The regulation of mobile medical applications.

@article{Yetisen2014TheRO,
  title={The regulation of mobile medical applications.},
  author={Ali Kemal Yetisen and J. L. Martinez-Hurtado and Fernando da Cruz Vasconcellos and M C Emre Simsekler and Muhammad Safwan Akram and Christopher Robin Lowe},
  journal={Lab on a chip},
  year={2014},
  volume={14 5},
  pages={
          833-40
        }
}
The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those… 

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References

SHOWING 1-10 OF 83 REFERENCES

The regulation of mobile health applications

TLDR
The prevalence of mobile health, the context of regulation concerning mobile medical applications, and implications for the future are discussed.

Mobile Tablet Use among Academic Physicians and Trainees

TLDR
It is believed medical institutions, providers, educators, and developers should collaborate in ways that enhance the efficacy, reliability, and safety of integrating these devices into daily medical practice.

Features of Mobile Diabetes Applications: Review of the Literature and Analysis of Current Applications Compared Against Evidence-Based Guidelines

TLDR
There are obvious gaps between the evidence-based recommendations and the functionality used in study interventions or found in online markets, and current results confirm personalized education as an underrepresented feature in diabetes mobile applications.

The Uses of the Smartphone for Doctors: An Empirical Study from Samsung Medical Center

TLDR
This study aims to present a framework for a smartphone application to give doctors mobile access to patient information, then review the consequences of its use and discuss its future direction.

Mobile Applications for Diabetes Self-Management: Status and Potential

TLDR
Whether diabetes applications have been helping patients with type 1 or type 2 diabetes self-manage their condition and to identify issues necessary for large-scale adoption of such interventions are determined.

Mobile Health Applications for the Most Prevalent Conditions by the World Health Organization: Review and Analysis

Background New possibilities for mHealth have arisen by means of the latest advances in mobile communications and technologies. With more than 1 billion smartphones and 100 million tablets around the

Smartphone applications for pain management

TLDR
Pain apps appear to be able to promise pain relief without any concern for the effectiveness of the product, or for possible adverse effects of product use, and there is considerable risk of individuals being misled.

'Mobile' health needs and opportunities in developing countries.

TLDR
This work examines various m-health applications and defines the risks and benefits of each, finding positive examples but little solid evaluation of clinical or economic performance, which highlights the need for such evaluation.

A Data Encryption Solution for Mobile Health Apps in Cooperation Environments

TLDR
The proposed data encryption algorithm DE4MHA with cooperation mechanisms in mobile health allow users to safely obtain health information with the data being carried securely and offers a robust and reliable increase of privacy, confidentiality, integrity, and authenticity of their health information.

The Current Status of mHealth for Diabetes: Will it Be the Next Big Thing?

  • D. Klonoff
  • Medicine
    Journal of diabetes science and technology
  • 2013
TLDR
Three additional hurdles must be overcome to facilitate widespread adoption of this technology, including demonstration of the following: (1) privacy to satisfy regulators, (2) clinical benefit to satisfies clinicians, and (3) economic benefit to satisfy payers.
...