[Don't lose sight of the disadvantages of screening: concerns on proposed amendments of the Dutch Population Screening Act]. / Verlies de nadelen van screening niet uit het oog.

There are more and more possibilities to screen individuals early for health problems or risks thereof. When it comes to screening, it is tempting to think: the sooner a disease (risk) is detected, the better. But screening also has disadvantages, such as distress and fear among participants and the need for further diagnostics in the event of a positive result, with all the related medical risks and burden on the health care system. In short, screening is only useful if the benefits outweigh the disadvantages. In this article we discuss - by means of examples - ethical considerations relevant for weighing the benefits and disadvantages of screening. In closing we reflect on future legislation pertaining to screening that - in our opinion - leaves too much leeway for screening of which the disadvantages outweigh the benefits.

Resuscitation with an AED: putting the data to use.

The increased use of the automated external defibrillator (AED) contributes to the rising survival rate after sudden cardiac arrest in the Netherlands. When used, the AED records the unconscious person's medical data (heart rhythm and information about cardiopulmonary resuscitation), which may be important for further diagnosis and treatment. In practice, ethical and legal questions arise about what can and should be done with these 'AED data'. In this article, the authors advocate the development of national guidelines on the handling of AED data. These guidelines should serve two purposes: (1) to safeguard that data are handled carefully in accordance with data protection principles and the rules of medical confidentiality; and (2) to ensure nationwide availability of data for care of patients who survive resuscitation, as well as for quality monitoring of this care and for related scientific research. Given the medical ethical duties of beneficence and fairness, existing (sometimes lifesaving) information about AED use ought to be made available to clinicians and researchers on a structural basis. Creating a national AED data infrastructure, however, requires overcoming practical and organisational barriers. In addition, further legal study is warranted.

[Whole-body donation in the Netherlands: Current regulations and suggestions for improvement]. / Lichamen voor onderwijs en wetenschap.

Whole-bodies, or human cadavers, are of great value for medical education and science. The process of body donation and its regulation is, however, questionable. The Dutch legal framework is not sufficient. For example, the collaboration of anatomy departments with industry is not covered by existing regulations. Also, it is unclear what should be done in case of unexpected findings. Moreover, consent in whole-body donation does not meet specific conditions for informed consent. It takes the form of 'broad consent', allowing for unspecified use of the bodies. A monitoring system concerning the use for a specific educational program or research falls is absent. Therefore, we propose to develop a Code of Conduct and an adequate system of monitoring.

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands.

BACKGROUND: Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. METHODS: We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. RESULTS: Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries. CONCLUSIONS: Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Privacy of patient data in quality-of-care registries in cardiology and cardiothoracic surgery: the impact of the new general data protection regulation EU-law.

Quality-of-care registries have been shown to improve quality of healthcare and should be facilitated and encouraged. The data of these registries are also very valuable for medical data research. While fully acknowledging the importance of re-using already available data for research purposes, there are concerns about how the applicable privacy legislation is dealt with. These concerns are also articulated in the new European law on privacy, the 'General Data Protection Regulation' (GDPR) which has come into force on 25 May 2018. The aim of this review is to examine what the implications of the new European data protection rules are for quality-of-care registries in Europe while providing examples of three quality-of-care registries in the field of cardiology and cardiothoracic surgery in Europe. A general overview of the European and national legal framework (relevant data protection and privacy legislation) applying to quality-of-care registries is provided. One of the main rules is that non-anonymous patient data may, in principle, not be used for research without the patient's informed consent. When patient data are solely and strictly used for quality control and improvement, this rule does not apply. None of the described registries (NHR, SWEDEHEART, and NICOR) currently ask specific informed consent of patients before using their data in the registry, but they do carry out medical data research. Application of the GDPR implies that personal data may only be used for medical data research after informing patients and obtaining their explicit consent.

[From record keeping to scientific research: obstacles and opportunities for research with electronic health records]. / Van statusvoering naar wetenschappelijk onderzoek.

