The German Medical Technology Association (BVMed) and the German Health IT Association (bvitg e.V.) welcome in principle the draft bill of the German Federal Ministry of Health (BMG) on the Digital Care and Nursing Modernization Act (DVPMG).
However, both associations are critical of a number of key points: in a statement, the bvitg criticizes the BMG’s plan that the implementation of digital solutions should be subject to the state and self-administration. As examples the federation calls among other things the planned switching portal for video consulting hours. If there is no clear division of competencies, Germany’s position as a center of innovation would be in jeopardy, says managing director Sebastian Zilch. The association of leading IT providers in the German healthcare sector also thinks that too rigid specifications in the area of telemedicine services are bad because doctors would not be able to exploit enough potential.
The bvitg finds the expansion of the connection of various healthcare players to the telematics infrastructure (TI) positive.
BVMed also welcomes the introduction of digital care applications (DiPA). The utilization of data from care aids is viewed positively, because this enables findings to be drawn on the need for positioning processes, a change of product and potential complications. Affected aids in this category are, for example, infusion and nutrition therapies, but also the incontinence care of affected persons. Furthermore, the introduction of digital care applications indirectly affects decubitus patients and those with an artificial bowel outlet (enterostoma) or with a stoma in general.
However, BVMed criticizes the conformity assessment procedure for medical devices by notified bodies within a two-and-a-half-year period, which involves too much effort and challenges of various kinds in too short a time. The association therefore calls for an extension of the deadline to at least five years and not before 2025 for newly certified medical devices, with a view to the product life cycle. Traditionally proven and existing products should be exempt at the request of BVMed.
Furthermore, according to the bvitg, interoperability is of great importance so that, for example, the electronic patient file (ePA) and the planned knowledge platform for medical information objects (MIO) are more compatible.
Source: Medtech-Zwo