Background: The European Medical Devices Regulation (MDR) 2017/745 aims to reduce clinical uncertainty by improving the generation, dissemination, and quality of clinical evidence throughout the medical device lifecycle: pre-market, market approval, post-market, and disinvestment. Although MDR encourages gold-standard methods such as Randomized Controlled Trials, healthcare organizations face major challenges in applying them. These challenges affect the effectiveness of evidence generation, dissemination, and quality. To address this, healthcare systems must adopt technological, organizational, and managerial tools. This study identifies tools that can reduce clinical uncertainty related to medical devices. Methods: A qualitative case study approach was applied to the Tuscany Regional Healthcare System, nationally recognized for effective, efficient, and appropriate care delivery. Results: Most tools are concentrated in pre-market and post-market stages. Examples include study coordinators (organizational), standardized templates (technological), and case report forms (managerial), all improving evidence quality. Additional tools, such as patient diaries (managerial) and surgical trainers (organizational), support evidence generation and dissemination. Discussion and Implications: Findings offer guidance for policymakers on how to direct healthcare organizations in the effective implementation of the MDR. Clinical registries, surveillance systems, and data platforms are crucial for collecting real-world evidence, especially in post-market phase. This study contributes to the debate on clinical uncertainty, showing how technological, organizational, and managerial tools can strengthen evidence for medical devices.

Health Technology Assessment (HTA) is an organizational process used to determine the value of health-technologies. There is considerable variation in how HTA is developed globally, with Canada at the forefront of this field, having pioneered the use of HTA and implemented it extensively across healthcare organisations at all levels. This study is relevant for its unique focus on citation networks and author keywords regarding HTA in Canada, providing a holistic view by analysing HTA as an organizational process. By identifying fundamental process elements and differentiating research streams (RSs), it addresses a notable gap in the literature, offering fresh insights and informing policy recommendations to enhance HTA practices. While referring to the Canadian HTA, this study conducts a Systematic Literature Network Analysis to identify the RSs that will be analysed according to a process perspective. This analysis allows highlighting the process components-like stakeholders, phases, and methods-that have played a role in the success of Canada's HTA, as well as pinpointing the ongoing challenges that need to be tackled to create greater value. Analysing documents published in peer-reviewed English-language journals from the Scopus-Elsevier database, we identified seven RSs, including macro-HTA, meso-HTA, micro-HTA, ethical considerations, and patient involvement. For each stream, this study delineates the process elements, that is, the involved stakeholders, process phases, methodologies, and evaluation criteria. It is evident that while expert panels and specialist groups are crucial for technical HTA activities, patients and caregivers play a pivotal role in social and ethical evaluations. The study also highlights future challenges for HTA procedures: integrating qualitative and quantitative considerations, assessing the real impact of macro-HTA outputs, and overcoming barriers to patient involvement. Theoretically, this paper clarifies the differences between streams in terms of HTA process elements, and practically, it assists practitioners in tailoring the HTA process to their specific needs. Policymaking recommendations include considerations regarding the number and intensity of stakeholder engagement.

Il presente studio analizza il ruolo strategico delle aziende sanitarie pubbliche nella promozione della ricerca clinica, attraverso un caso di studio sull'Azienda Ospedaliero-Universitaria Pisana (AOUP). Utilizzando una metodologia qualitativa basata su interviste e dati istituzionali, si evidenzia la duplice funzione dell'AOUP nel coordinamento di progetti competitivi e nella gestione di studi clinici sponsorizzati, sia profit che non profit. I risultati mostrano un progressivo consolidamento della capacità organizzativa, scientifica e regolatoria dell'Azienda, che rafforza la propria attrattività come partner di ricerca. L'integrazione tra assistenza, formazione e ricerca emerge come fattore abilitante per la generazione di valore, innovazione e relazioni istituzionali. Lo studio propone spunti utili per la definizione di modelli sostenibili di governance della ricerca nelle aziende sanitarie.

