USA's FDA releases its final mobile apps regulations
At last, the guidance is out. On 25 September 2013, the USA’s Food and Drug Administration (FDA) published is guidance on mobile medical applications. It is similar to its draft guidance released on 21 July.
It is a collaborative effort by the USA’s. Department of Health and Human Services Food and Drug Administration, the Center for Devices and Radiological Health, part of the FDA responsible for protecting and promoting the public health, and the Center for Biologics Evaluation and Research, part of the FDA that regulates biological products for human use.
For African countries actively pursuing eHealth regulation, the document is an extremely valuable source of initiatives and ideas. Before adopting or modifying any of these, countries must have their regulatory processes, organizations and resources in place.
Acfee is planning to add some of these new regulations to its Reference Regulation Model (RRM) as another global benchmark for African countries to use.
- 273 views
- October 02, 2013
- Tom Jones
New iPhone app to reduce the risk of strokes
The WHO estimated that 17.3 million people died from Cardio Vascular Diseases (CVD) in 2008, representing 30% of all global deaths. Of these deaths, an estimated 6.2 million were due to stroke, with over 80% of the world’s deaths from CVDs occurring in low- and middle-income countries.
Researchers from the University of Sydney have found a way to detect cardiovascular conditions early using inexpensive, portable equipment. They have developed a smartphone-based screening device that coupled with a web-based prediction facility can detect atrial fibrillation (AF) with an accuracy of 97%. Undiagnosed AF increases the risk of stroke five-fold and is responsible for around a third of all strokes.
Ten community pharmacies tested the AliveCor Heart Monitor for iPhone (iECG). The app gives a live ECG reading while uploading a PDF of the ECG to a server where the results are analyzed automatically for AF. The results can then be shared with doctors and specialists.
Early detection of AF is critical and is easily treatable. This new iPhone device highlights the potential benefits of mHealth and how a simple device can be used to save the lives of thousands of people who would otherwise not have access to screening and treatment options.
Editor's note: the study refered to above was published in Thromb Haemost in June 2014. It's abstract is available here.
- 309 views
- August 23, 2013
- Lesley Dobson
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