scholarly journals Blockchains, Property Rights and Health Technology Assessment in the Pharmaceutical and Device(s) Industries

2018 ◽  
Vol 9 (4) ◽  
pp. 1
Author(s):  
Paul Langley ◽  
Robert E Martin
Keyword(s):  
Property Rights ◽  
Health Technology Assessment ◽  
Health Information ◽  
Technology Assessment ◽  
Health Management ◽  
Value Added ◽  
Health Technology ◽  
Health Data ◽  
Blockchain Technology

Ongoing concerns with the security of health information, both from the perspective of the individual patient as well as health systems has led to increased attention being given to the potential role of blockchain technology in the secure storage of health information through encryption, the integration of diverse health record systems and the vesting of property and access rights to health data in the patient. While the security offered by blockchain technology has long been recognized in the finance sector with the emergence of a range of cryptocurrencies as a medium of exchange and store of value, demonstrating the value of blockchain technology in health management and health technology assessment has yet to be achieved. In this commentary, a number of questions are raised as to the potential value offered by blockchain technology as a complement to existing electronic medical record systems. Chief among these are: (i) the allocation of property rights as a necessary precondition for blockchain uptake; (ii) access and incentives for active as opposed to passive blockchain membership; (iii) monetization of blockchain access; (iv) capturing data from within the blockchain and the possibility of value added data; (v) the potential for blockchain platforms in formulary evaluations; (vi) the blockchain as a managed market for health data; and (vii) the role of intermediation in blockchain management.   Article Type: Commentary

scholarly journals If You Build it Will They Come? Patients, Providers and Blockchains in Health Technology Assessment

2018 ◽  
Vol 9 (4) ◽  
pp. 3
Author(s):  
Paul Langley ◽  
Robert E Martin
Keyword(s):  
Health Care ◽  
Property Rights ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Value Added ◽  
Health Technology ◽  
Added Value ◽  
Process Of Care ◽  
Market Place ◽  
Critical Issues

It is an open question as to whether blockchains can become an integral part of health care management in the US. On the one hand, there are the advocates of blockchains who see them as empowering patients to capture property rights to their medical records in a secure, encrypted, and portable form. On the other hand, there are blockchain critics that see the opportunities offered in health care as little different from those offered in other industries, viewing a blockchain structure as one that may reduce administrative and transaction costs, with little thought given to the potential of blockchain platforms to support a range of health technology assessment activities. While previous commentaries have pointed to this potential, the obstacles offered by the absence of clearly defined property rights and the absence of a market for DNA profiles have not been explored. The case put forward here is that any expectation that a blockchain as a ‘one-stop-shop’ for the interrogation of personal health records alone is unlikely to succeed. Apart from property rights effectively blocking this business model the blockchain vendor should consider targeted value added activities. At best, only a subset of records has the possibility of being transferred, with ongoing concerns regarding their quality and scope. This does not mean that the blockchain software model should be rejected. Far from it. The blockchain as a health technology assessment platform has the potential to support added value activities which not only improve the process of care and reduce costs and improve efficiencies, but also provide an ideal framework for property rights assignment. This opens the door to incentives and the monetization of value added health data by patients and providers, capturing rents that are at the moment expropriated by third parties. Critical issues are not only property rights and creation of a market place, but the ability to link and incentivize patients and their providers to support active blockchains to generate value added.   Article Type: Commentary

OP75 Facts And Values In Health Technology Assessment: The Case Of Non-Invasive Prenatal Testing

2019 ◽  
Vol 35 (S1) ◽  
pp. 19-19
Author(s):  
Bart Bloemen ◽  
Maarten Jansen ◽  
Wouter Rijke ◽  
Wija Oortwijn ◽  
Gert Vanderwilt
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Prenatal Testing ◽  
Health Technology ◽  
Non Invasive ◽  
Relevant Evidence ◽  
Healthcare Technologies ◽  
General Abstract ◽  
Structured Questionnaire

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.

