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

BACKGROUND: Since fall 2020, mobile health (mHealth) apps have become an integral part of the German health care system. The belief that mHealth apps have the potential to make the health care system more efficient, close gaps in care, and improve the economic outcomes related to health is unwavering and already partially confirmed. Nevertheless, problems and barriers in the context of mHealth apps usually remain unconsidered. OBJECTIVE: The focus groups and interviews conducted in this study aim to shed light on problems and barriers in the context of mHealth apps from the perspective of patients. METHODS: Guided focus groups and individual interviews were conducted with patients with a disease for which an approved mHealth app was available at the time of the interviews. Participants were recruited via self-help groups. The interviews were recorded, transcribed, and subjected to a qualitative content analysis. The content analysis was based on 10 problem categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs") identified in a previously conducted scoping review. Participants were asked to fill out an additional questionnaire about their sociodemographic data and about their use of technology. RESULTS: A total of 38 patients were interviewed in 5 focus groups (3 onsite and 2 web-based) and 5 individual web-based interviews. The additional questionnaire was completed by 32 of the participants. Patients presented with a variety of different diseases, such as arthrosis, tinnitus, depression, or lung cancer. Overall, 16% (5/32) of the participants had already been prescribed an app. During the interviews, all 10 problem categories were discussed and considered important by patients. A myriad of problem manifestations could be identified for each category. This study shows that there are relevant problems and barriers in the context of mHealth apps from the perspective of patients, which warrant further attention. CONCLUSIONS: There are essentially 3 different areas of problems in the context of mHealth apps that could be addressed to improve care: quality of the respective mHealth app, its integration into health care, and the expandable digital literacy of patients.

Serological assays to measure dimeric IgA antibodies in SARS-CoV-2 infections.

Current serological tests cannot differentiate between total immunoglobulin A (IgA) and dimeric IgA (dIgA) associated with mucosal immunity. Here, we describe two new assays, dIgA-ELISA and dIgA-multiplex bead assay (MBA), that utilize the preferential binding of dIgA to a chimeric form of secretory component, allowing the differentiation between dIgA and monomeric IgA. dIgA responses elicited through severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were measured in (i) a longitudinal panel, consisting of 74 samples (n = 20 individuals) from hospitalized cases of coronavirus disease 2019 (COVID-19); (ii) a longitudinal panel, consisting of 96 samples (n = 10 individuals) from individuals with mild COVID-19; (iii) a cross-sectional panel with PCR-confirmed SARS-CoV-2 infection with mild COVID-19 (n = 199) and (iv) pre-COVID-19 samples (n = 200). The dIgA-ELISA and dIgA-MBA demonstrated a specificity for dIgA of 99% and 98.5%, respectively. Analysis of dIgA responses in the longitudinal panels revealed that 70% (ELISA) and 50% (MBA) of patients elicited a dIgA response by day 20 after PCR diagnosis with a SARS-CoV-2 infection. Individuals with mild COVID-19 displayed increased levels of dIgA within the first 3 weeks after diagnosis but responses appeared to be short lived, compared with sustained IgA levels. However, in samples from hospitalized patients with COVID-19 we observed high and sustained levels of dIgA, up to 245 days after PCR diagnosis. Our results suggest that severe COVID-19 infections are associated with sustained levels of plasma dIgA compared with mild cases.

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis.

BACKGROUND: With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. OBJECTIVE: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. METHODS: A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. RESULTS: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. DISCUSSION: It is striking that- although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes - all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. CONCLUSION: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.

