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Medical research is increasingly becoming data-intensive; sensitive data are being re-used, linked and analysed on an unprecedented scale. The current EU data protection law reform has led to an intense debate about its potential effect on this processing of data in medical research. To contribute to this evolving debate, this paper reviews how the dominant 'consent or anonymise approach' is challenged in a data-intensive medical research context, and discusses possible ways forwards within the EU legal framework on data protection. A large part of the debate in literature focuses on the acceptability of adapting consent or anonymisation mechanisms to overcome the challenges within these approaches. We however believe that the search for ways forward within the consent or anonymise paradigm will become increasingly difficult. Therefore, we underline the necessity of an appropriate research exemption from consent for the use of sensitive personal data in medical research to take account of all legitimate interests. The appropriate conditions of such a research exemption are however subject to debate, and we expect that there will be minimal harmonisation of these conditions in the forthcoming EU Data Protection Regulation. Further deliberation is required to determine when a shift away from consent as a legal basis is necessary and proportional in a data-intensive medical research context, and what safeguards should be put in place when such a research exemption from consent is provided.

Objective: To give an overview of disciplinary cases regarding action taken by paediatricians and paediatric residents in cases of (suspected) child abuse and to discuss the considerations of the disciplinary board in these cases., Design: Retrospective, descriptive study., Method: We considered all disciplinary cases instigated from 2001 to 2013 against paediatricians or paediatric residents and selected complaints regarding action taken in cases of (suspected) child abuse. We divided these complaints into six categories and studied the considerations of the disciplinary board in these cases., Results: From 33 disciplinary cases instigated from 2001 to 2013, we selected 76 complaints regarding action taken by paediatricians or paediatric residents in cases of (suspected) child abuse. The majority of these complaints concerned the reporting or requesting of information in the context of (suspected) child abuse. All of the complaints in the category 'unwarranted reporting of child abuse' were declared unfounded by the disciplinary judge., Conclusion: The disciplinary board declared all complaints unfounded in cases where the paediatrician or paediatric resident had followed the Dutch national protocol regarding reporting of child abuse and domestic violence. The disciplinary board examines whether action was taken in accordance with reasonable standards of professional competence and considers that paediatricians have an important role in identifying child abuse.

This article describes the role played by a patient's mental competency in the assessment and treatment of patients who are under the influence of alcohol and expressing suicidal thoughts. The factors that should be taken into consideration in the assessment of suicidality are not always clear: somatic complications or possible discharge from the emergency room. The treating physician at the emergency department should evaluate the mental competency. The risk of suicide should also be assessed by a psychiatrist. In order to make the right decisions about treatment and mental competency, the key concepts of proportionality, effectiveness and subsidiarity in the assessment of mental competency are crucial. These concepts require a personalized, multidisciplinary approach and result in unique decisions which may differ from case to case. In the assessment and treatment of patients under the influence of alcohol who are suicidal and do not want to have a proper medical evaluation, communication between the emergency physician, internist and psychiatrist is crucial to optimize both evaluation and treatment. In this context, tasks and responsibilities should be clearly defined in order to minimize the risk of errors and complications.

Objective: Investigation into the considerations taken into account by the central and regional disciplinary tribunals for the health service (CTG and RTG) in cases where a doctor was permanently removed from the national professional register., Design: Retrospective study of jurisprudence and literature., Method: A search was carried out for jurisprudential cases in which doctors were removed from the professional register during the period January 2006-December 2011, using the following sources: the websites of the disciplinary tribunals, the Dutch Government Gazette (Staatscourant) and two journals concerned with healthcare law. The verdicts were analysed, general statistical records were kept and categories for the consideration were set up on the basis of short, characteristic quotations from the verdicts. These verdicts were subsequently re-examined and divided into these categories., Results: A total of 34 verdicts concerning 13 different physicians were found in the study period. There were 17 verdicts from the RTGs and 16 verdicts from the CTG. One verdict was pronounced by the Medical Supervisory Board (CMT). In 12 cases the final verdict was permanent removal from the professional register. In one case the CTG imposed a lower sanction than that earlier imposed by the RTG. The most common considerations taken into account by removal from the professional register were the combination of medical-technical errors, incomplete and/or inaccurate maintenance of patient records and the doctor's attitude towards his or her own actions., Conclusion: Removal from the professional register is rarely imposed. In most cases, an accumulation of obvious errors is involved. Improper sexual behaviour is also punished severely. Acting in accordance with professional medical standards, adequate medical record-keeping and self-reflection are important factors in the prevention of this sanction.

Physicians are expected to take into account the cost of medical decisions. From a legal point of view, this need not to be problematic as long as it does not detract from good care. A controversial issue is whether a doctor may offer a less effective treatment than would be possible, because of financial constraints. At present, the courts in the Netherlands would seem to leave only marginal room for that, although they do not require a maximization of care. This means that clinical practice guidelines cannot be based, at least not to an unlimited extent; on cost-effectiveness, if they are to retain their professional character. If this restriction is not respected and cost-effectiveness based guidelines are not distinguished from professional ones, a likely result is confusion over their legal status and over the professional duties and liability of physicians.

Recent health legislation in the Netherlands makes specific provisions for patients who are not (fully) capable of acting reasonably in their own interests. If this legislation is actually to improve the legal position of incompetent people, it must be clear to whom these provisions apply. The description in modern legislation is that the person 'is regarded as not being able to make a reasonable assessment of his interests in the issue in question'. The law does not provide criteria according to which competence can be assessed in practice. In the present study, data on the competence assessment of 133 clients were collected by means of a poll held among those people who decide on competence in practice and a total of 485 assessors were polled. Client files were also examined with the intention of gaining insight into the carers' motivation to involve or exclude clients from the decision-making process. Finally, interviews were conducted with clients who have a mild or moderate intellectual disability. Large differences appeared to exist between the various assessors in the assessment of the general competence of clients. A general assessment of a client's competence is not sufficient in daily practice; therefore, partial competence was also assessed. Opinions about the partial competence of clients varied considerably among assessors. A ranking was compiled of discriminating characteristics in the qualification of competence or incompetence.