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1.
J Law Biosci ; 11(1): lsae001, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38313429

RESUMEN

The General Data Protection Regulation (GDPR) of the European Union, which became applicable in 2018, contains a new accountability principle. Under this principle, controllers (ie parties determining the purposes and the means of the processing of personal data) are responsible for ensuring and demonstrating the overall compliance with the GDPR. However, interpretive uncertainties of the GDPR mean that controllers must exercise considerable judgement in designing and implementing an appropriate compliance strategy, making GDPR compliance both complex and resource-intensive. In this article, we provide conceptual clarity around GDPR compliance with respect to one core aspect of the law: the determination and relevance of the purpose of personal data processing. We derive from the GDPR's text concrete requirements for purpose specification, which we subsequently apply to the area of secondary use of personal data for scientific research. We offer guidance for correctly specifying purposes of data processing under different research scenarios. To illustrate the practical necessity of purpose specification for GDPR compliance, we then show how our proposed approach can enable controllers to meet their compliance obligations, using the example of the overarching GDPR principle of lawfulness to highlight the relevance of purpose specification for the identification of a suitable legal basis.

2.
Herzschrittmacherther Elektrophysiol ; 34(3): 193-197, 2023 Sep.
Artículo en Alemán | MEDLINE | ID: mdl-37434022

RESUMEN

Since 2016, quarterly telemedical remote monitoring of patients with an implanted defibrillator or cardiac resynchronization therapy (CRT) system is part of the Einheitlichen Bewertungsmaßstab (EBM, physician's fee schedule) and is the first telemedical service to be reimbursed in German cardiology. Many publications like the TIM-HF2 or the InTime trial have shown a significant benefit for different endpoints in patients with advanced heart failure. Therefore, the German Society of Cardiology (DGK) has published different recommendations that emphasize an obvious indication of telemedical care with daily control of implantable cardioverter-defibrillator (ICD) information, parameters like blood pressure and weight, and telemedical counselling of patients with heart failure with reduced ejection fraction. This recommendation is also part of the guidelines of the European Society of Cardiology (ESC) published in 2021. It has a level IIb for patients with heart failure. In December 2020 the "Gemeinsame Bundesausschuss" (G-BA) decided to accept telemonitoring as a diagnostic tool and treatment option for patients with heart failure. This service of physicians became part of the EBM and ever since may be offered to patients. This development is accompanied with many questions regarding a physician's accountability, protection of data privacy, and also regarding the structures given by the G­BA and the "Kassenärztlichen Vereinigungen" (KV). Thus, this paper tries to give an overview of these topics. It will also provide a critical discussion of these structures and their legal foundation because there are many constraints that need to be taken into consideration as a cardiologist. These constraints may ultimately hinder the expansion of this service to patients in Germany.


Asunto(s)
Terapia de Resincronización Cardíaca , Cardiología , Desfibriladores Implantables , Insuficiencia Cardíaca , Telemedicina , Humanos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Alemania
3.
Healthcare (Basel) ; 11(13)2023 Jul 05.
Artículo en Inglés | MEDLINE | ID: mdl-37444775

RESUMEN

BACKGROUND: Digitalization in the health system is a topic that is rapidly gaining popularity, and not only because of the current pandemic. As in many areas of daily life, digitalization is becoming increasingly important in the medical field amid the exponential rise in the use of computers and smartphones. This opens up new possibilities for optimizing patient education in the context of anesthesia. The main aim of this study was to assess the implementation of remote consent in Europe. METHODS: An online survey entitled "Digital online Patient Informed Consent for Anesthesia before Elective Surgery. Recent practice in Europe," with a total of 27 questions, was sent by the European Society of Anesthesiology and Intensive Care (ESAIC) to their members in 47 European countries. To assess the effect of the economy on digitalization and legal status with regard to anesthesia consent, data were stratified based on gross domestic product per capita (GDPPC). RESULTS: In total, 23.1% and 37.2% of the 930 participants indicated that it was possible to obtain consent online or via telephone, respectively. This observation was more often reported in countries with high GDPPC levels than in countries with low GDPPC levels. Furthermore, 27.3% of the responses for simple anesthesia, 18.7% of the responses for complex anesthesia, and 32.2% of the responses for repeated anesthesia indicated that remote consent was in accordance with the law, and this was especially prevalent in countries with high GDPPC. Concerning the timing of consent, patients were informed at least one day before in 67.1% of cases for simple procedures and in 85.2% of cases for complex procedures. CONCLUSION: Even European countries with high GDPPC use remote informed consent only in a minority of cases, and most of the time for repeated anesthetic procedures. This might reflect the inconsistent legal situation and inhomogeneous medical technical structures across Europe.