This study considers the Opera del Duomo in Pisa, the organisation tasked with building the world-renowned complex located in the Square of Miracles, from its inception to the formation of the Grand Duchy of Tuscany in the sixteenth century. It draws upon Besharov and Smith's understanding of hybridity to document the factors driving the transition from a form of hybridity characterised by a high level of conflict between the logics of the State, the Church and the Commune of Pisa to a form in which the State logic dominated over the others and conflict was overcome. The article unveils how the regulatory power of the State generates changes in the interactions among logics over time, with particular attention to the role of accounting and accountability practices. It shows how historical studies help to untangle situations in which logics coexist in extreme conflict and identify new ways to engage with them.

Background: Chronic back pain stands as the most common musculoskeletal disorder and a primary cause of disability in people under 45 years old. Multidisciplinary consultation offers an efficient approach to chronic back pain management compared to traditional therapeutic-rehabilitative paths. This paper aims to show the benefit of a diagnostic-therapeutic multidisciplinary program pathway for patients with chronic back pain. Methods: Twenty-six patients who underwent a second-level multidisciplinary consultation with a neurosurgeon and a pain therapist at our University Hospital were retrospectively identified from April 2023 to September 2023. The second-level multidisciplinary consultation is a second step consultation after a first consultation with a single specialist doctor (neurosurgeon, orthopedic, and pain therapist) who did not get the diagnosis and/or did not solve the painful symptom after medical or surgical treatment. Clinical outcomes, patient experience, and cost-effectiveness analysis were assessed using lean healthcare tools. Results: With the introduction of second-level multidisciplinary consultation, patients were assessed by multiple physicians during a single visit, reducing the costs of individual visits, reducing the time to obtain the diagnosis, and facilitating early agreement on a diagnostic-therapeutic plan. The lean value-based healthcare approach showed an average of 45 working days lost per single patient and a total cost per single patient with chronic back pain of € 1069 for the national health system for an average Lead time of 18 months. Questionnaire analysis on service quality and utility, along with overall satisfaction, revealed excellent resolution of back pain in 53.8% of cases and partial resolution of back pain in 11.5% of cases after second-level multidisciplinary consultation. Conclusion: Our multidisciplinary approach to chronic back pain has significantly improved healthcare efficiency. This new proposed clinical model reduces waiting times and costs and improves patient experience by improving clinical outcomes in the management of chronic back pain.

PurposeThis study aims to explore how firms can enhance their innovation processes by effectively utilizing external knowledge and employing digital technologies. Specifically, it emphasizes the role of absorptive capacity (ACAP) in external knowledge acquisition and assimilation (potential ACAP), as well as transformation and exploitation (realized ACAP), highlighting the necessity of equipping firms with digital technologies to support ACAP activities.Design/methodology/approachTo achieve the research purpose, we conducted a structured literature review of academic papers sourced from Scopus-Elsevier.FindingsThe key findings encompass the identification of common digital technologies supporting ACAP and explore how these technologies contribute to knowledge acquisition, assimilation, transformation and exploitation. The main results show that social media and online communities are the most studied technologies in relation to ACAP activities. Research predominantly centres on potential ACAP – with acquisition activity more studied than assimilation – rather than realized ACAP – with only social media and online communities demonstrating full support for transformation and exploitation activities.Research limitations/implicationsThis research represents a pioneering joint study of ACAP and digital technologies, advancing understanding beyond organizational perspectives and expanding open innovation literature by integrating ACAP role in technology collaborations. A call for qualitative investigations into the relationship between digital technologies and ACAP emerged.Practical implicationsThe findings offer valuable guidance to innovation managers, aiding them in selecting appropriate digital technologies to strengthen ACAP activities.Originality/valueThis work’s uniqueness lies in bridging the gaps between open innovation, ACAP and digital technologies, which are often studied in isolation.

