scholarly journals Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices

10.2196/30545 ◽  
2021 ◽  
Vol 23 (10) ◽  
pp. e30545
Author(s):  
Stephen Gilbert ◽  
Matthew Fenech ◽  
Martin Hirsch ◽  
Shubhanan Upadhyay ◽  
Andrea Biasiucci ◽  
...  
Keyword(s):  
Machine Learning ◽  
Health Care ◽  
Real Time ◽  
Medical Devices ◽  
Health Care Systems ◽  
World Health ◽  
Health Care Need ◽  
Care Systems ◽  
Health Organization ◽  
Innovative Approaches

One of the greatest strengths of artificial intelligence (AI) and machine learning (ML) approaches in health care is that their performance can be continually improved based on updates from automated learning from data. However, health care ML models are currently essentially regulated under provisions that were developed for an earlier age of slowly updated medical devices—requiring major documentation reshape and revalidation with every major update of the model generated by the ML algorithm. This creates minor problems for models that will be retrained and updated only occasionally, but major problems for models that will learn from data in real time or near real time. Regulators have announced action plans for fundamental changes in regulatory approaches. In this Viewpoint, we examine the current regulatory frameworks and developments in this domain. The status quo and recent developments are reviewed, and we argue that these innovative approaches to health care need matching innovative approaches to regulation and that these approaches will bring benefits for patients. International perspectives from the World Health Organization, and the Food and Drug Administration’s proposed approach, based around oversight of tool developers’ quality management systems and defined algorithm change protocols, offer a much-needed paradigm shift, and strive for a balanced approach to enabling rapid improvements in health care through AI innovation while simultaneously ensuring patient safety. The draft European Union (EU) regulatory framework indicates similar approaches, but no detail has yet been provided on how algorithm change protocols will be implemented in the EU. We argue that detail must be provided, and we describe how this could be done in a manner that would allow the full benefits of AI/ML-based innovation for EU patients and health care systems to be realized.

scholarly journals THE WAY THE HEALTH CARE SYSTEM IN UKRAINE LOOKS LIKE: INTERNATIONAL PRACTICES WITHIN NATIONAL REALITIES

2019 ◽  
Vol 72 (4) ◽  
pp. 685-691
Author(s):  
Borys O. Lohvynenko ◽  
Roman V. Myroniuk ◽  
Olexander P. Svitlychnyy ◽  
Aleksey Y. Prokopenko ◽  
Lidija I. Kalenichenko
Keyword(s):  
Health Care ◽  
Health Care System ◽  
National Health ◽  
Health Care Systems ◽  
World Health ◽  
National Health Care ◽  
National Health Care System ◽  
Care Systems ◽  
Health Organization ◽  
Care System

Introduction: Nowadays there is the transformation of the national health care system in Ukraine, the ultimate goal of which is to create a modern, competitive model of medical care of citizens on the basis of forming packages of free medical services. However, the model adopted by Ukraine is in contradiction with national legislation in part of free medical aid guaranteed by the Art. 49 of the Constitution of Ukraine, and fragmentary considers positive international practices. The aim of the paper is to determine the mistakes of the reform of the Ukrainian health care system and to reveal the positive international practices of the organization of health care systems that can be implemented in Ukraine. Materials and methods: National and international legislation, official web resources of the executive authorities of Ukraine, statistics of the World Health Organization, materials of journalistic and scientific periodicals are the materials for the research of the health care system in Ukraine in comparison with international practices. Research methods are cross-sectoral, complex statistical, comparative, generalization, analysis and synthesis. In order to obtain the results, the authors have conducted a critical analysis of the current norms of the national Ukrainian legislation in the health care sector. Review: The authors of the article have studied the main disadvantages of the national health care system in accordance with the concept of reforming the medical sector. Positive international practices that can be implemented into Ukrainian system for the real improvement of medical human rights in Ukraine have been revealed. Conclusions: It has been proved that the ongoing reform of the health care system in Ukraine needs to be reviewed and optimized. It has been offered to consolidate a perspective model of the Ukrainian health care system, its principles and guarantees of immunity at the legislative level.

scholarly journals Unfavorable Mortality-To-Incidence Ratio of Lung Cancer Is Associated with Health Care Disparity

2018 ◽  
Vol 15 (12) ◽  
pp. 2889 ◽  
Author(s):  
Cheng-Yu Huang ◽  
Kwong-Kwok Au ◽  
Sung-Lang Chen ◽  
Shao-Chuan Wang ◽  
Chi-Yu Liao ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Health Care ◽  
Health Care Systems ◽  
Health Care Expenditures ◽  
Good Health ◽  
World Health ◽  
Incidence And Mortality ◽  
Care Systems ◽  
Adequate Quality ◽  
Health Organization

