Legal perspectives on black box recording devices in the operating environment.

BACKGROUND: A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review. METHODS: A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre. RESULTS: After removing duplicates, 116 citations were retrieved and abstracts screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record. CONCLUSION: Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.

ANTECEDENTES: Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico. MÉTODOS: Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano. RESULTADOS: Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente. CONCLUSIÓN: Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.

A decade of litigation regarding surgical informed consent in the Netherlands.

OBJECTIVE: An inadequate surgical informed consent process (SIC) may result in a medical malpractice claim or medical disciplinary board (MDB) complaint. Aim of this study was to analyse characteristics of a decade of malpractice claims and MDB decisions regarding SIC in the Netherlands. METHODS: A retrospective analysis of malpractice claims and MDB decisions concerning SIC disputes in four major surgical specialties was conducted based on company data from the largest medical malpractice insurance company and two public available online MDB databases. RESULTS: A total of 11376 malpractice claims and 661 MDB complaints were filed between 2004-2013 and 676(6%) of these claims and 69(10%) of these complaints involved an alleged deficient SIC process. A random sample of 245(37%) claims and all MDB decisions were analysed. Reasons for filing a claim or complaint were insufficient counselling or recording of SIC elements. In 20% of lawsuits and 25% of claims the case resulted in favour of the complainant. CONCLUSION: A substantial portion of malpractice claims and MDB decisions is related to a deficient SIC process. PRACTICE IMPLICATIONS: Focusing on crucial SIC elements for patients may improve satisfaction and expectations and result in a lower risk for malpractice claims and MDB complaints.

['Just Culture': legal potential and limits]. / 'Just culture': juridische mogelijkheden en grenzen.

In the context of patient safety, the concept of 'Just Culture' is of the utmost importance. Just Culture implies that quality systems in health care should focus on learning from incidents and errors rather than on blaming individuals; however, the basic assumptions of Just Culture cannot always be upheld in certain specific circumstances. This article focuses on the importance and the limits of Just Culture from a legal perspective.

[Video recording and data collection in the operating room: the way to a 'just culture' in the OR]. / Video- en dataregistratie op de operatiekamer.

The Academic Medical Center, Amsterdam, has started a trial to evaluate the usefulness to team debriefings of performance reports generated by a medical data recorder (MDR) in the operating room (OR). Outcome performance reports in structured debriefings in a secure, non-punitive environment are likely to heighten the level of situational awareness of OR teams. This may prevent future error. In addition, the use of video and - even more likely - use of an MDR may contribute to establishing a 'just culture' in the OR. MDRs offer a wealth of data, but only if these data are processed well do the resulting outcome reports reveal insights useful for structured debriefings. The implementation of video recordings or MDRs must be preceded by carefully addressing privacy and litigation issues relating to both OR staff and patients. In this article, we address viewpoints and discuss implementation strategy and the legal considerations involved in enabling the use of video and data registration in the OR.

Concurrence between complaints procedures in the Dutch healthcare system.

There are various ways in which complaints about healthcare providers' performance can be handled in The Netherlands. In practice, situations occur relatively frequently in which one and the same treatment by a provider results in various different complaints procedures being instigated or, in other words, in concurrence between complaints procedures. Dutch periodicals published information on a total of 42 cases of concurrence between 1997 and 2007. Concurrence between complaints procedures prompts a series of questions about how it arises, its legal implications, the possible consequences for those involved and whether it has any added value. This article examines these various issues.

[Criminal prosecution for medical errors]. / De strafrechtelijke vervolging van medische zaken.

A policy document providing instructions on the decision to prosecute in medical errors came into effect on November 1st 2010. In this document the Dutch Public Prosecution Service has attempted to make clear which criteria should be adopted when deciding to prosecute in the case of a medical error. There have also been other recent developments in this context: the public prosecutor can now demand access to medical files in certain, highly exceptional circumstances, such as when patients are themselves suspected of committing a criminal offence; and the Dutch Health Care Inspectorate may only pass on a patient's medical file to the public prosecutor if the prosecutor is already in possession of a copy of it. The new policy document leaves several questions unanswered. It does not consider the criminal liability of health care institutions, for example, and there is too much focus on the responsibilities of individual health care workers.

Supervision by the Dutch Healthcare Inspectorate.

The Dutch Healthcare Inspectorate's (Inspectie voor de Gezondheidszorg) supervisory activities are based on proportional use of the instruments. The primary instruments it uses are advice and encouragement. If these do not achieve the desired result, it can implement corrective action by, for example, enhancing its supervision or through agreements limiting the ability to practise a profession. Recourse to disciplinary or administrative measures can be sought, if necessary. There is a tendency to use statutory instruments, which means greater equality before the law and greater legal certainty. It is important in this respect for the Inspectorate to make its considerations more uniform, transparent and predictable.

