TY - JOUR
T1 - Apps in healthcare and medical research; European legislation and practical tips every healthcare provider should know
AU - van der Storm, Sebastiaan L.
AU - Jansen, Marilou
AU - Meijer, Henriëtte A. W.
AU - Barsom, Esther Z.
AU - Schijven, Marlies P.
N1 - Funding Information: Within the overwhelming amount of apps it is challenging to find the apps with peer reviewed content and in compliance with the GDPR and MDR. Medical apps should be assessed on several aspects. A frequently used framework to assess medical apps are the Health on the Net (HON)-criteria. [22] . The HON foundation was founded in May 1996 and promoted the effective and reliable use of the new technologies for telemedicine in healthcare worldwide. Unfortunately, this non profit organisation was not able to maintain their foundation and has discontinued their services as of December 15, 2022. The mHealthHUB, supported by the European Union’s Horizon 2020 research and innovation programme, has published a knowledge tool reviewing available frameworks in 2021. [23] In August 2021 a new standard was published regarding the quality requirements for health and wellness apps, the ISO/TS 82304–2. The standard covers the entire life cycle of a medical app (post market surveillance and quality control). Apps are scored on four different domains, as shown below in Fig. 1 . An overall quality score is also provided. [24] . Publisher Copyright: © 2023 The Author(s)
PY - 2023/9/1
Y1 - 2023/9/1
N2 - Background: The use of apps in healthcare and medical research is increasing. Apps in healthcare may be beneficial to patients and healthcare professionals, but their use comes with potential risks. How to use apps in clinical care is not standard part of medical training, resulting in a lack of knowledge. As healthcare professionals and their employers can be held accountable for the wrongful use of medical apps, this situation is undesirable. This article addresses the most important European legislation regarding medical apps from the perspective of healthcare providers. Methods: This review provides an overview of current and changing regulations, focusing on apps used in healthcare and medical research. Three topics are discussed: 1) the relevant European legislation and its enforcement, 2) the responsibilities and liability of the medical professional when using these apps, and 3) an overview of the most practical considerations medical professionals should know when using or building a medical app. Results: When using and developing medical apps, data privacy must be guaranteed according to the GDPR guidelines. Several international standards make it easier to comply with the GDPR, such as ISO/IEC 27001 and 27002. Medical Devices Regulation was implemented on May 26, 2021, and as a result, medical apps will more often qualify as medical devices. The important guidelines for manufacturers to comply with Medical Devices Regulation are ISO 13485, ISO 17021, ISO 14971 and ISO/TS 82304–2. Conclusion: The use of medical apps in healthcare and medical research can be beneficial to patients, medical professionals, and society as a whole. This article provides background information on legislation and a comprehensive checklist for anyone wanting to start using or building medical apps.
AB - Background: The use of apps in healthcare and medical research is increasing. Apps in healthcare may be beneficial to patients and healthcare professionals, but their use comes with potential risks. How to use apps in clinical care is not standard part of medical training, resulting in a lack of knowledge. As healthcare professionals and their employers can be held accountable for the wrongful use of medical apps, this situation is undesirable. This article addresses the most important European legislation regarding medical apps from the perspective of healthcare providers. Methods: This review provides an overview of current and changing regulations, focusing on apps used in healthcare and medical research. Three topics are discussed: 1) the relevant European legislation and its enforcement, 2) the responsibilities and liability of the medical professional when using these apps, and 3) an overview of the most practical considerations medical professionals should know when using or building a medical app. Results: When using and developing medical apps, data privacy must be guaranteed according to the GDPR guidelines. Several international standards make it easier to comply with the GDPR, such as ISO/IEC 27001 and 27002. Medical Devices Regulation was implemented on May 26, 2021, and as a result, medical apps will more often qualify as medical devices. The important guidelines for manufacturers to comply with Medical Devices Regulation are ISO 13485, ISO 17021, ISO 14971 and ISO/TS 82304–2. Conclusion: The use of medical apps in healthcare and medical research can be beneficial to patients, medical professionals, and society as a whole. This article provides background information on legislation and a comprehensive checklist for anyone wanting to start using or building medical apps.
KW - Data privacy
KW - Health apps
KW - Legislation
KW - Medical apps
KW - Medical device
KW - Mobile applications
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85164212580&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ijmedinf.2023.105141
DO - https://doi.org/10.1016/j.ijmedinf.2023.105141
M3 - Review article
C2 - 37419042
SN - 1386-5056
VL - 177
JO - International Journal of Medical Informatics
JF - International Journal of Medical Informatics
M1 - 105141
ER -