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

BACKGROUND: The digitization of health care led to a steady increase in the adoption and use of mobile health (mHealth) apps. Germany is the first country in the world to cover the costs of mHealth apps through statutory health insurance. Although the benefits of mHealth apps are discussed in detail, aspects of problems and barriers are rarely studied. OBJECTIVE: This scoping review aimed to map and categorize the evidence on problems and barriers related to the use of mHealth apps. METHODS: Systematic searches were conducted in the MEDLINE, Embase, and PsycINFO databases. Additional searches were conducted on JMIR Publications and on websites of relevant international organizations. The inclusion criteria were publications dealing with apps similar to those approved in the German health care system, publications addressing problems and barriers related to the use of mHealth apps, and articles published between January 1, 2015, and June 8, 2021. Study selection was performed by 2 reviewers. The manuscript was drafted according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The analysis of the included publications and categorization of problems and hurdles were performed using MAXQDA (VERBI Software GmbH). RESULTS: The database search identified 1479 publications. Of the 1479 publications, 21 (1.42%) met the inclusion criteria. A further 8 publications were included from citation searching and searching in JMIR Publications. The identified publications were analyzed for problems and barriers. Problems and barriers were classified into 10 categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs"). The most frequently mentioned categories were use and adherence (eg, incorporating the app into daily life or dropouts from use; n=22) and usability (eg, ease of use and design; n=19). CONCLUSIONS: The search identified various problems and barriers in the context of mHealth apps. Although problems at the app level (such as usability) are studied frequently, problems at the system level are addressed rather vaguely. To ensure optimal use of and care with mHealth apps, it is essential to consider all types of problems and barriers. Therefore, researchers and policy makers should have a special focus on this issue to identify the needs for quality assurance. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/32702.

[Digitalization in healthcare: today and in the future]. / Digitalisierung im Gesundheitswesen: heute und in Zukunft.

Although Germany continues to struggle with the digital transformation of healthcare, there is reason for optimism. The political will to improve healthcare with digital technologies has been underpinned by numerous legal initiatives since 2018. In addition, there is growing acceptance among healthcare providers and the population. The latter has clearly been driven by the corona pandemic, which underscored the need for more digitized care.Digitalization in healthcare has three key drivers: the rapid technological development in data processing, the ever-improving understanding of the biological basis of human life, and growing patient sovereignty coupled with a growing desire for transparency. Prerequisites for digital medicine are data interoperability and the establishment of a networking (telematics) infrastructure (TI). The status of the most important digital TI applications affecting German healthcare are described: the electronic patient record (ePA) as its core as well as electronic prescriptions, medication plans, and communication tools such as Communication in Medicine (KIM) and TI Messenger (TIM). In addition, various telemedical offerings are discussed as well as the introduction of digital health applications (DiGA) into the statutory healthcare system, which Germany has pioneered. Furthermore, the use of medical data as the basis for artificial intelligence (AI) algorithms is discussed. While helpful and capable of improving diagnostics as well as medical therapy, such AI tools will not replace doctors and nurses.

Market access and value-based pricing of digital health applications in Germany.

In December 2019, the Digital Health Care Act ("Digitale-Versorgung-Gesetz") introduced a general entitlement to the provision and reimbursement of digital health applications (DiGA) for insured persons in the German statutory health insurance. As establishing a new digital service area within the solidarity-based insurance system implies several administrative and regulatory challenges, this paper aims to describe the legal framework for DiGA market access and pricing as well as the status quo of the DiGA market. Furthermore, we provide a basic approach to deriving value-based DiGA prices.To become eligible for reimbursement, the Federal Institute for Drugs and Medical Devices evaluates the compliance of a DiGA with general requirements (e.g., safety and data protection) and its positive healthcare effects (i.e., medical benefit or improvements of care structure and processes) in a fast-track process. Manufacturers may provide evidence for the benefits of their DiGA either directly with the application for the fast-track process or generate it during a trial phase that includes temporary reimbursement. After one year of \]reimbursement, the freely-set manufacturer price is replaced by a price negotiated between the National Association of Statutory Health Insurance Funds and the manufacturer. By February 2022, 30 DiGA had successfully completed the fast-track process. 73% make use of the trial phase and have not yet proven their benefit. Given this dynamic growth of the DiGA market and the low minimum evidence standards, fair pricing remains the central point of contention. The regulatory framework makes the patient-relevant benefits of a DiGA a pricing criterion to be considered in particular. Yet, it does not indicate how the benefits of a DiGA should be translated into a reasonable price. Our evidence-based approach to value-based DiGA pricing approximates the SHI's willingness to pay by the average cost-effectiveness of one or more established therapy in a field of indication and furthermore considers the positive healthcare effects of a DiGA.The proposed approach can be fitted into DiGA pricing processes under the given regulatory framework and can provide objective guidance for price negotiations. However, it is only one piece of the pricing puzzle, and numerous methodological and procedural issues related to DiGA pricing are still open. Thus, it remains to be seen to what extent DiGA prices will follow the premise of value-based pricing.

