scholarly journals Legal and Regulatory Framework for AI Solutions in Healthcare in EU, US, China, and Russia: New Scenarios after a Pandemic

Radiation ◽  
2021 ◽  
Vol 1 (4) ◽  
pp. 261-276
Author(s):  
Filippo Pesapane ◽  
Daniele Alberto Bracchi ◽  
Janice F. Mulligan ◽  
Alexander Linnikov ◽  
Oleg Maslennikov ◽  
...  
Keyword(s):  
Digital Health ◽  
Healthcare Setting ◽  
Regulatory Framework ◽  
Ethical Guidelines ◽  
Policy Initiatives ◽  
Regulatory Frameworks ◽  
Timely Fashion ◽  
Solid Foundation ◽  
And Control ◽  
Robust Integration

The COVID-19 crisis has exposed some of the most pressing challenges affecting healthcare and highlighted the benefits that robust integration of digital and AI technologies in the healthcare setting may bring. Although medical solutions based on AI are growing rapidly, regulatory issues and policy initiatives including ownership and control of data, data sharing, privacy protection, telemedicine, and accountability need to be carefully and continually addressed as AI research requires robust and ethical guidelines, demanding an update of the legal and regulatory framework all over the world. Several recently proposed regulatory frameworks provide a solid foundation but do not address a number of issues that may prevent algorithms from being fully trusted. A global effort is needed for an open, mature conversation about the best possible way to guard against and mitigate possible harms to realize the potential of AI across health systems in a respectful and ethical way. This conversation must include national and international policymakers, physicians, digital health and machine learning leaders from industry and academia. If this is done properly and in a timely fashion, the potential of AI in healthcare will be realized.

The Quality of Botswana's Environmental Protection Regulatory Framework

2020 ◽  
Vol 64 (2) ◽  
pp. 215-228
Author(s):  
Tinashe Madebwe
Keyword(s):  
Environmental Protection ◽  
Regulatory Framework ◽  
Control Approach ◽  
Context Sensitive ◽  
Environmental Deterioration ◽  
Regulatory Frameworks ◽  
The World ◽  
Enforcement Mechanisms ◽  
And Control

AbstractThis article explores why Botswana's environmental protection regulatory framework is failing to stem environmental deterioration. Based on the observation that such deterioration persists despite the fact that there is a framework in place, the discussion draws from experience with successful environmental protection regulatory frameworks around the world. The discussion establishes that successful environmental protection regulatory frameworks incorporate numerical quality and ecological standards, a command and control approach (with context-sensitive alternatives to account for the approach's limitations), and credible enforcement mechanisms. This article measures the extent to which Botswana's environmental protection regulatory framework incorporates these elements; it identifies that the reason why the framework has failed to stem environmental deterioration is that it does not adequately incorporate these qualities and proposes how this could be addressed going forward.

scholarly journals Joint Action on cancer iPAAC - building on experience and streamlining recommendations for the future

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Jelenc ◽  
T Albreht
Keyword(s):  
Cancer Care ◽  
National Level ◽  
Cancer Control ◽  
Professional Community ◽  
The Other ◽  
Consensus Building ◽  
Good Practices ◽  
Policy Initiatives ◽  
European Code ◽  
And Control

Abstract Background Policy initiatives, proposals and projects often end up proposing solutions and/or measures that are eventually either not or only partially implemented or they are lacking a system, which would consistently evaluate their implementation and/or impact. Good solutions are often not visible enough to the broader professional community and it is important to identify certain outstanding challenges in cancer control and policy. Driven by the need to better use the outputs from projects on cancer policy, European Commission was trying to address two challenges - one was in solving the problems with the implementation and use of the solutions that have already been proposed and the other one in identifying the outstanding challenges in cancer policy. Results We have decided to follow the structure to develop a series of recommendations and examples of good practices at the national level by selected areas. These would be streamlined into a roadmap to support policymakers at the national and EU level in formulating their cancer policies. Three pairs of targeted recommendations have been identified: Cancer prevention, including health promotion, implementation of the European Code Against Cancer and the reshaping and extension of cancer registriesGenomics and immunotherapy in cancerChallenges in cancer care and governance of cancer control Conclusions Multinational collaboration can bring about important consensual solutions, which build on the existing good practices in the countries. This can be combined well with the existing work on specific areas, carried out both internationally and nationally. Consensus building on jointly defined challenges represents a task that appears to be resolved rather pragmatically. Key message It is important that advance in cancer care and control are quickly analysed and that policymakers receive up-to-date recommendations to improve their policies on cancer control.

