persona. ---------- The explanation of the relationship between economics and ethics developed along a chronological axle suggests that, going back to positivistic and neo-positivistic culture, the ideas both of a separation between the two disciplines and of an economic science - only directed to the recovery of the efficiency and intended as avaluational matter - represents an obsolete way to conceive it and today this position is basically outdated. Particularly, the paper shows, as beginning from the ‘60s of the XX century, the ideas of the necessity of an opening of economics towards ethics and of a greater consideration of the appeals to equity begins to clear a way also through economics (in correspondence of a re-evaluation of the “Hume’s law” in philosophical area and of the consequent opening of the social sciences to the ethics). From here, the article expresses the auspice of a greater opening of the health economics to the ethical reflection and the invitation to a closer collaboration with the bioethics. A great consideration from health economics of the substantial contributions that - since the birth of bioethics - were produced on the theme of the ethics of the healthcare resources allocation would facilitate, in fact, the individualization in distributive matter of a point of convergence (trade-off) between the economical and ethical appeals on the value of the human person as a whole.
It is estimated that by 2025 more than 20% of Europeans will be 65 or over, with a particularly r... more It is estimated that by 2025 more than 20% of Europeans will be 65 or over, with a particularly rapid increase in the number of over 80s. Chronic diseases, malnutrition, weakened immune system and other health factors increase risk of foodborne illness and hazardous nutritional habits in elderly. Food safety and nutrition security are essential to promote active ageing. In order to evaluate elderly’s perceptions, practices and attitudes with respect …
Background: The relevance of incorporating ethical analysis into an HTA is increasingly acknowled... more Background: The relevance of incorporating ethical analysis into an HTA is increasingly acknowledged. Accordingly, there is a need for experts involved in HTA to learn and to apply methods that can be used to explore potential ethical implications of health care technologies. This half day introductory course in Ethics in HTA combines lectures, discussions and case study group work. The Faculty who are leading this course is a group of international experts who have contributed substantially over the last several years to methodological developments in this area. Requirements/Prerequisites: This course offers a lively introduction to the role of ethics for Health Technology Assessment (HTA) for those who are familiar with HTA, but who are not that familiar with ethics in HTA. Description/Objectives: The course has been specifically developed for international participants and is based on more recent international achievements in the field. It will emphasize adapting approaches in ethics for all types of health technologies and across international settings. Participants who attend this course will strengthen their understanding and facilitate their participation in ethical assessment in HTA, as well their ability to participate in broader discussions.Most importantly it provides a number of approaches for \u2018how to\u2019 incorporate ethics into an HTA. After the preconference workshop participants will be able to: \u2022 explain and acknowledge the role of ethical issues in HTA, \u2022 recognize potential ethical issues in HTA and formulate appropriate research questions, \u2022 know and use methodology for analyzing ethical issues, \u2022 know how to critically appraise primary research aimed at identifying ethical implications of health care technologies. \u2022 describe different ways of synthesizing and communicating the results of ethics analyses
Digital therapeutics (DTx) are a subset of digital health which are often coupled with artificial... more Digital therapeutics (DTx) are a subset of digital health which are often coupled with artificial intelligence (A.I.) techniques and machine learning systems. DTx differ from common wellness apps or medication reminder tools in that they require "rigorous" clinical evidence. They are emerging as a new treatment option and are being applied in a variety of areas, including type II diabetes, hypertension, chronic respiratory problems, obesity, insomnia, Alzheimer's disease, various types of dementia or addiction (smoking, alcohol, drugs), anxiety, depression, autism, learning disabilities, and attention deficits. Today, there are roughly 35 to 40 products on the market, 8 of which approved by regulatory agencies. The value of the global DTx market was estimated at USD 1.8 billion in 2018, and it is expected to reach USD 8.9 billion by 2027. Implementing DTx across healthcare systems raises a number of ethical concerns. The present article aims to provide an overview of the main ethical issues pertaining the assessment, implementation, and use of this emerging technology. The final purpose is to support and facilitate an open and transparent deliberation with regard to DTx.
espanolLa contribucion recorre el debate sobre el tema de la etica y la colocacion de los recurso... more espanolLa contribucion recorre el debate sobre el tema de la etica y la colocacion de los recursos en ambito sanitario en los ultimos sesenta anos de publicaciones de la Revista Medicina e Morale. Apelando a algunas fuentes documentales que certifican la insercion de esta tematica entre los objetos de indagacion de la disciplina bioetica, sigue una breve resena de los contenidos de todos los escritos de la Revista en la materia, una discusion de los elementos que la contra distinguen y la indicacion de las perspectivas de publicacion deseables. EnglishThe article deals with the debate on ethics and resource allocation in health care over the past sixty years of the Journal Medicina e Morale publications. The reference to some documental sources certifying the inclusion of this issue among the objects of investigation of bioethics discipline is followed by a brief overview of the contents of all text of the Journal on the subject, a discussion of the elements that mark them and the i...