4.
Heliyon ; 9(5): e15701, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-37180890

RESUMEN

Since Japan announced its plan to discharge Fukushima nuclear wastewater into the sea on April 13, 2021, the discussions on the hazards and illegality of this act have never stopped. In this discharge crisis, countries neighboring Japan are direct stakeholders, so the coping strategies they will adopt particularly attract worldwide attention. The paper focuses on the Challenges of Fukushima Nuclear Wastewater Discharge into the sea and discussing China's responses to Fukushima nuclear wastewater discharge into the sea from the perspective of China's right-safeguarding strategies. It has reached the following conclusions: once Fukushima nuclear wastewater is discharged into the sea, it will result in a serious hazard and cause social and economic impacts on all aspects; the Japanese government's decision and act to discharge Fukushima nuclear wastewater into the sea are against laws; the legal basis for China to safeguard its rights includes China's domestic laws and Japan's domestic and international laws. Regarding the right-safeguarding strategy, China can act on the domestic and international levels to defend its rights and interests and safeguard the security of the ocean environment and humans.

5.
Conserv Biol ; 35(2): 437-446, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33749044

RESUMEN

Social media data are being increasingly used in conservation science to study human-nature interactions. User-generated content, such as images, video, text, and audio, and the associated metadata can be used to assess such interactions. A number of social media platforms provide free access to user-generated social media content. However, similar to any research involving people, scientific investigations based on social media data require compliance with highest standards of data privacy and data protection, even when data are publicly available. Should social media data be misused, the risks to individual users' privacy and well-being can be substantial. We investigated the legal basis for using social media data while ensuring data subjects' rights through a case study based on the European Union's General Data Protection Regulation. The risks associated with using social media data in research include accidental and purposeful misidentification that has the potential to cause psychological or physical harm to an identified person. To collect, store, protect, share, and manage social media data in a way that prevents potential risks to users involved, one should minimize data, anonymize data, and follow strict data management procedure. Risk-based approaches, such as a data privacy impact assessment, can be used to identify and minimize privacy risks to social media users, to demonstrate accountability and to comply with data protection legislation. We recommend that conservation scientists carefully consider our recommendations in devising their research objectives so as to facilitate responsible use of social media data in conservation science research, for example, in conservation culturomics and investigations of illegal wildlife trade online.


Cómo Abordar las Preocupaciones por Privacidad al Usar las Redes Sociales en las Ciencias de las Conservación Resumen Cada vez se usan más los datos de las redes sociales en las ciencias de la conservación para estudiar las interacciones humano-naturaleza. El contenido generado por usuarios (imágenes, videos, textos y audios) y los metadatos asociados a estos pueden usarse para evaluar dichas interacciones. Un gran número de redes sociales proporcionan acceso gratuito al contenido generado por usuarios en las redes sociales. Sin embargo, como con cualquier investigación que involucre personas, las investigaciones basadas en los datos obtenidos de la redes sociales requieren cumplir con los estándares más altos de privacidad de datos y protección de la información, incluso cuando éstos están disponibles públicamente. En caso de que se le dé un uso inapropiado a la información obtenida de las redes sociales, los riesgos para la privacidad del usuario y para su bienestar pueden ser sustanciales. Investigamos las bases legales para el uso de la información de redes sociales en conjunto con la garantía de derechos para los sujetos de la información por medio de un estudio de caso basado en la Regulación de la Protección de Datos Generales (GDPR) de la Unión Europea (EU). Los riesgos asociados con el uso de información de las redes sociales en la investigación incluyen la identificación errónea accidental o intencional, la cual tiene el potencial de ocasionar daño psicológico o físico a la persona identificada. Para recolectar, almacenar, proteger, compartir y administrar la información de las redes sociales de manera que se prevengan los riesgos potenciales para los usuarios involucrados, se deben minimizar los datos, volverlos anónimos y seguir un procedimiento estricto de manejo de datos. Las estrategias basadas en riesgos, como la evaluación del impacto de la privacidad de datos, pueden usarse para identificar y minimizar los riesgos de privacidad presentes para los usuarios de las redes, para demostrar responsabilidades y para cumplir con la legislación de protección de datos. Recomendamos a los científicos de la conservación que consideren con cuidado nuestras recomendaciones para el diseño de sus objetivos de investigación para así facilitar el uso responsable de la información de redes sociales en la investigación de las ciencias de la conservación, por ejemplo para las investigaciones sobre el mercado ilegal de fauna en línea y para la culturomia de la conservación.


