Legal Guidelines Research Articles

Implementation and performance of haemovigilance systems in 10 sub-saharan African countries is sub-optimal

BackgroundHaemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We describe the results of the pilot of the integrated GBT+ Blood for the haemovigilance function in 10 sub-Saharan African countries.MethodsWe piloted the integrated WHO Global Benchmarking Tool plus Blood (GBT+ Blood) to assess the haemovigilance function of national regulatory authorities (NRAs) in Ethiopia, Kenya, Malawi, Nigeria, Liberia, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. Data obtained from documents and face to face interviews were used to determine the status of implementation and performance of the following six indicators; legal provisions regulations and guidelines, organisation and governance, human resources, regulatory processes, transparency and accountability and finally, monitoring progress and assessing impact, by estimating median scores across 20 sub-indicators. In addition, a cluster analysis was performed.ResultsThe countries showed inter-organisation variability in implementation and performance of the haemovigilance function. The overall median score (all sub-indicators) was 44 % (range: 7.5 % - 70 %). The lowest average performance scores were for the arrangement for effective organisation and coordination (35 %) and human resources (35 %) indicators. The highest average scores were observed for the mechanism to promote transparency and mechanism to monitor regulatory performance indicators (50 % and 60 %, respectively). We identified clusters of best-implemented sub-indicators from the procedures for haemovigilance and poorly implemented sub-indicators from the legal provisions, regulations and guidelines for haemovigilance and human resources.ConclusionsImplementation of sub-indicators and performance of haemovigilance systems varied greatly for all countries with a few countries performing reasonably well in the implementation of some sub-indicators under procedures for haemovigilance. Most countries were poorly implementing sub-indicators in the legal provisions, arrangement for effective organisation and human resources indicators. The legislative provisions in most countries were at a nascent stage. There is a need to set up targeted and customised technical support coupled with prioritised interventions to strengthen the capacities of NRAs.

Informed consent in psychotherapy: a survey on attitudes among psychotherapists in Switzerland

BackgroundThe legal and ethical guidelines of psychological professional associations stipulate that informed consent by patients is an essential prerequisite for psychotherapy. Despite this awareness of the importance of informed consent, there is little empirical evidence on what psychotherapists’ attitudes towards informed consent are and how informed consent is implemented in psychotherapeutic practice.Methods155 psychotherapists in Switzerland completed an online survey assessing their attitudes regarding informed consent.ResultsAmong the surveyed psychotherapists, there was a high consensus on important information that should be communicated to patients in the context of informed consent. Almost all psychotherapists rated confidentiality and its exemptions (95%) and self-determined decision-making (97%) as important. The importance to disclose information regarding fees and the empirical effectiveness of the provided treatment, were both seen as important by more than 80% of participants. The disclosure of personal information about the therapist was rated as important by 60%. Other aspects, which are not direct components of informed consent but rather overarching goals, were also evaluated rather homogeneously: self-determined decision making of the patient was rated as important by almost all of the surveyed psychotherapists (97%). The following components were also judged as important by a majority of the participants: promotion of hope (80%) and discussion of treatment goals (93%). Most psychotherapists described the implementation of informed consent as an ongoing process, rather than a one-time event during the first session of therapy. Therapists’ age, postgraduate training, treated patient group, and setting influenced attitudes towards informed consent.ConclusionsThe present study shows that informed consent is perceived by psychotherapists as both a challenge and a resource. The implementation of informed consent in psychotherapy requires further research from a clinical and ethical perspective.

