[What regulations have launched autonomous communities to going forward on patient safety culture in healthcare organizations?] / ¿Qué normativas han desarrollado las comunidades autónomas para avanzar en cultura de seguridad del paciente en sus organizaciones sanitarias?

INTRODUCTION: Patient Safety Culture is based on learning from incidents, developing preventive strategies to reduce the likelihood to happen and recognizing and accompanying those who have suffered unnecessary and involuntary harm derived from the health care received. To go ahead on patient safety culture entails facilitating the implementation of these behaviors and attitudes in healthcare professionals. Objective was to describe the regulations of some autonomous communities and national proposals for regulations changes. MATERIAL AND METHODS: Search of normative changes made in the autonomous communities of Catalonia, Navarra and the Basque Country. Proposals for legislative changes at national level were agreed. RESULTS: Activities and normative changes made in the autonomous communities of Catalonia, Navarre and the Basque Country are described and proposals for normative changes at the national level at short-term and long-term changes are made. In such a way that it is easier to advance in creating culture of patient safety in the whole National Health System CONCLUSION: Currently there is no global regulation that facilitates to advance in patient safety culture. Changes at the national legislation level are essential. It is at the Inter-territorial Council where the proposed legislative amendment should be defined, promoted by the representatives of the health systems of the autonomous communities.

Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape.

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients' rights.

[In case of an adverse event don´t forget to say sorry]. / Si ocurrió un evento adverso piense en decir "lo siento".

BACKGROUND: Disclosing information to a patient who is a victim of an adverse event (AE) presents some particularities depending on the legal framework in the country where the AE occurred. The aim of this study is to identify the limits and conditions when apologizing to a patient who has suffered an AE. METHODS: A consensus conference involving 26 professionals from different autonomous communities, institutions, and profiles (health, insurance, inspection, academic) with accredited experience in patient safety management systems and criminal law. RESULTS: Open disclosure should include an apology expressed in neutral terms (showing empathy and regret for what has happened) without the informant being identified as responsible for the damage, blaming third parties, or offering compensation on behalf of the insurance company. The professional who feels most directly involved in the incident is usually the least likely to report it and apologise. The informant profile must conform to the type and severity of the AE. The rules and conditions of liability insurance advise against providing specific information on the amount of compensation. CONCLUSIONS: The apology should be offered in terms of the regulatory framework in force in each country. In Spain, an appropriate response of empathy for the patient is warranted, expressing regret for what happened (apologising), which can facilitate the relationship with the patient, mitigate their mistrust, and reduce the number of disputes.

Some ethical aspects of xenotransplantation in light of the proposed European directive on the protection of animals used for scientific purposes.

Unlike what has happened in other times, society in general and especially the scientific community has become aware that animals share our sensitivity to pain and the capacity to suffer. In this regard, it is generally accepted that animals must be protected from all types of abuse. In fact, it is unavoidable today that animals used in scientific experiments enjoy the maximum degree of protection and well-being. This view is based on an ecocentric notion of living matter as opposed to the traditional anthropocentric approach because it has become evident that ethics should not be limited to those belonging to the same species. Likewise, there is a broad consensus-with the exception of members of certain animal protection groups-regarding the need to experiment with animals, when no alternative methods (AM) are available, given that the current state of scientific knowledge still does not allow for this type of experimentation to be entirely abolished. Nevertheless, we must keep in mind that not every scientific procedure in which animals are used is legitimate. On one side of the scale that symbolizes the legislation in this field, we find the weight of science and safety, and on the other side, the weight of ethics. In this article we have reviewed some of the main ethical criteria that serve as a basis to balance the scale, in other words, to guide and legalize animal experimentation in the field of xenotransplantation (XT). To that end, we take into account the current revisions made to the European Directive regarding the welfare of animals used in scientific procedures (86/609/EEC), in order to reflect, in turn, on the following issue: where is European institutional ethics headed on this issue?