Asunto(s)
Privacidad , Medios de Comunicación Sociales , Conservación de los Recursos Naturales , Humanos
6.
Schmerz ; 34(2): 127-132, 2020 Apr.
Artículo en Alemán | MEDLINE | ID: mdl-32236699

RESUMEN

Interdisciplinary multimodal pain therapy (IMST) is recognized as a scientifically founded form of therapy for inpatient treatment of chronic pain conditions. The indications are assessed by private practitioners and must be confirmed by physicians at the inpatient institution. The health insurance companies are obliged to remunerate this treatment but are allowed to test the conditions in individual cases. Recently, reports from members of the German Pain Society on a drastic increase in testing and rejection quotas have become more frequent. Therefore, this article discusses the legal foundations of the treatment of patients with chronic pain in the inpatient sector. Hard criteria for treatment in a certain sector could not be established. A decision in individual cases will depend on the complexity of the disease in the individual patient. A treatment in hospital is principally only necessary when the treatment corresponds to the generally recognized state of medical knowledge and treatment options in daycase units have not been successful. Important guidance can be found in the treatment guidelines of the medical specialist societies. The transfer to a more intensive treatment sector must be made dependent on the severity and complexity of the symptoms and the insufficient effectiveness of the treatment in the previous sector. Simple ICD-10 diagnoses are not suitable as decision-making criteria and therefore, also not as testing criteria for the indications for inpatient treatment. Decompensated and acutely exacerbated chronic pain conditions must as a rule be treated in hospital, also due to the mental component of the pain disease.


Asunto(s)
Dolor Crónico , Pacientes Internos , Dolor Crónico/terapia , Terapia Combinada , Hospitalización , Humanos , Sociedades Médicas
7.
Stomatologiia (Mosk) ; 98(2): 4-7, 2019.
Artículo en Ruso | MEDLINE | ID: mdl-31089111

RESUMEN

The existing normative legal framework does not fully correspond to modern requirements for the organization and delivering dental care for adult population with various infectious diseases. The authors basing on the analysis of regulatory guidelines consider that in order to provide timely, high-quality and affordable medical care to patients in the infectious diseases departments and clinical hospitals, it is necessary to update the normative legal framework and develop criteria for monitoring the quality of dental care for infectious patients at the stages of its delivering.


Asunto(s)
Enfermedades Transmisibles , Atención Odontológica , Legislación como Asunto , Atención Odontológica/legislación & jurisprudencia , Humanos
8.
BMC Public Health ; 17(1): 787, 2017 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-28982348

RESUMEN

BACKGROUND: The United Nations General Assembly (UNGA), the International Labour Organization (ILO), the World Health Organization (WHO), the International Commission on Occupational Health (ICOH), and the European Union (EU) have encouraged countries to organize occupational health services (OHS) for all working people irrespective of the sector of economy, size of enterprise or mode of employment of the worker. The objective of this study was to survey the status of OHS in a sample of countries from all continents. METHODS: A questionnaire focusing on the main aspects of OHS was developed on the basis of ILO Convention No. 161 and several other questionnaire surveys used in various target groups of OHS. The questionnaire was sent to 58 key informants: ICOH National Secretaries. RESULTS: A total of 49 National Secretaries responded (response rate 84.5%), from countries that employ 70% of the total world labour force. The majority of the respondent countries, 67%, had drawn up an OHS policy and implement it with the help of national occupational safety and health (OSH) authorities, institutes of occupational health or respective bodies, universities, and professional associations. Multidisciplinary expert OHS resources were available in the majority (82%) of countries, but varied widely in quantitative terms. The average OHS coverage of workers was 24.8%, with wide variation between countries. In over two thirds (69%) of the countries, the content of services was mixed, consisting of preventive and curative services, and in 29% preventive only. OHS financing was organized according to a mixed model among 63% and by employers only among 33% of the respondents. CONCLUSIONS: The majority of countries have drawn up policies, strategies and programmes for OHS. The infrastructures and institutional and human resources for the implementation of strategies, however, remain insufficient in the majority of countries (implementation gap). Qualitatively, the content and multidisciplinary nature of OHS corresponds to international guidance, but the coverage, comprehensiveness and content of services remain largely incomplete due to a lack of infrastructure and shortage of multiprofessional human resources (capacity gap). The estimated coverage of services in the study group was low; only a quarter of the total employed population (coverage gap).


