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(Series Information) European Papers - A Journal on Law and Integration, 2023 8(2), 583-610 | Article | (Table of Contents) I. Introduction. – II. The evolution of the “New Approach” to harmonisation in the EU: setting the scene. – II.1. The “New Approach” to technical harmonisation. – II.2. The Digital Single Market. – III. Harmonisation in the Draft AI Act: old wine in a new bottle, or new wine? – III.1. Risk-based approach of the Draft AI Act. – III.2. The “New Approach” technique in the Draft AI Act. – III.3. “Privatization” of AI Regulation by ESOs and conformity assessment bodies. – IV. Future-proofing AI regulation through the “New Ap-proach”. – IV.1. The future-proofness from the perspective of the Internal Market. – IV.2. Future-proofness from the perspective of fundamental rights and ethics. – IV.3. The future-proofness from a democratic and legitimacy perspective. – V. Conclusion and recommendations. | (Abstract) In April 2021, the European Commission proposed a Regulation on Artificial Intelligence (AI) as part of a package of EU legislative harmonization measures that seek to tackle the societal challenges of digitalization and technological innovation. The proposed legislation draws heavily on the “New Approach” technique for the technical harmonization and standardization of goods. This raises several questions and concerns. Firstly, it can be questioned whether a harmonization technique that has been developed for health and safety standards in the offline, physical market, can be that easily transposed to the field of AI, where ethical and fundamental rights issues abound. Secondly, despite its success, the “New Approach” regulatory technique has been subject to much criticism, such as the responsibility of the manufacturers to carry out a conformity assessment, the role and decision-making powers of the private law standardization organizations and notified bodies, and the lack of public participation and public oversight in standardization and certification processes. These concerns are aggravated in the AI environment due to the pertaining legal, ethical and fundamental rights issues. This Article therefore seeks to explore the future-proofness of the proposed AI Act from three perspectives: i) the internal market; ii) protection of fundamental rights and iii) democratic legitimacy in the EU decision-making processes. Ultimately, it offers a broader reflection on the policy and legal implications of AI and proposes a number of recommendations on how to increase the fitness of the future AI Act, bearing in mind the balance between the economic and fundamental rights goals of the AI Regulation.

(Series Information) European Papers - A Journal on Law and Integration, 2023 8(2), 579-582 | Article | (Abstract) This Special Section is devoted to assessing whether core areas and core values of European law are future-proof (and how they could or should be made future-proof) in light of developments in terms of digitalisation and technological innovation. It is the result of a joint project of researchers at the Utrecht Centre for Regulation and Enforcement in Europe (RENFORCE) at Utrecht University, focusing on the impact of digitalisation in different fields of EU law including EU internal market law, consumer protection law, data protection law, competition law, financial law, intellectual property law and criminal law. Digital technologies create various challenges, in many cases associated with the use of algorithms, the massive collection of personal data and the possibilities (and difficulties) of access to digital content. All these challenges require careful consideration, and regulation and enforcement arrangements which protect and balance the possibly conflicting values that we deem important in our societies, including innovation and technological development and protection of fundamental rights. Yet, it is exactly the continuous and fast-paced technological developments that make it difficult to regulate in these areas. In the EU, this response is predominantly shaped and guided within the multi-level legal order, whereby the EU legislature has gained a growing role in shaping our digital societies. The Special Section editors hope that the contributions provide food for thought, useful insights and inspiration for the process of making regulation and enforcement in the EU (more) future-proof for digitalisation – both within the specific fields of expertise and beyond.

