Frontiers in Medical Technology | Regulatory Affairs

Opinion

Published on 23 Dec 2022

Valuing infertility treatment: Why QALYs are inadequate, and an alternative approach to cost-effectiveness thresholds

in Regulatory Affairs

Elena Keller
Georgina M. Chambers

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.1053719

3,538 views
11 citations

Perspective

Published on 29 Nov 2022

The need for action by evaluators and decision makers in Europe to ensure safe use of medical software

in Regulatory Affairs

Mattias Kyhlstedt

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.1063622

2,345 views
4 citations

Perspective

Published on 25 Nov 2022

Engaging patients and citizens in digital health technology development through the virtual space

in Regulatory Affairs

Romina Helena Barony Sanchez
Laurie-Ann Bergeron-Drolet
Maxime Sasseville
Marie-Pierre Gagnon

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.958571

7,406 views
16 citations

Original Research

Published on 21 Nov 2022

Brazilian breast cancer patient-reported outcomes: What really matters for these women

in Regulatory Affairs

Aline Silveira Silva
Ana Cláudia Wekmuller França
Matheus Piccin Padilla
Luana Schroeder Macedo
Carlos Alberto da Silva Magliano
Marisa da Silva Santos

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.809222

2,095 views
3 citations

Original Research

Published on 13 Sep 2022

Infections and hospital bed-days among aging adults: A five-year retrospective study in a Belgian general hospital

in Regulatory Affairs

Anne-Marie De Cock
Danielle Strens
Peter Van Osta
Baudouin Standaert

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.912469

1,918 views
6 citations

Policy and Practice Reviews

Published on 05 Sep 2022

Value assessment of medicinal products by the Italian Medicines Agency (AIFA) and French National Authority for Health (HAS): Similarities and discrepancies

in Regulatory Affairs

Entela Xoxi
Rossella Di Bidino
Serena Leone
Andrea Aiello
Mariangela Prada

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.917151

7,849 views
5 citations

Policy and Practice Reviews

Published on 16 Jun 2022

A Proposal for Value-Based Managed Entry Agreements in an Environment of Technological Change and Economic Challenge for Publicly Funded Healthcare Systems

in Regulatory Affairs

Entela Xoxi
Filippo Rumi
Panos Kanavos
Hans-Peter Dauben
Iñaki Gutierrez-Ibarluzea
Olivier Wong
Guido Rasi
Americo Cicchetti

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.888404

6,939 views
16 citations

Review

Published on 28 Mar 2022

Optimization of Anti-SARS-CoV-2 Neutralizing Antibody Therapies: Roadmap to Improve Clinical Effectiveness and Implementation

in Regulatory Affairs

Karlijn van der Straten
Marit J. van Gils
Steven W. de Taeye
Godelieve J. de Bree

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.867982

5,953 views
15 citations

Perspective

Published on 24 Feb 2022

Where National Medicines Policies Have Taken Us With Patient Involvement and Health Technology Assessment in Africa

in Regulatory Affairs

Kawaldip Sehmi
Janet L. Wale

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.810456

7,828 views
4 citations

Perspective

Published on 24 Feb 2022

Solving the Evidence Interpretability Crisis in Health Technology Assessment: A Role for Mechanistic Models?

in Regulatory Affairs

Eulalie Courcelles
Jean-Pierre Boissel
Jacques Massol
Ingrid Klingmann
Riad Kahoul
Marc Hommel
Emmanuel Pham
Alexander Kulesza

Frontiers in Medical Technology

doi 10.3389/fmedt.2022.810315

3,315 views
7 citations

Original Research

Published on 26 Jan 2022

Reconstructing the Effectiveness of Policy Measures to Avoid Next-Wave COVID-19 Infections and Deaths Using a Dynamic Simulation Model: Implications for Health Technology Assessment

in Regulatory Affairs

Arnold Hagens
Kathya Cordova-Pozo
Maarten Postma
Jan Wilschut
Lorenzo Zino
Jurjen van der Schans

Frontiers in Medical Technology

doi 10.3389/fmedt.2021.666581

4,723 views
4 citations

Perspective

Published on 25 Jan 2022

Can We Afford to Exclude Patients Throughout Health Technology Assessment?

in Regulatory Affairs

Janet L. Wale
David Chandler
Deborah Collyar
Dominique Hamerlijnck
Roberto Saldana
Zack Pemberton-Whitely

Frontiers in Medical Technology

doi 10.3389/fmedt.2021.796344

5,440 views
8 citations

Original Research

Published on 21 Jan 2022

Patient Involvement in the Health Technology Assessment Process in Taiwan

in Regulatory Affairs

Kuei An Chen
Li Ying Huang
Churn Shiouh Gau

Frontiers in Medical Technology

doi 10.3389/fmedt.2021.732160

4,746 views
1 citation

Original Research

Published on 05 Jan 2022

In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors

in Regulatory Affairs

Gabriel Rojas-Jiménez
Daniela Solano
Álvaro Segura
Andrés Sánchez
Stephanie Chaves-Araya
María Herrera
Mariángela Vargas
Maykel Cerdas
Gerardo Calvo
Jonathan Alfaro

Frontiers in Medical Technology

doi 10.3389/fmedt.2021.772275

3,474 views
7 citations

Policy and Practice Reviews

Published on 24 Dec 2021

Patient and Citizen Participation in the Identification of Ethical Considerations Aiming to Address Uncertainty in the Evaluation of Promising Interventions in a Pandemic Context

in Regulatory Affairs

Catherine Olivier
Isabelle Ganache
Olivier Demers-Payette
Louis Lochhead
Sandra Pelaez
Michèle de Guise
Marie-Pascale Pomey

Frontiers in Medical Technology

doi 10.3389/fmedt.2021.794003

2,364 views
1 citation

Perspective

Published on 20 Dec 2021

Innovative Patient Involvement During Covid-19: Keeping Patients at the Heart of HTA

in Regulatory Affairs

Mark Rasburn
Helen Crosbie
Amanda Tonkinson
David Chandler
Tasneem Dhanji
Stephen Habgood
Stella O'Brien

Frontiers in Medical Technology

doi 10.3389/fmedt.2021.793119

2,516 views
9 citations