[What potential and added value do DiGA offer for primary care?-Results of a survey of general practitioners in Germany]. / Welche Potenziale und Mehrwerte bieten DiGA für die hausärztliche Versorgung? ­ Ergebnisse einer Befragung von Hausärzt*innen in Deutschland.

BACKGROUND: For almost two years, physicians have been able to prescribe digital health applications (DiGA) to patients. So far, there has been a lack of studies that shed light on the possible use of DiGA in the context of primary care and take stock of the benefits and potential for optimization. OBJECTIVES: This study explores general practitioners' (GPs) attitudes, expectations, and experiences with regard to the application potential of DiGA. METHODS: In the spring of 2022, all 13,913 general practitioners in the federal states Baden-Württemberg, Hesse, Rhineland-Palatinate, and Saarland were invited to take part in an online survey. Included in the evaluation were 3829 completed questionnaires (response rate: 28%). A t-test on independent samples was used to determine significant differences between two groups. Moreover, a factor analysis was carried out. RESULTS: A majority of those surveyed consider DiGA to be reliable (67%) and secure (61%) applications. In addition, 22% trust themselves to competently advise patients on DiGA, 14% have already prescribed DiGA, and 13% plan to do so. Of the GPs with DiGA experience, 83% rate the prescribed applications as useful. Observed healthcare effects mainly relate to the improvement of compliance (95%), mobility (94%), and education (93%) as well as weight reduction (82%). The respondents suggest further optimization of DIGA, especially with regard to usability (59%), systematic further training of doctors (52%), and the expansion of gamification elements (49%). CONCLUSIONS: It is important to better inform GPs about the basics of the Digital Healthcare Act (DVG) and to address concerns in a targeted manner. Comprehensive training courses that explain the framework conditions and advantages of using DiGA appear to be crucial. There is also a need for more well-founded sources of information and research for doctors.

[Interoperability in healthcare: also prescribed for digital health applications (DiGA)]. / Interoperabilität im Gesundheitswesen: auch für digitale Gesundheitsanwendungen (DiGA) verordnet.

Digital health applications (DiGA) are a cog in the machine of a digital health system that must be interoperable like all other communicating applications in order to function smoothly. Interoperability takes place at four levels: functional subject definition of content, semantic and syntactic standardization, security and transport requirements, and organizational aspects.In Germany, a major leap towards a more digital healthcare system has been initiated in recent years, reinforced by the experience gained from the COVID-19 pandemic. Current legislation aims at a uniform definition of standards and processes and thus establishes the required binding framework for an overall concept in digitization. DiGA can communicate with other healthcare systems using the same semantic and syntactic standardizations if the patient so desires. With the possible connection to electronic patient records and the accompanying data donation option, patients can benefit more than once through interoperable DiGA - not only through the direct positive care effect of the digital health application, but also indirectly through data donation, which can contribute to improving the entire healthcare system through appropriate research.

[Digital health applications (DiGA) on the road to success-the perspective of the German Digital Healthcare Association]. / Digitale Gesundheitsanwendungen (DiGA) auf dem Weg zum Erfolg ­ die Perspektive des Spitzenverbandes Digitale Gesundheitsversorgung.

The approval of the first digital health applications (DiGA) in October 2020 resulted in a lot of buzz - not only in the healthcare sector but also beyond. The integration of DiGA to the public healthcare system was seen as a significant innovation and stakeholders worldwide were looking to Germany. How did the start of the DiGA innovation project go and what is the current standing? The first months of DiGA becoming part of standard care brought new experiences and knowledge to manufacturers, doctors and patients as well as to health insurance companies and associations. More than six months later, it is time for a preliminary review.This article looks at the achievements so far as well as the status quo of DiGA in the market as of March 2021. It also focuses on current and upcoming challenges that the various stakeholders face on the way to integrate DiGA into standard care in a widespread and sustainable way.

