Ethical and Regulatory Challenges of Emerging Health Technologies

2022 ◽  
pp. 84-100
Author(s):  
Samia Hassan Rizk
Keyword(s):  
Decision Making ◽  
Patient Safety ◽  
Data Privacy ◽  
Health Technology ◽  
Decision Processes ◽  
The Other ◽  
Health Technologies ◽  
Regulatory Decision ◽  
Data Analytic ◽  
Human Healthcare

The advances in biotechnology and computer and data sciences opened the way for innovative approaches to human healthcare. Meanwhile, they created many ethical and regulatory dilemmas such as pervasive global inequalities and security and risk to data privacy. The assessment of health technology is a systematic multidisciplinary process that aims to examine the benefits and risks associated with its use including medical, social, economic, and ethical impacts. It is used to inform policy and optimize decision-making. The advance of technology is creating significant challenges to healthcare regulators who strive to balance patient safety to fostering innovation. The FDA and EMA are modernizing their regulatory approaches to foster innovation in digital technology and improve safety and applicability to patients. On the other hand, data analytic technologies have been introduced into regulatory decision processes.

Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems)

2006 ◽  
Vol 22 (1) ◽  
pp. 10-18 ◽  
Author(s):  
John Hutton ◽  
Clare McGrath ◽  
Jean-Marc Frybourg ◽  
Mike Tremblay ◽  
Edward Bramley-Harker ◽  
...  
Keyword(s):  
Decision Making ◽  
Policy Implementation ◽  
Technology Assessment ◽  
Health Technology ◽  
Analytical Framework ◽  
Decision Processes ◽  
Policy Makers ◽  
Health Technologies ◽  
Fourth Hurdle ◽  
Key Aspects

Objectives:Australia, Canada, and many European countries now use various forms of health technology assessment (HTA) in decision making regarding the reimbursement of drugs and other health technologies. To achieve a better understanding of the potential for use of HTA in this context, an analytical framework was developed to describe and classify existing fourth hurdle systems.Methods:Based on a review of published literature, and official documentation, the key aspects of a fourth hurdle system were identified at two levels: policy implementation and individual technology decision. Characteristics of the systems were grouped under four main headings: constitution and governance, objectives, use of evidence and decision processes, and accountability. The comprehensiveness and relevance of this framework was assessed by an independent group of experts in HTA. A pilot study was undertaken, using only published sources, to test the feasibility of obtaining the information needed to complete the framework.Results:The framework was found to be sufficiently broad to encompass all the issues of interest regarding the systems, but the proportion of information available from published sources was variable between sections of the framework and between countries, with average availability of 45 percent.Conclusions:The analytical framework will help researchers and policy-makers in individual countries to understand their own systems and will allow some preliminary sharing of experience between countries. More experience of its application is needed to judge whether it will provide the basis for more formal comparison of systems and whether it will determine the appropriateness for particular decision contexts.

scholarly journals Announcing the Canadian Journal of Health Technologies — A New Journal From CADTH

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Nicole Mittmann
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Health System ◽  
Canadian Journal ◽  
Health Technology ◽  
Health Care Decision ◽  
Health Technologies ◽  
Care Decision

The COVID-19 pandemic has put a spotlight on science and reaffirmed the value of evidence in health care decision-making. CADTH is a major Canadian publisher of evidence, advice, and recommendations regarding the assessment and management of health technologies. The Canadian Journal of Health Technologies will publish CADTH work in a single, PubMed-indexed, online location, making it easier for our health system partners to search and find CADTH work. Through the Canadian Journal of Health Technologies, CADTH will expand its reach and its collaborations with producers and users of health technology assessments.

scholarly journals The concept of multi-criteria analysis of decision-making in the current system of health technology assessment in Russia

2018 ◽  
Vol 11 (3) ◽  
pp. 3-7 ◽  
Author(s):  
V. V. Omelyanovsky ◽  
V. K. Fedyaeva ◽  
N. Z. Musina
Keyword(s):  
Decision Making ◽  
Decision Analysis ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Government Regulation ◽  
Current System ◽  
Health Technology ◽  
Assessment Methodology ◽  
Current Version ◽  
Health Technologies

In the article, we analyze the current version of Government Regulation No. 871 where the principles of health technologies assessment (HTA) and the reimbursement strategies in Russia have been put forward. We conclude that the HTA methodology in Russia is consistent with the multi-criteria decision analysis. Recommendations on the improvement of the assessment methodology in Regulation No. 871 are provided.