Survey of 275 Patients and Caregivers Affected By Pyruvate Kinase Deficiency: Impact of Communication with Hematologists on Mental Health and Quality of Life

Background. Pyruvate Kinase deficiency (PKD) is a rare congenital hemolytic anemia which affects approximately three people per million individuals worldwide. With no disease-modifying treatments currently available, management tends to focus on supportive symptom control such as blood transfusions. PKD has a profound, wide-ranging impact on quality of life (QoL). Patient advocacy and patient-reported outcomes research has been limited. The PKD Advocacy Advisory Council (AAC), a group of patients, caregivers, patient advocates and physicians, was formed in 2020, by Agios Pharmaceuticals, to improve both timely diagnosis and access to education, support and care for individuals with PKD.Objective. The AAC initiated a survey to explore communication between patients/ caregivers affected by PKD and their hematologists to inform future best practices and improve outcomes.Methods. A web-based, quantitative and qualitative survey was conducted amongst adult patients with PKD, and adult caregivers, with respondents from 11 countries including France, Germany, Italy, Spain, the UK and US. Question types included closed-ended, multiple choice, Likert scale and binary choice plus free text. The survey was carried out according to British Healthcare Business Intelligence Association Legal and Ethical Guidelines, as well as guidelines established by the UK's Market Research Society. Participants were recruited via online panels and via AAC member channels, including PKD Facebook groups.Results: The survey was completed by 200 adult patients with PKD and 75 adult caregivers (n=275). Twenty percent of patients were >50 years of age, 64% were ages 31-50 years and 17% were 18-30 years of age. Half of the patients had been diagnosed for >10 years. Although 82% of patients reported that their hematologist manages PK deficiency “well”, the survey revealed gaps in hematologists' understanding. Only 56% of respondents stated their hematologist is able to answer disease management questions and only 44% say their hematologist searches for and finds solutions to optimize disease management. Less than half of respondents, 44%, reported that their hematologists demonstrate a deep knowledge of PKD.The survey revealed an unmet need regarding emotional and psychosocial support with 25% of respondents reporting feeling neither positive nor negative, or somewhat negative, after hematologist interactions and 29% reporting at least one negative emotion following interactions. After meeting with their hematologist, 21% of respondents report feeling worried, 17% anxious, and 17% depressed.Communication with the hematologist was reported to be negative most often among patients who receive 0 transfusions per year. Within this group, only 62% report that their hematologist manages their condition well compared to 82% overall (p=0.003). Only 51% state that their hematologist understands the impact of PK deficiency on their QoL (compared to 83% amongst respondents receiving one or more transfusions per year, p<0.001). Of those who are not transfused, only 44% state their hematologist takes their perspective and experiences into consideration for their disease management plan (compared to 75% amongst respondents receiving one or more transfusions per year, p<0.001).ConclusionsPKD is a lifelong chronic disease that significantly impacts QoL of patients and families. The results of this largest ever survey of patients and caregivers with PKD point to a need to adapt clinical approaches to improve outcomes. Hematologists should seek to improve their understanding of the disease and its burden, particularly in non-transfused patients. Care should attend to emotional and psychosocial health aspects. Clinicians should consult with other medical specialists, including hematologists who specialize in PKD, to ensure complications are managed effectively. More research is needed to build on the survey insights, drive further awareness and understanding of the needs of those living with PKD among hematologists, and inform approaches to improve outcomes.The authors would like to acknowledge and thank members of the AAC that made this work possible. [Display omitted] DisclosuresGrace: Dova: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Agios: Research Funding; Principia: Membership on an entity's Board of Directors or advisory committees. Barcellini: Novartis: Honoraria; Bioverativ: Membership on an entity's Board of Directors or advisory committees; Agios: Honoraria, Research Funding; Alexion Pharmaceuticals: Honoraria; Incyte: Membership on an entity's Board of Directors or advisory committees.

CURRENT TRENDS IN THE LEGAL REGULATION OF THE PHARMACEUTICAL WORKERS ACTIVITIES

The article considers modern trends in the development of the legal regulation of the pharmaceutical workers job. The practice of the International Pharmaceutical Federation, including in the context of continuing professional development, is of great importance in the activities and training of pharmacists (as in the case of OECD universities). International legal guidelines and quality standards for pharmaceutical services have been found to have a direct impact on various aspects of pharmaceutical law.

