Health Technology Assessment for Cardiovascular Digital Health Technologies and Artificial Intelligence: Why is it Different?

2021 ◽  
Author(s):  
Dominique Vervoort ◽  
Derrick Y. Tam ◽  
Harindra C. Wijeysundera
Keyword(s):  
Artificial Intelligence ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Digital Health ◽  
Health Technology ◽  
Health Technologies

Application of a health technology assessment framework to digital health technologies that manage chronic disease: a systematic review

2021 ◽  
Vol 38 (1) ◽  
Author(s):  
Amy von Huben ◽  
Martin Howell ◽  
Joseph Carrello ◽  
Sarah Norris ◽  
Sally Wortley ◽  
...  
Keyword(s):  
Chronic Disease ◽  
Health Services ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Digital Health ◽  
Investment Decisions ◽  
Health Technology ◽  
Cochrane Library ◽  
Primary Research ◽  
Health Technologies

Abstract Background As health services increasingly make investment decisions in digital health technologies (DHTs), a DHT-specific and comprehensive health technology assessment (HTA) process is crucial in assessing value-for-money. Research in DHTs is ever-increasing, but whether it covers the content required for HTA is unknown. Objectives To summarize current trends in primary research on DHTs that manage chronic disease at home, particularly the coverage of content recommended for DHT-specific and comprehensive HTA. Methods Medline, Embase, Econlit, CINAHL, and The Cochrane Library (1 January 2015 to 20 March 2020) were searched for primary research studies using keywords related to DHT and HTA domains. Studies were assessed for coverage of the most frequently recommended content to be considered in a nine domain DHT-specific HTA previously developed. Results A total of 178 DHT interventions were identified, predominantly randomized controlled trials targeting cardiovascular disease/diabetes in high- to middle-income countries. A coverage assessment of the cardiovascular and diabetes DHT studies (112) revealed less than half covered DHT-specific content in all but the health problem domain. Content common to all technologies but essential for DHTs was covered by more than half the studies in all domains except for the effectiveness and ethical analysis domains. Conclusions Although DHT research is increasing, it is not covering all the content recommended for a DHT-specific and comprehensive HTA. The inability to conduct such an HTA may lead to health services making suboptimal investment decisions. Measures to increase the quality of trial design and reporting are required in DHT primary research.

scholarly journals The Impact of Digital Therapeutics on Current Health Technology Assessment Frameworks

2021 ◽  
Vol 3 ◽  
Author(s):  
Kevin Yan ◽  
Chakrapani Balijepalli ◽  
Eric Druyts
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Digital Health ◽  
Health Technology ◽  
Health Technologies ◽  
Current Health ◽  
Recent Emergence ◽  
Economic Analyses ◽  
The Impact

Historically healthcare has been delivered offline (e.g., physician consultations, mental health counseling services). It is widely understood that healthcare lags behind other industries (e.g., financial, transportation) whom have already incorporated digital technologies in their workflow. However, this is changing with the recent emergence of digital therapeutics (DTx) helping to bring healthcare services online. To promote adoption, healthcare providers need to be educated regarding the digital therapy to allow for proper prescribing. But of equal importance is affordability and many countries rely on reimbursement support from the government and insurance agencies. Here we briefly explore how national reimbursement agencies or non-profits across six countries (Canada, United States of America, United Kingdom, Germany, France, Australia) handle DTx submissions and describe the potential impact of digital therapeutics on current health technology assessment (HTA) frameworks. A targeted review to identify HTA submissions and guidelines from national reimbursement agencies or non-profits was conducted. We reviewed guidelines from the Institute for Clinical and Economic Review (ICER) in the USA, the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK), the Institute for Quality and Efficiency in Health Care (IQWIG) in Germany, Haute Autorité de Santé (HAS) in France, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia. Our review identified one set of guidelines developed by NICE in the UK. The guidelines by NICE outlined an evidence standards framework for digital health technologies (DHT). Depending on the organizational impact, financial commitment, and economic risk for the payer, different economic analyses are required. Economic analyses levels are separated into 3 categories, basic, low financial commitment, and high financial commitment. All economic analyses levels require a budget impact analysis. A cost-utility analysis is recommended for DHTs categorized in the high financial commitment category. Whereas, for DHTs that are in the low financial commitment category, a cost-consequence analysis is typically recommended. No HTA guidelines for DTx submissions were identified for the remaining countries (Canada, USA, Germany, France, and Australia)

Health Technology Assessment: Current Issues Impacting on the Regulatory and Legal Framework

2021 ◽  
pp. 158-176
Keyword(s):  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Digital Health ◽  
Health Technology ◽  
Legal Framework ◽  
Systematic Evaluation ◽  
Health Technologies ◽  
Based Medicine ◽  
Significant Milestone

6This chapter reviews how new or innovative pharmaceuticals, medical devices, diagnostics, and digital health technologies are appraised for their clinical and cost effectiveness by the National Institute for Health and Care Excellence. It gives context on the processes and considerations in following the regulation of medical devices and medicines. It also refers to the Health Technology Assessment (HTA) as a branch of policy that aims at examining and rationally optimising the value of measures to improve healthcare and prevent ill health. The chapter defines the HTA as a systematic evaluation of the properties and effects of a health technology. It recounts the beginnings of health technology that go back to the dawn of evidence-based medicine, in which the randomised comparative experiments of naval surgeon James Lind on scurvy in the eighteenth century were a significant milestone.

