scholarly journals Artificial Intelligence and Health Technology Assessment: Anticipating a New Level of Complexity (Preprint)

2020 ◽  
Author(s):  
Hassane Alami ◽  
Pascale Lehoux ◽  
Yannick Auclair ◽  
Michèle de Guise ◽  
Marie-Pierre Gagnon ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Real World ◽  
Health Sector ◽  
Health Technology ◽  
System Transformation ◽  
Novel Technologies ◽  
Technical Performance

UNSTRUCTURED Artificial intelligence (AI) is seen as a strategic lever to improve access, quality, and efficiency of care and services and to build learning and value-based health systems. Many studies have examined the technical performance of AI within an experimental context. These studies provide limited insights into the issues that its use in a real-world context of care and services raises. To help decision makers address these issues in a systemic and holistic manner, this viewpoint paper relies on the health technology assessment core model to contrast the expectations of the health sector toward the use of AI with the risks that should be mitigated for its responsible deployment. The analysis adopts the perspective of payers (ie, health system organizations and agencies) because of their central role in regulating, financing, and reimbursing novel technologies. This paper suggests that AI-based systems should be seen as a health system transformation lever, rather than a discrete set of technological devices. Their use could bring significant changes and impacts at several levels: technological, clinical, human and cognitive (patient and clinician), professional and organizational, economic, legal, and ethical. The assessment of AI’s value proposition should thus go beyond technical performance and cost logic by performing a holistic analysis of its value in a real-world context of care and services. To guide AI development, generate knowledge, and draw lessons that can be translated into action, the right political, regulatory, organizational, clinical, and technological conditions for innovation should be created as a first step.

scholarly journals Artificial Intelligence and Health Technology Assessment: Anticipating a New Level of Complexity

10.2196/17707 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e17707
Author(s):  
Hassane Alami ◽  
Pascale Lehoux ◽  
Yannick Auclair ◽  
Michèle de Guise ◽  
Marie-Pierre Gagnon ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Real World ◽  
Health Sector ◽  
Health Technology ◽  
System Transformation ◽  
Novel Technologies ◽  
Technical Performance

Artificial intelligence (AI) is seen as a strategic lever to improve access, quality, and efficiency of care and services and to build learning and value-based health systems. Many studies have examined the technical performance of AI within an experimental context. These studies provide limited insights into the issues that its use in a real-world context of care and services raises. To help decision makers address these issues in a systemic and holistic manner, this viewpoint paper relies on the health technology assessment core model to contrast the expectations of the health sector toward the use of AI with the risks that should be mitigated for its responsible deployment. The analysis adopts the perspective of payers (ie, health system organizations and agencies) because of their central role in regulating, financing, and reimbursing novel technologies. This paper suggests that AI-based systems should be seen as a health system transformation lever, rather than a discrete set of technological devices. Their use could bring significant changes and impacts at several levels: technological, clinical, human and cognitive (patient and clinician), professional and organizational, economic, legal, and ethical. The assessment of AI’s value proposition should thus go beyond technical performance and cost logic by performing a holistic analysis of its value in a real-world context of care and services. To guide AI development, generate knowledge, and draw lessons that can be translated into action, the right political, regulatory, organizational, clinical, and technological conditions for innovation should be created as a first step.

scholarly journals IMPROVING THE EFFECTIVENESS AND EFFICIENCY OF EVIDENCE PRODUCTION FOR HEALTH TECHNOLOGY ASSESSMENT

2015 ◽  
Vol 31 (4) ◽  
pp. 201-206 ◽  
Author(s):  
Karen Facey ◽  
Chris Henshall ◽  
Laura Sampietro-Colom ◽  
Sarah Thomas
Keyword(s):  
Life Cycle ◽  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Real World ◽  
Innovation System ◽  
Health Technology ◽  
Real World Data ◽  
Whole Life Cycle ◽  
Policy Forum

Objectives: Health Technology Assessment (HTA) needs to address the challenges posed by high cost, effective technologies, expedited regulatory approaches, and the opportunities provided by collaborative real-world evaluation of technologies. The Health Technology Assessment International (HTAi) Policy Forum met to consider these issues and the implications for evidence production to inform HTA. This paper shares their discussion to stimulate further debate.Methods: A background paper, presentations, group discussions, and stakeholder role play at the 2015 HTAi Policy Forum meeting informed this paper.Results: HTA has an important role to play in helping improve evidence production and ensuring that the health service is ready to adopt effective technologies. It needs to move from simply informing health system decisions to also working actively to align stakeholder expectations about realistic evidence requirements. Processes to support dialogue over the health technology life cycle need to be developed that are mindful of limited resources, operate across jurisdictions and learn from past processes. Collaborations between health technology developers and health systems in different countries should be encouraged to develop evidence that will inform decision making. New analytical techniques emerging for real-world data should be harnessed to support modeling for HTA.Conclusions: A paradigm shift (to “Health Innovation System 2.0”) is suggested where HTA adopts a more central, proactive role to support alignment within and amongst stakeholders over the whole life cycle of the technology. This could help ensure that evidence production is better aligned with patient and health system needs and so is more effective and efficient.

