- This event has passed.
Webinar: Regulatory updates on harmonization of HTA among medical devices and digital medicine
December 6, 2023 4:00 am – 5:00 am
This webinar is hosted by the HTAi Medical Devices Interest Group (MDIG)
Overview
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.
Date
December 6, 2023
Time
12:00 CET (UTC +1) | 04:00 MST (UTC -7)
Speakers
Marco Marchetti
Marco Marchetti is the leading expert of the medical devices division in the preparation of the Health Technology Assessment Regulation (HTAR 2021/2282) in Europe. He is a part of Board of Director in Health Technology Assessment international. Marco has participated since the beginning to the activities of the European Network of Health Technology Assessment.
Petra Hoogendoorn
Petra Hoogendoorn is lead expert of CEN-ISO/TS 82304-2 (health and wellness apps – quality and reliability), an assignment from the European Commission that went global in its cooperation with the International Standardization Organization. Petra currently coordinates the Horizon Europe Label2Enable project that supports the implementation of CEN-ISO 82304-2’s health app quality assessment framework and related health app quality label, which was inspired by the EU Energy label, Nutri-Score front-of-pack nutrition label and FDA over-the-counter medicine label. The project deliverables include an ISO 17065/67 compliant certification scheme, which is tested with 24 intentionally very diverse health apps. Other tasks include a series of roundtables for health authorities, HTA bodies and insurers to explore the value of 82304-2 in decision-making on reimbursement of health apps and a detailed comparison of CEN-ISO/TS 82304-2, EUnetHTA core model and several national assessment frameworks.