DIGITALIZATION OF THE PROCESSES OF PROVIDING SOCIAL SUPPORT MEASURES TO CITIZENS AS A FACTOR IN IMPROVING THE EFFICIENCY OF STATE BUDGETARY ACTIVITIES

Relevance of the study. Given the significant budget expenditures on the digital transformation of government bodies and social policy, the large number of recipients of state support measures, the urgent need for digital services, the initiatives taken by the state to create a single platform for targeted social support of citizens (social treasury) within the emerging domestic ecosystem are of particular interest. Research objectives. The objectives of the study are to analyze the current state of digitalization of the processes of assigning and providing basic support measures, to establish and identify guidelines and needs of legal regulation, to study potential opportunities for implementing a platform approach in the field of social security to improve the efficiency of state budgetary activities. Conclusions. The legal guidelines for improving the processes of providing social support measures are strategic planning documents, the full implementation of which requires a comprehensive study and the creation of the necessary regulatory framework. To date, the principle of targeting and the targeted nature of budgetary funds in relation to the provision of social support measures has not been properly implemented, and therefore the comprehensive state social policy does not fully ensure the achievement of the goals and objectives. The introduction of an innovative model of the social treasury, the primary source of information for which will be the reference data of the federal population register, will bring the process of budget administration in the field of social security to a qualitatively new level, reduce the risks of non-fulfillment by the state of its obligations, will contribute to strengthening the culture of publicity and openness of management decision-making processes, the development of accountability of authorities at all levels to society for achieving national development goals.

Patient experience with telemedicine in primary care during the COVID pandemic: a qualitative study

BackgroundThe Czech Republic is one of the countries with the low rate of digitization of health care processes, and the current legislation provides only isolated elements of electronic health care. Due to the COVID-19 pandemic, general practitioners (GPs) in the Czech Republic, as in other countries, had to rapidly switch to telemedicine visits. Information on patient perspectives about these visits is lacking. Our study aims to understand patients' perceptions about telemedicine visits at GPs during COVID-19, and to identify barriers and benefits of telemedicine in primary care.MethodsA qualitative approach was applied. 40 semi-structured interviews were conducted (25 with patients who had telemedicine visits with a GP, and 15 with representatives of patients' organisations). Data was analysed using a thematic analysis.ResultsIt has been shown that telemedicine visits took place mainly through telephone and email communication, without using the full potential of telemedicine. The absence of legal regulation and guidelines for telemedicine and the implementation of telemedicine in primary care without prior adaptation generates a number of problems in the patient-physician relationship. In some cases, the unregulated use of telemedicine leads to inequalities in access to healthcare. Persistent medical paternalism has also been shown to significantly affect telemedicine visits in primary care.ConclusionsThe results of the research will be used for the proposal of legislative changes in the field of distance care. Telemedicine guidelines will be created, considering the specifics of primary care. An educational program for patients on the improvement of their digital health literacy and on communication in healthcare using digital technologies will be created.Project funding: TL04000105 Digital literacy in primary health care: COVID-19 as a challenge for the development of information communication technologies, Technology Agency of the Czech Republic.Key messages Implementation of telemedicine in primary care, without prior adaptation to a new way of communication, generates problems in the patient-physician relationship.The absence of legal regulations and guidelines for telemedicine can lead to inequalities in access to healthcare.

Health Information Portal - One-stop-shop for health information

Abstract Background A vast amount of health information in the form of data sources, experts, research networks, and tools related to collection, use and knowledge transfer of health information exists in EU Member States (MSs) but this information is scattered around and often difficult to find. Researchers and policy makers don't have a centralized place where information could be easily obtained. This hampers effective use of existing information and materials for research and evidence informed policy making. Methods There is a need for a centralized place where different components of health information can be easily found. Information should be described in structured, standardized format to allow comparisons and searchability. Results InfAct and PHIRI have established the Health Information Portal (HIP, healthinformationportal.eu), a one-stop-shop for health information. This portal brings together health information from different EU MSs and research networks and projects as well as from international organizations. HIP has catalogues on health information data sources, research networks, national nodes, health information initiatives and projects, health information related publications and guidelines including legal and ethical guidelines, and available capacity building activities. These catalogues are searchable and support open and fair access to the health information. Conclusions The Health Information Portal will facilitate secondary use of existing health information data for research and evidence informed policy making. Through HIP, researchers can find experts from different domains of health information as well as existing tools for data collection, analysis and knowledge transfer. It also facilitates health information capacity building within the EU. Aim is to support a more effective, also more cost-effective, health research environment which can enhance population health and healthcare in the EU, and through that productivity and European economy.