scholarly journals Future of Health Technology Assessment System in Iran: Necessity of Reinforcement in Both Scenarios of Continuation or Relief of Sanctions

2021 ◽  
Author(s):  
Ali Sarrafkia ◽  
Saharnaz Nedjat ◽  
Reza Majdzadeh
Keyword(s):  
Health Technology Assessment ◽  
Health System ◽  
Capacity Building ◽  
Technology Assessment ◽  
Health Sector ◽  
Health Technology ◽  
Assessment System ◽  
Health Technologies ◽  
Political Events ◽  
Future Events

Background: In Iran, health technology assessment (HTA) system dates back to nearly a decades ago (2008). Objectives: The current study aimed to define steps required to expand HTA in Iran by emphasizing possible future events related to the health sector. Methods: A preliminary list of future trends potentially influencing Iran’s HTA system was extracted through the literature review. Then, the trends were presented to 12 experts to obtain their opinions. Afterward, their influence on the future of the HTA system in Iran was investigated using in-depth interviews. The interviews were analyzed using the thematic analysis method; Initially, in three categories of capacity building, provision of HTA, and supportive mechanisms, and then according to the essential functions of a health system (i.e., control knobs). Results: Interviewees believed that strengthening the HTA system is mandatory, regardless of future political events. In the category of capacity building, adjusting training to the needs, using the capacity of graduates in conducting HTAs, training more students in the HTA profession as well as the establishment of a Ph.D. program, turning HTA into public demand, and preventing overuse of medical technologies were elaborated. In the second category (i.e., provision of HTA), the following themes were extracted: modernization and equipping of health system infrastructure based on the evidence provided by HTA, the legitimization of HTA to be used for all health technologies, preventing the introduction of unnecessary technologies and similar technologies that are currently using in Iran, and employing HTA in developing the basic benefit package. Conclusions: Due to international sanctions, Iran has a niche healthcare market. If sanctions continue, HTA would be a serious necessity to increase the resilience of the health system. In the case of sanctions relief, HTA is still necessary for the optimization of allocating resources. These steps, in both scenarios, are mostly related to the institutionalization of HTA, mostly on the legitimization of HTA and behavioral changes.

scholarly journals Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements

2021 ◽  
Vol 37 ◽  
Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Practical Experience ◽  
Added Value ◽  
Real World Data ◽  
Conflicting Demands ◽  
Real World Evidence ◽  
Semistructured Interviews

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.

R WE ready for reimbursement? A round up of developments in RWE relating to health technology assessment: part 2

2021 ◽  
Author(s):  
Alex Simpson ◽  
Sreeram V Ramagopalan
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Health Inequity ◽  
Real World Data ◽  
World Data

In this round up, we cover how COVID-19 has been beneficial for improved access to real-world data, as well as how real-world data can be used to address health inequity, an area of increasing interest for health technology assessment.

OP123 Health Technology Assessment In Digital Health: A Rapid Approach To Assess Health Apps

2017 ◽  
Vol 33 (S1) ◽  
pp. 56-56
Author(s):  
Bernice Dillon ◽  
John Powell ◽  
Mark Campbell ◽  
Mark Salmon ◽  
Mirella Marlow
Keyword(s):  
Health Service ◽  
Cost Saving ◽  
Health Technology Assessment ◽  
Economic Impact ◽  
Technology Assessment ◽  
Real World ◽  
Rapid Assessment ◽  
Health Technology ◽  
Health Apps ◽  
Evidence Summary

INTRODUCTION:The Health Technology Assessment (HTA) of mobile health applications involves significant challenges including rapid product development cycles, sparse evidence and uncertainty over the economic impact. However apps also provide unique opportunities, such as their potential reach and use of real-world data, which will facilitate their contribution to healthcare delivery. The National Institute for Health and Care Excellence (NICE), alongside other agencies, has been piloting the development of a health app assessment programme. This presentation reports the results of a study about the development of the Health App Briefing (HAB) which is designed as the output from a rapid assessment of the effectiveness and cost-saving potential of apps to inform decision makers in the United Kingdom National Health Service.METHODS:The HAB is built on the success of the NICE Medtech Innovation Briefings programme because many of the HTA challenges are similar to those found with medical devices. HAB development is grounded in four principles: rapid assessment; transparent process; independence from industry or the health service and input from commentators. The content includes an evidence summary for effectiveness including comments from specialist experts and users; a summary of information relating to the cost saving potential and a summary of other user benefits (including issues of access and usability). Novel features are the presentation of a rating of the potential value of the app to the health system and working with commissioners of the app to obtain real-world information for a case study about the economic impact.RESULTS:The development of four HABs along with a review of the learning from the piloting process will be presented. The review will include stakeholder feedback from a workshop.CONCLUSIONS:We believe the evaluation of this work presented here will be of interest to other HTA agencies around the world that are deciding how to approach the issues surrounding the assessment of health apps.

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