109 research outputs found
Regulating algorithmic decision-making one case at the time:A note on the Dutch 'SyRI' judgment
Een wet op de articifiĂŤle intelligentie?:De Europese wetgever haalt de nationale in
Waar de nationale wetgever nog zoekende is naar haar rol in de regulering van ArtificiĂŤle Intelligentie (AI), is de Europese Commissie voortvarend te werk gegaan met een voorstel dat specifiek betrekking heeft op AI. Op 21 april 2021 publiceerde de Commissie haar voorstel voor een Wet op de ArtificiĂŤle Intelligentie (AI-verordening). De reguleringsinsteek van de Commissie wijkt af van de aanpak die momenteel nog de boventoon voert en waarbij AI âslechtsâ wordt beschouwd als een bepaalde (bijzondere) vorm van geautomatiseerd handelen. Kenmerkend voor de AI-verordening is haar zogeheten ârisicogerichteâ benadering, die ook wel bekend is geworden als de piramidestructuur van de AI-verordening. Dat betekent dat niet elk AI-systeem aan dezelfde verzameling van (geharmoniseerde) regels wordt onderworpen, maar dat de toepasselijke regels worden bepaald door de omvang van het risico dat gepaard gaat met het betreffende AI-systeem. In deze bijdrage staat de vraag centraal wat de gevolgen van de AI-verordening voor de Nederlandse rechtsorde zullen zijn. Want de verwachting is dat het voorstel, weliswaar in gewijzigde vorm wat betreft definities en formuleringen, maar ongeschonden ten aanzien van de hoofdlijnen en de âpiramidevormâ in het bijzonder, de eindstreep gaat halen
Incorporating Baseline Outcome Data in Individual Participant Data Meta-Analysis of Non-randomized Studies.
Background
In non-randomized studies (NRSs) where a continuous outcome variable (e.g., depressive symptoms) is assessed at baseline and follow-up, it is common to observe imbalance of the baseline values between the treatment/exposure group and control group. This may bias the study and consequently a meta-analysis (MA) estimate. These estimates may differ across statistical methods used to deal with this issue. Analysis of individual participant data (IPD) allows standardization of methods across studies. We aimed to identify methods used in published IPD-MAs of NRSs for continuous outcomes, and to compare different methods to account for baseline values of outcome variables in IPD-MA of NRSs using two empirical examples from the Thyroid Studies Collaboration (TSC).
Methods
For the first aim we systematically searched in MEDLINE, EMBASE, and Cochrane from inception to February 2021 to identify published IPD-MAs of NRSs that adjusted for baseline outcome measures in the analysis of continuous outcomes. For the second aim, we applied analysis of covariance (ANCOVA), change score, propensity score and the naĂŻve approach (ignores the baseline outcome data) in IPD-MA from NRSs on the association between subclinical hyperthyroidism and depressive symptoms and renal function. We estimated the study and meta-analytic mean difference (MD) and relative standard error (SE). We used both fixed- and random-effects MA.
Results
Ten of 18 (56%) of the included studies used the change score method, seven (39%) studies used ANCOVA and one the propensity score (5%). The study estimates were similar across the methods in studies in which groups were balanced at baseline with regard to outcome variables but differed in studies with baseline imbalance. In our empirical examples, ANCOVA and change score showed study results on the same direction, not the propensity score. In our applications, ANCOVA provided more precise estimates, both at study and meta-analytical level, in comparison to other methods. Heterogeneity was higher when change score was used as outcome, moderate for ANCOVA and null with the propensity score.