PP135 Setting The Scope For Assessing e-Health Technologies In Hungary

2019 ◽  
Vol 35 (S1) ◽  
pp. 63-63
Author(s):  
Bence Takács ◽  
Gergő Merész
Keyword(s):  
Literature Review ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Digital Health ◽  
Public Funding ◽  
Health Technology ◽  
Current Status ◽  
Health Technologies ◽  
Assessment Approach

IntroductionE-health and m-health are emerging health technology fields that could possibly give a new scope to health technology assessment (HTA). The Division for Health Technology Assessment (DfHTA) is currently assessing medicines and non-drug technologies (medical devices intended for patient use or for use in hospitals). The experience assessing medical devices for use in hospitals yielded difficulties which could also arise from the critical appraisal of e-health or m-health technologies. The objective of this study was to explore the foundations for HTA guidance on e-health or m-health technologies.MethodsA targeted literature review was conducted to map the current status of technology assessment practices for e-health and m-health technologies and to assess its concordance with current reimbursement processes in countries belonging to the Organisation for Economic Co-operation and Development. Experiences from past evaluations of other medical devices that could not be evaluated under the current guidance guided the literature search. The findings of this research were used to create a recommendation to amend the current Hungarian Guideline for Health Economic Analyses.ResultsThe resulting articles of the targeted literature review provided an insight into current practices on of assessing e-health and m-health products, particularly with respect to the domains of safety, quality, and impact. Recommendations suggested including a list of requirements for companies to submit for critical evaluations of e-health and m-health technologies, in support of a self-assessment approach.ConclusionsAs for other HTA bodies, there is an urgent need for the DfHTA to increase its capacity to assess digital health technologies for entry into the healthcare system, with a focus on the relevant clinical domains. The reimbursement process for these technologies remains a challenge for public funding bodies.

scholarly journals Estimating an EQ-5D-3L Value Set for Romania Using Time Trade-Off

2021 ◽  
Vol 18 (14) ◽  
pp. 7415
Author(s):  
Marian Sorin Paveliu ◽  
Elena Olariu ◽  
Raluca Caplescu ◽  
Yemi Oluboyede ◽  
Ileana-Gabriela Niculescu-Aron ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Assessment Process ◽  
Computer Assisted ◽  
Health State ◽  
Health States ◽  
Value Set ◽  
Health Technologies ◽  
Related Quality

Objective: To provide health-related quality of life (HRQoL) data to support health technology assessment (HTA) and reimbursement decisions in Romania, by developing a country-specific value set for the EQ-5D-3L questionnaire. Methods: We used the cTTO method to elicit health state values using a computer-assisted personal interviewing approach. Interviews were standardized following the most recent version of the EQ-VT protocol developed by the EuroQoL Foundation. Thirty EQ-5D-3L health states were randomly assigned to respondents in blocks of three. Econometric modeling was used to estimate values for all 243 states described by the EQ-5D-3L. Results: Data from 1556 non-institutionalized adults aged 18 years and older, selected from a national representative sample, were used to build the value set. All tested models were logically consistent; the final model chosen to generate the value set was an interval regression model. The predicted EQ-5D-3L values ranged from 0.969 to 0.399, and the relative importance of EQ-5D-3L dimensions was in the following order: mobility, pain/discomfort, self-care, anxiety/depression, and usual activities. Conclusions: These results can support reimbursement decisions and allow regional cross-country comparisons between health technologies. This study lays a stepping stone in the development of a health technology assessment process more driven by locally relevant data in Romania.

