{"title":"PP106 将组织影响纳入健康技术评估:如何将组织影响纳入医疗技术评估?","authors":"Estelle Piotto, Emmanuelle Fouteau, Camille Marguerite, Hubert Galmiche, Isabelle Adenot","doi":"10.1017/s0266462323002301","DOIUrl":null,"url":null,"abstract":"<span>Introduction</span><p>The organizational impact (OI) of new technologies is becoming a major driver for our healthcare systems and for modernizing the care pathway for the benefit of users and professionals. Some technologies give rise to a reorganization of the healthcare system, particularly in the case of connected medical devices.</p><p>The Medical Device Committee at Haute Autorité de Santé (HAS) appraises medical devices (MD) in view of their reimbursement by the French health insurance scheme. The Committee’s evaluation criteria take account of the therapeutic benefit of the MD and its public health benefit. OI-related aspects are frequently claimed by health technology developers (HTD) in their MD submission dossiers. However, this aspect is rarely documented. Therefore, guidance explaining how HTD should support and structure any claim of an OI was needed.</p><span>Methods</span><p>This work was based on the HAS OI Map for Health Technology Assessment published in 2020, the analyses of specific HAS opinions, hearings with concerned stakeholders (HTD, service providers and patients), and a committee meeting focused on OI.</p><span>Results</span><p>The HTD guide for MD submission was updated with guidance to support OI claims. For each claimed OI, the HTD should identify the criterion corresponding to the most relevant OI, the indicator to describe each selected criterion, the stakeholders concerned, and the data to be provided. The choice of method is according to the OI: if the indicator is measurable, data from validated measurement tools are expected. If not, especially in cases where the use of the MD requires a specific organization before its deployment, the absence of data must be justified and a detailed impact analysis is necessary. In this case, the development plan for the demonstration of the OI is needed.</p><span>Conclusions</span><p>With this updated guide for HTDs, claimed OI dimension shall be better supported in future MD dossiers submitted to HAS in view of their reimbursement in France.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":2.6000,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"PP106 Integrating Organizational Impacts Into Health Technology Assessment: How To Take Them Into Account For Medical Devices?\",\"authors\":\"Estelle Piotto, Emmanuelle Fouteau, Camille Marguerite, Hubert Galmiche, Isabelle Adenot\",\"doi\":\"10.1017/s0266462323002301\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<span>Introduction</span><p>The organizational impact (OI) of new technologies is becoming a major driver for our healthcare systems and for modernizing the care pathway for the benefit of users and professionals. Some technologies give rise to a reorganization of the healthcare system, particularly in the case of connected medical devices.</p><p>The Medical Device Committee at Haute Autorité de Santé (HAS) appraises medical devices (MD) in view of their reimbursement by the French health insurance scheme. The Committee’s evaluation criteria take account of the therapeutic benefit of the MD and its public health benefit. OI-related aspects are frequently claimed by health technology developers (HTD) in their MD submission dossiers. However, this aspect is rarely documented. Therefore, guidance explaining how HTD should support and structure any claim of an OI was needed.</p><span>Methods</span><p>This work was based on the HAS OI Map for Health Technology Assessment published in 2020, the analyses of specific HAS opinions, hearings with concerned stakeholders (HTD, service providers and patients), and a committee meeting focused on OI.</p><span>Results</span><p>The HTD guide for MD submission was updated with guidance to support OI claims. For each claimed OI, the HTD should identify the criterion corresponding to the most relevant OI, the indicator to describe each selected criterion, the stakeholders concerned, and the data to be provided. The choice of method is according to the OI: if the indicator is measurable, data from validated measurement tools are expected. If not, especially in cases where the use of the MD requires a specific organization before its deployment, the absence of data must be justified and a detailed impact analysis is necessary. In this case, the development plan for the demonstration of the OI is needed.</p><span>Conclusions</span><p>With this updated guide for HTDs, claimed OI dimension shall be better supported in future MD dossiers submitted to HAS in view of their reimbursement in France.</p>\",\"PeriodicalId\":14467,\"journal\":{\"name\":\"International Journal of Technology Assessment in Health Care\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2023-12-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Technology Assessment in Health Care\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1017/s0266462323002301\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Technology Assessment in Health Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1017/s0266462323002301","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
PP106 Integrating Organizational Impacts Into Health Technology Assessment: How To Take Them Into Account For Medical Devices?
Introduction
The organizational impact (OI) of new technologies is becoming a major driver for our healthcare systems and for modernizing the care pathway for the benefit of users and professionals. Some technologies give rise to a reorganization of the healthcare system, particularly in the case of connected medical devices.
The Medical Device Committee at Haute Autorité de Santé (HAS) appraises medical devices (MD) in view of their reimbursement by the French health insurance scheme. The Committee’s evaluation criteria take account of the therapeutic benefit of the MD and its public health benefit. OI-related aspects are frequently claimed by health technology developers (HTD) in their MD submission dossiers. However, this aspect is rarely documented. Therefore, guidance explaining how HTD should support and structure any claim of an OI was needed.
Methods
This work was based on the HAS OI Map for Health Technology Assessment published in 2020, the analyses of specific HAS opinions, hearings with concerned stakeholders (HTD, service providers and patients), and a committee meeting focused on OI.
Results
The HTD guide for MD submission was updated with guidance to support OI claims. For each claimed OI, the HTD should identify the criterion corresponding to the most relevant OI, the indicator to describe each selected criterion, the stakeholders concerned, and the data to be provided. The choice of method is according to the OI: if the indicator is measurable, data from validated measurement tools are expected. If not, especially in cases where the use of the MD requires a specific organization before its deployment, the absence of data must be justified and a detailed impact analysis is necessary. In this case, the development plan for the demonstration of the OI is needed.
Conclusions
With this updated guide for HTDs, claimed OI dimension shall be better supported in future MD dossiers submitted to HAS in view of their reimbursement in France.
期刊介绍:
International Journal of Technology Assessment in Health Care serves as a forum for the wide range of health policy makers and professionals interested in the economic, social, ethical, medical and public health implications of health technology. It covers the development, evaluation, diffusion and use of health technology, as well as its impact on the organization and management of health care systems and public health. In addition to general essays and research reports, regular columns on technology assessment reports and thematic sections are published.