The mortality-to-incidence ratio (MIR) is associated with the clinical outcome of cancer treatment. For several cancers, countries with relatively good health care systems have favorable MIRs. However, the association between lung cancer MIR and health care expenditures or rankings has not been evaluated. We used linear regression to analyze the correlation between lung cancer MIRs and the total expenditures on health/gross domestic product (e/GDP) and the World Health Organization (WHO) rankings. We included 57 countries, for which data of adequate quality were available, and we found high rates of incidence and mortality but low MIRs in more developed regions. Among the continents, North America had the highest rates of incidence and mortality, whereas the highest MIRs were in Africa, Asia, Latin America, and the Caribbean. Globally, favorable MIRs correlated with high e/GDP and good WHO ranking (regression coefficient, −0.014 and 0.001; p = 0.004, and p = 0.014, respectively). In conclusion, the MIR for lung cancer in different countries varies with the expenditure on health care and health system rankings.

Oral Health Care Systems: An International Collaborative Study Coordinated by the World Health Organization

1987 ◽  
Vol 8 (1) ◽  
pp. 125
Author(s):  
Max H. Schoen ◽  
Harald A. Arnljot ◽  
David E. Barmes ◽  
Lois K. Cohen ◽  
Peter B. V. Hunter ◽  
...  
Keyword(s):  
Health Care ◽  
Oral Health ◽  
World Health Organization ◽  
Health Care Systems ◽  
Collaborative Study ◽  
World Health ◽  
The World ◽  
Care Systems ◽  
Health Organization ◽  
International Collaborative Study

Overview of health care systems

2013 ◽  
Author(s):  
Blánaid Daly ◽  
Paul Batchelor ◽  
Elizabeth Treasure ◽  
Richard Watt
Keyword(s):  
Health Care ◽  
Health Care System ◽  
Care Delivery ◽  
Health Care Systems ◽  
Dental Service ◽  
World Health ◽  
Care Systems ◽  
Health Organization ◽  
The Uk ◽  
Care System

The World Health Organization defines a health care system as: . . . all organizations, people and actions whose primary intent is to promote, restore or maintain health. This includes efforts to influence determinants of health as well as more direct health-improving activities. . . . . . . (WHO 2007) . . . Such a definition covers a myriad of potential elements and factors, of which the dental element is but one. A health care system is not static: it evolves as part of the more general social and welfare arrangements in a society. As a member of a health care profession, all dental care providers need to have an appreciation of the wider aspects of any arrangements of health, its determinants, and care delivery, if only to understand how the pressures on a system may impact on their current and future activities. This chapter provides an overview of health care systems and provides the framework for Chapters 18–23. Health care systems are complex organizations that are in a constant process of change and evolution. Dentistry is one very small component of the wider health care system, which is itself part of the overall social welfare system within society. Dentists, as health professionals, need to understand the basic elements of the health care system within which they are working. The development of health care systems is an ongoing process in which all societies try to meet the health needs of its citizens. There is no society that has yet designed a system that meets the needs of all its citizens. Indeed, historically in many countries it was only the wealthy that were able to access health care in a society. As societies evolved, the pressures to make the health care system accessible to all its members grew. Mays (1991) has highlighted the political importance of health care, showing that many health care systems reforms were designed to prevent political instability and improve the fitness of army recruits. Indeed, the development of the then School Dental Service in the UK was brought about following questions in Parliament about the poor state of soldiers’ teeth in the Boer War.

Informatics to Improve Medical Care of a Nation

1982 ◽  
Vol 21 (03) ◽  
pp. 109-113 ◽  
Author(s):  
M. Subramanian
Keyword(s):  
Health Care ◽  
Care Management ◽  
Health Care Systems ◽  
World Health ◽  
World Health Assembly ◽  
Primary Health ◽  
The World ◽  
Care Approach ◽  
Care Systems ◽  
Health Organization

At the Thirtieth World Health Assembly in 1977 the Member States of the World Health Organization endorsed the policy of developing their health care systems through the primary health care approach. The present paper is concerned with the application of certain significant features of informatics for the development and improvement of health care management in different countries.

scholarly journals War on SARS: a Singapore experience

CJEM ◽  
2004 ◽  
Vol 6 (01) ◽  
pp. 31-37 ◽  
Author(s):  
Ong E.H. Marcus
Keyword(s):  
Health Care ◽  
Health Care Systems ◽  
World Health ◽  
Atypical Pneumonia ◽  
Care Providers ◽  
New Paradigm ◽  
Modular Systems ◽  
The World ◽  
Care Systems ◽  
Health Organization