Designing an interactive model of factors affecting the health technology assessment (HTA) in Iran

2018 ◽  
Vol 23 (4) ◽  
pp. 301-311 ◽  
Author(s):  
Mohammadkarim Bahadori ◽  
Ramin Ravangard ◽  
Mahya Tohidi Nezhad ◽  
Naeimeh Pourtaheri ◽  
Sayyed Morteza Hosseini-Shokouh
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Social Dimension ◽  
Ethical Dimension ◽  
Policy Makers ◽  
Content Type ◽  
Factors Affecting ◽  
Health Technologies ◽  
Interactive Model

PurposeAccording to the great importance of community health as well as the ever-increasing development of health technologies, the importance of designing an interactive model of factors affecting health technology assessment (HTA) can be highlighted. The purpose of designing and implementing the framework of health information system assessment is to ensure that the required accurate data which are necessary to measure the main health indicators are available. The purpose of this paper is to design an interactive model of factors affecting HTA.Design/methodology/approachThis is a cross-sectional, descriptive-analytic study conducted in the Iran Ministry of Health and Medical Education in the second half of 2017. A sample of 60 experts and professionals working in the field of health technologies are selected using purposive and snowball sampling methods. Two researcher-made questionnaires are used to collect the required data. The collected data are analyzed using decision-making trial and evaluation laboratory (DEMATEL) and MATLAB R2013a.FindingsThe results showed that “Legal dimension,” “safety,” “Effectiveness” and “Social dimension” were the affecting factors and net causes, and “Current application,” “Knowledge of technology,” “Ethical dimension,” “Costs” and “Organizational dimension” were the affected factors and net effects in the interactive model. Furthermore, “Legal dimension” with the coordinates C: [1.88, 1.27] and “Ethical dimension” with the coordinates C: [1.75, −75] were known as the most affecting and most affected factors in the interactive model, respectively.Originality/valueThe DEMATEL model is an appropriate tool for managers and policy makers to structure and prioritize factors influencing the HTA. Policy makers and decision makers can use this model for identifying relationships among factors and prioritize them. Because health policy makers and managers have a major role in formulating the regulations and guidelines related to the HTA, they should pay more attention to the legal considerations in their decisions and use the management tools to move the available resources toward implementing and enforcing rules and guidelines related to the HTA.

scholarly journals Digi-HTA: Health technology assessment framework for digital healthcare services

2019 ◽  
Vol 11 (4) ◽  
Author(s):  
Jari Haverinen ◽  
Niina Keränen ◽  
Petra Falkenbach ◽  
Anna Maijala ◽  
Timo Kolehmainen ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
State Of The Art ◽  
Health Technology ◽  
Healthcare Services ◽  
The State ◽  
Systematic Evaluation ◽  
Health Technologies ◽  
Digital Healthcare ◽  
And Robotics

Health technology assessment (HTA) refers to the systematic evaluation of the properties, effects, and/or impacts of health technology. The main purpose of the assessment is to inform decisionmakers in order to better support the introduction of new health technologies. New digital healthcare solutions like mHealth, artificial intelligence (AI), and robotics have brought with them a great potential to further develop healthcare services, but their introduction should follow the same criteria as that of other healthcare methods. They must provide evidence-based benefits and be safe to use, and their impacts on patients and organizations need to be clarified. The first objective of this study was to describe the state-of-the-art HTA methods for mHealth, AI, and robotics. The second objective of this study was to evaluate the domains needed in the assessment. The final aim was to develop an HTA framework for digital healthcare services to support the introduction of novel technologies into Finnish healthcare. In this study, the state-of-the-art HTA methods were evaluated using a literature review and interviews. It was noted that some good practices already existed, but the overall picture showed that further development is still needed, especially in the AI and robotics fields. With the cooperation of professionals, key aspects and domains that should be taken into account to make fast but comprehensive assessments were identified. Based on this information, we created a new framework which supports the HTA process for digital healthcare services. The framework was named Digi-HTA.

scholarly journals Examination of Opinions of the Senior Health Managers Working in Private Hospitals on Health Technology Assessment

2020 ◽  
Author(s):  
Mehmet Akif Erişen ◽  
Fatma Özlem Yılmaz
Keyword(s):  
General Education ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Structured Interview ◽  
Private Hospitals ◽  
Face To Face ◽  
Health Technologies ◽  
Assessment Approach ◽  
Health Administrators

INTRODUCTION: In this study, it was aimed to evaluate the views and opinions of the health administrators, who are working in the private hospitals in Konya province centre about health technology assessment and applications. METHODS: Qualitative research methods have been used in research, and phenomologic method is preferred. The research was conducted using face-to-face interviews with health administrators working in private hospitals serving in the centre of Konya and accepting to participate in the research. A semi-structured interview form was used as a data collection tool in the survey. RESULTS: As a result of the analysis, sub-themes were created under the headings of health technologies, health technology assessment, health technology assessment applications in Turkey, health technology assessment approach of private hospitals, establishment of health technology assessment department, health technology assessment applications of the respondents’ hospitals and future position of health technology assessment. And the findings under the created themes are interpreted. DISCUSSION AND CONCLUSION: The managers had various information about health technology assessment applications however it was limited. In this respect, it would be beneficial to provide a general education about health technology assessment in order to increase awareness and application of health technology assessment practices.

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.

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