INTRODUCTION: HEALTH TECHNOLOGY ASSESSMENT AND THE EUROPEAN UNION

2000 ◽  
Vol 16 (2) ◽  
pp. 299-302 ◽  
Author(s):  
David Banta ◽  
Wija Oortwijn
Keyword(s):  
Public Health ◽  
Decision Making ◽  
European Union ◽  
Health Technology Assessment ◽  
European Commission ◽  
Technology Assessment ◽  
Health Technology ◽  
The European Union ◽  
European Level

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.

PP120 Health Technology Assessment Framework To Capture The Full Value Of Value Added Medicines

2017 ◽  
Vol 33 (S1) ◽  
pp. 128-129
Author(s):  
Mondher Toumi ◽  
Cecile Remuzat ◽  
Adam Plich
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Repositioning ◽  
Value Added ◽  
Health Technology ◽  
Access To Medicines ◽  
Deliberative Process ◽  
Study Objective ◽  
Healthcare Needs ◽  
Patient Reported

INTRODUCTION:Value added medicines (VAM) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers through drug repositioning, drug reformulation or drug combination (1-3). Recently, the European Commission, through the Safe and Timely Access to Medicines for Patients (STAMP) program, considered the issue of VAM development and regulatory process. Current Health Technology Assessment (HTA) tools may not fully capture the benefits of VAM, which could lead to obstacles for patient access to VAM in several European countries (1). The study objective was to identify how HTA frameworks should evolve to reflect VAM value.METHODS:HTA expert interviews were performed as a preparatory step to an advisory board meeting. The following topics were addressed: (i) Eligibility for HTA and early HTA dialogues; (ii) Attributes that should be considered in HTA; (iii) HTA methodology; and (iv) Involvement of stakeholders in HTA.RESULTS:VAMs bring additional benefit to patients and society. Therefore, the possibility for VAM assessment on a voluntary basis and within the appropriate assessment patterns/tools should be, in principle, included into HTA frameworks, as well as into early HTA dialogues. HTA should be patient-centric, and attributes such as patient preference, adherence, and patient reported outcomes should be considered where relevant. Unmet patient needs and disease burden should be used in a transparent and reproducible deliberative process. All these attributes should be used as explicitly and meaningfully weighted appraisal modifiers. HTA methodology should be comprehensive and should integrate societal perspectives. Patient representatives should take part in the decision-making process.CONCLUSIONS:Current HTA frameworks should evolve to enhance VAM value recognition and encourage industry investment in medicines with high potential value for society.

scholarly journals COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Rossella Tomaiuolo ◽  
Pietro Derrico ◽  
Matteo Ritrovato ◽  
Massimo Locatelli ◽  
Frida Milella ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Evaluation Method ◽  
New Technologies ◽  
Health Management ◽  
Health Technology ◽  
Innovative Technology ◽  
Serological Tests ◽  
Antibody Tests

Abstract Objective In vitro diagnostic tests for SARS-COV-2, also known as serological tests, have rapidly spread. However, to date, mostly single-center technical and diagnostic performance's assessments have been carried out without an intralaboratory validation process and a health technology assessment (HTA) systematic approach. Therefore, the rapid HTA for evaluating antibody tests for SARS-COV-2 was applied. Methods The use of rapid HTA is an opportunity to test innovative technology. Unlike traditional HTA (which evaluates the benefits of new technologies after being tested in clinical trials or have been applied in practice for some time), the rapid HTA is performed during the early stages of developing new technology. A multidisciplinary team conducted the rapid HTA following the HTA Core Model® (version 3.0) developed by the European Network for Health Technology Assessment. Results The three methodological and analytical steps used in the HTA applied to the evaluation of antibody tests for SARS-COV-2 are reported: the selection of the tests to be evaluated; the research and collection of information to support the adoption and appropriateness of the technology; and the preparation of the final reports and their dissemination. Finally, the rapid HTA of serological tests for SARS-CoV-2 is summarized in a report that allows its dissemination and communication. Conclusions The rapid-HTA evaluation method, in addition to highlighting the characteristics that differentiate the tests from each other, guarantees a timely and appropriate evaluation, becoming a tool to create a direct link between science and health management.

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
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Legal Issues ◽  
Extensive Literature ◽  
Legal Analysis ◽  
Swiss Health ◽  
Extensive Literature Search ◽  
Legal Technology

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.

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