Experience at Italian National Institute of Health in the assessment of the quality in telemedicine: submission to a quality control process.
For applying a quality control of the telemedicine (TM) applications, in order to prevent device and/or service failure and to standardize some features of TM applications, a telemedicine quality control (TM-QC) process was proposed by authors. This TM-QC process was submitted to some TM manufacturers in order to assess their products/services and applied in two following phases, during which a set of procedures and tools were delivered to the TM suppliers. In the 1 degrees phase an Informative Questionnaire (InQu) and the Classification Form (ClFo) were delivered: the InQu gathered all the relevant information about the TM application in exam, the ClFo classified the TM product as belonging to one category (or application area) of TM. In the 2nd phase a Technical File (TF) and a Quality Assessment CheckList (QACL) were delivered: the TF was intended as a technical dossier of product; the QACL was a checklist of requirements that TM products must be agreed. The number of met requirements was computed and a Quality Level (QL), ranging from Basic Quality Level (QL1-B) to the Excellent Quality Level (QL7-E), was assigned to the examined TM products. The tested TM products presented in this paper, reached at least the minimum quality level (QL1-B). The TM-QC process allowed the definition of standardized quality levels for the TM products/services and the proposed procedures should be useful for promoting the using of standardized TM applications, so to speed up the integration process into the National Health Service.
Giansanti
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Member, IEEE, Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, via Regina Elena 299, 00161, Roma.
Morelli
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Macellari
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D000047:Academies and Institutes; D007558:Italy; D009313:National Health Programs; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards*; D013673:Technology Assessment, Biomedical / Q000592:standards; D017216:Telemedicine / Q000295:instrumentation* / Q000592:standards*