Objectives: Health Technology Assessment (HTA) is a multidisciplinary process that collect inform... more Objectives: Health Technology Assessment (HTA) is a multidisciplinary process that collect information about medical/economic/organizational/ethical/legal/social issues related to the use of an health technology (HT) in a systematic/transparent/unbiased manner. Its purpose is to support health care decision-makers. From the conception of HTA in the 1970s, it has been argued that the ethical (ETH) domain is a constitutive part of HTA and that value judgments are inherent in the whole HTA process. This contribution is aimed at discussing methodologies, issues and experiences in HTA-ETH domain. Methods: Research query on Pubmed and manual web retrieval on international/national HTA bodies was carried out. Results: HTA-ETH domain aims at analyzing both the ethical questions that a given technology raises when it is put into use/disinvestment as well as ethical issues that the HTA process itself raises. Even though ETH domain is a constitutive part of HTA, ethics has not so frequently been part of HTA reports. Reasons for that are analyzed. Available HTA ethical analyses are worded as an assessment, a list of ethical issues, and/or an appraisal, a moral judgement regarding an HT. A wide range of (up to 43) approaches have been suggested to address HTA-ETH domain. Two further questions are open: standard operative procedures for HTA-ETH domain quality check and the definition of specific core competencies for experts involved. Finally, the experience in HTA-ETH domain of Institute of Bioethics & Medical Humanities (IBioMedH) of Universit\ue0 Cattolica del Sacro Cuore (UCSC), Fondazione Policlinico Universitario \u201cAgostino Gemelli\u201d (FPG), Rome (Italy), from 2005 up to now is showed. Conclusion: HTA-ETH domain is a further expanding field for carrying out healthcare ethical expertise/consultation
Background: From the conception of HTA in the 1970s, it has been argued that ethics is a constitu... more Background: From the conception of HTA in the 1970s, it has been argued that ethics is a constitutive part of HTA. However, integration of ethics (ETH) domain into HTA processes remains challenging for HTA practitioners. The Institute of Bioethics and Medical Humanities (IBioMedH) of the Universit\ue0 Cattolica del Sacro Cuore of Rome has gained 11 years of experience (2008-18) on ETH analyses within HTA processes. Aim of the contribution is: To categorize this experience according to technology, evaluation, and method type, as well as to identify potential issues related to this activity
This workshop will deepen understanding the role of Hospital Based HTA on the decision making; pa... more This workshop will deepen understanding the role of Hospital Based HTA on the decision making; participants will learn the steps for developing an assessment in hospital-based context and tools to perform a rapid assessment; it will be presented the implementation process of its recommendations. For each section there is an analysis of the impact of the pandemic. The coronavirus pandemic has changed the global scenario regarding healthcare and the use of tools such as HB-HTA. Operational processes have become much faster and there has been a greater need for information on technologies for diagnosing and treating COVID. Which of these had a rationale, some potential evidence, which impact on the organization and which costs. All questions to which the Hospital Based HTA was asked to give answers that required its reorganization both of a methodological and operational type. The workshop aims to illustrate these changes resulting from real experiences lived in different parts of the globe. 1. Main role of HB-HTA \u2013 functions 2. Has HB-HTA role changed as a consequence of the pandemic? 3. Steps for a HB-HTA, relying on AdHopHtA 4. Rapid Assessment? Criteria 4.a. Assessment of clinical outcomes, evidence level and safety 4.b. Assessment with real world HTA 4.c. Assessment of patient perception 4.d. Assessment of economic consequences 4.e. Assessment of organizational consequences 4.f. Assessment of other potential aspects: Strategical, legal, ethical etc. 4.g. How to ensure the quality of HB HTA? 5. Implementation process of the HB-HTA recommendations into the hospital decision making. Impact of pandemic 6. Discussion and closing \u2022 To give the participants: - an understanding of how HB HTA can be organized, produced and implemented at hospitals as the basis for decisions on investment in new health technologies - skills to produce high quality HB HTAs on their hospitals on the basis of the evidence from the AdHopHTA project. \u2022 To show potentials of HB-HTA to push for value-based innovations in hospitals \u2022 To discuss examples of HB HTAs including assessments of innovative, digital health technologies produced within hospitals. \u2022 To share the challenges and strategies to implement and carry out HB-HTA in the pandemic contex
Tra gli strumenti che si sono maggiormente diffusi, negli ultimi anni, nel contesto del governo d... more Tra gli strumenti che si sono maggiormente diffusi, negli ultimi anni, nel contesto del governo dell\u2019innovazione tecnologica, vi \ue8 senza dubbio l\u2019Health Technology Assessment (HTA). Si tratta di una particolare attivit\ue0 di ricerca di sistematica valutazione multidisciplinare delle conseguenze assistenziali (cliniche e organizzative), economiche, giuridiche, sociali ed etiche provocate in modo diretto e indiretto, nel breve e nel lungo periodo, dalle tecnologie sanitarie esistenti e da quelle di nuova introduzione. In particolare, il domain etico nell\u2019HTA ha come obiettivo fondamentale quello di analizzare le questioni etiche sollevate dal potenziale impiego o non impiego di una determinata tecnologia sanitaria, come pure dal processo stesso di HTA. Obiettivo del contributo \ue8 quello di presentare le caratteristiche fondamentali di questa che pu\uf2 essere considerata come una diversa forma di consulenza etica in ambito sanitario, con una breve ricostruzione di alcune questioni presenti nel dibattito a esse connesso, e con l\u2019esplicitazione di alcune notazioni su somiglianze e differenze tra le due attivit\ue0
