Rosanna Tarricone, Francesco Petracca, Hannah-Marie Weller
{"title":"“Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning”","authors":"Rosanna Tarricone, Francesco Petracca, Hannah-Marie Weller","doi":"10.1038/s41746-024-01263-w","DOIUrl":null,"url":null,"abstract":"Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable gaps in maturity levels, cross-country learning effects are becoming prevalent. We expect more countries, both within the EU and beyond, to follow the steps of current frontrunners, hence expediting the harmonization process.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":null,"pages":null},"PeriodicalIF":12.4000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01263-w.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"NPJ Digital Medicine","FirstCategoryId":"3","ListUrlMain":"https://www.nature.com/articles/s41746-024-01263-w","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable gaps in maturity levels, cross-country learning effects are becoming prevalent. We expect more countries, both within the EU and beyond, to follow the steps of current frontrunners, hence expediting the harmonization process.
期刊介绍:
npj Digital Medicine is an online open-access journal that focuses on publishing peer-reviewed research in the field of digital medicine. The journal covers various aspects of digital medicine, including the application and implementation of digital and mobile technologies in clinical settings, virtual healthcare, and the use of artificial intelligence and informatics.
The primary goal of the journal is to support innovation and the advancement of healthcare through the integration of new digital and mobile technologies. When determining if a manuscript is suitable for publication, the journal considers four important criteria: novelty, clinical relevance, scientific rigor, and digital innovation.