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1.
J Med Internet Res ; 22(4): e14201, 2020 04 28.
Artigo em Inglês | MEDLINE | ID: mdl-32343254

RESUMO

BACKGROUND: Societies around the world are aging. Widespread aging creates problems for social services and health care practices. In this light, research on connected health (CH) is becoming essential. CH refers to a variety of technological measures that allow health care to be provided remotely with the aim of increasing efficiency, cost-effectiveness, and satisfaction on the part of health care recipients. CH is reshaping health care's direction to be more proactive, more preventive, and more precisely targeted and, thus, more effective. CH has been demonstrated to have great value in managing and preventing chronic diseases, which create huge burdens on health care and social services. In short, CH provides promising solutions to diseases and social challenges associated with aging populations. However, there are many barriers that need to be overcome before CH can be successfully and widely implemented. OBJECTIVE: The research question of this study is as follows: How can CH facilitate smart, remote, and targeted health care? The objective is to identify how health care can be managed in more comprehensive ways, such as by providing timely, flexible, accessible, and personalized services to preserve continuity and offer high-quality seamless health care. METHODS: A qualitative approach was used based on 60 multistage, semistructured stakeholder interviews. RESULTS: The results can be divided into two functions of CH: ecosystem and platform. On the one hand, the interviews enabled the authors to develop a stakeholder classification and interaction diagram. These stakeholders interacted sequentially to provide technology-based content to end users. On the other hand, interviewees reflected on how CH serves as a platform to address remote monitoring and patient self-management. In the Discussion section, three innovation strategies are discussed to reflect the manner in which CH promotes smart, timely, and precise health care. CONCLUSIONS: This study indicates that it is essential to continually revise CH business models, given the ongoing and rapid changes in technology across groups of CH stakeholders. We also found that global trends toward smart, timely, and precise health care shape what individuals expect from products and services, providing firms with unique opportunities for growth.


Assuntos
Atenção à Saúde/métodos , Pesquisa Qualitativa , Humanos
2.
J Med Internet Res ; 22(5): e15976, 2020 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-32459181

RESUMO

BACKGROUND: In remote areas, connected health (CH) is needed, but as local resources are often scarce and the purchasing power of residents is usually poor, it is a challenge to apply CH in these settings. In this study, CH is defended as a technological solution for reshaping the direction of health care to be more proactive, preventive, and precisely targeted-and thus, more effective. OBJECTIVE: The objective of this study was to explore the identity of CH stakeholders in remote areas of Taiwan and their interests and power in order to determine ideal strategies for applying CH. We aimed to explore the respective unknowns and discover insights for those facing similar issues. METHODS: Qualitative research was conducted to investigate and interpret the phenomena of the aging population in a remote setting. An exploratory approach was employed involving semistructured interviews with 22 participants from 8 remote allied case studies. The interviews explored perspectives on stakeholder arrangements, including the power and interests of stakeholders and the needs of all the parties in the ecosystem. RESULTS: Results were obtained from in-depth interviews and focus groups that included identifying the stakeholders of remote health and determining how they influence its practice, as well as how associated agreements bring competitive advantages. Stakeholders included people in government sectors, industrial players, academic researchers, end users, and their associates who described their perspectives on their power and interests in remote health service delivery. Specific facilitators of and barriers to effective delivery were identified. A number of themes, such as government interests and power of decision making, were corroborated across rural and remote services. These themes were broadly grouped into the disclosure of conflicts of interest, asymmetry in decision making, and data development for risk assessment. CONCLUSIONS: This study contributes to current knowledge by exploring the features of CH in remote areas and investigating its implementation from the perspectives of stakeholder management. It offers insights into managing remote health through a CH platform, which can be used for preliminary quantitative research. Consequently, these findings could help to more effectively facilitate diverse stakeholder engagement for health information sharing and social interaction.


Assuntos
Envelhecimento/ética , Grupos Focais/métodos , Humanos , Pesquisa Qualitativa , Participação dos Interessados
3.
Int J Health Care Qual Assur ; 20(1): 16-33, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-18240505

RESUMO

PURPOSE: This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. DESIGN/METHODOLOGY/APPROACH: Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. FINDINGS: The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. ORIGINALITY/VALUE: This study is valuable because comparative analysis in this domain is uncommon.


Assuntos
Ensaios Clínicos como Assunto/normas , Serviços Contratados/normas , Indústria Farmacêutica/normas , Gestão da Qualidade Total/normas , Serviços Contratados/organização & administração , Indústria Farmacêutica/organização & administração , Humanos , Cooperação Internacional , Auditoria Administrativa , Gestão da Qualidade Total/organização & administração
4.
Artigo em Inglês | MEDLINE | ID: mdl-15552394

RESUMO

The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed inrelation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.


Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Avaliação de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Regulamentação Governamental , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Avaliação de Medicamentos/ética , Avaliação de Medicamentos/normas , Indústria Farmacêutica/organização & administração , Comitês de Ética em Pesquisa , Europa (Continente) , União Europeia , Humanos , Inovação Organizacional , Reino Unido
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