As a result of increasing digitisation of medical record keeping, electronic health records (EHRs) are an attractive source for data reuse. However, such record-based research is still suffering from poor quality of data stored in EHRs. Lack of consent for reuse of data also plays an impeding role, especially in retrospective record-based research. That said, increasing cooperation between healthcare institutions and current attention for EHR organisation also offer opportunities for record-based research. Patient data can be recorded in more standardised ways and in increasingly harmonised EHRs. In addition, if healthcare institutions were to establish a generic consent procedure - preferably with national scope - the potential of EHRs for scientific research could be exploited in considerably better ways.

A mother's gift of life: exploring the concerns and ethical aspects of fertility preservation for mother-to-daughter oocyte donation.

With the introduction of oocyte vitrification, a special form of intergenerational intrafamilial medically assisted reproduction (IMAR) has now become feasible: fertility preservation for mother-to-daughter oocyte donation (FPMDD). For girls diagnosed with premature ovarian insufficiency (POI), banking of their mothers' oocytes can preserve the option of having genetically related offspring. Since policy documents on IMAR do not discuss specific concerns raised by FPMDD, clinicians can feel at a loss for guidance with regard to handling these requests. Through a comparison of FPMDD with reproductive practices in which similar concerns were raised, proportionality of cryopreservation for self-use and pressure to use the oocytes in fertility preservation in minors, we argue that FPMDD can be acceptable under conditions. The paper ends with recommendations for handling FPMDD-requests, including different options for the legal construction of this form of oocyte donation.

[Making embryos for research: first prohibited, now allowed?] / Embryo's maken voor onderzoek: eerst niet, nu wel?

The Dutch Embryos Act (2000) contains a temporary ban on the creation of embryos for research, meaning that, at present, only research using "spare" IVF embryos is allowed. Recently, the government has announced a plan to lift this ban. This is in line with the original intention of the Act, which already contains conditions for research with specially created embryos that will come into force after the lifting of the ban, including the restriction that the research must be expected to yield new insights in the domains of infertility, assisted reproduction, hereditary or congenital disorders, or transplantation medicine. The government plans announced allow research only in the first three of these domains, adding the further criterion that the research must be 'directly relevant for clinical application'. According to the government, the reason for these additional restrictions was the need to protect 'human dignity'. The authors of this paper are not convinced.

A Duty To Warn Relatives in Clinical Genetics: Arguably 'Fair just and reasonable' in English Law?

The use of 'next-generation' genetic sequencing technology that allows the sequencing of large parts, or even the entirety, of a patient's genome is advancing rapidly in the UK and around the world. This is set to greatly increase the level of health information that will be of relevance to relatives and the latest medical guidance advises that there is a professional duty to consider warning a patient's relatives of a serious genetic risk in limited circumstances. However, the High Court in ABC v St George's Healthcare NHS Trust [2015] EWHC 1394 (QB), recently found that a legal duty on the part of doctors to warn a patient's daughter of a genetic risk of Huntington's Disease without the patient's consent, was not even 'reasonably arguable' and would not be 'fair, just and reasonable'. This article considers the courts' approach to a duty of care towards 'third parties' in this context and concludes that some form of a duty of care to genetic relatives in clinical genetics is at very least arguably 'fair, just and reasonable'.

[The 'interesting case' and patient privacy: handling patient data in medical education]. / De 'interessante casus' en patiëntprivacy: Omgaan met patiëntgegevens in het medisch onderwijs.

The use of patient histories has become an essential part of medical education. Patient histories are important for the relevance, effectiveness and appeal of medical education. The sharing of patient-related information in education and further training is expected to increase in the coming years. The sharing of patient information with colleagues, students or other interested parties can conflict with the rules protecting patient privacy. The most important rule in this context is that it is the patients who decide whether their cases can be shown to others for educational purposes. Patient consent is not required if the data or images used have been fully anonymized. If the information can be traced to the patient, consent is required, preferably documented in writing. The teaching physician is responsible for the storage, protection and destruction of patient data and for controlling access to information.