[Digital health applications (DiGA): assessment of reimbursability by means of the "DiGA Fast Track" procedure at the Federal Institute for Drugs and Medical Devices (BfArM)]. / Digitale Gesundheitsanwendungen (DiGA): Bewertung der Erstattungsfähigkeit mittels DiGA-Fast-Track-Verfahrens im Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

With the Digital Health Care Act (DVG), the legislator has made it possible for digital health applications (DiGA) to be included in standard care and reimbursement in accordance with the Fifth Book of the German Social Code (SGB V). The prerequisite for the "app on prescription" is a listing in the DiGA directory after a positive evaluation procedure at the Federal Institute for Drugs and Medical Devices (BfArM). In addition to comprehensive quality and safety parameters, the manufacturers must also prove a positive healthcare effect.With the DiGA directory, the BfArM has been offering addressee-oriented comprehensive transparency on DiGA and their properties since October 2020. The article explains the path to the app on prescription from the support and advisory services offered by the BfArM to the evaluation procedure (DiGA Fast Track) and the evaluation criteria to the contents of the directory. It can be seen that there is great interest in the Fast Track procedure. The evidence of positive healthcare effects, i.e. an actual added value for patients, is balanced and at an appropriate level with predominantly randomised controlled trial evidence. The fact that the procedure can also be associated with challenges for the applicants, e.g. to adequately address deficiencies in the legally prescribed assessment period, is indicated by the numbers of withdrawn applications in relation to the listed DiGA. The BfArM is in close exchange with all parties involved regarding this new procedure. The conclusion of this article shows which considerations and potentials result from this for further development from the point of view of the BfArM.

[Digital health applications: statutory introduction of patient-centred digital innovations into healthcare]. / Digitale Gesundheitsanwendungen: gesetzliche Einführung patientenzentrierter digitaler Innovationen in die Gesundheitsversorgung.

The Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV) defined digital health applications (DiGA) and included these as an entitlement of statutory health insurance (GKV). Further development of this new area of healthcare occurred within the Digital Healthcare and Care Modernization Act (DVPMG). Every doctor and psychotherapist can prescribe digital applications at the expense of statutory health insurance funding, provided the applications have successfully undergone a three-month test procedure at the Federal Institute for Drugs and Medical Devices (BfArM) and are listed in their DiGA directory. Provisional admissions of DiGA accompanied by scientific studies and evaluations are also possible.The legislator has thus actively incorporated the highly dynamic technological and social development of digital innovations into healthcare by introducing mobile applications for therapeutic purposes. The legal framework is designed in such a way that DiGA can not only potentially support aspects of patient-centred care, such as strengthening of self-management, health literacy and adherence but also optimize treatment procedures and interaction between patients and service providers in many ways.Extensive specifications for technical interoperability between DiGA and other types of medical devices and implants, as well as the electronic patient record (ePA), will accelerate the integration of DiGA into day-to-day care. Overall, it is of utmost importance to incorporate DiGA into existing care as enriching, user-friendly and digitally supported processes. Hence, the initial regulatory framework will continuously be adapted and developed in the years to come - shaped by the experiences gained with innovative products and the administrative procedures used to admit them.

[Support for innovation at the BfArM-experiences from the consultations on digital health applications (DiGA)]. / Innovationsunterstützung im BfArM ­ Erfahrungen aus den Beratungen zu digitalen Gesundheitsanwendungen (DiGA).

Since May 2020, manufacturers have been able to submit an application to the Federal Institute for Drugs and Medical Devices (BfArM) for the inclusion of a digital health application (DiGA) in the directory pursuant to section 139e of the German Social Code Book V. This new application procedure is based on specific requirements and assessment parameters for which a large number of procedural and scientific questions arise on the side of the manufacturers.In order to meet this need, the BfArM has specifically expanded its established information and advisory services for these new questions. This article describes in detail what these are in relation to DiGA, where the corresponding information and documents can be found and what distinguishes them in each case. Furthermore, with a view to the counselling interviews conducted between May 2020 and April 2021, their influence on the outcome of the respective application procedure for inclusion in the DiGA directory is analysed. This confirms that the early discussion of parameters relevant to the evaluation and the consideration of the advisory recommendations correlate with a positive evaluation result. For the DiGA listed in the directory, 80% of the manufacturers had previously received advice from the BfArM. The rate of withdrawn or rejected applications, on the other hand, was significantly higher if manufacturers had not previously sought advice from the BfArM in advance compared to manufacturers who discussed key aspects (63% vs. 35%). Overall, all sides benefit from the early, intensive exchange - in the end especially the patients through introduction of DiGA into standard healthcare due to higher application quality without delay.

