Dr cynthia iglesias please note that booking closes on 10th february 2020. Medical technologies are assessed both in absolute terms and in. Health technology assessment washington state health. Topic identification and prioritization process health. A designated staff member should complete the required form and forward it or an electronic equivalent to the appropriate party as required by law. To address these and other challenges specific to medical devices, the european union launched the methods for health technology assessment of medical devices. The medtechta project rosanna tarriconea,b, aleksandra torbicaa,b and michael drummonda,c acergas, bocconi university, milan, italy bdepartment of policy analysis and public management, bocconi university, milan, italy ccentre for health economics, university of york, york, uk abstract.
The reason is that the main objective of hta studies for devices is not. Medical equipment management 8 report the incident as required by the safe medical devices act smda. Policy brief health technology assessment an introduction to objectives, role of evidence, and structure in europe by marcial velascogarrido the european observatory on health systems and policies is a partnership between the world health organization regional office reinhard busse. The evolving health technology assessment for medical. Uets health technology assessment unit, madrid, spain uk united kingdom vaspvt state health care accreditation agency, lithuania wp work package. While the process and methodology for pharmaceuticals is wellestablished, guidance for medical devices is sparse. Medical devices are different to pharmaceuticals in the health technology assessment process. Health technology assessment hta is a formal, systematic research process designed to synthesize and evaluate the existing evidence for a medical treatment or health delivery innovation referred to as technology in subsequent sections of this document. Guide to understanding health technology assessment hta.
The medical devices industry is one of the most dynamic and innovative areas of healthcare, medicine and pharmacy, with thousands of new products introduced every year in the market. The canadian experience in canada, health care decisionmaking and priority setting are decentralized and occur at various levels. Mapping of hta national organisations, programmes and processes in eu may 2017 julia chamova, mba stellalliance ab 1 disclaimer. Pdf health technology assessment and medical devices. The pancanadian health technology assessment collaborative was formed in 2011 to share best practices, mitigate the risk of duplication of effort through information sharing, and to identify and participate in joint initiatives in the. Although it is routinely applied in drugs and surgery, hta in medical devices is still quite challenging. Advances in medical technology and designs have impacted patient care, as medical devices systems have an expanding capability to store patient data and connect to healthcare networks. Effects of clinical evaluation on the diffusion of medical technology. Topic identification and prioritization process health technology assessment and optimal use. Prosthesis list advisory committee plac and the medical. A guide to health technology assessment at hiqa health information and quality authority 5 technologies include, but are not limited to. Health technology assessment of medical devices in korea sukyeong kim phd mph bpharm senior research fellow, international cooperation advisor evidencebased healthcare research department ispor asia pacific 2018, 811 september, tokyo, japan medical devices less mature industry less experience preparing submission. This third version follows two done in 1998 and 2004 at the request of the national information center on health.
In preparing this document, wp acknowledges the availability of other health technology assessment guidelines. The evolving health technology assessment for medical devices and. Starting a health technology assessment should be preceded by decision problem. A framework for comprehensive assessment of medical. It highlights the factors that should shape its progress in the near future. Medical technology assessment in developed countries.
Health technology assessment world health organization. Pdf health technology assessment of medical devices. Health technology assessment and health policy today. Health technology assessment hta seeks to provide policy makers with information on the clinical and economic value of health technologies including pharmaceuticals, medical devices mds, clinical procedures, and organizational systems used in health care to inform their reimbursement or coverage decisions. Washingtons health technology assessment hta program uses scientific evidence to determine if health services are safe and effective. Healthtechnology assessment hta is a recognized mechanism to determine the relative benefits of innovative medical technologies. Health technology assessment washingtons health technology assessment hta program uses scientific evidence to determine if health services are safe and effective. The hta roundtable was attended by expert members of the.
Hfeue considerations in the development of medical devices involve the three major components of the deviceuser system. Health technology is everything that can be utilized in medical processes, i. Health technology assessment washington state health care. Pdf health technology assessment as a tool for medical. Health technology assessment of medical devices who has developed a reference document to provide an introduction to the concept and programme of health technology assessment hta around the world and to highlight the contribution that hta can make to informed policy and decisionmaking, particularly in developing and emerging countries. Although it is routinely applied in drugs and surgery, hta in medical. Good governance can rely on health technology assessment to provide a policy. Contains nonbinding recommendations applying human. The hta roundtable was attended by expert members of the prosthesis list advisory committee plac and the medical services advisory committee msac, and their subcommittees, and members of the therapeutic goods. Health technology assessment hta ion of a medical device can be impeded by inappropriate evidence and faulty understanding of its place in the care pathway. Health technology assessment hta is the systematic empirical assessment for effectiveness, costeffectiveness, and community acceptability of health technologies including drugs, devices, and organization of care. Advamed believes that these principles warrant broad adoption by all stakeholders involved in value assessments payers, providers, health technology assessment hta bodies, patient advocates, and medtech companies. Health technology assessment hta comprises a number of various methods utilized to assess health technologies. Health systems are strengthened when hta is integrated into the human and material resources, data, transparent decision and policymaking, and linked to the overall vision of equity and accountability.
The healthcare industry is an increasingly challenging environment for medical technology innovation. The gap is widening between health care that can be provided and health care that can be afforded. A framework for comprehensive assessment of medical technologies. The information and views set out in this study are those of the author and do not necessarily reflect the official opinion of the commission.