[Maintaining solidarity: is mutuality the solution?]. / Voor wat, hoort wat?

Solidarity is essentially the willingness to contribute to the community and its demands, which may even involve contributing more than one is expecting to receive. Another principle is mutuality: this refers to a balance between rights and obligations or between mutual obligations. In its advisory document 'The importance of mutuality......solidarity takes work!', The Dutch Council for Public Health and Health Care underlines the importance of ensuring solidarity within the Dutch health care system, e.g. by encouraging patients to take responsibility for their own health, possibly by introducing elements of mutuality. In our contribution, we comment on the Council's advice. Although we fully agree with the overall conclusion that solidarity should be maintained within the system, we do not see how the introduction of increased mutuality will contribute to this goal.

Understanding health care providers' reluctance to adopt a national electronic patient record: an empirical and legal analysis.

BACKGROUND: Several countries are implementing a national electronic patient record (n-EPR). Despite the assumed positive effects of n-EPRs on the efficiency, continuity, safety and quality of care, their overall adoption remains low and meets resistance from involved parties. The implementation of the Dutch n-EPR also raised considerable controversy, which eventually caused the Dutch government to stop its contribution to the national infrastructure. AIM: To explain Dutch health care providers' reluctance in adopting the n-EPR, we investigated their perceptions of problems associated with the n-EPR and their legal position regarding then-EPR. We hereby aim to provide suggestions about approaches that could promote successful implementation. METHODS: The study consisted of two parts. The empirical part of the study was conducted in three health care settings: acute care, diabetes care, and ambulatory mental health care. Two health care organisations were included per setting. Between January and June 2010, 17 stakeholders working in these organisations were interviewed to investigate health care providers' perceptions of problems associated with the n-EPR. In the legal part of the study, legal documents were analysed to study health care providers' legal position regarding the n-EPR and any associated problems. RESULTS: The respondents expressed concerns about the confidentiality and safety of information exchange and the reliability and quality of patient data in the n-EPR, and indicated that their liability in case of medical errors was not sufficiently clear. The perceived problems could partly be attributed to legal uncertainties. CONCLUSIONS: It is recommended to start the implementation of an n-EPR in limited geographical areas. This will allow health care providers to experience benefits of electronic information exchange before being asked to participate in information exchange at a larger scale. The problems that health care providers perceive in the n-EPR should be minimised. Legislation underlying the n-EPR should provide sufficient clarity about health care professionals' responsibilities and liabilities.

[Vigilance in experimental treatment]. / Zorgvuldig handelen bij experimentele behandeling.

When all standard care options are exhausted, it may be justifiable to carry out an experimental treatment. In the Netherlands, experimental treatment is distinguished from medical research; the latter primarily serves the public interest (obtaining medical knowledge), while the former does not. In experimental treatment, it is a doctor's duty to explain the treatment to the patient carefully and to obtain the patient's explicit consent. In addition, the doctor needs to list all relevant aspects of the treatment in the patient's medical record. A medical practitioner who abides by these rules has acted in accordance with the Dutch law. But, given the sometimes highly risky nature of experimental treatments, is this enough? We do not think so and therefore argue for two additional conditions which are focused on transparency. First, there is a need for a service to ensure that experimental treatments are registered. Second, the effects and side effects of each experimental treatment should be reported. We envision the further elaboration of these conditions to be not only a task for the medical profession but possibly also for government-appointed institutions.

[Experimental treatment or medical research?]. / Experimentele behandeling of medisch-wetenschappelijk onderzoek?