[The new approval process for the reimbursement of digital health applications (DiGA) from the perspective of the German statutory health insurance]. / Das neue Bewertungsverfahren zur Erstattung digitaler Gesundheitsanwendungen (DiGA) aus Sicht der gesetzlichen Krankenversicherung.

Since fall of 2020, the first Digital Health Applications (DiGA) have been available as a service of the statutory health insurance. The National Association of Statutory Health Insurance Funds considers digital applications to have the potential to improve health care, e.g., for people with chronic diseases, and to consolidate the interconnectedness of the provided offers. DiGA can empower the insured persons to help shape their health care actively and to self-contribute to a successful treatment. At the same time, statutory health insurance identifies a number of basic and substantial critical issues regarding the legal requirements for the authorization of DiGA for reimbursement by insurance and the conceptional design of the fast-track process from the Federal Institute for Drugs and Medical Devices (BfArM).This article examines the DiGA, which have been listed in the BfArM directory up to this point, and takes stock after six months of the fast-track process being in place. According to this, the requirements and legal specifications for directory listings and reimbursement via the fast-track process are insufficient from the point of view of the statutory health insurance regarding proven medical effectiveness and economically efficient health care. At present, most of the authorized DiGA, which so far could not provide sufficient evidence about positive healthcare effects, are subsequently only listed provisionally. At the same time, the requirements for proof of medical benefit do not ensure the generation of valid results in studies or clinical trials with regards to routine everyday care. So far, there has been only a moderate qualitative reliability of results. Furthermore, in the context of free pricing by manufacturers, significant price increases can be observed in some cases compared to prices before the BfArM listing.This paper gives recommendations towards further development of the legal basis for the fast-track process, particularly in the subject areas of benefit and patient safety as well as cost effectiveness.

Simplifying the synthesis of SIgA: combination of dIgA and rhSC using affinity chromatography.

The mucosal epithelia together with adaptive immune responses, such as local production and secretion of dimeric and polymeric immunoglobulin A (IgA), are a crucial part of the first line of defense against invading pathogens. IgA is primarily secreted as SIgA and plays multiple roles in mucosal defense. The study of SIgA-mediated protection is an important area of research in mucosal immunity but an easy, fast and reproducible method to generate pathogen-specific SIgA in vitro has not been available. We report here a new method to produce SIgA by co-purification of dimeric IgA, containing J chain, and recombinant human SC expressed in CHO cells. We previously reported the generation, production and characterization of the human recombinant monoclonal antibody IgA2 b12. This antibody, derived from the variable regions of the neutralizing anti-HIV-1 mAb IgG1 b12, blocked viral attachment and uptake by epithelial cells in vitro. We used a cloned CHO cell line that expresses monomeric, dimeric and polymeric species of IgA2 b12 for large-scale production of dIgA2 b12. Subsequently, we generated a CHO cell line to express recombinant human secretory component (rhSC). Here, we combined dIgA2 b12 and CHO-expressed rhSC via column chromatography to produce SIgA2 b12 that remains fully intact upon elution with 0.1M citric acid, pH 3.0. We have performed biochemical analysis of the synthesized SIgA to confirm the species is of the expected size and retains the functional properties previously described for IgA2 b12. We show that SIgA2 b12 binds to the HIV-1 gp120 glycoprotein with similar apparent affinity to that of monomeric and dimeric forms of IgA2 b12 and neutralizes HIV-1 isolates with similar potency. An average yield of 6 mg of SIgA2 b12 was achieved from the combination of 20mg of purified dIgA2 b12 and 2L of rhSC-containing CHO cell supernatant. We conclude that synthesized production of stable SIgA can be generated by co-purification. This process introduces a simplified means of generating a variety of pathogen-specific SIgA antibodies for research and clinical applications.

Remodeling of anti-tumor immunity with antibodies targeting a p53 mutant.