ABSTRACT On Mar. 12, 2003, the World Health Organization issued a global alert regarding cases of a severe atypical pneumonia termed “severe acute respiratory syndrome” (or SARS). In Singapore alone, there have been 238 SARS cases and 33 deaths, including 5 health care workers. With modern global inter-connectivity, SARS rapidly spread to become a worldwide phenomenon. This article describes the Singapore “war on SARS” from an emergency physician’s perspective, focusing on the “prevent, detect and isolate” strategy. Notable innovations include the use of home quarantine orders, mass temperature screening using thermal imaging, modular systems of hospital staffing, “virtual” hospital visits, and innovations in emergency department design. Most emergency departments, hospitals and health care systems appear to be psychologically and logistically unprepared for a massive infectious disease outbreak. In light of recent natural and terrorism-related threats, emergency care providers around the world must adopt a new paradigm. The current SARS outbreak may be merely a taste of things to come.

scholarly journals A Comprehensive Study of Artificial Intelligence and Machine Learning Approaches in Confronting the Coronavirus (COVID-19) Pandemic

2021 ◽  
pp. 002073142110174
Author(s):  
Md Mijanur Rahman ◽  
Fatema Khatun ◽  
Ashik Uzzaman ◽  
Sadia Islam Sami ◽  
Md Al-Amin Bhuiyan ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Machine Learning ◽  
Health Care ◽  
Language Processing ◽  
Probabilistic Models ◽  
Health Care Systems ◽  
Learning Approaches ◽  
Care Systems ◽  
Novel Coronavirus ◽  
Comprehensive Study

The novel coronavirus disease (COVID-19) has spread over 219 countries of the globe as a pandemic, creating alarming impacts on health care, socioeconomic environments, and international relationships. The principal objective of the study is to provide the current technological aspects of artificial intelligence (AI) and other relevant technologies and their implications for confronting COVID-19 and preventing the pandemic’s dreadful effects. This article presents AI approaches that have significant contributions in the fields of health care, then highlights and categorizes their applications in confronting COVID-19, such as detection and diagnosis, data analysis and treatment procedures, research and drug development, social control and services, and the prediction of outbreaks. The study addresses the link between the technologies and the epidemics as well as the potential impacts of technology in health care with the introduction of machine learning and natural language processing tools. It is expected that this comprehensive study will support researchers in modeling health care systems and drive further studies in advanced technologies. Finally, we propose future directions in research and conclude that persuasive AI strategies, probabilistic models, and supervised learning are required to tackle future pandemic challenges.

Accounting for the Rising Caesarean Section Rate in Canada: What Are the Roles of Changing Needs, Practices, and Incentives?

2021 ◽  
Author(s):  
Michael Baker ◽  
Maripier Isabelle ◽  
Mark Stabile ◽  
Sara Allin
Keyword(s):  
Caesarean Section ◽  
Financial Incentives ◽  
Health Care Systems ◽  
Caesarean Section Rate ◽  
The United States ◽  
World Health ◽  
Strong Increase ◽  
Primary Determinant ◽  
Care Systems ◽  
Health Organization

In most high-income countries, including Canada, the share of births by Caesarean section (C‑section) has risen over the past decades to far exceed World Health Organization recommendations of the proportion justified on medical grounds (15 percent). Although unnecessary C-sections represent an important cost for health care systems, they are not associated with clear benefits for the mother and the child and can sometimes represent additional risks. Drawing on administrative records of nearly four million births in Canada, as well as macro data from the United States and Australia, we provide a comprehensive account of rising C-section rates. We explicitly consider the contributions of the main factors brought forward in the policy literature, including changing characteristics of mothers, births, and physicians as well as changing financial incentives for C-section deliveries. These factors account for at most one-half of the increase in C-section rates. The majority of the remaining increase in C-sections over the period 1994–2011 occurred in the early 2000s. We suggest that some event or shock in the early 2000s is likely the primary determinant of the recent strong increase in the C-section rate in Canada.

Organizing a diabetes service

2011 ◽  
pp. 2005-2011
Author(s):  
Stephen C. L. Gough
Keyword(s):  
Health Care ◽  
Health Care Systems ◽  
Cost Effective ◽  
Health Care Need ◽  
Delivery Of Care ◽  
Strategic Approach ◽  
Effective Manner ◽  
Care Systems ◽  
The Individual ◽  
The Uk

The increasing worldwide incidence and prevalence of diabetes is placing substantial pressures on health care systems and economies. As a consequence individuals involved in the care of people with diabetes are looking at services currently being provided and examining ways in which care can be organized in the most cost-effective manner. Whilst the degree to which diabetes care is delivered differs from country to country, similar fundamental questions are being asked by those involved in the delivery of care, including: What are we currently providing? What do we need to provide? What are we able to provide? Although the answers to these questions are quite different not just between countries but often within specific localities within a country, the ultimate aim is the same: to provide the best possible care to as many people with diabetes as possible. The global diversity of diabetes health care need is enormous and while the solutions will be equally diverse, the approach to the development of a diabetes service will, for many organizations, be similar. The main focus of this chapter is based upon the model or the strategic approach developed in the UK, but many of the individual component parts are present in most health care settings.

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