In recent years, the medical world has seen rapid digitalisation. Digitalisation of healthcare and the opportunities of remote monitoring can help to keep the healthcare system affordable and accessible. A promising application of remote monitoring is the use of consumer-grade wearables for clinical care. However, vulnerabilities leave consumer-grade wearables susceptible to cybersecurity and privacy risks. When the wearables gain clinical care functionality, increased risks are problematic for the success of the technology. This research examined this problem by analysing the role of users in the cybersecurity and privacy environment and the impact of human factors on the cybersecurity and privacy system of medical wearables. Vulnerabilities and associated risks were identified with the help of notions from human-centric cybersecurity. To establish a user-centred approach to tackle these risks, the user needs and limitations were examined by performing a quantitative survey research. Based on the results of the survey and the human-centric components of user, usage, and usability, guidelines for the user-centred approach were formulated. These guidelines were subsequently linked with the challenges and attacker-oriented and user-oriented risks to establish recommendations for medical wearable providers. Providers can use these to steer the design of the cybersecurity and privacy system and the structuring of the system environment. The research showed that by taking into account the needs and limitations of users, the cybersecurity and privacy system design can be more effective in tackling user-oriented risks. The research concludes that a user-centred approach to cybersecurity and privacy can contribute to the successful use of consumer-grade wearables for clinical care purposes.

The third version of the Green Deal Sustainable Healthcare 3.0 (GD3) in the Dutch elderly care sector represents a dynamic and shared governance model that promotes widespread participation and implementation of sustainability practices. The GD3 provides a blueprint for elderly care organisations to pursue sustainability goals, but its success depends on collaborative efforts supported by various tools and frameworks. This research explores how joining the GD3 facilitates the achievement of sustainability goals in elderly care organisations. Successful implementation of the GD3 can have far-reaching effects, of which inspiring other sectors to adopt similar collaborative approaches. However, its effectiveness depends on the performance of the participating organisations and their use of empowering tools such as the Milieuthermometer Zorg (MTZ). Interaction and cooperation between the diverse group of actors is essential to achieve the desired results, as the GD3 operates through a shared form of governance involving both bottom-up and governmental actors. Active participation, implementation of sustainable actions and maintaining trust and cooperation are crucial for the effectiveness of the GD3. Repeated experience with climate agreements such as the GD3 helps to build trust, reciprocity and reputation among participating actors. All of this is being explored in the context of other challenges specific to care for the elderly, such as staff shortages and an ageing population. Ultimately, the GD3 represents a valuable initiative within the health sector that provides a script for sustainability efforts, while allowing organisations the flexibility to adapt and take artistic license in achieving the intended outcomes. The aim is to present a dazzling sustainability show within three years, signalling a transformed system. Given the urgency of sustainability and the challenges posed by an ageing population, embracing GD3's collaborative and adaptive approach is essential for the future of healthcare, particularly in the context of elderly care in the Netherlands.