THE ROLE OF PATIENT DECISION-MAKING IN EVALUATING HEALTH TECHNOLOGY ASSESMENT (LITERATURE REVIEW)

Vestnik ◽  
2021 ◽  
pp. 315-323
Author(s):  
Л.К. Кошербаева ◽  
З.Р. Сагындыкова ◽  
Т.Б. Егеубаев
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Expert Knowledge ◽  
Health Technology ◽  
Social Consequences ◽  
Patient Decision Making ◽  
Health Technologies ◽  
Patient Decision ◽  
Giving Feedback

В условиях ограниченных бюджетов для современного здравоохранения рациональное потребление ресурсов является очень актуальной проблемой. Оценка технологий здравоохранения (ДСТБ) - комплексная оценка относительно доказанной клинической и клинико-экономической (фармаколого-экономической) эффективности и безопасности технологий здравоохранения, а также экономических, социальных и этических последствий их применения. Цель оценки технологий здравоохранения-одобрение заявленных технологий здравоохранения и включение заявленных технологий здравоохранения в перечень компенсации и информирование политиков в области здравоохранения. Следует ли применять здоровье сберегающую технологию, как ее применять и какую пользу от нее получают пациенты. Обучение экспертным знаниям о выживаемости, диагностике и лечении болезней и болезней, в том числе о методе оказания помощи (для анализа затрат и выгод), бремени болезней, выявлении пробелов в уходе, выявлении и удовлетворении потребностей. Предоставление отзывов о лечении (или отсутствии лечения и поддержки) социальных последствий заболевания способствует подходу пациентов, процессу принятия решений по мере необходимости. In the context of limited budgets for modern healthcare, rational resource consumption is a very urgent problem. Health Technology Assessment (OST) - a comprehensive assessment of the relatively proven clinical and clinical- economic (pharmacological-economic) effectiveness and safety of health technologies, as well as the economic, social and ethical consequences of their use. The purpose of the health technology assessment is to approve the claimed health technologies and include the claimed health technologies in the compensation list and inform health policy makers. It shows whether healthcare technology should be used or not, how it should be used, and how patients can benefit from it. Providing expert knowledge on the pain and burden of living, diagnosis and treatment, including the method of providing assistance (to analyze costs and benefits), the burden of diseases, identifying gaps in care, identifying and meeting needs. Giving feedback on the treatment (or lack of treatment and support) of the social consequences of the disease contributes to the decision-making process depending on the patient's attitude, needs.

VP214 Criteria That Influence The Brazilian Public Decision-Making

2017 ◽  
Vol 33 (S1) ◽  
pp. 248-248
Author(s):  
Andrea Brígida de Souza ◽  
Marisa Santos
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Health System ◽  
Public Health System ◽  
Bipolar Affective Disorder ◽  
Health Technology ◽  
Multiple Criteria ◽  
Emission Computed Tomography ◽  
Hematopoietic Stem ◽  
Health Technologies

INTRODUCTION:In Brazil, the National Committee for Health Technology Incorporation in the public health system (CONITEC) advises the Ministry of Health about incorporation, exclusion and alteration of health technologies in Brazilian public health system (SUS). Decision making considers multiple criteria, included or not in legislation. This analysis was the first step for a multiple-criteria decision analysis (MCDA) building. This study aims to identify criteria that influence Health Technology Assessment (HTA) for SUS.METHODS:Five real cases of controversial recommendations of technology incorporation made by CONITEC were reviewed by listening to the plenary recordings and reviewing committee minutes. The choice was guided by convenience, with prioritization according to CONITEC's members, using a pre-defined standardized form. Weight in decision making was also raised and identified. Selected technologies judgments were: Trastuzumab for metastatic/advanced Breast Cancer; Fingolimod for Multiple Sclerosis; Clozapine, Lamotrigine, Olanzapine, Quetiapine and Risperidone for Bipolar Affective Disorder; Hematopoietic stem cell transplantation for Sickle Cell Disease; and Positron Emission Computed Tomography (PET-CT) for Lung Cancer and for hepatic metastasis from Colorectal Cancer.RESULTS:The choice of different technologies allowed verifying specific criteria used for the incorporation of each type of technology, as well as the similar criteria discussed and used by all these technology types. In addition, some identified criteria were specific to the Brazilian reality, such as: “Incorporation by other countries”, “Potential technologies without registration in Brazil” and “Off-label use”. These criteria were not previously identified in studies conducted in other countries. Some criteria have been identified in all decisions, such as: efficacy, disease severity, quality and confidence in the evidences, logistic challenges for implementation, unmet needs, budget impact and treatment costs. Relative impact of cost-effectiveness was considered low.CONCLUSIONS:CONITEC's recordings are an important source to understand the Brazilian decision-making process. To identify the important criteria can help to standardize and improve the HTA process.

