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Mobile health technologiesMobile health technologies, remote careRemote care, and digital therapeuticsDigital therapeutics are finding their way into clinical care for patients with chronic respiratory diseases like asthma. A trend that gained momentum during preventative contact restrictions due to the COVID-19 pandemic, has shown its potential to continuously improve (home) care for patients, particularly in underserved or remote areas also afterward. However, many solutions like smart inhalers, connective spirometers, apps, and comprehensive monitoring platforms haven’t found their way into clinical routines yet, despite their potential to improve symptom control, quality of life, treatment adherence, and patient satisfaction in the field of asthma and allergies. This may be in part due to the current lack of standardization across different countries. As more and more apps and devices are being developed, regulatory guidance, and standardized quality criteria become essential. The present manuscript aims to summarize current knowledge and challenges related to the process of digital health device standardization and data integration. It further provides an update on ongoing research projects designed to optimize home care solutions for asthmatic and atopic patients.

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Smart Devices and Digital Therapeutics for Asthma Care: Regulatory Challenges

  • 章节

  • 发表日期：

    2025年

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  • Francesca Cefaloni,
  • Luca Passantino,
  • Mario Di Stasio,
  • Matteo Bonini

摘要

Mobile health technologiesMobile health technologies, remote careRemote care, and digital therapeuticsDigital therapeutics are finding their way into clinical care for patients with chronic respiratory diseases like asthma. A trend that gained momentum during preventative contact restrictions due to the COVID-19 pandemic, has shown its potential to continuously improve (home) care for patients, particularly in underserved or remote areas also afterward. However, many solutions like smart inhalers, connective spirometers, apps, and comprehensive monitoring platforms haven’t found their way into clinical routines yet, despite their potential to improve symptom control, quality of life, treatment adherence, and patient satisfaction in the field of asthma and allergies. This may be in part due to the current lack of standardization across different countries. As more and more apps and devices are being developed, regulatory guidance, and standardized quality criteria become essential. The present manuscript aims to summarize current knowledge and challenges related to the process of digital health device standardization and data integration. It further provides an update on ongoing research projects designed to optimize home care solutions for asthmatic and atopic patients.