The internal innovation activities of firms often encounter obstacles (i.e., factors hampering innovation activities) such as economic constraints and lack of skilled employees within enterprises, prompting them to adopt an Open Innovation (OI) approach as a means to overcome the obstacles and thus to achieve innovation performance, intended as Innovation Industrial Performance (IIP) and Innovation Financial Performance (IFP). Using data from the Community Innovation Survey (CIS), the study firstly investigates whether OI is able to exert this mediation role. Second, the study investigates the moderating role of financing techniques, specifically debt and equity, on the relationship between OI and firm Innovation Industrial Performance (IIP) and Innovation Financial Performance (IFP). It explores whether equity and debt support OI in enhancing such performance types. Our results show that, while OI proves effective in overcoming innovation hurdles, it does not mediate the relationship between the factors hampering innovation activities and IFP, suggesting a temporal lag between innovation and its financial outcomes. The findings of this study suggest that equity enhances both IIP and IFP by bolstering competencies and financial capacity. In contrast, debt primarily benefits IFP by providing readily available resources. Notably, debt does not influence IIP, indicating its limited contribution to cognitive and knowledge resources essential for innovation. However, the study acknowledges limitations, including the lack of longitudinal data, which hinders the assessment of time lag effects between innovation and financial performance.

Purpose This paper aims to provide a helpful tool for those who plan to implement blockchain-based solutions for the governance of the electronic medical record (EMR) in health-care settings. The goals are to identify each type of stakeholders involved in these projects and to clarify the relevance, to achieve success, of their readiness, intended as availability and ability to adopt blockchain. Design/methodology/approach The chosen methodology is a multiple case study on three initiatives that used blockchain to manage EMRs. This study relied on multiple sources of evidence. The primary data consisted of two rounds of semi-structured interviews with different informants. This study followed a grounded theory approach and performed within- and cross-case analyses. Findings This study identified the types of stakeholders – nodes and not-nodes – of the network and how their readiness level affects the implementation of blockchain-based projects applied to EMR. The nodes (e.g. patients and doctors) are pivotal in making the network working once this has been constructed. Out of the four readiness dimensions suggested by literature, motivational readiness, has the higher impact. Not-nodes stakeholders play a pivotal role in the project’s pre-implementation phase. For them, structural readiness is the dimension with the higher relevance. Originality/value To the best of the authors’ knowledge, it is the first time that a paper analyses the differences between nodes and not-nodes stakeholders of the blockchain network, in terms not only of type but also of readiness. Identifying the readiness level to implement successful projects is a fundamental step that has never been analysed in the health field.

A company's most valuable asset is its employees. Since the 1970s, corporate social responsibility (CSR) has been a topic of increasing interest in terms of performance and disclosure. However, little attention has been paid to the history of CSR practices, which should be studied within historical and cultural contexts. Based on archival material and secondary sources, and using arguments from moral economics and Catholic Social Theory, this study uniquely investigates the role of religious and ethical beliefs in influencing CSR actions and accountability. We focus on the case of Vaccari, an entrepreneurial Italian Catholic family in the early-twentieth century, which was clearly inspired by upward accountability (to God) and not just economic returns. The family took CSR actions to improve the welfare and living conditions of its workers (downward accountability). Vaccari's religious value system was strongly based on the principles of Catholic Social Teaching (CST) contained in the 1891 encyclical Rerum Novarum of Pope Leo XIII, addressed to 'all men of good will'. Our historical analysis informs modern CSR practices, revealing that management's commitment to ethics and sound values is the correct starting point for developing good and sustainable business practices.

The use of Health Technology Assessment (HTA) for the evaluation of medical devices in healthcare organisations implies the creation of new knowledge to be combined with that stored in the human, relational, and structural dimensions of their Intellectual Capital (IC).Therefore, HTA can represent a trigger for innovating the IC and this process can be influenced by external factors that can be reconducted to the Institutional Theory (IT). However, to the best of our knowledge, there are no studies in the literature analysing these aspects. By using the case study methodology, this work explores how the innovation of the IC dimensions is triggered by the use of the HTA tools, considering also the moderating role of the IT pillars.