The gap between planning and budgeting is a problem for improving health systems. In decentralisation health care services, authority, resources, and responsibilities are moved from central actors (i.e. national government) to peripheral actors (i.e. municipalities). Adding the risk of creating silos within sub-national governments, creating the need for collaboration in some form. Data analytical forecasting, like prognosis tools, may facilitate planning for health care service implementation. When operating on the interface between actors, as a boundary object, they may mitigate the risk of fragmentation and isolation associated to decentralisation, by enabling collaboration. In the case of decentralised Assisted Living in the Netherlands ("Beschermd Wonen") citizens dealing with psycho-social problems, receive guidance to participate in society. Newly responsible sub-regions have limited facilities and funds for their own citizens. Newly responsible sub-regions having limited facilities and funds, may face incurring costs and inaccessible care when citizens seek to other areas due to uncoordinated implementation and elimination of facilities. To plan these, a prognosis tool was designed and developed for the three sub-regions. A literature review was conducted on decentralisation of health care services globally. The prognosis tool’s technical design and development, and observations during, were studied. Analysed Interviews with actors involved in the prognosis tool, assessed if and how collaborating was enabled. Lack of research on the implementation of decentralisation for health services, the use of prognosis tools for this purpose, the risk fragmentation resulting from independent processes and lack of system focus and the need for collaboration were highlighted in the literature, justifying building and testing a tool. The design of the tool was therefore intentional: colour codes stimulated usability, the three sub-regions sub-files were stored in one place promoting transparency, and standardisation was stimulated by representing all sub-regions’ demands and resources into a general fitting categorisation and identical calculations from input to results for all sub-regions. The tool and outcome is usable for agreements with care suppliers (procurement) or housing and enables organisation through agreements between sub-regions. The meta-analysis of the interviews revealed that from the prognosis tool’s design and development, shared understanding emerged through shared language and extensive problem demarcation. An independent expert mediated the needs of sub-regions, staying close to the task. This combined with the factual outcome led to insight and clarity in the content of subregions’ own and other’s task. Inducing trust and confidence in the relation and in achieving own and shared goals. Leading to tranquility and comfort, setting the atmosphere for collaboration. By clarifying the uncertainties and interdependencies, where or why collaboration is needed (the identified risk) has stimulated collaborative action. This prognosis tool has enabled collaboration for decentralised health services by addressing both socio-technical aspects. The latter integrate the effected sub-systems, ensuring the outcome can be used for organising future steps (such as procurement). The former, extensive problem demarcation and shared language emerged a shared understanding of the system. In combination with the factual outcome (prognosis), insight and clarity was created into the actual need and to enable trust and comfort, enabling collaboration.

In 2020, the world was hit by a global pandemic through COVID-19, causing millions of deaths worldwide. The last two years proved that a health-related crisis like COVID-19 strains us as a society and the capacities of health systems worldwide. Severe infections of COVID-19 require higher capacities of hospital beds, ICUs with ventilators and Personal Protective Equipment. For health systems, the question arises of how to secure enough PPE and ventilators before and during a health-related crisis like COVID-19. This research explores how health systems can create responsive and prepared supply strategies to meet the rising demand for critical medical supplies during health-related crises. Concerning the availability of critical medical supplies, preparedness entails stockpiling as a supply strategy. Furthermore, preparedness entails actions decision-makers in health systems can take to increase the effectiveness of responsive supply strategies. Responsiveness refers to supply strategies used at the beginning of a health-related crisis in the short term. Responsive supply strategies include ramping up domestic production, supporting innovations, loaning medical supplies, and purchasing medical supplies from the world market or through direct tender. In this research, a System Dynamics model was developed to explore how health systems can create resilient and responsive supply strategies, a System Dynamics model was developed, focusing on the English health system as an example for the Global North. Given the deep uncertainties surrounding the supply chain of critical medical supplies, Exploratory Modelling and Analysis was conducted to identify candidate policies and explore their performance given the uncertainties. Specifically, uncertainties affecting the success of purchasing supplies through direct tender and from the world market had the most impact on the availability of PPE and ventilators. The results of the analysis and the findings in the literature provide the following recommendations to decision-makers in health systems to create prepared and responsive supply strategies that ensure the availability of critical medical supplies during health-related crises. Decision-makers can implement (i) stockpiles exhibiting higher inventory levels than recommended, and no delays concerning the operation within the warehouse or the delivery of the medical supplies. Furthermore, it is suggested to (ii) implement diverse supplier frameworks and crisis frameworks, (iii) diversify supplier, (iv) implement stocks of raw material for domestic production. It is useful for decision-makers to apply several responsive supply strategies simultaneously. Furthermore, health systems can further investigate additional supply strategies. In this research, it is assumed that collaboration is not relevant nor of interest for the English health system. Hence, it would be interesting to explore the effect that sharing critical medical supplies between national health systems could have on the shortage of PPE and ventilators in the future.

This thesis aimed to aid ErasmusMC in the workforce planning process of deciding how to implement training among the nursing personnel in order to build a more flexible workforce, so the hospital can be prepared for fluctuating and unexpected demand, while minimizing the costs of doing so. To accomplish this, a mathematical model was developed taking into account the structure of the nursing personnel within the hospital, and the structure of how training among nurses is implemented. Since the planning was aimed to be done on a daily basis, the contractual obligations between nurses and the hospital had to be respected as well. The resulted model was tested using real data provided by Erasmus MC, and with the mathematical optimization solver Gurobi. Consequently, a Genetic Algorithm (GA) approach was proposed; this heuristic accomplished to outperform Gurobi when applied to the biggest two instances considered in this project.