Regulating Religious Broadcasting

1992 ◽  
Vol 2 (10) ◽  
pp. 287-304
Author(s):  
Ian Leigh
Keyword(s):  
New Technologies ◽  
Technological Advance ◽  
Regulatory Framework ◽  
Religious Expression ◽  
Satellite Broadcasting ◽  
Religious Broadcasting ◽  
The Creation ◽  
The Uk ◽  
A Minor ◽  
And Control

The broadcasting world is currently undergoing a revolution. The new technologies of cable and, more importantly, satellite broadcasting have brought within reach an enormous potential expansion and diversity in broadcasting. The Broadcasting Act 1990 is the government's response to the challenge, creating a mostly new regulatory framework. Alongside technological advance there has been a growing concern with regulating programme quality, as the creation of the Broadcasting Standards Commission (placed by Pt. V of the Act on a statutory footing) bears witness. A minor, but not insignificant, place in these cross-currents of ferment is occupied by religious broadcasting. This article seeks to place the controls and duties relating to religious broadcasting under the new regime within the context of its history in the UK and to consider the extent to which the new legal and administrative controls achieve an acceptable balance between religious expression and control of standards.

The concept of development of the Contract System of the Ministry of Internal Affairs of Russia as a tool for effective use of budget funds and ensuring competition in the state procurement market

2021 ◽  
pp. 76-87
Author(s):  
A. A. Tsviliy-Buklanova
Keyword(s):  
Public Procurement ◽  
The State ◽  
Regulatory Framework ◽  
Structural Elements ◽  
Departmental Level ◽  
Internal Affairs ◽  
Effective Use ◽  
And Control

The article is devoted to the relevance of the development and adoption of the Concept for the development of the Contract System of the Ministry of Internal Affairs of Russia in order to increase the efficiency of using budget funds and eliminate corruption risks in the implementation of public procurement. The regulatory framework of federal and departmental level was considered, attention was paid to practical aspects of procurement of goods, works and services for the needs of internal affairs bodies, issues of regulation and control are reflected. Structural elements of the Concept, ways to improve the Contract System of the Ministry of Internal Affairs of Russia are proposed.

Heritage values and legal rules

2017 ◽  
Vol 7 (3) ◽  
pp. 345-363 ◽  
Author(s):  
Jeremy C. Wells ◽  
Lucas Lixinski
Keyword(s):  
Regulatory Framework ◽  
Participatory Action ◽  
Content Type ◽  
Legal Rules ◽  
Regulatory Frameworks ◽  
Heritage Studies ◽  
Decision Making Processes ◽  
Critical Heritage ◽  
Fundamental Shift ◽  
New Framework

Purpose Existing regulatory frameworks for identifying and treating historic buildings and places reflect deference to expert rule, which privileges the values of a small number of heritage experts over the values of the majority of people who visit, work, and reside in historic environments. The purpose of this paper is to explore a fundamental shift in how US federal and local preservation laws address built heritage by suggesting a dynamic, adaptive regulatory framework that incorporates heterodox approaches to heritage and therefore is capable of accommodating contemporary sociocultural values. Design/methodology/approach The overall approach used is a comparative literature review from the fields of heterodox/orthodox heritage, heterodox/orthodox law, adaptive management, and participatory methods to inform the creation of a dynamic, adaptive regulatory framework. Findings Tools such as dialogical democracy and participatory action research are sufficiently pragmatic in implementation to envision how an adaptive regulatory framework could be implemented. This new framework would likely require heterodox definitions of law that move beyond justice as a primary purpose and broaden the nature of legal goods that can be protected while addressing discourses of power to benefit a larger group of stakeholders. Practical implications The authors suggest that an adaptive regulatory framework would be particularly beneficial for architectural and urban conservation planning, as it foregrounds considerations other than property rights in decision-making processes. While such a goal appears to be theoretically possible, the challenge will be to translate the theory of an adaptive regulatory framework into practice as there does not appear to be any precedent for its implementation. There will be issues with the need for increased resources to implement this framework. Originality/value To date, there have been few, if any, attempts to address critical heritage studies theory in the context of the regulatory environment. This paper appears to be the first such investigation in the literature.

