Digital health applications from a government-regulated directory of reimbursable health apps in Germany—a systematic review for evidence and bias

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Abstract

Background

The Digital Healthcare Act, passed in November 2019, authorizes healthcare providers in Germany to prescribe digital health applications (DiGA) to patients covered by statutory health insurance. If DiGA meet specific efficacy requirements, they may be listed in a special directory maintained by the German Federal Institute for Drugs and Medical Devices. Due to the lack of well-founded app evaluation tools, the objectives were to assess (I) the evidence quality situation for DiGA in the literature and (II) how DiGA manufacturers deal with this issue, as reflected by the apps available in the aforementioned directory.

Methods

A systematic review of the literature on DiGA using PubMed, Scopus, and Web of Science was started on February 4, 2023. Papers addressing the evidence for applications listed in the directory were included, while duplicates and mere study protocols not reporting on data were removed. The remaining publications were used to assess the quality of the evidence or potential gaps in this regard. Results were aggregated in tabular form.

Results

The review identified fourteen relevant publications. Six studies suggested inadequate scientific evidence, five mentioned shortcomings of tools for validating DiGA-related evidence, and four publications described a high potential for bias, potentially influencing the validity of the results. Concerns about limited external generalizability were also raised.

Conclusions

The literature review found evidence-related gaps that must be addressed with adequate measures. Our findings can serve as a basis for a plea for a more detailed examination of the quality of evidence in the DiGA context.

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Most cited references 22

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The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

Matthew J L Page, Joanne E McKenzie, Patrick Bossuyt … (2024)

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.

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Health App Use Among US Mobile Phone Owners: A National Survey

Paul Krebs, Dustin Duncan (2015)

Background Mobile phone health apps may now seem to be ubiquitous, yet much remains unknown with regard to their usage. Information is limited with regard to important metrics, including the percentage of the population that uses health apps, reasons for adoption/nonadoption, and reasons for noncontinuance of use. Objective The purpose of this study was to examine health app use among mobile phone owners in the United States. Methods We conducted a cross-sectional survey of 1604 mobile phone users throughout the United States. The 36-item survey assessed sociodemographic characteristics, history of and reasons for health app use/nonuse, perceived effectiveness of health apps, reasons for stopping use, and general health status. Results A little over half (934/1604, 58.23%) of mobile phone users had downloaded a health-related mobile app. Fitness and nutrition were the most common categories of health apps used, with most respondents using them at least daily. Common reasons for not having downloaded apps were lack of interest, cost, and concern about apps collecting their data. Individuals more likely to use health apps tended to be younger, have higher incomes, be more educated, be Latino/Hispanic, and have a body mass index (BMI) in the obese range (all P<.05). Cost was a significant concern among respondents, with a large proportion indicating that they would not pay anything for a health app. Interestingly, among those who had downloaded health apps, trust in their accuracy and data safety was quite high, and most felt that the apps had improved their health. About half of the respondents (427/934, 45.7%) had stopped using some health apps, primarily due to high data entry burden, loss of interest, and hidden costs. Conclusions These findings suggest that while many individuals use health apps, a substantial proportion of the population does not, and that even among those who use health apps, many stop using them. These data suggest that app developers need to better address consumer concerns, such as cost and high data entry burden, and that clinical trials are necessary to test the efficacy of health apps to broaden their appeal and adoption.