(Series Information) European Papers - A Journal on Law and Integration, 2022 7(3), 1405-1429 | Article | (Table of Contents) I. Introduction. - II. Different levels of social mainstreaming and EU law. - II.1. The relationship be-tween the economic and social at EU level. - II.2. Art. 9 TFEU. - III. A story of hope (I): Art. 9 TFEU, EU competition law, and the Four Freedoms. - III.1. The "social exemption" for collective bargaining. - III.2. Social interests as an exception ground to free movement. - IV. A story of hope (II): Art. 9 TFEU and EU legislative harmonisation. - IV.1. The internal market legal bases of inter alia art. 114 TFEU. - IV.2. The importance of art. 153 TFEU in making the EU internal market more socially inclusive. - V. Fears undermining the safeguarding of social interests in the EU single market through art. 9 TFEU. - V.1. Relatively vague and unclear wording of art. 9 TFEU. - V.2. The constitutionalisation of EU (free movement) law and the unclear scope of EU fundamental social rights protection. - V.3. The (some-times) flawed reasoning in the case law on EU free movement law. - V.4. The question of competence, technological innovation and digitalization. - VI. Conclusion. | (Abstract) In this Article, we assess to what extent art. 9 TFEU, which contains the social mainstreaming clause, may be used to shore up the social dimension of the EU Single Market. The story of hope of a more socially inclusive internal market starts with the "porous" EU internal market legal framework itself and ends with art. 153 TFEU and the European Pillar of Social Rights. Yet, there are also fears that, despite the language of social mainstreaming, the EU cannot deliver on the promise of art. 9 TFEU for various reasons, including the limited legislative competences of the EU to pursue social policies. While we mainly want to emphasize the story of hope, we will also look into the fears and how some of these could be addressed.

This contribution shines a critical light on the representation of Afrikaans as a language of the Church in external histories about the development and advancement of the language, inclusive histories particularly. It seems the history of Afrikaans within a Christian or Church context has escaped the critical attention which since the 1970s created awareness of the politicisation of and silences in the history, and the way in which the history is documented. Therefore, the history of Afrikaans as a language of the Christian faith is still told from an exclusively white Reformed perspective and held as a 20 th century phenomenon, despite research pointing to its usage in the Moravian Church (Genadendal) in the 18 th century and the Anglican Church in the 19 th century. Though various denominations are included in so-called inclusive histories, it is done in a manner that suggests the dominance of the white Reformed Churches. These conclusions were primarily drawn from a content analysis of two inclusive histories, subjecting them to the same penetrating, sceptical questions of decades ago, focused primarily on the representation of Afrikaans as a language of the Church. For this purpose, the inclusive histories were analysed within the framework of poststructuralist tendencies which shifted the focus to historiography as a function of power, a meaning-making practice and history as a construct, not a reconstruction of the past. As such it creates space to imagine alternatives to the dominant discourse. To this end, the attention is drawn to the mobilisation of Afrikaans in the Roman Catholic Church since the 1820s as an alternative history of a spoken Afrikaans praying at the altar long before it was formalised and allowed to ascend the pulpit in the Reformed Churches since 1916.

Comments upon the polysemy of the names of Calisto and Melibea and suggests that the latter was taken from the name of a town in Thessaly mentioned by Homer.

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In Ezek 11:16, we find the promise that YHWH will be for the people of Israel in exile a מִקְדָּ֣שׁ מְעַט. This promise of YHWH is an answer to the desperate exclamation of the prophet: “Ah, Lord God! Will you make a full end of the remnant of Israel?” (Ezek 11:13b). In this article, I investigate not only whether we must understand this expression as “a little sanctuary” or “a sanctuary for a while”, but also in what sense we must understand the presence of YHWH among the exiles in the form of a sanctuary. Ezekiel was the only Hebrew prophet mentioned in the HB to receive his calling in exile. The kernel of his message was that hope for Israel would exclusively be realized through the exilic community. The readers of his book are urged to distance themselves from the past and orientate themselves on the future. In his second vision, the prophet sees the glory of YHWH depart the temple. This is the very time at which he receives the promise for the exilic community that YHWH will be for them a מִקְדָּ֣שׁ מְעַט. This expression can be understood both as a small and a temporal sanctuary. In exile, both the prophet himself and the oracles of hope he receives mediate the presence of YHWH for the exilic community. Hence, we can say that the message of the prophet Ezekiel is the embodiment of the מִקְדָּ֣שׁ מְעַט, and especially with the final vision of the return of the glory of YHWH to a completely new and purified temple, Ezekiel the prophet functions as a priest. This vision gives hope to the exiles in their present condition. It also makes clear that when that is fulfilled, a מִקְדָּ֣שׁ מְעַט will be finally be a thing of the past. The temporary character of the מִקְדָּשׁ will then definitely have elapsed, and the presence of YHWH will no longer be a reduced presence.