BACKGROUND: p53, the most frequently mutated gene in cancer, lacks effective targeted drugs. METHODS: We developed monoclonal antibodies (mAbs) that target a p53 hotspot mutation E285K without cross-reactivity with wild-type p53. They were delivered using lipid nanoparticles (LNPs) that encapsulate DNA plasmids. Western blot, BLI, flow cytometry, single-cell sequencing (scRNA-seq), and other methods were employed to assess the function of mAbs in vitro and in vivo. RESULTS: These LNP-pE285K-mAbs in the IgG1 format exhibited a robust anti-tumor effect, facilitating the infiltration of immune cells, including CD8+ T, B, and NK cells. scRNA-seq revealed that IgG1 reduces immune inhibitory signaling, increases MHC signaling from B cells to CD8+ T cells, and enriches anti-tumor T cell and B cell receptor profiles. The E285K-mAbs were also produced in the dimeric IgA (dIgA) format, whose anti-tumor activity depended on the polymeric immunoglobulin receptor (PIGR), a membrane Ig receptor, whereas that of IgG1 relied on TRIM21, an intracellular IgG receptor. CONCLUSIONS: Targeting specific mutant epitopes using DNA-encoded and LNP-delivered mAbs represents a potential precision medicine strategy against p53 mutants in TRIM21- or PIGR-positive cancers.

Corrigendum: Integration of digital health applications into the German healthcare system: development of "The DiGA-Care Path".

[This corrects the article DOI: 10.3389/frhs.2024.1372522.].

Integration of digital health applications into the German healthcare system: development of "The DiGA-Care Path".

Introduction: Since 2019 people who have insured in the German statutory health insurance are entitled to use certified apps called the Digitale Gesundheitsanwendungen [Digital Health Applications (DiGAs)]. The prerequisite for this is that an app certified as DiGA and suitable for their diagnosis exists. The DiGA can then either be prescribed by a physician or psychotherapist or requested by the patient from the statutory health insurance fund. Given the novelty of this type of healthcare, the implementation of a DiGA should be closely monitored to identify potential weaknesses and achieve quality improvements. To enable an analysis of the supply of DiGAs step-by-step, we aimed to create the DiGA-Care Path. Methods: We conducted three steps to create the DiGA-Care Path. First, a knowledge base was created based on a structured literature research matched with knowledge gathered from the superordinate research project "QuaSiApps" funded by the German Federal Joint Committee. Second, we aimed to create an "ideal-typical" DiGA-Care Path using a flowchart. Third, based on the first path, a final path was developed using the graphical modeling language "Event-Driven Process Chain." Results: The DiGA-Care Path was developed to depict the supply of DiGAs in Germany. The final path is constituted by a "main path" as well as a corresponding "sub-path". While the "main path" focuses more on the supply environment in which a DiGA is used, the "sub-path" depicts the supply delivered by the DiGA itself. Besides the process itself, the paths include relevant actors to indicate responsibilities for individual process steps. Discussion: The DiGA-Care Path helps to analyze the current supply of DiGAs step-by-step. Thereby, each step can be investigated in detail to identify problems and to detect further steps where quality improvements can be enabled. Depending on the perspective, focused either on the supply environment, or the supply delivered by the DiGA itself, the "main path" or the "sub-path" can be used, respectively. Besides the potential of the DiGA-Care Path to improve the current supply of DiGAs, it can help as an orientation for international policymakers or further stakeholders either to develop their own integration of apps into healthcare systems or for international manufacturers to consider entering the German market.

Critical success factors for creating sustainable digital health applications: A systematic review of the German case.

Objective: The Covid-19 pandemic has accelerated the adoption of digital technologies to address social needs, leading to increased investments in digital healthcare applications. Germany implemented a special law called the "Digitales Versorgungsgesetz" (DVG-Digital Supply Act) in 2019, which enables the reimbursement of digital health applications, including digital therapeutics (DTx), through a fast-track process. The Federal Institute for Drugs and Medical Devices (BfArM), the German federal authority responsible for overseeing digital health applications, has implemented legislative adjustments since the law's introduction, which have increased requirements for these applications and potentially led to the removal of some from the directory as well as a slowdown in the addition of new ones. To counteract this trend, this work aimed to identify key success factors for digital health applications (DiGAs). Methods: This research identifies critical success factors through a structured literature review for developing sustainable digital health applications within the European healthcare systems, specifically DiGAs. The study aims to support the ongoing digital transformation in healthcare. Results: The identified success factors that significantly impact the sustainability of DiGAs include patient-centered design, application effectiveness, user-friendliness, and adherence to data protection and information security regulations using standardized approaches. These factors are crucial in preventing the failure of DiGA manufacturers in European countries. Conclusion: By considering and implementing these critical success factors, DiGA manufacturers can enhance their chances of long-term success and contribute to the digital transformation of the healthcare system in Europe.