Conclusion
ANCOVA provided the most precise estimates at both study and meta-analytic level and thus seems preferable in the meta-analysis of IPD from non-randomized studies. For the studies that were well-balanced between groups, change score, and ANCOVA performed similarly
The Disjointed Dutch Policies to Fight COVID-19
The lyrics of a popular 90s Nederpop song called â15 miljoen mensenâânamed after the number of inhabitants in the Netherlands at the timeâfamously contains the line that on the âtiny piece of Earthâ that is the Netherlands âone does not lay down the law.â Indeed, Dutch Prime Minister Mark Rutte may have had in the back of his mind the conventional wisdom that the Dutch do not like to bow to authority when he called for an âintelligent lockdownââa term that the Prime Minister personally invented. By calling the approach a âlockdown,â it becomes harder for opposition hawks to criticize the government. According to one report, the meaning of the word âintelligentâ is twofold: people are called upon to be âsmartâ about the situation, and the government wants to convey that it intends to be flexible when it comes to adjusting measures over time. It does not, however, appear to be a reference to âsmart regulation.â The intelligent lockdown approach emerged in mid-March, following the National Institute for Public Health and the Environmentâs slow reaction to COVID-19 during the early days of the pandemic. Like in Britain, the Prime Minister in the Netherlands flirted with the idea of herd immunity. In a speech on March 16, Rutte indicated that out of three possible approachesâmitigating the virusâs spread, allowing the virus to run its course, and working endlessly to contain the virusâthe government had chosen mitigation. The National Institute for Public Health and the Environment and the Prime Minister both quickly clarified that herd immunity was not the governmentâs aim, but rather a by-product of the pandemic. In subsequent communications, the government avoided the controversial term, but in essence the Dutch approach remains âto control the virus as much as possible,â which means that it is not always clear whether the strategy is to do everything reasonably possible to fight the spread of the virus or to âflatten the curve but not too much.â The sizable list of Dutch coronavirus measures grew over the course of several weeks in March and April 2020. The intelligent lockdown was given effect through a Swedish-style collection of recommendations, which cannot be traced to any official document, and a set of rules and bans laid down in decentralized emergency regulations. The result is a confusing blend of soft law, hard law, general norms, such as âstay at home as much as possible,â and overwhelmingly specific policies, including mandatory requirements that people stay home if they have certain symptoms. The Dutch regulatory approach also has some overly subtle distinctions, such as the difference between âorganized gatherings,â which are prohibited everywhere with certain exceptions, and âspontaneous gatherings,â which are allowed in most places with 1.5 meters interpersonal distance. These subtle distinctions make for a compliance nightmare. The Netherlands is among the countries that did not invoke a state of emergency, but instead it relied on the possibility of enacting regional emergency regulations. The Dutch unitary but decentralized state structure at first glance appears to be relatively deferential to local government. The regional emergency regulations are adopted by 25 safety regions, which have existed since 2010 and consist of collectives of municipalities that specifically cooperate on security matters. Super mayorsâthe mayors of the largest cities in these regionsâare authorized to adopt these emergency regulations. The regions, however, have coordinated on the vast majority of provisions with involvement from the central government. This coordination has resulted in a core set of what effectively are national rules, with some regions adopting additional bans on activities such as tourism and barbecuing from the start, and with more differentiation occurring as the easing of the lockdown began in the first half of May. Critics of the regional emergency regulations have raised questions about the constitutionality of these regulatory measures. A crucial difference between these regulations, based in Article 176 of the Municipalities Act, and emergency laws and regulations adopted in a state of emergency, is that the former must comply with the Dutch Constitution in its entirety. The COVID-19 emergency regulations do not, however, always comply with the Dutch Constitution. For instance, the emergency regulations banning gatherings include exceptions for religious gatherings, in compliance with the Constitution, but not for other constitutionally protected practices. A COVID-19 emergency regulation has been used at least once to prohibit a far-right demonstration, when a regulation of this kind cannot lawfully sustain such a decision. Authorities also assert that these regulations could be used to break up and sanction gatherings in private homes, violating Article 12 of the Constitution, which outlaws âentry into a home against the will of the occupant.