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Abstract In 1999 Hurricane Floyd pummeled the eastern portion of North Carolina (NC, U.S.A.), and in its wake many localities participated in federal home acquisition-relocation programs in flood-prone areas, with shared and devolved governance. This article reports on one such program that was conducted in the City of Kinston, where a historical African-American neighborhood called Lincoln City was badly flooded by water containing raw sewage from a compromised wastewater treatment plant upstream. Afterwards, some of the acquired homes were relocated to an adjacent area populated by middle-class, African-American families. The article explores to what extent political devolution of flood mitigation disempowered residents to deal with this crisis in their waterscape. Combining a framework from medical anthropology regarding the logics of choice and care with historical political ecology, it illustrates how devolved government policy led to a continuation of the waterscape's discriminatory history after the buyout program, with no recourse for local citizens as the program worked through a logic of choice that demarcated responsibilities. Understanding this case requires a historically informed assessment of social impact, in which the chosen flood mitigation measures are critically assessed using tools from historically-informed political ecology, leading to a longerterm logic of care where needed. Keywords: Devolution, flooding, path-dependency, waterscape, buyout, mitigation, care, choice

Background: There is a global increase in the prevalence of non-communicable diseases and a growing understanding that patients need to be involved in their care. Patient experience should be assessed and the information used to improve on the planning and delivery of health services. Aim: This study described the development and validation of a patient-reported experience measure (PREM) tool which is appropriate for the South African context, to assess self-reported patient experience of chronic care. Setting: The study was conducted at four primary health care facilities in the Cape Town Metropole. Methods: This was a validity and reliability study with multiple phases to develop and determine the psychometric properties of a novel tool. It consisted of three phases, namely: Phase 1 – Consensus Validity; Phase 2 – Face Validity; Phase 3 – Reliability. Phase 1 consisted of an expert panel reaching consensus on a draft tool. Phase 2a consisted of qualitative semi-structured interviews and cognitive interviews. Phase 3 tested the internal consistency of the tool, the time necessary to complete, as well as floor and ceiling effects with 200 questionnaires. Results: The process described resulted in a final questionnaire with n = 10 items in three languages that was easily understood by patients. Internal consistency was determined with the overall Cronbach’s alpha 0.86. This PREM has been named Chronic Care Assessment of Patient Experience. Conclusion: Using best practice guidance in tool construction and validation, we delivered a PREM with the potential to improve the quality of care from the perspective of patients. Implementation studies are now required to determine how best to use this tool in routine practice.

The dynamics of drugs discovery imposes severe time constraints on the development chemist in charge of implementing the large scale production of a new Active Pharmaceutical Ingredient (API). This results in the use of well-established and robust transformations at the expense of the cost-efficiency and the sustainability of the process. In order to cope with the short development time and allow the implementation of new more efficient production technologies such as asymmetric hydrogenation, we have turned towards the use of high throughput experimentation for the discovery of new catalysts. The protocol for the preparation of a library of chiral ligands and its application to real-life pharmaceutical molecules is described in this article. La découverte de nouvelles molécules pharmaceutiques a sa propre dynamique qui impose des contraintes temporelles très strictes au chimiste en charge de développer la production du principe actif à large échelle. En conséquence, ce dernier va se tourner vers l’utilisation de technologies éprouvées et robustes quitte à rendre le procédé plus coûteux ou plus polluant. Afin de pouvoir faire face à des temps de développement très courts et d’introduire en production des technologies modernes et non polluantes comme l’hydrogénation asymétrique, nous avons développé une plateforme de criblage haut débit pour la découverte de nouveaux catalyseurs. Dans cet article, nous décrivons une des facettes de cette plateforme qui est la synthèse de librairies de ligands chiraux et leur application au cas réel d’une molécule pharmaceutique.