The research was conducted looking into the possibilities of local manufacturing and assembly of medical devices in low and middle-income countries. Desktop research and expert interviews were conducted to learn the operations of medical devices (and other product) manufacturers. The interview process validated the literature study and also brought to light some new information on how medical device manufacturing (both local and international) operates. The research resulted in key drivers and inhibitors that companies need to consider when shifting their operations (or not) to low and middle-income countries.

The pressure on healthcare systems is increasing all over the world. With an ageing world population, the costs for healthcare and the shortages in medical staff are continually increasing. In the Netherlands, out-of-hours general practitioner departments, or ‘huisartsenposten’, suffer from this increasing pressure in their telephone triage systems: the departments are crowded and the staff capacity is too low to adequately handle the amount of patients. This often leads to long waiting times on the phone for patients in need of potentially urgent medical care and to high pressure work environments for staff. There is no insight into when and why it is crowded, how high waiting times emerge from this, and how changes can be made in the departments internally and beyond to reduce this problem. In this thesis, research is presented that addresses the practical and scientific lack of knowledge of the factors that influence the out-of-hours departments and that identifies how waiting times can be reduced. The results of this thesis focus on the identification of the factors that influence the demand for healthcare and the service times of people at the out-of-hours departments, and they focus on the practical implications for reducing waiting times at these departments. Based on extensive data analysis of two out-of-hours departments in the Netherlands, it was found that temporal factors such as season, part of the week, day of the week and hour of the day, but also the weather conditions and the urgency of the problem of the patient have an impact on demand for healthcare and on service times at these departments. These factors determine how busy it will be and whether or not waiting times will emerge. With the knowledge of these factors, a discrete event simulation model was implemented to identify what system changes are necessary to reduce waiting times at these out-of-hours departments. It was found that there are several quick-win interventions that can help reduce waiting times: shifting of patients from peak demand, implementation of overlapping work shifts for staff and automatic retrieval of patient information when they are waiting in the queue on the phone. There are also some long term interventions, more focused on behavior change of people, that can be implemented: increased accessibility and understanding of the primary healthcare system, a small (dis)incentive for out-of-hours care, separate telephone lines for home care and implementation of working from home for staff.

After the start of the COVID19 pandemic, many countries decided to develop digital contact tracing applications to assist in contact tracing. This aimed to warn people who were potentially infected as early as possible and stop them from spreading the virus further and bringing down the total amount of new infections. Even though there was some proof of the potential effectiveness of applications such as these, they had never been deployed at scale before the pandemic and there was no standardised and shared vision on how to best implement these applications, meaning that countries that wanted to include digital contact tracing as part of their COVID19 strategies needed to design and develop an application themselves...

The Netherlands is experiencing a significant increase in its aging population. Multi morbidity and a rapidly growing shortage of healthcare personnel are putting pressure on the healthcare system, leading to capacity issues. The capacity problems of care have medical, safety, social, and economic consequences. Policy measures are needed to address these challenges and improve the transfer care system. Therefore, the research question is: On which factors should policy interventions by the Ministry of Health, Welfare, and Sport be aimed, to improve the performance of the Dutch transfer care system? This study uses qualitative System Dynamics (SD), a method that uses causal loop diagrams, to analyze the relationships between factors that influence the transfer care system performance, such as the demographic changes and workforce shortage. The goal is to find strategies and solutions for a sustainable healthcare system. A visual SD model is used to highlight the complexity of the transfer care system and to reveal inter dependencies, interactions, and feedback loops, aiming to understand system dynamics. A literature review, multiple interviews and case studies have revealed factors and interactions that are modeled in a causal loop diagram. This qualitative System Dynamics analysis revealed both unidirectional (+ or -) and different polarity (+/-) interactions/feedback loops between/among the indicators, which implicates that certain policy interventions (mentioned in Dutch policy notes and other publications) may not achieve the intended results. Based on the interactions found, the Ministry of Health, Welfare and Sport can start using a bundle of interventions aiming on reducing workload/number of admissions and simultaneously keeping availability of aftercare constant. Additionally, the Ministry can improve other indicators, when keeping workload constant. However, to determine how many additional interventions are needed to keep workload and availability aftercare constant and to determine the net total effect of interactions with different polarities, quantitative System Dynamics is needed. In addition, quantitative System Dynamics is needed to be able to prioritize policy interventions, because qualitative System Dynamics is not able to determine the net effect of feedback loops. However, this qualitative System Dynamics study provides a solid foundation with which researchers (and the Ministry of Health, Welfare and Sport) can proceed to construct a quantitative model.