Il chiarimento del rapporto tra economia ed etica svolto lungo un asse cronologico suggerisce com... more Il chiarimento del rapporto tra economia ed etica svolto lungo un asse cronologico suggerisce come le idee, risalenti alla cultura positivista e neo economica volta al recupero della sola efficienza e intesa come “avalutativa”, rappresentino un modo obsoleto di concepirla e siano a oggi tendenzialmente superate. Il contributo mostra, in particolare, come a partire dagli anni ’60 del XX secolo inizi a farsi strada anche in economia (in corrispondenza di un ridimensionamento della “legge di Hume” in ambito filosofico e della conseguente apertura delle scienze sociali all’etica) l’idea della necessità di una sua apertura all’etica e di una maggiore considerazione delle istanze relative all’equità. Da qui l’auspicio, che l’articolo esprime, di una maggiore apertura dell’economia sanitaria ai discorsi etici e l’invito a una sua più stretta collaborazione con la bioetica. Una maggiore considerazione da parte dell’economia sanitaria dei consistenti contributi che, fin dal suo momento costitutivo, la bioetica ha prodotto sul tema dell’”etica dell’allocazione delle risorse scarse in sanità” faciliterebbe, infatti, l’individuazione in materia distributiva di un punto di convergenza (un trade-off) tra le istanze economiche e quelle etiche, rappresentato dal valore-persona. ---------- The explanation of the relationship between economics and ethics developed along a chronological axle suggests that, going back to positivistic and neo-positivistic culture, the ideas both of a separation between the two disciplines and of an economic science - only directed to the recovery of the efficiency and intended as avaluational matter - represents an obsolete way to conceive it and today this position is basically outdated. Particularly, the paper shows, as beginning from the ‘60s of the XX century, the ideas of the necessity of an opening of economics towards ethics and of a greater consideration of the appeals to equity begins to clear a way also through economics (in correspondence of a re-evaluation of the “Hume’s law” in philosophical area and of the consequent opening of the social sciences to the ethics). From here, the article expresses the auspice of a greater opening of the health economics to the ethical reflection and the invitation to a closer collaboration with the bioethics. A great consideration from health economics of the substantial contributions that - since the birth of bioethics - were produced on the theme of the ethics of the healthcare resources allocation would facilitate, in fact, the individualization in distributive matter of a point of convergence (trade-off) between the economical and ethical appeals on the value of the human person as a whole.
It is estimated that by 2025 more than 20% of Europeans will be 65 or over, with a particularly r... more It is estimated that by 2025 more than 20% of Europeans will be 65 or over, with a particularly rapid increase in the number of over 80s. Chronic diseases, malnutrition, weakened immune system and other health factors increase risk of foodborne illness and hazardous nutritional habits in elderly. Food safety and nutrition security are essential to promote active ageing. In order to evaluate elderly’s perceptions, practices and attitudes with respect …
Background: The relevance of incorporating ethical analysis into an HTA is increasingly acknowled... more Background: The relevance of incorporating ethical analysis into an HTA is increasingly acknowledged. Accordingly, there is a need for experts involved in HTA to learn and to apply methods that can be used to explore potential ethical implications of health care technologies. This half day introductory course in Ethics in HTA combines lectures, discussions and case study group work. The Faculty who are leading this course is a group of international experts who have contributed substantially over the last several years to methodological developments in this area. Requirements/Prerequisites: This course offers a lively introduction to the role of ethics for Health Technology Assessment (HTA) for those who are familiar with HTA, but who are not that familiar with ethics in HTA. Description/Objectives: The course has been specifically developed for international participants and is based on more recent international achievements in the field. It will emphasize adapting approaches in ethics for all types of health technologies and across international settings. Participants who attend this course will strengthen their understanding and facilitate their participation in ethical assessment in HTA, as well their ability to participate in broader discussions.Most importantly it provides a number of approaches for \u2018how to\u2019 incorporate ethics into an HTA. After the preconference workshop participants will be able to: \u2022 explain and acknowledge the role of ethical issues in HTA, \u2022 recognize potential ethical issues in HTA and formulate appropriate research questions, \u2022 know and use methodology for analyzing ethical issues, \u2022 know how to critically appraise primary research aimed at identifying ethical implications of health care technologies. \u2022 describe different ways of synthesizing and communicating the results of ethics analyses
Uploads
Papers by Dario Sacchini