L’ouverture actuelle des jeux de formation vers des environnements hybrides (numériques et non numériques) et des objectifs d’apprentissages plus larges complexifie la nature des interactions entre les acteurs durant les différentes phases de la conception d’un tel jeu et interroge les pratiques mobilisées. Notre étude s’attache à décrire les ressources interactionnelles mobilisées lors de la conception de jeux épistémiques numériques. En nous appuyant sur des enregistrements vidéo, nous nous intéressons à la manière dont les pratiques des participants, au fil des différentes phases de la conception d’un jeu, configurent les interactions. Au-delà de l’intérêt théorique, la problématisation des ressources mobilisées est nécessaire à une meilleure compréhension des mécanismes mis en oeuvre pour la production d’un jeu et pour l’apprentissage des joueurs. Elle permet ainsi un éclairage sur les conditions qui pourraient avoir un effet sur l’efficacité de ce type de dispositifs.

This paper examines the construction of real estate databases and the valuation of properties in Buzau, Romania. One of the criteria for candidate states for EU membership is an effective monitoring system for the land and real estate markets.The objective of this paper is twofold. First, the development of a set of databases, procedures and guidelines that enables a valuation process on the Romanian real estate market and secondly, using those databases, to gain insight into the real market value of recently sold properties. We use the observations of estate agents and banks starting in May 2007. Using hedonic regression, with house andneighbourhood characteristics, we estimate the house prices

Background: An integrated audit tool was developed for five chronic diseases, namely diabetes, hypertension, asthma, chronic obstructive pulmonary disease and epilepsy. Annual audits have been done in the Western Cape Metro district since 2009. The year 2012 was the first year that all six districts in South Africa’s Western Cape Province participated in the audit process. Aim: To determine whether clinical audits improve chronic disease care in health districts over time. Setting: Western Cape Province, South Africa. Methods: Internal audits were conducted of primary healthcare facility processes and equipment availability as well as a folder review of 10 folders per chronic condition per facility. Random systematic sampling was used to select the 10 folders for the folder review. Combined data for all facilities gave a provincial overview and allowed for comparison between districts. Analysis was done comparing districts that have been participating in the audit process from 2009 to 2010 (‘2012 old’) to districts that started auditing recently (‘2012 new’). Results: The number of facilities audited has steadily increased from 29 in 2009 to 129 in 2012. Improvements between different years have been modest, and the overall provincial average seemed worse in 2012 compared to 2011. However, there was an improvement in the ‘2012 old’ districts compared to the ‘2012 new’ districts for both the facility audit and the folder review, including for eight clinical indicators, with ‘2012 new’ districts being less likely to record clinical processes (OR 0.25, 95% CI 0.21–0.31). Conclusion: These findings are an indication of the value of audits to improve care processes over the long term. It is hoped that this improvement will lead to improved patient outcomes.

Background: In Tanzania, a country of 42 million, access to oral morphine is rare. Aim: To demonstrate the effectiveness of palliative care teams in reducing patients’ pain and in increasing other positive life qualities in the absence of morphine; and to document the psychological burden experienced by their clinical providers, trained in morphine delivery, as they observed their patients suffering and in extreme pain. Setting: One hundred and forty-fie cancer patients were included from 13 rural hospitals spread across Tanzania. Method: A mixed method study beginning with a retrospective quantitative analysis of cancer patients who were administered the APCA African POS tool four times. Bivariate analyses of the scores at time one and four were compared across the domains. The qualitative arm included an analysis of interviews with six nurses, each with more than fie years’ palliative care experience and no access to strong opioids. Results: Patients and their family caregivers identifid statistically signifiant (p < 0.001) improvements in all of the domains. Thematic analysis of nurse interviews described the patient and family benefis from palliative care but also their great distress when ‘bad cases’ arose who would likely benefi only from oral morphine. Conclusion: People living with chronic cancer-related pain who receive palliative care experience profound physical, spiritual and emotional benefis even without oral morphine. These results demonstrate the need for continued advocacy to increase the availability of oral morphine in these settings in addition to palliative care services.

