Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device
| Autor: | van der Walt, Anneke, Butzkueven, Helmut, Shin, Robert K., Midaglia, Luciana, Capezzuto, Luca, Lindemann, Michael, Davies, Geraint, Butler, Lesley M., Costantino, Cristina, Montalban, Xavier, Universitat Autònoma de Barcelona |
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| Přispěvatelé: | Institut Català de la Salut, [van der Walt A] Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. The Alfred, Melbourne, VIC 3004, Australia. [Butzkueven H] Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC 3004, Australia. [Shin RK] MedStar Georgetown University Hospital, Washington, DC 20007, USA. [Midaglia L] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Capezzuto L, Lindemann M] F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Aplicacions mòbils
Information privacy Medical device Process management Monitoring Participatory health Computer science Process (engineering) digital health Neurosciences. Biological psychiatry. Neuropsychiatry Esclerosi múltiple Review multiple sclerosis digital health solution development Multiple sclerosis Software Software as a medical device Digital health solution development Assistència sanitària software as a medical device Environmental Health::Health::Health Services::Medical Care [PUBLIC HEALTH] salud ambiental::salud::servicios de salud::atención médica [SALUD PÚBLICA] Home environment Technical validation business.industry General Neuroscience MS apps Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases CNS::Multiple Sclerosis [DISEASES] Clinical validation Ciencias de la información::metodologías computacionales::soporte lógico (informática)::aplicaciones en aparatos electrónicos portátiles [CIENCIA DE LA INFORMACIÓN] Digital health Remote observation Information Science::Computing Methodologies::Software::Mobile Applications [INFORMATION SCIENCE] monitoring Software deployment enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES] smartphone-based assessments Smartphone-based assessments technical validation participatory health business clinical validation RC321-571 |
| Zdroj: | Scientia Brain Sciences Brain Sciences, Vol 11, Iss 1247, p 1247 (2021) |
| Popis: | Validación clínica; Salud digital; Salud participativa Validació clínica; Salut digital; Salut participativa Clinical validation; Digital health; Participatory health There is increasing interest in the development and deployment of digital solutions to improve patient care and facilitate monitoring in medical practice, e.g., by remote observation of disease symptoms in the patients’ home environment. Digital health solutions today range from non-regulated wellness applications and research-grade exploratory instruments to regulated software as a medical device (SaMD). This paper discusses the considerations and complexities in developing innovative, effective, and validated SaMD for multiple sclerosis (MS). The development of SaMD requires a formalised approach (design control), inclusive of technical verification and analytical validation to ensure reliability. SaMD must be clinically evaluated, characterised for benefit and risk, and must conform to regulatory requirements associated with device classification. Cybersecurity and data privacy are also critical. Careful consideration of patient and provider needs throughout the design and testing process help developers overcome challenges of adoption in medical practice. Here, we explore the development pathway for SaMD in MS, leveraging experiences from the development of Floodlight™ MS, a continually evolving bundled solution of SaMD for remote functional assessment of MS. The development process will be charted while reflecting on common challenges in the digital space, with a view to providing insights for future developers. The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: F. Hoffmann-La Roche Ltd., Basel, Switzerland provided financial support for the publication of this manuscript. |
| Databáze: | OpenAIRE |
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