scholarly journals THE VULNERABLE ASPECTS OF APPLICATION OF “HEALTH TECHNOLOGY ASSESSMENT”

2015 ◽  
Vol 31 (3) ◽  
pp. 197-198 ◽  
Author(s):  
Reza Dehnavieh ◽  
Somayeh Noori Hekmat ◽  
Sara Ghasemi ◽  
Nadia Mirshekari
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Developed Countries ◽  
Economic Outcomes ◽  
The Other ◽  
Ethical Aspects ◽  
Health Technologies ◽  
Other Hand ◽  
The World

Many countries in the world have tried to examine the possible methods for import and logical use of health technologies to manage their budgets on one hand and to prevent the entry of uncertain, inefficient, and insecure technologies on the other hand (1). The “health technology assessment” (HTA) is one of the dominant methods in most developed countries (2). HTA is a multidisciplinary field which studies the medical, social, and ethical aspects, as well as economic outcomes of production, diffusion, and application of health technologies (3).

scholarly journals Harmonization of evidence requirements for health technology assessment in reimbursement decision making

2008 ◽  
Vol 24 (04) ◽  
pp. 511-517 ◽  
Author(s):  
John Hutton ◽  
Paul Trueman ◽  
Karen Facey
Keyword(s):  
Decision Making ◽  
Local Control ◽  
Technology Assessment ◽  
Health Technology ◽  
Multiple Stakeholders ◽  
Data Standards ◽  
Rate Of Development ◽  
Health Technologies ◽  
Medical Technologies ◽  
General Data

As more countries use HTA to inform decisions on the reimbursement of health technologies, harmonization of evidence requirements between jurisdictions has been proposed, mainly on the grounds of improved efficiency. Harmonization has the potential to avoid duplication of effort for both manufacturers and HTA bodies involved in preparing and reviewing HTA submissions for innovative technologies. However, it also carries risks of loss of local control over decisions, the application of general data standards which are not universally accepted and slowing the rate of development of innovation in the analytical disciplines supporting HTA. This study reviews the issues associated with harmonization taking into account the perspectives of the multiple stakeholders. This study draws on experiences from recent initiatives intended to promote the harmonization of HTA and experience from related fields, particularly regulatory approval of new medical technologies.

scholarly journals DEVELOPMENT OF THE ONTARIO DECISION FRAMEWORK: A VALUES BASED FRAMEWORK FOR HEALTH TECHNOLOGY ASSESSMENT

2018 ◽  
Vol 34 (3) ◽  
pp. 290-299 ◽  
Author(s):  
Murray Krahn ◽  
Fiona Miller ◽  
Ahmed Bayoumi ◽  
Ann-Sylvia Brooker ◽  
Frank Wagner ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Conflicts Of Interest ◽  
A Priori ◽  
Health Technology ◽  
Optimal Decision ◽  
Decision Framework ◽  
Health Technologies ◽  
Decision Attributes

Objectives:In 2007, the Ontario Health Technology Advisory Committee (OHTAC) developed a decision framework to guide decision making around nondrug health technologies. In 2012, OHTAC commissioned a revision of this framework to enhance its usability and deepen its conceptual and theoretical foundations.Methods:The committee overseeing this work used several methods: (a) a priori consensus on guiding principles, (b) a scoping review of decision attributes and processes used globally in health technology assessment (HTA), (c) presentations by methods experts and members of review committees, and (d) committee deliberations over a period of 3 years.Results:The committee adopted a multi-criteria decision-making approach, but rejected the formal use of multi-criteria decision analysis. Three broad categories of attributes were identified: (I) context criteria attributes included factors such as stakeholders, adoption pressures from neighboring jurisdictions, and potential conflicts of interest; (II) primary appraisal criteria attributes included (i) benefits and harms, (ii) economics, and (iii) patient-centered care; (III) feasibility criteria attributes included budget impact and organizational feasibility.Conclusion:The revised Ontario Decision Framework is similar in some respects to frameworks used in HTA worldwide. Its distinctive characteristics are that: it is based on an explicit set of social values; HTA paradigms (evidence based medicine, economics, and bioethics/social science) are used to aggregate decision attributes; and that it is rooted in a theoretical framework of optimal decision making, rather than one related to broad social goals, such as health or welfare maximization.