THE REDUCTION OF GREEN HOUSE GASES EGRESSIONS DUE TO COVID-19 AND THE ASCENT OF RENEWABLE ENERGY GENERATION IN MALAYSIA

The current global pandemic COVID-19 definitely left a relatively large forceful consequence on humanity's mortality rate and economical records present-day. As reported or stated by the World Health Organization (WHO), the infectious agent gives rise to extreme danger to the wellbeing of a certain prone to death group (elderly people specifically). Nonetheless, there are several dissensions deem to be the cause of the pathogen and its host. The virus has forced most countries to take action by using strict curfew legal guidelines and terminated most operations in industrial and entertainment centres. The objective of this detailed critical inspection is to exhibit the inherent capacity for coming into being effective consequences of the virus towards ecology together with extending inexhaustible free power source technology. Malaysia took measures against COVID-19 by carrying out Movement Control Order (MCO) earlier in March 2020. The enforcement having to do with the MCO implicates a decrease in the contamination percentage, specifically pollution of the atmosphere. The greenhouse gas (GHG) egression, which was once 8 Mt CO2 eq. dated 2020 beginning out of January until March, made less in amount or degree to less than 1 Mt CO2 eq. in April at the same time as May. This decrease in greenhouse gas emissions along with toxic gas permitted an increase of rays of the sun to come through photovoltaic panels, thus improving the infinite free energy technology in Malaysia.

Analisis Yuridis terhadap Tindak Pidana Pembunuhan Berencana Dan Penganiayaan terhadap Anak yang Mengakibatkan Luka Berat (Studi Putusan No. 36/Pid.B/2016/PN.MLL)

This review inspects the use of the law to the wrongdoing of planned homicide and judges' contemplations in taking care of the wrongdoing of planned homicide and youngster misuse that outcomes in genuine wounds. This exploration is a regulating juridical examination. The regularizing juridical methodology is a methodology that inspects speculations, ideas, lawful standards and legal guidelines. The strategy of gathering essential lawful materials and optional legitimate materials utilizes the strategies of gathering lawful materials with writing study. The outcomes showed that the utilization of the law against the wrongdoing of planned homicide and abuse of kids bringing about genuine wounds disregards Article 340 of the Criminal Code and Article 80 Paragraph (2) of Law Number 23 of 2002 concerning Child Protection, demonstrating that the respondent perpetrated the wrongdoing of planned homicide. What's more, youngster misuse bringing about genuine wounds. The appointed authority's thought in dealing with this wrongdoing, forces a daily existence detainment. The respondent was accused of having perpetrated a wrongdoing of planned homicide which brought about the passing of casualty Christina Tandioga and youngster misuse which brought about genuine injury to Sestika Santika. For instance, the essential incrimination of the Public Prosecutor, Article 340 of the Criminal Code and the second prime incrimination of the Public Prosecutor, Article 80 Paragraph (2) of Law Number 23 Year 2002.