Background & Objective: The unprecedented value and long­term uncertainties of gene therapies have challenged established health technology assessment (HTA) methods. Real-world data (RWD) and real-world evidence (RWE) may mitigate the encountered uncertainties. However, empirical evidence appears to be lacking in the literature. This research aimed to provide this evidence and identify implications for EU-wide gene therapy joint clinical assessments. Methods: An initial literature review laid the theoretical foundation for the research. A retrospective comparative analysis delivered empirical evidence on RWD/RWE usage in gene therapy HTAs. Preliminary findings were probed in three use cases and verified in semi­structured interviews. Results: Nineteen HTA reports published by the HTA bodies G­BA (Germany) and NICE (England) were identified for the ten in­scope gene therapies. Whereas NICE had an average inclusion of 14 sources per HTA report (with an acceptance rate of 56%), G­BA had 8 (with 32% acceptance rate). While RWD/RWE supporting evidence on an external comparator had the lowest acceptance rate, RWD/RWE on intervention effectiveness had the highest acceptance rate. Insufficient information to substantiate the choice of RWD/RWE and inappropriate RWE study design was the most common exclusion rationales for RWD/RWE. Conclusions: The presented empirical evidence adds to the current knowledge base in two ways; it provides empirical evidence on HTAs of gene therapies (1) and RWD/RWE usage in gene therapy HTAs (2). This work provides insights into how RWD/RWE usage differs between HTA bodies and explicates relevant considerations for gene therapy manufacturers when using RWD/RWE in future HTA submissions. It also proposes that alignment on evidentiary requirements and assessment elements will optimise the transferability of future joint clinical assessment outcomes to national HTA bodies. Knowledge transfer and knowledge sharing initiatives will play a pivotal role in achieving such a consensus.