â The government could address some of these concerns by declaring a state of emergency and adopting emergency statutes. This approach would not, however, address every issue because Article 103 of the Constitution, which regulates the state of emergency, contains a limited list of rights that may be set aside. There also appears to be a consensus among the Dutch constitutional law community that declaring a state of emergency would not be suitableâor at least necessaryâbecause regular statutes may limit most constitutional rights to a certain extent. In response to criticism, the government announced that it is preparing urgent statutory legislation to replace most of the emergency regulations, acknowledging that the current construction of regional emergency regulations is too much of a shortcut. Despite these changes, the infamous absence of constitutional review of legislation in the Dutch system is likely to cast its shadow over this process. The Netherlandsâs chosen regulatory blend of soft and hard law and of advice and command-and-control creates a high degree of uncertainty, resulting in a lot of private discretionary decision-making. For instance, people tend to reconcile inconsistencies in the above-mentioned rules about different types of gatherings in a highly personalized way. Public spaces throughout the country remain crowded, indicating that people in the Netherlands do not all have the same ideas about when going outside is necessary. The governmentâs warnings that compliance on weekends was too low had some effect in the subsequent weekends, but overall compliance varies tremendously among people and over periods of time. On Kingâs Day, April 27, the Dutch largely stayed at home, but on several normal Sundays certain parks, beaches, and city centers were flooded with people. Perfect compliance is not necessary for the governmentâs COVID-19 regulations to be effective. The Prime Ministerâs mitigation strategy can handle a few free-riders. The strategy, however, crucially hinges on the governmentâand specifically the Prime Ministerâbeing able to convince the majority of Dutch people to take the rules and recommendations seriously. One of Rutteâs favorite lines in his COVID-19-themed press conferences is âwe are doing this with 17 million people.â But here the approach encounters its fatal flaw. Changing behavior was always going to be difficult due to the Dutch peopleâs dominant lifestyle and individualistic mindset. Bringing about such change is even harder because it must be done with a set of very open or very legalistic norms that regulators appear to have designed to make compliance difficult and arbitrary. Although both the substance of the COVID-19 challenge and the institutional setting are well-suited for regulations based on behavioral analysis, the Netherlands missed the opportunity to adopt such regulations. As in most countries, some behavioral tactics have been employed, such as tape on the floors of shops to indicate the desired distance to keep apart. The government has not experimented, however, with smart behavior-oriented instructions such as directing people to think of themselves as asymptomatic contagious carriers of the virus every time they leave the house. The shortcomings of the COVID-19 regulatory framework result from a number of challenges. The government did not have sufficient time to prepare for the pandemic and was forced to react quickly. The governmentâs main advisory body lacks transparency and multidisciplinarity. Now that it appears, however, that the Netherlands will be in crisis mode for the foreseeable future, hopefully Dutch authorities will take the time to integrate behavioral insights into their regulatory approach to address the pandemic
Impact assessment in EU lawmaking
The European Commission introduced impact assessment (IA) in 2002 following recommendations from the Mandelkern group on Better Regulation. The basic rationale of IA is that proposals must be prepared on the basis of an analysis of whether regulatory intervention is needed and whether it is appropriate to intervene at the EU level. An IA report, published together with the proposal, summarises the results and highlights the trade-offs between the potential economic, social and environmental impacts associated with various policy options. Nowadays, IA is required for all major proposals. It is also increasingly being used throughout the whole legislative process as the European Parliament and the Council of Ministers are implementing their respective commitments to IA. The thesis starts out by developing a typology of possible uses of impact assessment in EU lawmaking, which serves as a framework of reference for the subsequent analysis of the development of EU IA. The idea is explored that the three âco-legislatorsâ are not the only relevant actors in IA processes; national institutions, advisory bodies, review institutions, regulatory bodies, private co-actors and third-country actors all play their part. Case-studies on the new chemicals regulation (REACH), the thematic strategy on air quality (CAFE), the pre-packaging directive and the data retention directive lend empirical backing to the theoretical claims. The thesis arrives at the conclusion that IA is becoming a self-standing normative force in EU lawmaking by contrasting EU IA as 'soft constitutional law' and EU IA as 'meta-regulation'.The Legitimacy and Effectiveness of Law & Governance in a World of Multilevel Jurisdiction
âDe toekomst van het bestuursrechtâ â een reactie vanuit Europeaniseringsperspectief
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