PurposeThe study investigates the use of early forms of environmental accounting in the implementation of environmental strategies in the Grand Duchy of Tuscany between the 16th and 17th centuries.Design/methodology/approachThe study adopts the Foucauldian concept of raison d’État to shed light on the ways in which environmental accounting practices were used by Tuscan Grand Dukes to form a detailed knowledge of the territory to be governed and act accordingly.FindingsFinancial and non-financial information relating to environmental issues enabled the Grand Dukes to “visualise” the territory to be managed as an enclosed disciplinary space whereby the conduct of people living therein could be decisively influenced. Accounting practices as a tool for the implementation of environmental strategies did not merely aim to protect the environment but were a means to reinforce the power of the State.Research limitations/implicationsThe paper can inform future works that investigate the ways in which environmental policies and accounting are used to pursue far-reaching governmental goals. It encourages scholars to examine further the origins of environmental accounting and its early forms.Social implicationsThe study documents how environmental strategies and the related use of accounting can have a significant influence on how individuals are allowed to conduct themselves. It also shows that environmental accounting practices can be an important tool in a State’s machinery of power.Originality/valueThe study offers a novel perspective on the use of environmental accounting information as a tool in the exercise of State power. It explores explicitly the interrelations between accounting, sustainability and power. It also adds new evidence to historical research that has engaged with early forms of environmental accounting.

Medical devices are introduced in the market with an ever-increasing rate, with important benefits for the whole society's health. In the greatest majority of cases, although representing the entry point for devices, healthcare local institutions/hospitals do not receive any macro-level guidance from (inter)national authorities for their assessment. Hence, in the absence of a methodological support, local institutions/hospitals started to assess devices autonomously, building on Health Technology Assessment (HTA) tools based on Multi-Criteria Decision Analysis (MCDA), in order to take into-account the multifaceted aspects connected with devices. However, the strategies described so far in the scientific literature for implementing MCDA in local-based HTA of medical devices suffer from a harsh methodological weaknesses - that is, the use of bespoke criteria for the specific device to be assessed - that severely affect the evaluation of medical devices. Within this scenario, this work proposes a new tool based on peer-to-peer IF-TOPSIS, intended for micro-level assessment of medical devices with the main objective of overcoming the above-mentioned critical issues and provide local institutions/hospitals with a general tool. An example of application of this tool in the choice between three neurological devices is shown. Contributions are both theoretical and practical. Theoretically, while proposing a general MCDA tool for micro-level HTA, we answer the call for the identification of key methodological principles for the local assessment of medical devices. At the practical level, this tool is readily implementable and can be adapted to consider the local idiosyncratic characteristics of the context where decisions have to be made.

Purpose This paper aims to expand the emerging literature on COVID-19 and the financial markets by searching for a relationship between the uncertainty of the first phase of the COVID-19 pandemic experienced through social media and the extreme volatility of the Italian stock market. Design/methodology/approach The authors analyze the relationship between social media and stock market trends during the first phase of the COVID-19 pandemic through the lens of social theory and Baudrillard's simulacra and hyperreality theory. The authors conducted the data analysis in two phases: the emotional and Granger correlation analysis by using the KPI6 software to analyze 3,275,588 tweets for the predominant emotion on each day and observe its relationship with the stock market. Findings The research results show a significant Granger causality relation between tweets on a particular day and the closing price of the FTSE MIB during the first phase of the COVID-19 epidemic. The results highlight a strong relationship between social media hyperreality and the real world. The study confirms the role of social media in predicting stock market volatility. Research limitations/implications The findings have theoretical and practical implications as they reveal the relevance of social media in our society and its relationship with businesses and economies. In an emergency, social media, as an expression of users' feelings and emotions, can generate a state of hyperreality that is strong correlated with reality. Since social media allows users to publish and share messages without any filter and mediation, the hyperreality generated is affected by highly subjective elements. Originality/value This research is different from the previous ones on the same topic because unlike previous studies, conducted under normal or simulated scenarios, this study is focused on the first phase of an unpredictable and unforeseen emergency event: the COVID-19 pandemic. This research adopts a multidisciplinary approach and integrates previous studies on the economic and financial effects generated by social media by applying well-known theories to a new and unexplored context. The study reveals the significant impact generated by social media on stock markets during a global pandemic.