scholarly journals Use of Digital Technology to Enhance Tuberculosis Control: Scoping Review

10.2196/15727 ◽  
2020 ◽  
Vol 22 (2) ◽  
pp. e15727 ◽  
Author(s):  
Yejin Lee ◽  
Mario C Raviglione ◽  
Antoine Flahault
Keyword(s):  
United States ◽  
Resource Management ◽  
Treatment Adherence ◽  
Scoping Review ◽  
Digital Technology ◽  
Digital Health ◽  
The United States ◽  
Data Services ◽  
The World ◽  
And Control

Background Tuberculosis (TB) is the leading cause of death from a single infectious agent, with around 1.5 million deaths reported in 2018, and is a major contributor to suffering worldwide, with an estimated 10 million new cases every year. In the context of the World Health Organization’s End TB strategy and the quest for digital innovations, there is a need to understand what is happening around the world regarding research into the use of digital technology for better TB care and control. Objective The purpose of this scoping review was to summarize the state of research on the use of digital technology to enhance TB care and control. This study provides an overview of publications covering this subject and answers 3 main questions: (1) to what extent has the issue been addressed in the scientific literature between January 2016 and March 2019, (2) which countries have been investing in research in this field, and (3) what digital technologies were used? Methods A Web-based search was conducted on PubMed and Web of Science. Studies that describe the use of digital technology with specific reference to keywords such as TB, digital health, eHealth, and mHealth were included. Data from selected studies were synthesized into 4 functions using narrative and graphical methods. Such digital health interventions were categorized based on 2 classifications, one by function and the other by targeted user. Results A total of 145 relevant studies were identified out of the 1005 published between January 2016 and March 2019. Overall, 72.4% (105/145) of the research focused on patient care and 20.7% (30/145) on surveillance and monitoring. Other programmatic functions 4.8% (7/145) and electronic learning 2.1% (3/145) were less frequently studied. Most digital health technologies used for patient care included primarily diagnostic 59.4% (63/106) and treatment adherence tools 40.6% (43/106). On the basis of the second type of classification, 107 studies targeted health care providers (107/145, 73.8%), 20 studies targeted clients (20/145, 13.8%), 17 dealt with data services (17/145, 11.7%), and 1 study was on the health system or resource management. The first authors’ affiliations were mainly from 3 countries: the United States (30/145 studies, 20.7%), China (20/145 studies, 13.8%), and India (17/145 studies, 11.7%). The researchers from the United States conducted their research both domestically and abroad, whereas researchers from China and India conducted all studies domestically. Conclusions The majority of research conducted between January 2016 and March 2019 on digital interventions for TB focused on diagnostic tools and treatment adherence technologies, such as video-observed therapy and SMS. Only a few studies addressed interventions for data services and health system or resource management.

scholarly journals Systemic Management of Pandemic Risks in Dental Practice: A Consolidated Framework for COVID-19 Control in Dentistry

2021 ◽  
Vol 8 ◽  
Author(s):  
Habib Benzian ◽  
Eugenio Beltrán-Aguilar ◽  
Richard Niederman
Keyword(s):  
Infection Control ◽  
Occupational Safety ◽  
Risk Mitigation ◽  
Healthcare Setting ◽  
Mitigation Measures ◽  
Health Administration ◽  
Safety And Health ◽  
Clinical Responses ◽  
And Control ◽  
The U.S