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

BACKGROUND: The enactment of the "Act to Improve Healthcare Provision through Digitalisation and Innovation " (Digital Healthcare Act; Digitale-Versorgung-Gesetz [DVG]) in Germany has introduced a paradigm shift in medical practice, allowing physicians to prescribe mobile health (mHealth) apps alongside traditional medications. This transformation imposes a dual responsibility on physicians to acquaint themselves with qualifying apps and align them with patient diagnoses, while requiring patients to adhere to the prescribed app use, similar to pharmaceutical adherence. This transition, particularly challenging for older generations who are less skilled with technology, underscores a significant evolution in Germany's medical landscape. OBJECTIVE: This study aims to investigate physicians' responses to this novel treatment option, their strategies for adapting to this form of prescription, and the willingness of patients to adhere to prescribed mHealth apps. METHODS: Using an exploratory qualitative study design, we conducted semistructured interviews with 28 physicians and 30 potential patients aged 50 years and older from August 2020 to June 2021. RESULTS: The findings reveal several factors influencing the adoption of mHealth apps, prompting a nuanced understanding of adoption research. Notably, both physicians and patients demonstrated a lack of information regarding mHealth apps and their positive health impacts, contributing to a deficiency in trust. Physicians' self-perceived digital competence and their evaluation of patients' digital proficiency emerge as pivotal factors influencing the prescription of mHealth apps. CONCLUSIONS: Our study provides comprehensive insights into the prescription process and the fundamental factors shaping the adoption of mHealth apps in Germany. The identified information gaps on both the physicians' and patients' sides contribute to a trust deficit and hindered digital competence. This research advances the understanding of adoption dynamics regarding digital health technologies and highlights crucial considerations for the successful integration of digital health apps into medical practice.

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

BACKGROUND: Musculoskeletal diseases affect 1.71 billion people worldwide, impose a high biopsychosocial burden on patients, and are associated with high economic costs. The use of digital health interventions is a promising cost-saving approach for the treatment of musculoskeletal diseases. As physical exercise is the best clinical practice in the treatment of musculoskeletal diseases, digital health interventions that provide physical exercises could have a highly positive impact on musculoskeletal diseases, but evidence is lacking. OBJECTIVE: This systematic review aims to evaluate the impact of digital physical health exercises on patients with musculoskeletal diseases concerning the localization of the musculoskeletal disease, patient-reported outcomes, and medical treatment types. METHODS: We performed systematic literature research using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The search was conducted using the PubMed, BISp, Cochrane Library, and Web of Science databases. The Scottish Intercollegiate Guidelines Network checklist was used to assess the quality of the included original studies. To determine the evidence and direction of the impact of digital physical health exercises, a best-evidence synthesis was conducted, whereby only studies with at least acceptable methodological quality were included for validity purposes. RESULTS: A total of 8988 studies were screened, of which 30 (0.33%) randomized controlled trials met the inclusion criteria. Of these, 16 studies (53%) were of acceptable or high quality; they included 1840 patients (1008/1643, 61.35% female; 3 studies including 197 patients did not report gender distribution) with various musculoskeletal diseases. A total of 3 different intervention types (app-based interventions, internet-based exercises, and telerehabilitation) were used to deliver digital physical health exercises. Strong evidence was found for the positive impact of digital physical health exercises on musculoskeletal diseases located in the back. Moderate evidence was found for diseases located in the shoulder and hip, whereas evidence for the entire body was limited. Conflicting evidence was found for diseases located in the knee and hand. For patient-reported outcomes, strong evidence was found for impairment and quality of life. Conflicting evidence was found for pain and function. Regarding the medical treatment type, conflicting evidence was found for operative and conservative therapies. CONCLUSIONS: Strong to moderate evidence was found for a positive impact on musculoskeletal diseases located in the back, shoulder, and hip and on the patient-reported outcomes of impairment and quality of life. Thus, digital physical health exercises could have a positive effect on a variety of symptoms of musculoskeletal diseases.