The Role of The Perlis State Mufti Department in Restraining Covid-19 Through Fatwas and Legal Guidelines

The spread of COVID-19 has had a detrimental effect on various sectors, especially on the health sector, where it has resulted in hundreds of thousands of deaths being recorded worldwide. The spread of this epidemic has led the World Health Organization (WHO) to declare COVID-19 a pandemic. Specifically, in Malaysia, the number of infected individuals is 1.8 million cases, and the number of deaths is 17,000 cases. Various parties comprising the Federal Government and the authorities have taken various approaches to curb the spread of the COVID-19 epidemic from continuing spread. Meanwhile, in the state of Perlis, among the bodies responsible for curbing the spread of this epidemic is the Perlis State Mufti Department which is responsible for issuing fatwas for Islamic religious affairs to be followed by Muslims, especially in the state of Perlis. Based on this background, this study would like to examine the role of fatwas issued by the Perlis Mufti Department in curbing the spread of COVID-19. This study uses a qualitative approach involving a literature review covering books, journals, fatwas and related circulars. The data obtained will be analyzed using document analysis methods. The study results show that there are four official fatwas and four legal guidelines issued related to COVID-19. The study results found that all fatwas and legal guidelines issued were aimed at curbing the spread of the COVID-19 epidemic and based on strong Islamic arguments. The study ended with some suggestions for improvement after a discussion was done on the study results.

Perspectives on the Clinical Use of Pharmacogenetic Testing in Late-Life Mental Healthcare: A Survey of the American Association of Geriatric Psychiatry Membership

To assess perspectives on pharmacogenetic (PGx) testing among members of the American Association of Geriatric Psychiatry (AAGP). Cross-sectional survey. Members of the AAGP. Anonymous web-based survey consisting of 41 items covering experiences, indications, barriers, facilitators and ethical, legal and social implications for PGx testing. A total of 124 surveys were completed (response rate=13%). Most respondents (60%) had used PGx testing but an equal proportion (58%) was uncertain about the clinical usefulness of PGx testing in late-life mental health. Despite self-reported confidence in the ability to order and interpret PGx testing, 60% of respondents felt there was not enough clinical evidence for them to use PGx testing in their practice. This was compounded by uncertainties related to their ethical obligation and legal liability when interpreting and using (or not using) PGx testing results. Respondents strongly affirmed that clinical and legal guidelines for PGx testing in older adults are needed and would be helpful. The findings suggest additional PGx research and physician education in late-life mental healthcare settings is required to reconcile uncertainties related to the clinical efficacy and ethico-legal aspects of PGx testing as well as address current knowledge barriers to testing uptake. These efforts would be further facilitated by the development of clinical practice guidelines to ensure equitable access to testing and standardized implementation of PGx-informed prescribing in older adults.

Competency of fishing boat crew from Indonesia in the framework of standards of training, certification, and watchkeeping for fishing vessel personnel 1995 (STCW-F 1995)

Fishing boat crews worked on foreign fishing vessels to obtain competency standards to be internationally qualified human resources. Currently, Indonesia has a limited number of certified fishing boat crews that are internationally recognized. Hence, the Indonesian government has ratified Training, Certification, and Watchkeeping for fishing vessel personnel (STCW-F 1995) to make Indonesian fishing boat crews compete globally. This research aims to examine government policy in creating strategies to improve the ability of Indonesian fishing boat crews by education and training to be able to work on foreign fishing vessels. This research employs the juridical empirical method with a case study approach, and it is then analyzed descriptively. The results show that: 1) there were overlapping regulations on guidelines for fishing boat crews on foreign vessels; 2) sectoral egocentrism towards the implementation authority on education and training for fishing boat crews. Therefore, the government needs to formulate a legal guideline to be referred by all parties. This legal guideline may lead the highest Indonesian authority to take political steps on assigning the Ministry of Marine Affairs and Fisheries as the authorized institution to carry out education and training for fishing boat crews.