Dental teams and their workplaces are among the most exposed to airborne and bloodborne infectious agents, and therefore at the forefront of pandemic-related changes to how dental care is organized and provided to patients. The increasing complexity of guidelines makes is challenging for clinicians to navigate the multitude of COVID-19 guidelines issued by different agencies. A comparative analysis of guidance issued for managing COVID-19 in dental settings leading U.S. agencies was conducted, including documents of the Occupational Safety and Health Administration (OSHA), an agency of the U.S. Secretary of Labor, and of the U.S. Centers for Disease Prevention and Control (CDC), an agency of the U.S. Secretary of Health and Human Services. Details of infection control and other risk mitigation measures were reviewed for consistency, overlaps and similarities, then clustered according to thematic areas covering all domains of managing a dental healthcare setting. The analysis revealed five distinct areas of pandemic control, comprising (1) planning and protocols, (2) patient screening, (3) preparation of facilities, (4) PPE and infection control, and (5) procedures and aerosol control; thereby covering systematically all aspects requiring adaptation in a pandemic context. The “Pandemic-5 Framework for COVID-19 Control in Dentistry” provides an opportunity to simplify comprehensive decision-making from a clinical practitioner perspective. The framework supports a comprehensive systems-driven approach by using dental clinics as a setting to integrate pandemic clinical responses with the implementation of appropriate infection control protocols. Traditionally these two aspects are addressed independently from each other in separate concepts.

scholarly journals Analysis of Legal and Regulatory Frameworks in Digital Health: A Comparison of Guidelines and Approaches in the European Union and United States

2020 ◽  
Vol 8 ◽  
Author(s):  
Fara Aninha Fernandes ◽  
Georgi V Chaltikyan
Keyword(s):  
United States ◽  
European Union ◽  
Digital Health ◽  
Clinical Decision Support Systems ◽  
Clinical Decision ◽  
The European Union ◽  
Regulatory Pathways ◽  
Regulatory Frameworks ◽  
The Impact ◽  
Regulatory Landscape

The advent of digital technology in healthcare presents opportunities for the improvement of healthcare systems around the world and the move towards value-based treatment. However, this move must be accompanied by strong legal and regulatory frameworks that will not only facilitate but encourage the good use of technology. The goal of the study was to assess the amenability and furtherance of regulatory frameworks in digital health by evaluating and comparing the processes, effectiveness and outcomes of these frameworks in the European Union and United States. Methods: This study incorporated two research methodologies. The first was a research of current legal and regulatory frameworks in digital health in the European Union and United States. A comprehensive online search for publications was carried out which included laws, regulations, policies, green papers, guidelines and recommendations. This research was complemented with interviews of five purposively sampled key informants in the legal and regulatory landscape. Results: Mind-maps revealed key features and challenges of the digital health field in the topics of the current state of regulation of digital health in the EU, Germany and US, regulatory pathways for digital health devices, protection and privacy of health data, mobile health validation, risk-based classification of medical devices, regulation of clinical decision support systems, telemedicine, artificial intelligence and emerging technologies, reimbursement for digital health services and liability for digital health products. The experts expressed and explained key points where current regulation is deficient. The review of the legal frameworks revealed deficiencies which provide opportunities and recommendations to further develop and strengthen the regulatory landscape. Conclusions: A key element to a robust regulatory framework is the ability to ensure trust and confidence in using digital health technology. Technology must measure the impact on quality of life and burden of disease and not merely involve the collection of data.