Asunto(s)
Internacionalidad , Servicios de Salud del Trabajador/estadística & datos numéricos , Encuestas y Cuestionarios , Humanos , Salud Laboral/estadística & datos numéricos , Servicios de Salud del Trabajador/organización & administración , Recursos Humanos
9.
Nervenarzt ; 88(7): 802-810, 2017 Jul.
Artículo en Alemán | MEDLINE | ID: mdl-27981375

RESUMEN

STUDY OBJECTIVE: A simple instrument to record case-related coercive measures was tested as part of a pilot project of the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN). METHODS: To assess coercive measures data were collected for 3 months in 8 German hospitals for psychiatry and psychotherapy. The type of measures used, the main diagnosis and the legal basis for the coercive measures were documented. RESULTS: In the sample studied, coercive measures were applied in 8% of cases. Coercive measures were most commonly used in patients with a schizophrenic disorder. The principle of justifiable necessity according to § 34 of the German Penal Code was used particularly often as the legal basis for justifying the coercive measures. CONCLUSION: Suitable measurement instruments and reliable data that enable the learning of best practices represent the basis for a reduction of coercive measures.


Asunto(s)
Coerción , Hospitales Psiquiátricos , Trastornos Mentales/psicología , Trastornos Mentales/terapia , Psicometría/estadística & datos numéricos , Psicoterapia , Garantía de la Calidad de Atención de Salud/estadística & datos numéricos , Estudios Transversales , Alemania , Hospitales Psiquiátricos/legislación & jurisprudencia , Humanos , Trastornos Mentales/epidemiología , Aislamiento de Pacientes/legislación & jurisprudencia , Proyectos Piloto , Psicoterapia/legislación & jurisprudencia , Garantía de la Calidad de Atención de Salud/legislación & jurisprudencia , Restricción Física/legislación & jurisprudencia , Esquizofrenia/epidemiología , Esquizofrenia/terapia , Psicología del Esquizofrénico , Sociedades Médicas , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/terapia
10.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-478871

RESUMEN

The rule of law is the basic approach of realizing harmonic relationship between doctors and patients.Therefore,the law on medicine and health should be consolidated,and the rights and obligations of both parties should be specified.Meanwhile,the enforcement of law should be strict and civilized,while developing the legal awareness of the people to maintain their rights legally,and creating nice medical sequences and doctor-patient relationship in legal environment.

11.
Glob Health Action ; 7: 24121, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24767601

RESUMEN

BACKGROUND: State parties to human rights conventions and declarations are often faced with the seemingly contradictory problem of having an obligation to protect people from harmful practices while also having an obligation to enable access to culturally appropriate effective healing. As people increasingly migrate across the globe, previous distinctions between 'traditional' and 'complementary and alternative medicine' practices are being transcended. There are connections across transnational healing pathways that link local, national, and global movements of people and knowledge. OBJECTIVE: This paper contributes to the development of the concept and practice of the right to health in all its forms, exploring the right to traditional, complementary, and alternative health (R2TCAH) across different contexts. DESIGN: The paper draws on four settings - England, South Africa, Kenya, and Jordan - and is based on key informant interviews and a literature review undertaken in 2010, and updated in 2013. The paper begins by reviewing the international legal context for the right to health. It then considers legal and professional regulations from the global north and south. RESULTS: Additional research is needed to establish the legal basis, compare regulatory frameworks, and explore patient and provider perspectives of regulation. This leads to being able to make recommendations on how to balance protection from harm and the obligation to ensure culturally appropriate services. Such an exploration must also challenge Western theories of human rights. Key concepts, such as individual harm, consent, and respect of the autonomy of the individual already established and recognised in international health law, could be adopted in the development of a template for future comparative research. CONCLUSIONS: Exploration of the normative content of the right to health in all its forms will contribute to supporting traditional, complementary, and alternative health service users and providers in terms of access to information, non-discrimination, clarification of state obligations, and accountability.