Marine Protected Area Networks in Indonesia: Progress, Lessons and a Network Design Case Study Covering Six Eastern Provinces

Indonesia is the largest archipelagic nation in the world with 17,504 islands, a coastline of 108,000 km and 15.8% (27,255 km2) of the world’s coral reefs. This paper reviews the status of marine protected areas (MPAs) and networks of MPA in Indonesia, draws on lessons learned, and highlights what has been learned from the design of a network of MPAs for Fisheries Management Area (FMA) 715 across six eastern provinces as an example of how such work can be adapted for other parts of the country and elsewhere. Nationally, the 235,622 km2 of MPAs are mostly large (average 2,380 km2) with use zones and small no-take areas (<15 percent). MPAs are implemented by provincial governments or one of 2 national agencies. The design of a network of MPAs across FMA 715 began with 14 MPAs covering 1,977,276 ha or 4% of the marine waters of FMA 715 in 2016. Now there are 48 MPAs covering 3,062,206 hectares in the planning area, and the design process identified an additional 44 Areas of Interest required to establish new MPAs to augment the existing MPAs in FMA 715 to achieve the objectives of enhancing fisheries, protecting biodiversity, adapting to climate change while supporting community livelihoods and traditional practices. Issues identified in the process are that the scale and complexity of science and management needed is beyond what most stakeholders can easily comprehend; that implementation cuts across multiple jurisdictions with a still-new formal mandate for planning and managing the large network area; and, that the present process could only be possible with outside facilitating expertise. Finally, since the national conservation agency is currently finalizing legal guidelines for the planning and implementation of sub-national networks of MPA, this process has educated many and the result will lend legal and governance support to the continued planning and implementation of the FMA 715 MPA Network and for other areas.

End-of-Life Decisions in Intensive Care Units in Croatia-Pre COVID-19 Perspectives and Experiences From Nurses and Physicians.

Healthcare professionals working in intensive care units (ICUs) are often involved in end-of-life decision-making. No research has been done so far about these processes taking place in Croatian ICUs. The aim of this study was to investigate the perceptions, experiences, and challenges healthcare professionals face when dealing with end-of-life decisions in ICUs in Croatia. A qualitative study was performed using professionally homogenous focus groups of ICU nurses and physicians (45 in total) of diverse professional and clinical backgrounds at three research sites (Zagreb, Rijeka, Split). In total, six institutions at the tertiary level of healthcare were included. The constant comparative analysis method was used in the analysis of the data. Differences were found between the perceptions and experiences of nurses and physicians in relation to end-of-life decisions. Nurses’ perceptions were more focused on the context and features of immediate care, while physicians’ perceptions also included the wider sociocultural context. However, the critical issues these specific professional groups face when dealing with end-of-life decisions seem to overlap. A high variability of practices, both between individual practitioners and between different organizational units, was omnipresent. The lack of adequate legal, professional, and clinical guidelines was commonly expressed as one of the most critical source of difficulties.

Правові цінності як детермінанти сталого розвитку суспільства

The goals of sustainable development, outlined in the final document of the UN Summit «Transforming our world: the 2030 agenda for sustainable development», continue to be the main model of development for all countries. Sustainable development is formed and provided by various determinants, among which legal values are not the last. They provide legal identification of objects recognized as benchmarking guidelines for sustainable development, and form the value and legal orientations of entities which activities are aimed at performing these tasks. The lack of a common system of legal values leads to the deformation of the legal consciousness of the population, the dominance of nihilistic trends, makes it impossible to achieve sustainability and stability in society. Therefore, the existence of a single value-legal paradigm is a consolidating factor of Ukrainian society, forms a positive attitude of the subjects to the political and legal life of the country, promotes their legal socialization and the development of a proper legal position. This allows to achieve social justice, build the foundations of inclusive development, ensure the rule of law, eradicate corruption and restore trust in the state and its institutions, strengthen social cohesion, ensure the interaction of public authorities with the public and self-organize the activities of citizens. Among the legal values that contribute to the achievement of sustainable development goals and form the foundation of legal culture, a special place is occupied by human, justice, freedom, responsibility, equality, patriotism, religious tolerance, etc. Keywords: life choice, legal culture, legal position, legal values, value and legal guidelines, sustainable development, value and legal attitudes

Engagement of ethics and regulatory authorities on human infection studies: Proceedings of an engagement workshop in Zambia.

Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development in high income settings. Over the last decade, this model has been implemented in LMICs with the aim of accelerating development of next generation vaccines that would perform better in these settings. However, in most LMICs, the ethics and regulatory framework for the conduct of these studies are not in place. In Zambia, these studies are yet to be conducted and thus we conducted a stakeholder engagement workshop in October 2019. We engaged with bioethicists, regulatory authority officials, and scientists from within Zambia and other African countries to anticipate and address foreseeable ethical and regulatory issues when conducting HIS in Zambia for the first time. The workshop largely focused on sensitizing the stakeholders on the benefits of these studies with the following main points for consideration on the implementation of these studies in Zambia: need for in-country legal framework and guidelines; need for adequate informed consent based on comprehensive understanding of the concept of HIS and study requirements; and requirements for heightened vigilance to assure participant safety including good ethical and clinical practice with regulatory, ethical, data safety, and community oversight. Additionally, the workshop emphasized the need for rigorous health screening prior to enrolment; suitable infrastructure for containment; and personnel to provide appropriate treatment including emergency resuscitation and evacuation if indicated. Specific recommendations included compensation for burden of participation; access to care and provision for study related injury (e.g. no-fault insurance); and withdrawal and exit procedures to preserve individual and community safety. Finally, the meeting concluded that researchers should actively engage key gate keepers including civic leaders such as parliamentarians, universities, researchers, potential participants and laypersons to avoid circulation of misinformation.

Is Your Collection Ambiguous?

The natural history specimens of the world have been documented on paper labels, often physically attached to the specimen itself. As we transcribe these data to make them digital and more useful for analysis, we make interpretations. Sometimes these interpretations are trivial, because the label is unambiguous, but often the meaning is not so clear, even if it is easily read. One key element that suffers from considerable ambiguity is people’s names. Though a person is indivisible, their name can change, is rarely unique and can be written in many ways. Yet knowing the people associated with data is incredibly useful. Data on people can be used to validate other data, simplify data capture, link together data across domains, reduce duplication-of-effort and facilitate data-gap-analysis. In addition, people data enable the discovery of individuals unique to our collections, the collective charting of the history of scientific researchers and the provision of credit to the people who deserve it (Groom et al. 2020). We foresee a future where the people associated with collections are not ambiguous, are shared globally, and data of all kinds are linked through the people who generate them. The TDWG People in Biodiversity Data Task Group is therefore working on a guide to the disambiguation of people in natural history collections. The ultimate goal is to connect the various strings of characters on specimen labels and other documentation to persistent identifiers (PIDs) that unambiguously link a name “string” to the identity of a person. In working towards this goal, 150 volunteers in the Bionomia project have linked 21 million specimens to persistent identifiers for their collectors and determiners. An additional 2 million specimens with links to identifiers for people have already emerged directly from collections that make use of the recently ratified Darwin Core terms recordedByID and identifiedByID. Furthermore, the CETAF Botany Pilot conducted among a group of European herbaria and museums has connected over 1.4 million specimens to disambiguated collectors (Güntsch et al. 2021). Still, given the estimated 2 billion (Ariño 2010) natural history specimens globally, there is much more disambiguation to be done. The process of disambiguation starts with a trigger, which is often the transcription of a specimen’s label data. Unambiguous identification of the collector may facilitate this transcription, as it offers knowledge of their biographical details and collecting habits, allowing us to infer missing information such as collecting date or locality. Another trigger might be the flagging of inconsistent data during data entry or resulting from data quality processes, revealing for instance that multiple collectors have been conflated. A disambiguation trigger is followed by the gathering of data, then the evaluation of the results and finally by the documentation of the new information. Disambiguation is not always straightforward and there are many pitfalls. It requires access to biographical data, and identifiers to be minted. In the case of living people, they have to cooperate with being disambiguated and we have to follow legal and ethical guidelines. In the case of dead people, particularly those long dead, disambiguation may require considerable research. We will present the progress made by the People in Biodiversity Data Task Group and their recommendations for disambiguation in collections. We want to encourage other institutions to engage with a global effort of linking people to persistent identifiers to collaboratively improve all collection data.

