The Role of Law in Creating Space for Innovation: An Example from the Healthcare Sector in Germany

Grinblat, Roman

doi:10.1007/978-3-030-57642-4_16

Cited by 3 publications

(1 citation statement)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Digital home exercise applications intend to substitute or support conventional in-person movement therapy to address this challenge. In this context, we present the first postmarketing follow-up data of the standalone digital therapeutic app "Vivira," a fully approved "Digitale Gesundheitsanwendung" (DiGA; Digital Health Application) under the "Digitale-Versorgung-Gesetz" (DVG; Digital Health Care Act) in Germany [8,9]. While a comprehensive introduction to the German health care system can be found elsewhere [10], several key elements of the health care system and the DVG legislation should be briefly introduced here.…”

Section: Introductionmentioning

confidence: 99%

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis

Teepe¹,

Kowatsch²,

Hans³

et al. 2023

J Med Internet Res

View full text Add to dashboard Cite

Background Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of “Digitale Gesundheitsanwendungen” (DiGAs; Digital Health Applications) as collectively funded medical services through the “Digitale-Versorgung-Gesetz” (Digital Health Care Act) in 2019. Objective This article presents real-world prescription data collected through the smartphone-based home exercise program “Vivira,” a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. Methods This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. Results Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). Conclusions This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. Trial Registration German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051

show abstract

Section: Introductionmentioning

confidence: 99%

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis

Teepe¹,

Kowatsch²,

Hans³

et al. 2023

J Med Internet Res

View full text Add to dashboard Cite

show abstract

How Innovation-Friendly is the EU Novel Food Regulation? The Case of Cellular Agriculture

Reinhardt,

Monaco

2024

Preprint

View full text Add to dashboard Cite

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis (Preprint)

Teepe¹,

Kowatsch²,

Hans³

et al. 2022

Preprint

View full text Add to dashboard Cite

BACKGROUND Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of “Digitale Gesundheitsanwendungen” (DiGAs; Digital Health Applications) as collectively funded medical services through the “Digitale-Versorgung-Gesetz” (Digital Health Care Act) in 2019. OBJECTIVE This article presents real-world prescription data collected through the smartphone-based home exercise program “Vivira,” a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. METHODS This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. RESULTS Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T<sub>3628</sub>=5308; <i>P</i><.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). CONCLUSIONS This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. CLINICALTRIAL German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051

show abstract

The Role of Law in Creating Space for Innovation: An Example from the Healthcare Sector in Germany

Cited by 3 publications

References 12 publications

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis

How Innovation-Friendly is the EU Novel Food Regulation? The Case of Cellular Agriculture

Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis (Preprint)

Contact Info

Product

Resources

About