The Dutch system of handling complaints in health care.

In the Netherlands, as in other countries, there are several ways of handling patients' complaints. These procedures have three main objectives: protecting individual rights of patients, improving the quality of health care, and protecting the public interest. In the Dutch system of handling complaints, informal and formal procedures are distinguished. The purpose of this article is to describe the formal complaints procedures: the complaints committee, the medical disciplinary board and the civil law procedure. In addition, the article describes the criminal procedure, which cannot be initiated by the patient but is also used to examine practices of health care professionals. Table 1 provides an overview of all procedures. Finally, the article discusses whether the existing procedures are appropriate to achieve the intended goals of the system for handling complaints in health care. Further research is needed to reveal whether these goals are actually realized in practice.

[Compulsory admission: developments in the Netherlands]. / Dwangopneming in de psychiatrie: ontwikkelingen in Nederland.

According to the Dutch Mental Health Act, there are three criteria governing compulsory admission to a psychiatric hospital: the subject himself does not agree with admission; he presents a danger to himself and others and the 'last resort' principles applies (i.e. there is no reasonable alternative). The criteria themselves are not under dispute, but certain elements relating to legislation and practice can be improved. International agreements and foreign legislation can serve as useful sources of introducing improvements into Dutch legislation.

[Support in the general practice: legal aspects]. / Ondersteuning in de huisartspraktijk: juridische aspecten.

Over the years an increasing number of general practitioners (GP) have been employing assistants with various levels of competence and experience to take over certain aspects of patient care. This raises several legal questions. The responsibility for the quality of care provided by these assistants remains with the GP. If the quality of care is to be safeguarded and legal problems avoided, then a GP who wants to employ assistants must meet a number of requirements.

[Perinatal audit: the most important legal aspects]. / Perinatale audit: de belangrijkste juridische aspecten.

In The Netherlands a perinatal audit system is being prepared. Perinatal audit is seen as a powerful means of identifying substandard factors in perinatal care and of increasing the quality of care with better grounding. The proposed system does not raise insurmountable legal problems. However, certain legal aspects should be given specific attention. These aspects include the rights of patients with respect to privacy and information and the protection of health professionals against use of information from the audit system for reasons other than quality purposes. Legislation from other countries may inspire legislative developments in The Netherlands in this area.

[Frankness regarding errors in medical care]. / Openheid over fouten in de gezondheidszorg.

In recent years, increasing attention has been given to the importance of disclosing medical errors. Many physicians are still reluctant to disclose errors and to discuss them with the patient. Recent legislative developments have reduced the existing uncertainty regarding the legal consequences of full disclosure. It is important that physicians are open and honest about the errors they make, that they apologise if necessary, and that measures are taken to prevent the same errors from happening again. Psychological factors hindering the full disclosure of errors require continued attention.

[Relief of symptoms and palliation versus ending a patient's life: looking back at the case against Vencken]. / Symptoombestrijding en palliatie versus levensbe6ëindiging: een terugblik op de zaak-Vencken.

In 2003, Peter Vencken who was working as a junior physician in a hospital, was accused of having ended the life ofa terminally ill man unjustly. He claimed that his treatment had been normal medical practice for the relief of symptoms and for palliation. The Public Prosecutor and the Medical Inspectorate filed complaints against Vencken and he was taken into custody for 9 days. However, both the Criminal Court and the Medical Disciplinary Board rejected the complaints made against Vencken on ending the patient's life and judged that he had acted according to professional standards. The Vencken case lasted for three years and was finalised in April 2006. It raises questions about the role and policy of the Public Prosecutor, the Medical Inspectorate as well as the hospital.

Dutch medical oath.

In the first part of this article, the booklet Dutch Medical Oath is reviewed. The content of the new oath is discussed as are the reasons for revision of the previous version of the oath. This is followed by a short history of the oath. In the second part of the article the oath is compared with the seven competencies of a medical specialist. The new oath contains elements of six of these seven competencies. This demonstrates that the oath is in keeping with the new medical educational demands.

[Reporting accidents and (near) mistakes: meaning and possibilities of legislation]. / Veilig melden van incidenten en (bijna-)fouten: betekenis en mogelijkheden van wetgeving.