Social enterprises play a significant role in achieving the Sustainable Development Goals (SDGs). Measuring the social impact of social enterprises presents several challenges, including the complexity of social issues, the need for standardized metrics, and the limited resources available. Obtaining funding is crucial for social enterprises to fulfill their mission. When applying for funding, they often have to report on the social impact they generate, as it is an essential part of the value they create. Another difficulty is that social impact is experienced differently by various actors. The research, therefore, adopts an exploratory approach to understand how funders and social enterprises perceive the impact assessment, particularly for those contributing to SDG 3. Thus, the central question of this research is 'How are funders and social enterprises aligned in measuring social impact on SDG3?'. This research was conducted in partnership with Unifix Care. Unifix Care is a social enterprise whose mission is to improve access to safe surgical care in Sub-Saharan Africa. The findings presented were derived from a review of the literature, interview rounds, and a survey. The first round of interviews were exploratory interviews with general impact funders. The second round consisted of interviews with social enterprises contributing to SDG and funders funding these social enterprises. The survey aimed to validate statements based on literature and interviews and to give an idea of the data funders and social enterprises use some impact indicators. A finding of this research is that the change in how the Theory of Change is used, from an internal tool to an external accountability mechanism, indicates a misalignment between funders and social enterprises. While funders may demand accountability, social enterprises initially used it for internal improvement. This shift suggests a divergence in how both parties perceive and utilize this tool for measuring social impact. Social enterprises' power imbalance and dependency on funders can lead to a misalignment in measuring social impact. Contributing to this is the fact that aligning the mission of social enterprises with the strategic goals of funders is considered very important. A subsequent finding is that there could be a reporting difference between easier-to-measure KPIs from the Theory of Change (input, activity, output) and harder-to-measure KPIs more aligned with the overall goal (outcome and impact). The survey results indicated a mild divergence in opinions between funders and social enterprises on the priority of measuring input, activity, and output indicators versus outcome and impact indicators. Social enterprises were somewhat in favor, whereas funders were somewhat opposed. In terms of quantifying outcome and impact indicators, a simple, state-of-the-art calculation was generally adequate for most social enterprises, in contrast to the preferences of funders. These findings could result in the miscalculation of social impact generated by social enterprises. For this, it is necessary to bring back the Theory of Change as an integrated framework. Another finding is that both social enterprises and funders focus more on a social enterprise's positive rather than negative impacts. Given that every social enterprise likely has some adverse effects, these should be acknowledged to ensure a comprehensive assessment of the overall positive social impact. Additionally, it is found that the inconsistency in defining 'impact investors' and the varied interpretation of 'impact first' approaches reflect a lack of uniformity in how social impact is perceived and measured. This variability can lead to challenges in aligning the measurement approaches of funders and social enterprises. The main limitations of this study are related to the small survey sample size, which only provides an indication. More research is needed to draw definitive conclusions. Another limitation is the selection and categorization of indicators in the survey; an attempt was made to do this as generically as possible. However, future research would benefit from validating this selection and categorization by multiple experts. The following recommendations aim to foster effective collaborations between funders and social enterprises, enhancing transparency and accountability in social impact measurement. A publicly accessible database should be created to share the social impact results of social enterprises. This will allow for establishing normal distributions and facilitate the assessment of the likelihood of success of similar interventions. Therefore, a portion of funding should be dedicated to monitoring the long-term impact of social enterprises. This enhances transparency and allows for a deeper understanding of the effectiveness of various investments in achieving social impact. Funders should also publicize the Theories of Change of the social enterprises in their portfolio. This transparency helps understand how the impact is achieved and mitigates the risk of 'impact washing.' The initiative for these recommendations, particularly the database and publication of Theories of Change, should come from the government or the actors funding the funders. They have the influence to drive more impact-focused decisions and support impact-driven social enterprises. Future studies should incorporate comparative cognitive mapping and game theory to understand better the preferences and incentives of funders and social enterprises. Additionally, using Agent-Based Modelling or System Dynamics with the EMA workbench could yield insights into the effectiveness of specific policies in a complex, uncertain environment.

The intellectual disability population increased from 65.545 people in 2011 to 116.200 people in 2020. In other words, the population almost doubled in less than ten years' time. Interventions are required to be able to make sure everyone receives the needed care. Therefore, the causes for the growth should be further examined before any decision on intervention can be taken. This thesis contributed to understanding the factors influencing the increase in the intellectual disability population and evaluating the behaviour of the sector. To improve the understanding, a System Dynamics model was designed analysing the influence of self-reliance on the intellectual disability population. The question of why there is an increase in the intellectual disability population has been attempted to be answered within this study. After evaluating multiple factors as a cause for the growth in the intellectual disability population, self-reliance was selected as being an important factor. In the conceptual model, three reinforcing feedback loops were found, indicating that when there is no intervention, the self-reliance of the intellectual disability population continuously decreases, resulting in more people applying for care from the Wlz. In the qualitative model, this proposition could not be rejected, indicating the importance of the role of self-reliance on the growth of the intellectual disability population. Especially for the population with an IQ score between 70 and 85, more attention should be paid to the increase or maintaining of self-reliance. In that way, the intellectual disability sector is always able to care for the ones who cannot live without.

In Dutch primary care, there is a dilemma that needs to be solved: caregivers using different digital platform in information system (DPIS) have difficulties in transferring necessary medical information. Although DPIS, as an emerging technology, assists in the decision making, coordination and control that occurs in the organizational environment. Its lack of openness leads to difficulties in exchanging information data. Therefore, this study focuses on the architectural requirements that can facilitate the openness of DPIS for primary care in the Netherlands. A design science approach was used to answer this question. The study first clarifies the current situation using document analysis and literature review, then defines the factors influencing openness and the requirements of stakeholders regarding openness and identifies architectural requirements. Finally, a conceptual artifact was developed and the requirements were validated in discussion with domain experts. The results of the study suggest that a clear distinction should be made between open to share or open to use when defining the openness of an architecture, and in addition, we should focus on the development of standardized data exchange regulations.

