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FDA Proposes Health App Guidelines
The FDA is seeking public input on proposed guidelines for certain mobile medical applications.
The mobile medical applications, or apps, are specific to medicine or healthcare and are designed for use on smartphones and other mobile computing devices. They include a variety of functions, ranging from monitoring calorie intake, to helping people maintain a healthy weight, to allowing doctors to view a patient’s radiology images. Research studies predict that 500 million smartphone users worldwide will be using a healthcare application by 2015.
The agency’s draft guidance defines a small subset of apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:
- Are used as an accessory to medical devices already regulated by the FDA, including apps that allow healthcare professionals to make specific diagnoses by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.
- Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices, including apps that turn smartphones into ECG machines to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
The FDA says it is not trying to discourage the development of new apps, but instead focus on a select group of applications whose misuse it feels may endanger patients.
Source: FDA, July 19, 2011
Benchmarks in Health & Wellness Incentives, 2011 Edition: Data to Drive Health Promotion, Compliance and ROI
This essential guide provides actionable information from 156 healthcare organizations on the use of incentives to promote health behavior change. This essential resource has been compiled from an analysis of responses to HIN's third annual survey on the use of health and wellness incentives, administered in March 2011.
Benchmarks in Health & Wellness Incentives, 2011 Edition: Data to Drive Health Promotion, Compliance and ROI is available from the Healthcare Intelligence Network for $127 by visiting our Online Bookstore or by calling toll-free (888) 446-3530.
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