Evolved Eugenics and Reinforcement of "Othering": Renewed Ethico-Legal Perspectives of Genome Editing in Reproduction.

This article extends an exploration into renewed ethico-legal perspectives of genome editing technologies, examined from an evolved conceptualization of eugenics in contemporary human reproduction. Whilst the ethico-legal conundrums presented by genome-editing technologies in various aspects of modern medicine have thus far inspired a comprehensive trove of academic scholarship-and notwithstanding the World Health Organization's (WHO) publication of guidelines on human genome editing in 2021-the legislative landscape for these technologies remain relatively unchanged. Accordingly, this paper presents the unresolved problematic questions that still require significant reflection. First, the paper highlights these questions, which primarily center around the tension between reproductive autonomy and the legal governance of reproductive/genome editing technologies by a democratic state. Secondly, the paper interrogates the evolved conceptualization of eugenics, exercised on the part of prospective parents as part of reproductive autonomy. By this, the paper predicates that it indirectly reinforces societal and systemic problems of discrimination and "othering", increasing reproductive inequalities in excluded communities. Thirdly, the paper attempts to offer narratives of intersectionality as a facilitating tool in a continuing dialogue to build belonging, foster a healthy and balanced exercise of reproductive autonomy, and increase reproductive equalities.

The digitization process and the evolution of Clinical Risk Management concept: The role of Clinical Engineering in the operational management of biomedical technologies.

Introduction: Digital transformation and technological innovation which have influenced several areas of social and productive life in recent years, are now also a tangible and concrete reality in the vast and strategic sector of public healthcare. The progressive introduction of digital technologies and their widespread diffusion in many segments of the population undoubtedly represent a driving force both for the evolution of care delivery methods and for the introduction of new organizational and management methods within clinical structures. Methods: The CS Clinical Engineering of the "Spedali Civili Hospital in Brescia" decided to design a path that would lead to the development of a software for the management of biomedical technologies within its competence inside the hospital. The ultimate aim of this path stems from the need of Clinical Engineering Department to have up-to-date, realistic, and systematic control of all biomedical technologies present in the company. "Spedali Civili Hospital in Brescia" is not just one of the most important corporate realities in the city, but it is also the largest hospital in Lombardy and one of the largest in Italy. System development has followed the well-established phases: requirement analysis phase, development phase, release phase and evaluating and updating phase. Results: Finally, cooperation between the various figures involved in the multidisciplinary working group led to the development of an innovative management software called "SIC Brescia". Discussion: The contribution of the present paper is to illustrate the development of a complex implementation model for the digitization of processes, information relating to biomedical technologies and their management throughout the entire life cycle. The purpose of sharing this path is to highlight the methodologies followed for its realization, the results obtained and possible future developments. This may enable other realities in the healthcare context to undertake the same type of pathway inspired by an accomplished model. Furthermore, future implementation and data collection related to the proposed Key Performance Indicators, as well as the consequent development of new operational management models for biomedical technologies and maintenance processes will be possible. In this way, the Clinical Risk Management concept will also be able to evolve into a more controlled, safe, and efficient system for the patient and the user.

Incorporating mammography into an overseas referral metric: Tongan doctors' assessments of patient eligibility for medical travel.

Tonga's largest public hospital received its second-although its first fully functioning-mammogram machine in 2016. If diagnosed with breast cancer, Tongan women must travel to New Zealand or Australia to access biomedical treatment (e.g. chemotherapy), but many can only do so with financial support from the Tongan government. Given limited funding, strict referral guidelines require doctors to quantify patients into calculations of risk. According to these guidelines, which I argue serve as an overseas referral metric, only "low-risk" patients-as determined by prognosis and treatment cost-are supposed to be funded. At present, doctors can sometimes draw on qualitative knowledge, such as long-term clinical experience, to circumvent referral guidelines. However, as mammography touts new epidemiological capabilities, it also has the potential to reinforce emphases on quantifiable evaluations of referral eligibility, which are often preferred by program funders. This could potentially exclude some women from treatment, as already-limited funding is increasingly reserved for those deemed "low-risk" according to numerical assessments. Based on recent ethnographic fieldwork (2016-2017) in Nuku'alofa, Tonga, I draw on in-depth interviews and conversations with local doctors to elucidate the interplay between mammography access and practitioners' processes of cancer diagnosis, patient risk assessment, and overseas referral. In following doctors' efforts to maximize accountability and risk management in referrals, I show how broader emphases on quantification and efficiency in global-health practice can generate intense moral dilemmas for those who must grapple with their implementation in the day-to-day. Significantly, these experiences demonstrate how numerical trends in global health not only permeate local health-care practices but also impact transnational health-care seeking, shaping a political economy of medical travel that structures opportunities for some women (and not others) to access biomedical treatment abroad.

HEALTH TECHNOLOGY ASSESSMENT FOR DECISION MAKING IN LATIN AMERICA: GOOD PRACTICE PRINCIPLES.

OBJECTIVES: The aim of this study was to identify good practice principles for health technology assessment (HTA) that are the most relevant and of highest priority for application in Latin America and to identify potential barriers to their implementation in the region. METHODS: HTA good practice principles proposed at the international level were identified and then explored during a deliberative process in a forum of assessors, funders, and product manufacturers. RESULTS: Forty-two representatives from ten Latin American countries participated. Good practice principles proposed at the international level were considered valid and potentially relevant to Latin America. Five principles were identified as priority and with the greatest potential to be strengthened at this time: transparency in the production of HTA, involvement of relevant stakeholders in the HTA process, mechanisms to appeal decisions, clear priority-setting processes in HTA, and a clear link between HTA and decision making. The main challenge identified was to find a balance between the application of these principles and the available resources in a way that would not detract from the production of reports and adaptation to the needs of decision makers. CONCLUSIONS: The main recommendation was to progress gradually in strengthening HTA and its link to decision making by developing appropriate processes for each country, without trying to impose, in the short-term, standards taken from examples at the international level without adequate adaptation of these to local contexts.

STAKEHOLDER INVOLVEMENT IN THE HEALTH TECHNOLOGY ASSESSMENT PROCESS IN LATIN AMERICA.

OBJECTIVES: Latin American countries are taking important steps to expand and strengthen universal health coverage, and health technology assessment (HTA) has an increasingly prominent role in this process. Participation of all relevant stakeholders has become a priority in this effort. Key issues in this area were discussed during the 2017 Latin American Health Technology Assessment International (HTAi) Policy Forum. METHODS: The Forum included forty-one participants from Latin American HTA agencies; public, social security, and private insurance sectors; and the pharmaceutical and medical device industry. A background paper and presentations by invited experts and Forum members supported discussions. This study presents a summary of these discussions. RESULTS: Stakeholder involvement in HTA remains inconsistently implemented in the region and few countries have established formal processes. Participants agreed that stakeholder involvement is key to improve the HTA process, but the form and timing of such improvements must be adapted to local contexts. The legitimization of both HTA and decision-making processes was identified as one of the main reasons to promote stakeholder involvement; but to be successful, the entire system of assessment and decision making must be properly staffed and organized, and certain basic conditions must be met, including transparency in the HTA process and a clear link between HTA and decision making. CONCLUSIONS: Participants suggested a need for establishing clear rules of participation in HTA that would protect HTA producers and decision makers from potentially distorting external influences. Such rules and mechanisms could help foster trust and credibility among stakeholders, supporting actual involvement in HTA processes.