HTAi Webinar: Regulatory updates on harmonization of HTA among Medical Devices and Digital Medicine

On regulatory basis, the safety, performance, risks and benefits of medical devices are strongly regulated before market access. Strong regulation-based approach can create the impression that market penetrated solutions are uniformly applicable. However, market access in itself does not guarantee the effectiveness or applicability of the device. The same applies to wellness technology, in which regulation is clearly at a lower level compared to medical devices. In addition to assess and qualify digital solutions the need for harmonization of assessment criteria is essential so the open market is not siloed between countries. It is a shared interest of manufactures, users and assessment bodies that digital solutions and mobile apps in the social, health and welfare sectors are evaluated with uniform criteria to support decision making while taking into account the needs of technology companies and citizens. The assessment criteria should not silent innovations or research but support them to ensure quality on high standard. From this point of view modularized and unified assessment methods support quality apps without additional market restriction.