FLAWED LAW: A CRITICAL ANALYSIS OF THE FAULTS AND SHORTCOMINGS OF CHAPTER 8 OF THE NATIONAL HEALTH ACT OF 2003

During 2011 health law grew by the addition of eight new Regulations dealing with stem cells and related matters. This added to the already existing six of Regulations which had been sporadically published since 2007. All these Regulations supplement the National Health Act of 2003. This legislative excess begs the question: Why has it been at all necessary to flood the legislative landscape surrounding the Act. The Act is a complex one and it entrenches various health policy principles. It is also framework-legislation meaning that only broad legal guidelines are provided and it must be “fleshed out” in Regulations. This however does not satisfy the question as to why this “fleshing out” has been done so overwhelmingly considering the period of time which the Act has been in force and keeping in mind these Regulations apply only to a single chapter of the Act. The aim of this article is thus an analysis of certain provisions in chapter 8 of the Act which will entail an explanation of its content, followed by a dissection thereof and suggestions. Ultimately, this article attempts to illustrate thatstem cell research, therapy and technology in general is not sufficiently regulated by chapter 8 which is so fatally flawed that it is almost dead legislation. It is recommended that new and comprehensive, updated and corresponding Regulations be drafted to supplement and correct the Act.

Developing a Measure of Social, Ethical, and Legal Content for Intelligent Cognitive Assistants

We address the issue of consumer privacy against the backdrop of the national priority of maintaining global leadership in artificial intelligence, the ongoing research in Artificial Cognitive Assistants, and the explosive growth in the development and application of Voice Activated Personal Assistants (VAPAs) such as Alexa and Siri, spurred on by the needs and opportunities arising out of the COVID-19 global pandemic. We first review the growth and associated legal issues of the of VAPAs in private homes, banks, healthcare, and education. We then summarize the policy guidelines for the development of VAPAs. Then, we classify these into five major categories with associated traits. We follow by developing a relative importance weight for each of the traits and categories; and suggest the establishment of a rating system related to the legal, ethical, functional, and social content policy guidelines established by these organizations. We suggest the establishment of an agency that will use the proposed rating system to inform customers of the implications of adopting a particular VAPA in their sphere.

Assessing air pollution in European cities to support a citizen centered approach to air quality management

European cities have made significant progress over the last decades towards clean air. Despite this progress, several cities are still facing acute air pollution episodes, with various urban areas frequently exceeding air quality levels allowed by the European legal standards and WHO guidelines. In this paper, six European cities/ regions (Bristol, UK; Amsterdam, NL; Sosnowiec, PL; Ljubljana, SI; Aveiro, PT; Liguria, IT) are studied in terms of air quality, namely particulate matter, nitrogen dioxide and ozone. The concentrations trends from 2008 to 2017 in the different typology of monitoring stations are addressed, together with the knowledge of daily, weekly and seasonal pollution patterns to better understand the city specific profiles and to characterize pollutant dynamics and variations in multiple locations. Additionally, an analysis of the duration and severity of air pollution episodes is also discussed, followed by an analysis of the fulfillment of the legislated limit values.Each of our 6 case study locations face different air pollution problems, but all these case studies have made some progress in reducing ambient concentrations. In Bristol, there have been strong downward trends in many air pollutants, but the levels of NO2 remain persistently high and of concern. In recent years, decreasing concentration levels point to some success of Amsterdam air quality policies. PM10 exceedances are a seasonal pollution problem in Ljubljana, Sosnowiec and Aveiro region (even if with different levels of severity). While, exceedances of NO2 and O3 concentrations are still problematic in Liguria region.The main findings of this paper are particular relevant to define and compare future citizen-led strategies and policy initiatives that may be implemented to improve and fulfill the EU legislation and the WHO guidelines.