FACTORS INFLUENCING DECISION MAKING ON THERAPEUTIC INTERVENTIONS

2013 ◽  
Vol 29 (3) ◽  
pp. 331-335
Author(s):  
Sang Moo Lee ◽  
Gaeun Kim ◽  
Jeonghoon Ahn ◽  
Hae Sun Suh ◽  
Dae Seog Heo
Keyword(s):  
Decision Making ◽  
Diagnostic Procedures ◽  
Health Technology ◽  
Therapeutic Interventions ◽  
Complication Rates ◽  
Health Technologies ◽  
Alternative Intervention ◽  
Lower Complication ◽  
Lower Complication Rate ◽  
Technology Heterogeneity

Objectives: The aim of this study was to explore factors that influenced decision making in the assessment of new health technology in Korea.Methods: We analyzed the decision-making results of the Committee for New Health Technology Assessment (CnHTA) on fifty-three new nondrug health technologies in Korea from July 2007 to December 2010. The scope of the committee was mainly limited to safety and efficacy/effectiveness, and every decision was based on a systematic review of the literature. The committee was composed of healthcare professionals, policy makers, lawyers, and representatives from nongovernmental organizations. Decisions made on therapeutic interventions were included, while those on diagnostic procedures were excluded.Results: Factors that positively influenced decisions were lower complication rate than existing technology, similar or greater effectiveness compared with existing technology, ability to save critical organs, absence of alternative intervention, decreased invasiveness, expansion of patient's set of choices, and similarity to the mechanism of existing technology. Factors that negatively influenced decisions were higher complication rates than existing technology, lower effectiveness than comparable technology, low levels of evidence, unknown mechanisms of intervention, inconsistency, lack of long-term outcomes, lack of comparative data, nonstandardized technology, heterogeneity between control and treatment, excessively diverse indications, and nongeneralizability.Conclusions: This qualitative analysis of past decision-making results provided us with clues on the values that decision makers on the Korean CnHTA considered in terms of safety and effectiveness. These findings will help us develop appraisal guidelines and enhance the objectivity of decision-making processes in Korea.

scholarly journals Resource allocation and health technology assessment in Australia: Views from the local level

2009 ◽  
Vol 25 (02) ◽  
pp. 134-140 ◽  
Author(s):  
Gisselle Gallego ◽  
Kees van Gool ◽  
Dianne Kelleher
Keyword(s):  
Decision Making ◽  
Health Service ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Online Survey ◽  
Local Level ◽  
Healthcare Providers ◽  
Health Technology ◽  
Health Technologies ◽  
Decision Making Processes

Objectives:Several studies have shown that a key determinant of successful health technology assessment (HTA) uptake is a clear, fair, and consistent decision-making process for the approval and introduction of health technologies. The aim of this study was to gauge healthcare providers' and managers' perceptions of local level decision making and determine whether these processes offer a conducive environment for HTA. An Area Health Service (AHS) aimed to use the results of this study to help design a new process of technology assessment and decision making.Methods:An online survey was sent to all health service managers and healthcare providers working in one AHS in Sydney, Australia. Questions related to perceptions of current health technology decisions in participants' own institution/facility and opinions on key criteria for successful decision-making processes.Results:Less than a third of participants agreed with the statements that local decision-making processes were appropriate, easy to understand, evidence-based, fair, or consistently applied. Decisions were reportedly largely influenced by total cost considerations as well as by the central state health departments and the Area executive.Conclusions:Although there are renewed initiatives in HTA in Australia, there is a risk that such investments will not be productive unless policy makers also examine the decision-making contexts within which HTA can successfully be implemented. The results of this survey show that this is especially true at the local level and that any HTA initiative should be accompanied by efforts to improve decision-making processes.

Sign in / Sign up

Export Citation Format

Share Document