scholarly journals HTA AND ITS LEGAL ISSUES: A FRAMEWORK FOR IDENTIFYING LEGAL ISSUES IN HEALTH TECHNOLOGY ASSESSMENT

2014 ◽  
Vol 30 (6) ◽  
pp. 587-594 ◽  
Author(s):  
Daniel Widrig ◽  
Brigitte Tag

Objectives: Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research.Methods: After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples.Results: This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions.Conclusions: The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.

2019 ◽  
Vol 35 (S1) ◽  
pp. 19-19
Author(s):  
Bart Bloemen ◽  
Maarten Jansen ◽  
Wouter Rijke ◽  
Wija Oortwijn ◽  
Gert Vanderwilt

IntroductionHealth Technology Assessment (HTA) is where facts and values meet: the evidence that is considered relevant to the assessment of a technology depends on the value framework used. In the context of the European project VALIDATE (Values in doing assessments of healthcare technologies), we assessed to what extent this interplay between facts and values is acknowledged in HTA reports on non-invasive prenatal testing (NIPT). Our aim is to gain a better understanding of this fact-value relationship, and to contribute to the development of capacity for ethical analyses in HTA.MethodsFive reviewers independently analyzed HTA reports on NIPT, obtained from the National Institute for Health Research (NIHR) HTA database, by answering a structured questionnaire on: (i) arguments, values, and conclusions; (ii) relations between values and collected evidence; (iii) operationalizations of the values involved. Ethical argumentation was analyzed using the method of specifying norms. This method holds that for general, abstract ethical principles to reach concrete cases, principles need to be specified in such a way as to achieve maximal coherence between different value commitments and practice. The results of the analysis were discussed in joint meetings to arrive at a consensus on interpretation.ResultsOur results show that the pivotal role of values in defining what counts as relevant evidence and why, is rarely acknowledged. The same holds for the importance of specifying values as a means to achieve greater coherence between the use of healthcare technologies and a range of values.ConclusionsThere is ample room for improvement in clarifying the role of values in HTA: they can serve to explain and justify what evidence is considered relevant to the assessment of a healthcare technology. Recognizing that abstract values need specification in order to reach concrete cases opens up new opportunities for exploring in what way values are affected by healthcare technologies.


2000 ◽  
Vol 16 (2) ◽  
pp. 299-302 ◽  
Author(s):  
David Banta ◽  
Wija Oortwijn

Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.


2017 ◽  
Vol 33 (S1) ◽  
pp. 33-34
Author(s):  
Mark Clowes

INTRODUCTION:One of the challenges of large scale Health Technology Assessment (HTA) projects is managing the large volume of studies retrieved by the requisite comprehensive literature searches. At the scoping stage of the project, a pragmatic judgement needs to be made as to how sensitive the search strategy should be in order to find all the relevant papers without returning an overwhelming volume of irrelevant studies.METHODS:For this HTA (evaluating prognostic and predictive markers in rheumatoid arthritis), the research team already had prior knowledge of several key markers of interest, but wanted to ensure that no others had been missed. Advice from practising clinicians was obtained, but for additional validation, a broad scoping search was conducted for ‘rheumatoid arthritis’ using the sensitive Haynes filters for prognostic (1) and clinical prediction (2) studies. Unsurprisingly, this initial search retrieved too many studies for them all to be admitted to the full review; but once those dealing with known markers had been removed, a sample of the remaining records was loaded into a software visualization tool (3) to display “heat maps” of frequently occurring terms and phrases.RESULTS:On this occasion, no additional markers were identified, however this provided reassurance that the advice obtained from clinicians was comprehensive, enabling the HTA team to proceed confidently with its evaluation of the selected markers.CONCLUSIONS:Visualization offers an alternative means of exploring and interrogating large text archives, and has the potential to complement the role of traditional search methods in identifying literature for systematic reviews and health technology assessments. As processing power increases and more and more full-text papers become available open access, it may provide a solution to some of the limitations associated with comprehensive searching.


Author(s):  
Katherine Duthie ◽  
Kenneth Bond

Objectives: The aim of this study was to critically examine the current guidance for conducting ethics analysis in health technology assessment (HTA) and to offer recommendations for how to improve this practice.Methods: MEDLINE, Philosopher's Index, and Google Scholar were searched for articles and reports using the keywords “ethics” and “health technology assessment” and related terms. Bibliographies of all relevant articles were also examined for additional references. A philosophical analysis of the existing guidance was conducted.Results: We offer three recommendations for improving ethics analysis in HTA. First, ethical and legal issues must be clearly separated so that all policy-relevant questions that the technology raises can be considered clearly and systematically. Second, analysts must make better use of ethics theory and discuss better how particular theoretical approaches and associated analytic tools are selected to make transparent which alternative approaches were considered and why they were rejected. Third, the necessity for philosophical expertise to adequately conduct ethics analysis needs to be acknowledged.Conclusions: To act on these recommendations for ethics analysis, we offer these three steps forward: acknowledge and use relevant expertise, further develop models for conducting and reporting ethics analyses, and make use of untapped resources in the literature.


Author(s):  
Wija Oortwijn ◽  
Gert Jan van der Wilt

The Special Interest Group on Ethics and HTA (health technology assessment) has invited two renowned philosophers, Norman Daniels from Harvard University and Henry Richardson from Georgetown University to reflect on the role of HTA in healthcare policy making. Both acknowledge its importance, but at the same time warn against a too mechanistic deployment of HTA. In their view, the relevance of HTA to healthcare policy making would considerably be enhanced if it were subsumed within a broader deliberative framework. Why should this be so? What is there to deliberate on, who should do the deliberating, where and when, and how does this relate to the more technical elements of HTA such as evidence synthesis and economic modeling?


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