Health technology assessment of medical devices in europe: processes, practices, and methods

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dc.contributor.authorFuchs, Sabine
dc.contributor.authorOlberg, Britta
dc.contributor.authorPanteli, Dimitra
dc.contributor.authorBusse, Reinhard
dc.date.accessioned2017-10-27T12:55:17Z
dc.date.available2017-10-27T12:55:17Z
dc.date.issued2016
dc.descriptionDieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG gefƶrderten) Allianz- bzw. Nationallizenz frei zugƤnglich.de
dc.descriptionThis publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.en
dc.description.abstractObjectives: To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions. Methods: A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution. Results: Information was obtained from eighty-four institutions, forty-seven of which were analyzed. Fifty-four methodological documents from twenty-three agencies in eighteen countries were identified. Only five agencies had separate documents for the assessment of MDs. A few agencies made separate provisions for the assessment of MDs in their general methods. The amount of publicly available HTA reports on MDs varied by device category and agency remit. Conclusions: Despite growing consensus on their importance and international initiatives, such as the EUnetHTA Core ModelĀ®, specific tools for the assessment of MDs are rarely developed and implemented at the national level. Separate additional signposts incorporated in existing general methods guides may be sufficient for the evaluation of MDs.en
dc.description.sponsorshipEC/FP7/305983/EU/Advancing and strengthening the methodological tools and practices relating to the application and implementation of Health Technology Assessment (HTA)/ADVANCE_HTAen
dc.identifier.eissn1471-6348
dc.identifier.issn0266-4623
dc.identifier.urihttps://depositonce.tu-berlin.de/handle/11303/7079
dc.identifier.urihttp://dx.doi.org/10.14279/depositonce-6388
dc.language.isoen
dc.relation.ispartof10.14279/depositonce-8884
dc.rights.urihttp://rightsstatements.org/vocab/InC/1.0/
dc.subject.ddc610 Medizin und Gesundheit
dc.subject.otherhealth technology assessmenten
dc.subject.othermedical devicesen
dc.subject.othereuropeen
dc.subject.otherhealth policyen
dc.titleHealth technology assessment of medical devices in europe: processes, practices, and methodsen
dc.typeArticle
dc.type.versionpublishedVersion
dcterms.bibliographicCitation.doi10.1017/s0266462316000349
dcterms.bibliographicCitation.issue4
dcterms.bibliographicCitation.journaltitleInternational journal of technology assessment in health care
dcterms.bibliographicCitation.originalpublishernameCambridge University Press
dcterms.bibliographicCitation.originalpublisherplaceCambridge
dcterms.bibliographicCitation.pageend255
dcterms.bibliographicCitation.pagestart246
dcterms.bibliographicCitation.volume32
tub.accessrights.dnbdomain
tub.affiliationFak. 7 Wirtschaft und Management::Inst. Technologie und Management (ITM)::FG Management im Gesundheitswesende
tub.affiliation.facultyFak. 7 Wirtschaft und Managementde
tub.affiliation.groupFG Management im Gesundheitswesende
tub.affiliation.instituteInst. Technologie und Management (ITM)de
tub.publisher.universityorinstitutionTechnische UniversitƤt Berlin

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