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Journal ArticleDOI

The EU commission's risky choice for a non-risk based strategy on assessment of medical devices

Paul Quinn
- 01 Jun 2017 - 
- Vol. 33, Iss: 3, pp 361-370
TLDR
The problems that are created by the ever-increasing amount of ‘well-being’ apps and the fact that most will not be classed as medical devices are discussed.
About
This article is published in Computer Law & Security Review.The article was published on 2017-06-01. It has received 16 citations till now. The article focuses on the topics: European union & mHealth.

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Citations
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Journal ArticleDOI

The Current State of Mobile Phone Apps for Monitoring Heart Rate, Heart Rate Variability, and Atrial Fibrillation: Narrative Review.

TL;DR: It is suggested that there is a role for mobile phone apps in the diagnosis, monitoring, and screening for arrhythmias and HR and further studies are warranted to validate their use for large scale AF screening.
Journal ArticleDOI

Methodological Shortcomings of Wrist-Worn Heart Rate Monitors Validations.

TL;DR: Device industries and the scientific community require robust standards for the validation of new wearable sensor technology, and such technology should undergo rigorous evaluation prior to market launch.
Journal ArticleDOI

Heart Rate Monitoring Apps: Information for Engineers and Researchers About the New European Medical Devices Regulation 2017/745

Michael
TL;DR: Whether or not the regulatory framework for health apps has changed substantially and what, if any, impact is to expected is examined and the issue of classification uncertainty raised by borderline cases such as heart rate monitoring and well-being apps is examined.
Journal ArticleDOI

The PICASO cloud platform for improved holistic care in rheumatoid arthritis treatment-experiences of patients and clinicians.

TL;DR: In this article, the authors evaluated an innovative ICT platform for integrated care which orchestrates data from various health care providers to optimize care management processes, and found that the platform use contributed to improved disease and comorbidity management.
Journal ArticleDOI

Development of an innovative double-chamber syringe for intravenous therapeutics and flushing: Nurses' involvement through a human-centred approach

TL;DR: An innovative double-chamber syringe that enables the filling and administration of both solutions and the evaluation of design solutions and prototypes in order to accomplish with usability and ergonomic features of the medical device.
References
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Journal ArticleDOI

Mobile App Rating Scale: A New Tool for Assessing the Quality of Health Mobile Apps

TL;DR: The MARS is a simple, objective, and reliable tool for classifying and assessing the quality of mobile health apps and can also be used to provide a checklist for the design and development of new high quality health apps.
Journal ArticleDOI

Mobile medical and health apps: state of the art, concerns, regulatory control and certification

TL;DR: The state of the art in mobile clinical and health-related apps is examined, as healthcare professionals and consumers continue to express concerns about the quality of many apps, calling for some form of app regulatory control or certification to be put in place.
Journal ArticleDOI

Smartphone App Use Among Medical Providers in ACGME Training Programs

TL;DR: The clinical use of smartphones and apps will likely continue to increase, and the absence of high-quality and popular apps despite a strong desire among physicians and trainees is demonstrated.
Journal ArticleDOI

mHealth 2.0: Experiences, Possibilities, and Perspectives

TL;DR: Interdisciplinary alliances and collaborative strategies are vital to achieve sustainable growth for "mHealth 2.0," the next generation mobile technology to support patient care.
Journal ArticleDOI

Price Discrimination and Bargaining: Empirical Evidence from Medical Devices

TL;DR: In this paper, the authors used new panel data on buyer-supplier transfers and a structural model to empirically analyze bargaining and price discrimination in a medical device market and found that non-discriminatory pricing actually works against hospitals because competition is more intense under price discrimination.
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