This paper analyses the main feautures of the Spanish national system for the notification and recording of adverse events and incidents in the health sector (SiNASP). On one hand, the structural and technical characteristics of the system are emphasised. On the other, the main questions that, from a strictly legal point of view, the implementation of the referred system can raise, are underlined.

Advances in genetic engineering offer a reality once seen as mere science fiction. Human gene editing techniques allow, on the one hand, the achievement of better levels of health from the beginning of life in formation; and, on the other hand, the improvement of any traits at the genetic level. The double face of bioscientific possibilities of genetic engineering offers benefits, but also increased risks, both scientific and social, namely with regard to the spectrum of eugenics. In order not to disregard the beneficial potential offered by biotechnology in the field of human genetic engineering, the present study examines the means for the development of genetic editing with due safety for all the patients involved (even in the future), envisioning the roles of the precautionary principle in dialogue with bioethics.

The aim of this article is to analyse the relationship between the criminalisation of health care and the safety of patients with respect to two major questions: on the one hand, does the criminalisation of healthcare promote or strengthen the quality of healthcare and, on the other hand, if the rules regarding the duty of health professionals in complying with medical information (medical chart /medical records) of the patient are to be admissible in criminal proceedings does admissibility have an influence on the quality of healthcare and the safety of patients.

Insufficient Patient Safety is a serious public health problem worldwide. International organizations (World Health Organization and European Union), and scientific communities, over the past two decades, have recommended changes in the safety culture of health care organizations and the behaviour of professionals, along with many other important risk management tools. They advise the implementation of confidential and non-punitive incident and adverse event reporting systems, as a way of learning, preventing and reducing harm to patients. This paper presents an overview of Patient Safety in Portugal, the National Reporting and Learning System, highlighting its ineffectiveness due to the lack of compliance of health care professionals in reporting incidents. The lack of existing law in our country regarding the regulation of the National Reporting and Learning System with legal guarantees of confidentiality and protection of those who notify, is not promoting the effectiveness of the existing system, nor the improvement of Patient Safety in Portugal.

Patient safety is a key priority for health policies as instigated by the WHO Global Action Plan for Patient Safety. The Portuguese National Plan for Patient Safety (NPPS) 2021-2026 was published by a legal act underscored by an innovative and robust methodology to design national plans for patient safety. The Plan was developed through triangulation methodology and followed-up by an advisory body of experts. This was made through a collaborative approach with academic institutions and with participation of different stakeholders. The NPPS 2021-2026 aims to consolidate and promote safety in the provision of health care, including in new setting, such as home-care and telehealth, but without neglecting core principles, namely culture of safety, communication, reporting of safety incidents, and implementation of safety practices. Finally, it also emphasizes the need for a more integrated approach in the fields of Health and Law, for the protection of the notifier in a non-punitive reporting system of safety incidents with possible conflicting constitutional rights.

Although it is theoretically and legally established that the right to safe health care implies that countries have the duty to implement policies, strategies and programs aimed at reducing the occurrence of avoidable harm and to adopt legislation that guarantees this right, in Latin America, public policies on patient safety and the right to health care related insurance are still being consolidated, as will be demonstrated in this article. In fact, this study aims to identify problems associated with the recognition of the right to safe health care in Latin America, We have concluded that there is no broad recognition of the right to safe health care in Latin America, as an expression of the right to health, it appears that quality has been incorporated into health systems through health policies and programs by most countries. On the other hand, it appears that patient safety, as a unique component of the quality of health care, is not yet a subject that is regularly introduced in health systems.

One consequence of the Covid19 pandemic in 2020 was disrupted supply chains for medical devices. In response, many providers began onsite 3d printing medical devices, without special training or custom tailored instructions. Traditional laws protecting patient safety and tort liability regarding possible malfunction of medical devices are not prepared to address the manufacture of medical devices by enduser health care facilities. The USA Food and Drug Administration (FDA) is one regulatory body that has expressed its desire to validate these uses of 3d printing in emergencies, despite concern about these home-grown devices from the standpoint of patient safety. This article explores the uncharted legal landscape concerning the growing need for national or international regulation addressing 3D printed medical devices in Health care facilities (HCFs) and point of care (POCs) venues. New laws may be needed to protect the integrity of medical products within an overarching duty to protect patient safety.

The growing use of nanotechnologies in healthcare - either to prevent, diagnose or treat illness and disease - will surely pose new challenges to patient safety, especially given the uncertain risks derived from the use of nanomaterials in the fabrication of several medical-pharmacological products and devices. In this context, the role of precaution and due diligence will be briefly discussed, namely, in order to clarify how these vectors might help us to protect human and fundamental rights of patients, without hampering innovation in this promising field. Also, a reference to the existing legal framework in this area will be made and some urgent regulatory needs identified and concisely evaluated.

This article demonstrates the importance of informative self determination and, consequently, consent in data protection, a fact that has fostered the enactment of protective laws in several countries. However, it also demonstrates that in the treatment of sensitive data related to health, including the treatment carried out by operators of private health care plans, the need for informative self-determination is relative, because as health activities, whether carried out by the public power or by the private initiative, are considered of public relevance by the Federal Constitution of Brazil, subject to government regulation, supervision and control. A large part of the requirements for the processing of this data stem from compliance with a legal or regulatory duty, not requiring the consent of the data subject. It also shows that this data protection is provided for within several scattered rules, many enacted even before the advent of the General Data Protection Law. Finally, it demonstrates that the protection of sensitive data related to health is based more on the principles described in art. 6. of the Brazilian General Data Protection Law rather than informative self-determination.

This article aims to provide a reflection on the defensive medicine (DM) fifty years after this concept was first explored in 1972. This phenomenon combines the deviation from good medical practice and the avoidance of claims against physicians. In this climate of litigation and medical errors with consequences for professionals, both human and professional, the term "second victim" was also coined, resulting in the compromising of patient safety. In depth analysis is done, aiming to gather different measures, causes, effects, excuses, and response to this global problem. After the covid-19 pandemic, scientific societies and authors offer a fresh view identifying DM as a cause of overuse of resources and updating the critical vision of the early authors from the seventies. Evidence seems to indicate that we are witnessing a return to the beginning.

This article aims to provide a reflection on the defensive medicine (DM) fifty years after this concept was first explored in 1972. This phenomenon combines the deviation from good medical practice and the avoidance of claims against physicians. In this climate of litigation and medical errors with consequences for professionals, both human and professional, the term "second victim" was also coined, resulting in the compromising of patient safety. In depth analysis is done, aiming to gather different measures, causes, effects, excuses, and response to this global problem. After the covid-19 pandemic, scientific societies and authors offer a fresh view identifying DM as a cause of overuse of resources and updating the critical vision of the early authors from the seventies. Evidence seems to indicate that we are witnessing a return to the beginning.