The WTI2017 project is responsible for the development of flood defence assessment tools for the 3600 km of Dutch primary flood defences, dikes/levees, dunes and hydraulic structures. These tools are necessary, as per January 1st 2017, the new flood risk management policy for the Netherlands will be implemented. Then, the seven decades old design practice (maximum water level methodology of 1958) and two decades old safety standards (and maximum hydraulic load methodology of 1996) will formally be replaced by a more risked based approach for the national policy in flood risk management. The formal flood defence assessment is an important part of this new policy, especially for flood defence managers, since national and regional funding for reinforcement is based on this assessment. This new flood defence policy is based on a maximum allowable probability of flooding. For this, a maximum acceptable individual risk was determined at 1/100 000 per year, this is the probability of life loss of for every protected area in the Netherlands. Safety standards of flood defences were then determined based on this acceptable individual risk. The results were adjusted based on information from cost -benefit analysis, societal risk and large scale societal disruption due to the failure of critical infrastructure e.g. power stations. The resulting riskbased flood defence safety standards range from a 300 to a 100 000 year return period for failure. Two policy studies, WV21 (Safety from floods in the 21st century) and VNK-2 (the National Flood Risk in 2010) provided the essential information to determine the new risk based safety standards for flood defences. The WTI2017 project will provide the safety assessment tools based on these new standards and is thus an essential element for the implementation of this policy change. A major issue to be tackled was the development of user-friendly tools, as the new assessment is to be carried out by personnel of the institutions managing flood the defences, and not by just a small number of experts in probabilistic assessment. Therefore, data management and use of software are main issues that have been covered in courses and training in 2016 and 2017. All in all, this is the largest change in the assessment of Dutch flood defences since 1996. In 1996 probabilistic techniques were first introduced to determine hydraulic boundary conditions (water levels and waves (wave height, wave period and direction for different return periods). To simplify the process, the assessment continues to consist of a three-step approach, moving from simple decision rules, to the methods for semi-probabilistic assessment, and finally to a fully probabilistic analysis to compare the strength of flood defences with the hydraulic loads. The formal assessment results are thus mainly based on the fully probabilistic analysis and the ultimate limit state of the strength of a flood defence. For complex flood defences, additional models and software were developed. The current Hydra software suite (for policy analysis, formal flood defence assessment and design) will be replaced by the model Ringtoets. New stand-alone software has been developed for revetments, geotechnical analysis and slope stability of the foreshore. Design software and policy analysis software, including the Delta model, will be updated in 2018. A fully probabilistic method results in more precise assessments and more transparency in the process of assessment and reconstruction of flood defences. This is of increasing importance, as large-scale infrastructural projects in a highly urbanized environment are increasingly subject to political and societal pressure to add additional features. For this reason, it is of increasing importance to be able to determine which new feature really adds to flood protection, to quantify how much its adds to the level of flood protection and to evaluate if it is really worthwhile. Please note: The Netherlands government policy is to develop open source models.

Vegetated foreshores in front of existing dikes can contribute to the overall reduction of wave loads on the dike. In order to test this concept in large shallow lakes a field pilot was constructed along the Houtribdijk in Lake Markermeer (the Netherlands) in 2014 to gain experience with construction, stability, maintenance and governance aspects. A large scale monitoring programme was set up to follow the hydrodynamic forcing, morphological changes and vegetation development on the pilot. The pilot is located on an exposed south-westerly direction, and experiences substantial wave impact. As a result the desired vegetation on the land-water interface has not been able to establish, but a rather dynamic sandy beach is currently the main feature along the waterline of the site. Higher up the slope planted reeds, and a mixture of willows has well established itself in the first growing season. The exposed position of the location makes that hardly any natural pioneer vegetation has settled, only in small sheltered areas some annuals were able to germinate and maintain themselves.

Predicting spalling of concrete due to fire loading is undoubtedly a complex task to come across. Existing numerical models are dealing with the phenomena on different complexity levels of describing the physical/chemical processes and material behavior. But still they do not take the highly stochastic nature of these processes into account. This paper discusses a proposal to develop a practical prediction method based on simplify numerical models and the probabilistic approach.