Hospitalbased health technology assessment in france. Nice medical technologies evaluation panel requires that medical devices should be cost saving or resource releasing to be recommended for use in the nhs. Health technology assessment scope a complete assessment report on a health technology a hta report comprises the following analyses. Pdf health technology assessment for medical devices. A comprehensive approach was adopted to identify institutions involved in hta in european countries. There are many benefits to having networkconnected medical devices systems that store data, including the availability of. Assessing medical technologies the national academies press. An indepth analysis of european assessments on highrisk medical devices.
Health systems struggling to find the right formula for balancing and aligning risks and rewards for medical providers and suppliers. Please note that booking closes on 10th february 2020. Medical devices constitute a large area of interest for hta. Olberg, britta fuchs, sabine panteli, dimitra perleth, matthias and busse, reinhard 2017. Jun, 2017 the pancanadian health technology assessment collaborative was formed in 2011 to share best practices, mitigate the risk of duplication of effort through information sharing, and to identify and participate in joint initiatives in the htas of medical devices, procedures and diagnostics. Scientific evidence in health technology assessment reports.
Contains nonbinding recommendations applying human factors. Hta serves washington citizens by ensuring that certain medical devices, procedures, and tests paid for with state health care dollars are safe and proven to work. Health technology assessment as a tool for medical devices management in hospitals conference paper pdf available november 2015 with 396 reads how we measure reads. This document integrates health technology assessment into the who framework for evidenceinformed policymaking. This book disentangles the issues in connection with the advancement of health technology assessment hta and its interface with health policy. Health technology assessment of medical devices in korea. Health economics surrounding medical devices scitech connect. Request pdf health technology assessment of medical devices. Technology assessment and regulation of medical devices. Hta activities for medical devices were evaluated from three perspectives. Conclusions through this roundtable, the working group was able to identify the key issues relating to hospitalbased hta and its development in france, based on an assessment of the current situation. Health technology assessment hta seeks to provide policy makers with information on the clinical and economic value of health technologies including pharmaceuticals, medical devices mds, clinical procedures, and organizational systems used in health care to inform their reimbursement or coverage decisions 1. Advances in medical technology and designs have impacted patient care, as medical devicessystems have an expanding capability to store patient data and connect to healthcare networks. It shall also embrace interventions such as companion diagnostics, surgical procedures, preventive and health promotion.
Medical technology assessment mta is the objective evaluation of a medical technology regarding its safety and performance, its future impact on clinical and nonclinical patient outcomes as well as its interactive effects on economical, organizational, social, juridical and ethical aspects of healthcare. The threeyear research programme ended on 31 december 2015 and was funded through the european commissions seventh framework programme for research. Making health technology assessment work for medical devices. There are many benefits to having networkconnected medical devicessystems that store data, including the availability of. Who health technology assessment of medical devices. Health technology assessment hta is a form of research that generates information about the clinical and costeffectiveness of health technologies in health care, the term health technology or in short technology can include medicinal products medicines, including biologics, medical devices, equipment, and supplies. Pdf 2 application submitted to the network in october 2014 3 article 8 rules of procedures. You can save up to 30% on managing medical devices within a regulatory framework when you order via the elsevier store. They found that although 75% of the agencies surveyed had adopted htaspeci. Mapping of hta national organisations, programmes and processes in eu. Technology assessment an overview sciencedirect topics. Health technology assessments on medical devices in europe. Health technology assessment of medical devices roundtable. Interdisciplinary and critical views from a number of professionals are put.
Hta and health economic principles lyg and outcome weighted survival metrics, dalys qalys htarelated initiatives at eu level 1. To provide an overview of the health economic aspect in current european hta guidelines. Eu cooperation on health technology assessment hta. Health technology assessment hta is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Health technology assessment hta methods have become a standard part of decisionmaking processes in healthcare service. The commission does not guarantee the accuracy of the data. Evaluation of medical devices for hta 2020 health sciences. Both politically, in terms of being accountable to those who fund the system, and also ethically, in terms of making sure that you. The international federation of medical and biological engineers ifmbe then convened a structured focus group, with experts from different fields, to identify potential gaps in the current hta guidelines, and to develop recommendations to fill these perceived gaps. The international federation of medical and biological engineers ifmbe then convened a structured focus group, with experts from different fields, to identify potential gaps in the current hta guidelines, and to develop. Its aim is to inform the formulation of safe, effective, health policies that are patient focused. A gray literature search of hta agency web sites for assessment methods guidelines on devices was conducted. We systematically searched institutional web sites and other online sources by.
The health technology assessment of medical devices roundtable hta roundtable was held in sydney on friday 9 june 2017. Interested individuals or entities can submit topics for consideration via. Assessment of medical devices for the national institute. Hta shapes policy and practice through primary research, research synthesis, and audit of practice and implementation. Topic identification topic suggestions for health technology assessment hta or optimal use ou reports come from a variety of sources. Mapping of hta national organisations, programmes and. Health technology assessment hta is defined by the international network of agencies for health technology assessment inahta as a multidisciplinary field of policy analysis, studying the medical, economic, social and ethical implications of development, diffusion and use of health technology 2011b.
Health technology assessment of medical devices roundtable outcomes report. Evaluation of medical devices for product development and health technology assessment. Health technology assessment hta is a recognized mechanism to determine the relative benefits of innovative medical technologies. Available from cambridge university press via the doi in this record.