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Unpacking Performance Factors of Innovation Systems and Studying Germany’s Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods Study

Digital health application (Di GA) manufacturers with patient-relevant structural and procedural improvement (p SVV; Di GA with p SVV): This category includes decision makers from manufacturers of Di GAs that are listed in the Di GA directory and have implemented p SVV as a positive health care effect. Di GA manufacturers without p SVV (Di GA without p SVV): This category comprises manufacturers who are listed in the Di GA directory but have not used p SVV as a positive health care effect.

Sara Gehder, Moritz Goeldner

J Med Internet Res 2025;27:e66356

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Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024

To prove the positive care effect, each Di GA requires conducting a clinical trial within Germany. In addition, a preliminary study demonstrating the Di GA’s basic features is required before preliminary listing as well. After almost 4 years into the implementation of the Di GA framework, we seek to investigate the evolving landscape of the Di GA market.

Moritz Goeldner, Sara Gehder

J Med Internet Res 2024;26:e59013

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Problems and Barriers Related to the Use of mHealth Apps From the Perspective of Patients: Focus Group and Interview Study

A more extensive certification program is the “Fast-Track Process for Digital Health Applications (Di GA)” established in Germany. In this process, in addition to the European conformity certification as proof of “safety” and “suitability,” other requirements, such as “data protection,” “information security,” “interoperability,” and “user-friendliness” are reviewed [6].

Godwin Denk Giebel, Carina Abels, Felix Plescher, Christian Speckemeier, Nils Frederik Schrader, Kirstin Börchers, Jürgen Wasem, Silke Neusser, Nikola Blase

J Med Internet Res 2024;26:e49982

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Effects of Digital Physical Health Exercises on Musculoskeletal Diseases: Systematic Review With Best-Evidence Synthesis

Reference 8: Das Fast-Track-Verfahren für digitale Gesundheitsanwendungen (DiGA) nach § 139e SGB V(httpsdiga

Johanna Nagel, Florian Wegener, Casper Grim, Matthias Wilhelm Hoppe

JMIR Mhealth Uhealth 2024;12:e50616

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Evidence of How Physicians and Their Patients Adopt mHealth Apps in Germany: Exploratory Qualitative Study

Because of the special role of the doctor as a gatekeeper, the doctor is the first to decide whether the patient is suitable for a Di GA. First, the familiar steps such as the patient’s trust in the doctor and the treating doctor’s determination of the patient’s medical condition represent the keystone of the process. Following these steps, when prescribing a Di GA, the next steps are the doctor’s consent to prescribe a Di GA under certain conditions and the assessment of the patient’s ability to use a Di GA.

Tanja Schroeder, Maximilian Haug, Andrew Georgiou, Karla Seaman, Heiko Gewald

JMIR Mhealth Uhealth 2024;12:e48345

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Problems and Barriers Related to the Use of Digital Health Applications: Scoping Review

Hereby, particular m Health apps with a low-risk class (I or IIa according to the Medical Device Regulation or, within the scope of the transitional provisions, the Medical Device Directive), known as Digital Health Applications (Digitale Gesundheitsanwendungen [Di GA]), became part of the German health care system [2,3]. During the corresponding approval process, the “Fast-Track Process for Di GA,” m Health apps have to fulfill a predefined set of criteria.

Godwin Denk Giebel, Christian Speckemeier, Carina Abels, Felix Plescher, Kirstin Börchers, Jürgen Wasem, Nikola Blase, Silke Neusser

J Med Internet Res 2023;25:e43808

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Integration of the Vision of People With Diabetes Into the Development Process to Improve Self-management via Diabetes Apps: Qualitative Interview Study

It allows physicians to prescribe apps that are listed in the Digitale Gesundheitsanwendungen (Di GA) directory by the Bundesinstitut für Arzneimittel und Medizinprodukte. Although there are 341,000 T1 D cases [10] in Germany, no diabetes apps were registered in the Di GA directory while the study was conducted. The Bundesinstitut für Arzneimittel und Medizinprodukte decides via a fast-track procedure whether an app will be accepted into the Di GA [11].

Isabel Klemme, Kamil J Wrona, Irja Marije de Jong, Christoph Dockweiler, Leona Aschentrup, Joanna Albrecht

JMIR Diabetes 2023;8:e38474

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The Definitions of Health Apps and Medical Apps From the Perspective of Public Health and Law: Qualitative Analysis of an Interdisciplinary Literature Overview

Referring to medical devices, the definition of Di GA reveals that the intended use is again essential for their definition. Hence, Di GA are a small subset of mobile medical apps and medical devices. Spoken more abstractly, all Di GA are medical apps—and, therefore, medical devices—but not all medical devices and medical apps are Di GA.

Laura Maaß, Merle Freye, Chen-Chia Pan, Hans-Henrik Dassow, Jasmin Niess, Tina Jahnel

JMIR Mhealth Uhealth 2022;10(10):e37980

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