INDIVIDUAL PREVENTION OF ESCAPES FROM SETTLEMENT COLONIES

2021 ◽  
pp. 131-136
Author(s):  
Василий Алексеевич Рудаев
Keyword(s):  
Russian Federation ◽  
Regulatory Framework ◽  
Current Application ◽  
Preventive Control ◽  
Constituent Entity ◽  
Freedom Of Movement ◽  
The Russian Federation ◽  
The Government ◽  
The Individual ◽  
And Control

В статье анализируются правовые и организационные аспекты профилактики побегов из колоний-поселений. Автор акцентирует внимание на недостатках и трудностях в обеспечении контроля и надзора за осужденными-поселенцами. Это связано с тем, что нормы пенитенциарного законодательства наделяют осужденных значительным объемом льгот в период отбывания наказания в колониях-поселениях. Отсутствие вооруженной охраны, наличный оборот денежных средств, свобода передвижения по территории колонии, использование труда осужденных на отдельных объектах в пределах субъекта Российской Федерации по месту дислокации учреждения обуславливают невозможность обеспечения должного надзора. В указанных условиях традиционные формы надзора и контроля мало результативны. Автор аргументирует эффективность использования инновационных технических средств контроля и надзора за осужденными, содержащимися в колониях-поселениях, для профилактики побегов. Однако данный вид контроля невозможно осуществлять без внесения изменений в законодательство. На основании изучения нормативной базы, регламентирующей индивидуальную профилактику правонарушений в пенитенциарных учреждениях, а также рекомендаций практических работников, автор делает вывод, что действующие нормы не отвечает современным реалиям. Автор обосновывает расширение круга подучетных лиц, с одновременным увеличением юридического значения профилактического учета посредством закрепления возможности использования технических средств контроля и надзора за ними. The article analyzes the legal and organizational aspects of the prevention of escapes from the settlement colonies. The author focuses on the shortcomings and difficulties in the government of control and supervision over convicted settlers. This is due to the fact that the norms of the penitentiary legislation endow convicts with a significant amount of benefits during the period of serving their sentences in settlement colonies. The lack of armed guards, cash circulation of funds, freedom of movement across the territory, the use of convicts' labor at certain facilities of the constituent entity of the Russian Federation at the location of the institution make it impossible to ensure proper supervision. Under these conditions, the forms of supervision and control are not very effective. The author argues the effectiveness of the use of innovative technical means of control and supervision over convicts held in settlement colonies for the prevention of escapes. However, this type of control cannot be carried out without amending the legislation. Based on the regulatory framework governing the individual prevention of offenses in penitentiary institutions, as well as the recommendations of practitioners, the author concludes that the current application of the measure does not correspond to modern realities. Use of technical means of preventive control over them.

Microbiological, scientific and regulatory perspectives of hand sanitizers

2021 ◽  
Vol 10 (3) ◽  
pp. 130-140
Author(s):  
Chong Hock Sia ◽  
Ying Ting Tan ◽  
Lai Wah Chan
Keyword(s):  
Test Methods ◽  
Regulatory Framework ◽  
Test Method ◽  
Active Ingredients ◽  
Consumer Awareness ◽  
Safety Standards ◽  
The Public ◽  
Hand Sanitizer ◽  
Regulatory Frameworks

Abstract: Hand sanitizers are rub-on formulations for the purpose of inactivating microorganisms on the hands. With the recent COVID-19 pandemic, a surge in the manufacturing, sale and use of hand sanitizers is observed. However, the effectiveness and safety of hand sanitizers are not well understood by the public; thus, hand sanitizer usage may not confer adequate protection and may pose safety threats. Globally, the emergence of safety threats and inappropriate manufacturer claims also suggest that regulatory frameworks are insufficient in ensuring optimal effectiveness and safety standards for hand sanitizers. This paper presents an overview of the activity of antimicrobials as active ingredients in hand sanitizers and the principles of test methods to evaluate the effectiveness of hand sanitizers. Different antimicrobials confer different activities, rendering some more useful than others. There are also no specific compendial test for efficacy of hand sanitizers and the choice of test method is left to the discretion of manufacturers. It has also been reported that a significant number of hand sanitizers were improperly labelled or had inappropriate claims. Implementing a tighter regulatory framework, developing pharmacists’ knowledge and capabilities, raising consumer awareness and debunking common myths are some possible solutions to address the problems encountered.

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