Several proposals have been made to introduce systems for blame-free reporting of medical accidents and possible mistakes in Dutch health-care facilities. These systems are aimed at improving patient safety. The question whether health-care workers who report accidents and mistakes should be protected by legislation has been raised. In a number of countries, this kind of legal protection has been developed. Most of these laws stipulate that information provided in the context of a reporting system may not be used against the reporter in a legal procedure. In order to improve the willingness of health-care workers to report, it may be worthwhile to introduce this kind of legal protection.

[Ending a patient's life without a request: time for a good assessment procedure]. / Levensbeëindiging zonder verzoek: tijd voor een goede toetsingsprocedure.

Empirical studies have shown that in approximately 900 cases per year, Dutch physicians end a patient's life without his or her explicit request. These cases involve mostly incompetent patients with cancer, but also severely handicapped newborns. In 1994, the Dutch government made it mandatory for physicians to report these cases to the public prosecutor. This policy has not been successful. Every year, only a handful of cases are reported. The regulatory problem has two dimensions: on the one hand, in contrast to euthanasia and assisted suicide, terminating life without a request cannot be legitimised by the national government, notably in view of international aspects. On the other hand, terminating life without a request is legally qualified as murder. However, the murder section in criminal law is perceived to be intended for other cases entirely. One option might be to introduce a separate category in criminal law. The medical profession favours a system in which the reported cases are analysed by a multidisciplinary committee consisting of a lawyer, a physician, and an ethicist. It is expected that such a system would increase the willingness to report cases.

[Better treatment for psychiatric patients avoiding health care: discussion on legislation should not be isolated from other factors and considerations]. / Betere behandeling van zorgmijdende psychiatrische patiënten: discussie over de wetgeving niet isoleren van andere factoren en overwegingen.

Does the present Formal Admissions to Psychiatric Hospitals Act (BOPZ) hinder rather than facilitate good psychiatric care? This question is being asked more and more often. The Dutch Psychiatric Society recently advocated a new law that provides more possibilities for involuntary admission and treatment. International regulations emphasize the necessity to be reluctant with the use of coercion but leave room for a broader and more differentiated approach than can be found in the present Dutch Act. However, it is important to recognize the influence of other factors as well, e.g. the organization of mental-health care and the competencies of the health-care workers. There are good reasons to replace the present Dutch Act, but this should not be done overnight. Careful consideration is called for and empirical research should be stimulated.

[Retention period for patient data: the health council of the Netherlands pleads for a change in the law]. / Bewaartermijn voor patiëntengegevens; Gezondheidsraad bepleit wetswijziging.

According to the Dutch Medical Treatment Act (WGBO), patient data must be retained for at least 10 years or as much longer as required for the provision of good medical care. In practice, patient data are often destroyed after 10 years. This may lead to problems, for example if a treatment turns out to have long-term consequences. A committee of the Health Council of the Netherlands has now recommended a change in the law. They propose a longer retention period for the care of the patient, a statutory regulation governing retention for research purposes and supplementary provisions that make it possible to retain hereditary data in the interest of relatives. Until the necessary changes in the law have been made, further destruction of medical data must be prevented. This can be accomplished by revising the existing transition provision in the WGBO, while extending it by 5 years. The scientific societies can use this time to develop guidelines for the longer storage of data in specific areas of care and for the periodic cleaning up of the files.

[Advantages and disadvantages of a "no-fault" compensation system]. / Voor- en nadelen van een 'no-fault'-compensatiesysteem.

Should the present legal regulation of medical negligence be replaced by a no-fault compensation system (NFCS)? The Dutch government is preparing a viewpoint on this issue on the basis of a research report that describes the pros and cons of a NFCS. Recently, the British chief medical officer (CMO) rejected the introduction of a comprehensive NFCS. Instead, the CMO proposed to introduce other reforms to mitigate the disadvantages of the present system of medical litigation. A NFCS has certain advantages but is supposedly very expensive. Other policy measures can be considered as well.

[The termination of life in the Netherlands and in Europe]. / Levensbeëindigend handelen in Nederland en in Europa.

Medical decisions concerning the end of life, including the termination of life, are taken not only in the Netherlands but in other European countries as well. In some of these countries, the social pressure to reform legislation is increasing. The World Medical Association remains strongly opposed to any involvement of physicians in bringing about people's death, but the rulings of the European Court of Human Rights so far do not prohibit national laws to regulate euthanasia. Whilst in other countries there is debate on whether permissive legislation should be adopted, in the Netherlands the emphasis is now on the development of instruments aimed at the quality and transparency of medical practice as well as on the improvement of the notification procedure, reducing the gap between medical and juridical reality.