Asunto(s)
Terapias Complementarias , Derechos Humanos , Medicina Tradicional , Terapias Complementarias/legislación & jurisprudencia , Salud Global , Accesibilidad a los Servicios de Salud/ética , Accesibilidad a los Servicios de Salud/legislación & jurisprudencia , Derechos Humanos/legislación & jurisprudencia , Humanos
12.
GMS Hyg Infect Control ; 8(2): Doc20, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-24327946

RESUMEN

Safe reprocessing of medical devices through cleaning, disinfection, and sterilization is essential for the prevention of health care associated infections (HAI) and to guarantee patient safety. Several studies detected residual contamination and even severe infections of patients, despite carrying out reprocessing. To develop appropriate solutions, the existing situation in Germany and selected European countries was analyzed. Additionally, in 27 medical practitioners' offices and 14 hospitals, the true practice of reprocessing was analyzed using a questionnaire, a checklist, and inspection on site. A structured analysis of potential alternatives to the internal reprocessing was conducted within the German and European context. The results indicate that the conditions for the execution of the reprocessing process in the analyzed health facilities in southern Hesse (Germany) do not satisfy legal requirements. The detected deficiencies were consistent with other reports from Germany and Europe. The analysis gave insight into several reasons for the detected deficiencies. The three main reasons were the high costs for proper implementation, the subjective value assigned to the reprocessing unit in health care facilities, and deficits in monitoring by the health authority. Throughout the European Union, a similar regulatory framework for the performance of the reprocessing process exists, while the environment, structures of the health systems and administrative supervision vary significantly. The German states as well as selected European countries are currently discussing the challenges of increased quality-assured execution of the reprocessing process. For instance, the same supervisory system for hospitals and medical practitioners should be established at an equal standard. Alternatives such as the use of single-use medical devices, outsourcing the decontamination processes, or the cooperation of health facilities may be considered. This paper also discusses economic and ecological aspects. Finally, different options are recommended to ensure the exclusive use of reliable medical devices for surgical procedures that guarantee an adequate standard of patient safety within economic constraints.

13.
Rev. cuba. salud pública ; 39(4): 796-803, sep.-dic. 2013.
Artículo en Español | LILACS | ID: lil-695385

RESUMEN

La calidad de los servicios de salud se fundamenta en la satisfacción de la población, la excelencia profesional, la eficiencia en el uso de los recursos, en ofrecer una atención con un riesgo mínimo para los pacientes y en la evaluación del impacto final de las acciones en términos de ganancia en salud para los ciudadanos. Para el logro de este fin los servicios deben organizarse de forma adecuada y establecer o aplicar las normas, guías de práctica clínica, procedimientos y protocolos diagnóstico terapéuticos necesarios, además de realizar los procesos relacionados con la verificación de los instrumentos de medición y de la tecnología biomédica basados en el cumplimiento de las legislaciones vigentes. Con el objetivo de identificar el marco legal relacionado con la calidad de los servicios asistenciales en el sector de la salud se realizó una revisión del tema y se identificaron los Decretos leyes y Resoluciones Ministeriales correspondientes que refrendan y soportan la calidad en los servicios de salud. Estos decretos y resoluciones están vigentes y su conocimiento es indispensable para su control y cumplimiento


The quality of health services is founded on the population's satisfaction, the professional excellence, the efficient use of resources, the provision of care with minimum risks for the patients, and the evaluation of the final impact of actions in terms of better health for the citizens. To this end, the services must be adequately organized and one must set or apply the required standards, clinical practice guidelines, procedures and therapeutic diagnosis protocols, in addition to implementing methods related to checking of measuring instruments and of biomedical technology, on the basis of the fulfillment of the present legislation. With the objective of identifying the legal framework associated to the quality of medical assistance services, a literature review on this topic was made and then the corresponding decree-laws and resolutions passed by the Ministry, which endorse the quality of health services, were identified. These decree-laws and resolutions are in effect, so it is indispensable to know them for their control and compliance


Asunto(s)
Calidad de la Atención de Salud/legislación & jurisprudencia , Servicios de Salud/legislación & jurisprudencia
14.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-623507

RESUMEN

We have engaged in active exploration on how to improve teaching effectiveness of Ideological and Moral Cultivation and Legal Basis.We used many methods,such as changing teaching concepts,studying teaching content,reforming teaching and test methods etc.and have achieved a certain degree of success.

15.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-624053

RESUMEN

To explore the character of ideological and moral culture and legal basis and the teaching methods of new course at medical college,and to improve the substantial and perti-nent results of teaching.

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