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Physicians’ Attitudes Toward Prescribable mHealth Apps and Implications for Adoption in Germany: Mixed Methods Study

Florian Dahlhausen, Maximillian Zinner, Linn Bieske … (2021)

Background In October 2020, Germany became the first country, worldwide, to approve certain mobile health (mHealth) apps, referred to as DiGA (Digitale Gesundheitsanwendungen, in German, meaning digital health applications), for prescription with costs covered by standard statutory health insurance. Yet, this option has only been used to a limited extent so far. Objective The aim of this study was to investigate physicians’ and psychotherapists’ current attitudes toward mHealth apps, barriers to adoption, and potential remedies. Methods We conducted a two-stage sequential mixed methods study. In phase one, semistructured interviews were conducted with physicians and psychotherapists for questionnaire design. In phase two, an online survey was conducted among general practitioners, physicians, and psychotherapists. Results A total of 1308 survey responses by mostly outpatient-care general practitioners, physicians, and psychotherapists from across Germany who could prescribe DiGA were recorded, making this the largest study on mHealth prescriptions to date. A total of 62.1% (807/1299) of respondents supported the opportunity to prescribe DiGA. Improved adherence (997/1294, 77.0%), health literacy (842/1294, 65.1%), and disease management (783/1294, 60.5%) were most frequently seen as benefits of DiGA. However, only 30.3% (393/1299) of respondents planned to prescribe DiGA, varying greatly by medical specialty. Professionals are still facing substantial barriers, such as insufficient information (1135/1295, 87.6%), reimbursement for DiGA-related medical services (716/1299, 55.1%), medical evidence (712/1298, 54.9%), legal uncertainties (680/1299, 52.3%), and technological uncertainties (658/1299, 50.7%). To support professionals who are unsure of prescribing DiGA, extended information campaigns (1104/1297, 85.1%) as well as recommendations from medical associations (1041/1297, 80.3%) and medical colleagues (1024/1297, 79.0%) were seen as the most impactful remedies. Conclusions To realize the benefits from DiGA through increased adoption, additional information sharing about DiGA from trusted bodies, reimbursement for DiGA-related medical services, and further medical evidence are recommended.

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Author and article information

Journal

Journal ID (nlm-ta): Mhealth

Journal ID (iso-abbrev): Mhealth

Journal ID (publisher-id): MH

Title: mHealth

Publisher: AME Publishing Company

ISSN (Electronic): 2306-9740

Publication date (Electronic): 24 July 2023

Publication date Collection: 2023

Volume: 9

Electronic Location Identifier: 35

Affiliations

[1 ]deptDepartment of Digital Medicine, Medical Faculty OWL , Bielefeld University , Bielefeld, Germany;

[2 ]Joint Centre Bergisch Land , Remscheid, Germany;

[3 ]deptDepartment of Cardiology and Intensive Care Medicine , University Hospital OWL of Bielefeld University , Campus Klinikum Bielefeld, Bielefeld, Germany;

[4 ]Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School , Hannover, Germany

Author notes

Contributions: (I) Conception and design: F Dittrich, U von Jan, UV Albrecht; (II) Administrative support: U von Jan, UV Albrecht; (III) Provision of study materials or patients: All authors; (IV) Collection and assembly of data: A. Mielitz, U von Jan, E Pustozerov, UV Albrecht; (V) Data analysis and interpretation: F Dittrich, A Mielitz, U von Jan, UV Albrecht; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Dr. rer. biol. hum. Ute von Jan. Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Email: ute.von.jan@ 123456plri.de .

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ORCID: Florian Dittrich, 0000-0002-5135-4736; Annabelle Mielitz: 0009-0008-1823-0900; Evgenii Pustozerov, 0000-0001-8109-1319; Dennis Lawin, 0000-0002-1292-7845; Ute von Jan, 0000-0001-9225-593X; Urs-Vito Albrecht, 0000-0002-8989-6696.

Article

Publisher ID: mh-09-23-17

DOI: 10.21037/mhealth-23-17

PMC ID: 10643174

SO-VID: 93c2b32c-2204-4c08-8969-6762f9fca27b

License:

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0.

Digital health applications from a government-regulated directory of reimbursable health apps in Germany—a systematic review for evidence and bias

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Karger: Digital Health

Most cited references 22

The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

Health App Use Among US Mobile Phone Owners: A National Survey

Physicians’ Attitudes Toward Prescribable mHealth Apps and Implications for Adoption in Germany: Mixed Methods Study

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