Purpose: The purpose of this chapter is to verify the degree of formalization and measurement of the third mission in the planning documents of European higher education institutions (HEIs). We will adopt the perspective of intellectual capital (IC) (Bezhani J Intellect Capital 11(2):179–207, 2010; Ramírez ad Gordillo J Intellect Capital 15(1):173–188, 2014) because the third mission dimensions (technology transfer innovation, continuing education, public engagement) are strictly related to the external dimensions of IC components (human capital, organizational capital, and social capital). Design/methodology/approach: A content analysis on the planning documents of a sample of 25 European HEIs in Italy, the United Kingdom (UK), France is carried out based on a validated third mission dictionary (Göransson et al. Sci Public Policy 36(2):157–164, 2009; Loi and Di Guardo Sci Public Policy 42(6):855–870, 2015; Marhl and Pausits Eval Higher Educ 5(1):43–64, 2011; Secundo et al. Technol Forecast Soc Change 123:229–239, 2017). Findings: Our findings confirm that despite the relevance of third mission activities for economic and social development, the lack of a comprehensive definition and measurement framework for the third mission leads to a low formalization of the third mission in university disclosure. As a consequence, the external dimension of IC is formalized and disclosed in a limited manner. Specifically, although third mission has evolved from a productive concept focused on the economic exploitation of research to a universalistic concept that also includes the social impact of university activities, the formalization of third mission is mainly related to the productive conception. Originality/value: This chapter attempts to link the third mission and IC. As knowledge-based institutions (Sánchez and Elena J Intellect Capital 7(4):529–548, 2006), HEIs pay high attention to IC, whose external dimension can be considered strictly related to third mission. This perspective highlights the relevance of third mission within HEIs’ activities. Implications: This chapter highlights the best-in-class experiences and provides suggestions for universities that are later adopters of third mission measures; it can further suggest the determinants for enhancing third mission disclosure to policy makers and public managers.

With climate change becoming more severe, policy makers must impose environmental regulations that will lead firms to adopt sustainable corporate models. According to the Porter hypothesis, environmental regulation can favour the implementation of business strategies that improve economic and environmental performances. In this study, we examine how one such form of regulation, the European Union Emission Trading Scheme (EU ETS), impacts firm performance, and we subsequently widen the examination beyond the regulation to evaluate an economic crisis which could potentially confound regulation effects. We estimate a panel model with time- and firm-fixed effects for different subsamples that disentangle the effect of the EU ETS policy from the 2008 economic crisis. The results indicate that the EU ETS policy in its third phase can activate the Porter hypothesis and is effective in fuelling the implementation of sustainable corporate models by firms. However, we also find that the economic crisis neutralises the effects of the regulation on firm performance, precluding the triggering of the Porter hypothesis in severely affected firms.

During the past few years, scholars have investigated accounting practices from different perspectives and in different contexts; however, the topics of accounting and fraud-corruption appear to be underresearched areas in accounting history literature. This article examines the case of Galliera Hospital of Genoa, established as Opera Pia De Ferrari Brignole Sale in 1877 by the Duchess Maria Brignole Sale. Currently, the Galliera Hospital is an important and specialised Italian hospital with 450 beds and almost 2,000 employees. Using the lens of Foucault’s governmentality and discipline power framework, this article explores how unforeseen events and misconduct can deeply change governance and control mechanisms, implying the adoption of empowered accounting practices. Thus, this article shows that accounting practices, when perceived as a real technology of government, allow the exercise of power. The study offers a relevant contribution to the extant accounting history literature by examining how accounting can be used as an instrument of power in the presence of misconduct.

The contribution is based on the emergency situation following the Covid-19 pandemic The dramatic situation that has arisen offers an opportunity to reflect on the characteristics of Italian health care and in particular on the model for the division of responsibilities in health matters between the State and the regions Every emergency requires exceptional interventions and extraordinary decisions In a health emergency such as the current one, it is natural to set up task forces, intervene with emergency decrees or act on the contingency way The basic question is whether the regionalization of health care, as it has been formed since 1992, is the suitable institutional model to respond in a unified and homogeneous way to the health needs of Italians The paper proposes and argues the hypothesis of bringing hospital care back to the central level The Regions would be kept in charge of primary care and low and medium-intensity hospitalization In this way, in front of critical issues the chain of responsibilities and the leadership of the system would be clear Copyright © FrancoAngeli