Floodlight™ MS
Track MS health, support clinical dialogue
About the product
Assessment Overview
Foundational criteria clusters
This constitutes the foundational threshold.
Clinical utility and safety
The clinical effectiveness of Floodlight™ MS is supported by research, including a study published in the Multiple Sclerosis Journal, which supports its potential use in clinical research and practice. The app provides data-driven insights that can inform clinical conversations and healthcare provider decisions2 4.
Usability and human centricity
Floodlight™ MS was co-designed with MS experts and people living with MS, ensuring its usability and relevance to the target audience. The app is easy to use and supports the interaction between healthcare professionals and patients3.
Data management
Floodlight™ MS has a clear privacy policy detailing data confidentiality, security, and usage. It respects informed consent and allows users to opt out of data collection. Data can be accessed anytime and across different platforms, and users can easily delete their data5.
Functionality
The app provides clear information about its features and their appropriate use. The functionality of each element is clearly identifiable, and the app's goals are specific, measurable, achievable, and obvious within the tool itself 3.
Endorsement
Floodlight™ MS has been verified and endorsed by legitimate and reliable sources. It is part of a comprehensive research effort, including observational studies to assess its validity and reliability. The Floodlight GaitLab study, for instance, represents a critical step in the technical validation of Floodlight technology, aiming to support its real-world use. This endorsement by the scientific and medical community, through rigorous studies and clinical trials, underscores its credibility and potential utility in managing Multiple Sclerosis (MS)2.
Maintenance
The ongoing research associated with Floodlight™ MS suggest that the tool likely receives periodic updates. These updates would address both technical aspects, such as software improvements and security patches, and content, including the latest medical guidelines and user feedback. Continuous improvement and adherence to medical standards are critical for maintaining the app's effectiveness and safety for users 2 5.
Developer
Ethical Conduct and Clinical Responsibility
The developer behind Floodlight™ MS, Roche, adheres to high standards of ethical conduct and clinical responsibility. The development and validation phases of Floodlight™ MS involved rigorous testing and validation, demonstrating a commitment to creating a scientifically backed and clinically effective product. The involvement in and publication of research studies further underscore the developer's dedication to ethical practices and patient safety 2 4 5.
Interaction Quality
The interaction quality between Roche and its users is likely to be high, given the app's design and functionality aimed at engaging patients in their treatment process. The development of Floodlight™ MS involved input from healthcare professionals and patients, ensuring that it meets patient needs effectively. While specific details about customer service practices are not provided, the successful deployment and clinical adoption of Floodlight™ MS suggest a user-oriented approach 2 3 4.
Proactive Approach to User Needs and Continuous Improvement
Roche demonstrates a proactive approach to assessing user needs and continuous improvement. The development of Floodlight™ MS was based on identifying a gap in MS management — the need for continuous, objective monitoring of the condition — and creating a solution that addresses this challenge. The ongoing research and development efforts, including feasibility studies and validation studies, indicate a commitment to innovation and the enhancement of patient care through digital health solutions 2 4 5.
Contextual criteria clusters
Emphasizes the tool's integration into specific scenarios.
Data-protection compliance
Floodlight™ MS complies with the EU Medical Device Regulation (MDR) and is compliant with ISO27001, GDPR, and HIPAA data privacy regulations, ensuring user data security 2.
Safety regulatory compliance
Floodlight™ MS has received MDR certification, confirming that it meets high standards of quality and safety for market access in the EU. The app includes disclaimers regarding the non-replacement of healthcare professional judgment 2.
Interoperability and data integration
The app allows for data exchange with the Floodlight MS Healthcare Professional's Portal, providing healthcare providers with objective measurements of their patients’ condition between visits3
Cultural requirements
While specific details are not provided, the app's co-design with people living with MS suggests consideration of user preferences and lifestyles, which may include cultural factors 3.
Affordability
The app's affordability within the local socioeconomic context is not detailed in the search results.
Cost-benefit
A cost-benefit analysis is not explicitly mentioned, but the app's potential to improve the monitoring of MS in clinical trials and daily practice suggests a positive impact on patient care 4.
Implementatability
Floodlight™ MS is designed for use by patients at home and healthcare providers in both specialty and primary care environments, suggesting ease of integration into existing workflows 4.