If in the Netherlands a doctor offers experimental treatment to patients purely because it is in their patients' best interest, thus without serving any scientific goal, this does not fall under the scope of the Dutch Medical Research involving Human Subjects Act (WMO), but under specifications on the medical treatment agreement (WGBO) laid down in the civil code. If the doctor deviates from professional standards and the current protocols and guidelines, he or she must be able to account for that. The WMO applies as soon as doctors offer experimental treatments within the context of a research protocol, or perform research interventions such as randomization or the removal of extra tissue. Then specific provisions regarding medical ethical protocol review and written informed consent should be met.

[Registration of ethnicity allowed with conditions]. / Registratie van etniciteit onder voorwaarden toegestaan.

Registration of an individual's ethnicity is, in the light of the potential risks of stigmatization and discrimination, rightfully considered a sensitive issue. Traditionally, privacy legislation offers special legal protection in the collection, registration etc. of data relating to race and ethnic background. However, if it can be established that registration of ethnicity is necessary for providing good care, registration is lawful. However, registration for health research purposes requires the explicit consent of the persons involved.

[Efforts to gain further insight into unexplained deaths among children]. / Maatregelen om meer zicht te krijgen op onverklaard overlijden bij minderjarigen.

Child abuse can be overlooked as a cause of death, particularly in cases in which there is initially no known cause of death and the death remains unexplained. To rectify this serious situation, both the government and member of parliament Arib have developed proposals to amend the procedures found in the Burial and Cremation Act regarding the deaths of minors. The government hopes to promote closer post-mortem examination for those paediatric cases, including sudden infant death syndrome, in which the cause of death remains unexplained by requiring further investigation into the cause of death (the so-called NODO procedure). Arib proposed a bill in May 2006 that would require all deceased minors to be examined by a forensic expert. Arguments against the latter proposal include the unnecessary burden it would place on surviving relatives of children who die of clearly natural causes. At this time, the NODO procedure proposed by the government appears to be the more rational choice. At the same time, training for medical professionals, particularly general practitioners and paediatricians, should give ample attention to identifying injuries caused by child abuse and how best to deal with the parents.

[Medical assistance by doctors on board an aircraft]. / Hulpverlening door artsen aan boord van een vliegtuig.

Medical assistance by doctors on board an aircraft The number of in-flight medical emergencies continues to increase due to the rise in the number of (older) passengers, the greater capacity of new airplanes and the constant increases in the distances flown. The most common medical problems on board an aircraft are vasovagal collapse, dizziness, and gastro-intestinal and cardiac complaints. According to Dutch law, a physician on board an aircraft is obliged to deliver medical assistance in case of a medical emergency involving a passenger if requested by the cabin crew. The chances of being involved in a lawsuit afterwards are, however, very small because the usual medical standards do not apply and because the patient usually does not know the doctor that has assisted him. Even if it should come to a legal procedure, the chance that a physician will be found guilty of malpractice is very small because of the special circumstances and limitations in an airplane.

[Disclosure of medical information after a patient's death: principles and recent developments in jurisprudence]. / Inzage in het medisch dossier na overlijden van de patiënt: uitgangspunten en actuele ontwikkelingen in de rechtspraak.

After a patient's death, the obligation of medical secrecy remains in force; the physician is still bound to confidentiality and when necessary should invoke his right to remain silent. However, it is generally accepted that circumstances can occur in which a doctor may disclose confidential information to third parties like the relatives Inspection of the medical file after the patient's death is subject to the following principles. Disclosure of medical data after a patient's death is--apart from the general exceptions on medical secrecy--justified when the wish of the deceased can be reconstructed, or (if this is impossible) if there are such important interests of third parties involved that the obligation to maintain confidentiality may be put aside. The relatives have no personal right of access to medical data of the deceased, and they cannot authorize disclosure of data to other parties (e.g. the attorney of the hospital). With regard to the ex-mentor it seems as if the traditional opinion on medical secrecy after a patient's death has been abandoned. In principle, the physician should inform this person, unless it can be proven that disclosure is in conflict with the wish of the deceased.