From a practical perspective, the UK, like so many other countries, is struggling to have a complete HTM implementation. The sources suggest that British health care managers face financial and personnel availability pressures, and this makes it difficult to follow the instructions provided by the various organizations for the implementation of HTM activities including procurement. It is worth mentioning that the guidelines and decision-making frameworks provided by national organizations and various authors, mainly follow a project-based approach, characterized by linear HTM implementation/decision-making, and usually focusing on purely technical and legislative aspects of HTM. However, the health care sector, as well as procurement of medical devices, is characterised by complexity, constitutes an interconnected network of actors, parties and policies, and it is mainly context-dependent. Therefore, in addition to technical and legislative advice, it would be sensible to train health care managers in recognising the presence of internal networking relationships, and how to negotiate with all the actors involved in the different procurement, or more in general HTM, activities. From an academic perspective, almost all the articles analysing procurement aim to identify potential challenges, mainly related to financial and technical concerns, and subsequently provide decision-making frameworks to indicate the right path to follow when deciding which device to purchase. Very few articles perform a satisfactory analysis of the main actors involved during the procurement process and their responsibilities. Moreover, no attempts have been made to look at hospital-based procurement from a networking perspective and apply ‘Management in Networks’ theories and strategy to understand and improve it. Considering the aforementioned practical and academic issues, this study wants to investigate how hospital-based procurement could be analysed under the network point of view. Therefore, this dissertation wants to propose a new way of looking at hospital-based procurement, taking into account the presence of potential internal networks and interactions proper of an interconnected world. More specifically, this thesis project aims to provide a satisfactory description of the main procurement activities performed within the hospital, inform about who are the actors involved, how they interact, how/if they follow specif guidelines, and the main challenges encountered. Once the author will arrive at a satisfactory description of hospital-based procurement, she will analyse this last one under the paradigms of an interconnected world, explaining how the various networking strategies and paradigms can be used to understand and analyse hospital-based procurement. Finally, this research will identify factors that could be addressed by health care decision-makers to manage technology successfully. In particular, this study intends to identify valuable strategies for technology management decision-making and activities, to detect which one should be addressed by hospitals, and to establish technology management system priorities for health care managers and clinical engineers.

Medical equipment supplied to low- and middle-income countries (LMICs) are often substandard and inappropriate to the contextual needs. The majority of equipment entering these countries are donated or financed by external agencies. Procurement of equipment also happens through public tendering. However, the assessment and management of the equipment entering these countries are found to be inappropriate and ineffective. This has resulted in equipment that remains unused, malfunctions, or fails to meet its expected lifespan. This ultimately causes harmful consequences to the patient groups in LMIC. It is high time that this situation needs to be addressed and implement measures to provide quality, safe, affordable, accessible, and appropriate health technologies to people in these low-resource settings. One approach to create transparency around the notion of appropriate health technologies for LMICs is by creating a set of measurable criteria, tested in the form of a label. A global team of BioMedical engineers undertook an initiative to implement such a label, namely, ‘Appropriate Medical Equipment’ or ‘AME Label’. This research aims to examine the feasibility and constraints associated with implementing such an initiative from the perspective of medical equipment manufacturers. The study investigated four main topics to answer the research question: ‘How can a new product label support medical equipment manufacturers to sustainably enter the healthcare market of low- and middle-income countries?’. These are the value of product labels in the market, regulatory challenges faced by manufacturers in the MedTech industry, challenges for manufacturers in entering LMICs, and perception of manufacturers on the concept of AME label. A combination of desk research and qualitative interview was used to deduce the conclusion. Initially, a case study was conducted involving a medical equipment manufacturer based in the Netherlands, whose operations primarily targeted LMICs. The data was collected through one-to-one online semi-structured interviews with managers within this organization. The preliminary findings formed were later validated through survey and interviews conducted with a globally diverse sample size including industry and academic experts. The results of the study indicated that the adoption of AME label has the potential to benefit manufacturers with enhanced brand value, increased visibility, improved credibility, and greater product transparency in their target markets. These factors can in turn build confidence and trust among LMIC stakeholders on AME-labeled products, opening doors for sustained business opportunities for manufacturers in these countries. By optimizing the product design towards the contextual requirements and including competitive product features, manufacturers could use the AME label as a differentiating factor in their sales. Subsequently, manufacturers could attain higher commercial value for their products and improved operating efficiency in the healthcare market of LMICs. At the same time, it is found that the introduction of the AME label could increase the complexity of the regulatory system. Manufacturers of all sizes face challenges while undergoing any regulatory process, adhering to regulatory norms, or undertaking any product label. This is unavoidable for manufacturers while supplying medical equipment across boundaries. Therefore, the inclination of manufacturers to adopt AME label depends on how effectively it streamlines the supply process, cuts administrative costs, reduces documentation work, and expedites the distribution of equipment to target countries. Considering the novelty of the label, there are some concerns that could hinder the full-fledged adoption of the AME label by manufacturers. These concerns primarily revolve around the reliability and trustworthiness of the label. To overcome these concerns, the AME team should take into account the following aspects when implementing the label. They should carefully plan and execute steps to ensure that the label is recognized and accepted by authorized bodies like the UN, WHO, etc. It is equally important that measures need to be taken in the direction where the label is validated by all relevant stakeholders in LMICs. It is also essential to establish a clear positioning of the AME label within the regulatory system by highlighting the unique testing methods and distinctive tangible advantages it offers to the manufacturers compared to existing labels. By addressing these concerns, the widespread adoption of the AME label by medical equipment manufacturers could be achieved, leading to the availability of appropriate equipment in LMIC hospitals, and ultimately benefiting the patient groups within.

Substance use disorders, particularly alcohol use disorder (AUD), are a major global health challenge, significantly impacting morbidity and mortality rates. In the Netherlands, around 20% of the population is affected by excessive alcohol consumption, with a notable treatment gap and disproportionate effects on the elderly. Despite increased research into AUD treatments, patient numbers remain stable, straining healthcare systems. Moreover, the Dutch government anticipates that addressing the needs of both diagnosed and undiagnosed patients, the workforce should be increased in the general healthcare sector from the current level of 16.67% to 25% of the total Dutch workforce by 2040. Furthermore, existing regulations and policies appear inadequate in effectively managing these demands. This study aims to explore the socio-organisational drivers and policy effects on the Dutch mental health care system, focusing on AUD, to maintain sustainable quality care. It examines organizational drivers, expert perspectives, policy influence on system dynamics, and the relationship between capacity shortages and care quality. The research employs a mixed-method approach, including a literature review, exploratory interviews, a Participatory System Dynamics Modeling (PSDM) workshop, and a comparative analysis of data from 12 mental health services (MHS). Key findings include the significance of internal factors like patient satisfaction and therapeutic alliance, and the crucial role of over and undertreatment considerations during treatment processes. External factors like self-coping, and individualization and blurring of alcohol in shops also influence both treatment effectiveness and alcohol consumption. Current policy regulations inadvertently contribute to capacity shortages and treatment gaps. System Dynamics (SD) modelling reveals that increased regulatory pressures and quality care demands lead to capacity being consumed by administrative tasks and budget gaps. This relates to a 'fixes that fail' archetype, combined with social dynamics like an ageing population and increased alcohol consumption, exacerbates the 'growth and underinvestment' archetype in the Dutch mental healthcare system. The study highlights the unintended consequences of current policies, such as disjointed preventive measures and reduced practitioner autonomy. It also emphasizes the complexity of healthcare systems as revealed by the challenge of identifying cause-and-effect due to multiple aggregational levels, the diverse perspectives on the system both by literature and experts, the varied healthcare contexts and the multi-disciplinary and collaborative nature of (mental) healthcare. Key limitations include not fully addressing safety in health quality and challenges in integrating quantitative methods. This thesis underscores the importance of a holistic approach in healthcare, considering both social and organizational aspects. It suggests that current policies may lead to over-regulation or insufficient prevention awareness, impacting both society and MHS organisations. Adopting a holistic system approach can enhance further understanding of policy impacts crucial for preventing a growing treatment-capacity gap and ensuring a sustainable mental health care system for society’s vulnerable members.