Medical Devices Regulations UK

Regulartory Information - Alba Bioscience bio-manufacturing

The stethoscope, a symbol of medicine, an instrument that saves lives, the best friend of the physician, is disappearing from hospitals across the world. The specialists are increasingly using their smartphones to monitor the heart rate of their patients.

More than three million doctors have downloaded, for just 0.59 pounds sterling (about 0.72 euros), a computer program invented by Peter Bentley, a researcher at University College London, which converts the Apple iPhone into a stethoscope.

Last week, Bentley took a free version, which is being downloaded at a rate of more than 500 users per day. Experts say that this computer application, a breakthrough of paramount importance in medical technology has saved lives and enabled doctors working in remote areas have access to the expertise of specialists.

"Everyone feels very excited at the possibility of introducing mobile technologies in the medical field of work, and rightly so, " said Bentley, who initially developed the program "like a toy".

"Smartphones are incredibly powerful apparatuses, equipped with all kinds of sensors, cameras and high-quality microphones with amazing display possibilities, " he said. "They are able to save lives, save money and improve health care dramatically."

More than 6, 000 programs 'healthy'

The program iStethoscope, the one created by Bentley, is not the only mobile phone application that lightens weight and the doctor's bag that transforms medical practice: there are about 6, 000 health-related programs in the Apple App Store. Its acceptance has been rapid. In late 2009, two-thirds of doctors and 42% of the public using intelligent terminals, which are in fact low-cost laptops for professional and personal reasons. Over 80% of physicians stated that it expected to have a smartphone own in 2012.

It seems likely that this tendency will increase as you begin work younger doctors. There are some medical schools that provide students with smart phones. In the United States, Georgetown University, the Louisville and Ohio State University are among those that require their students to have one.

Legal obstacles

However, experts believe that they are not allowed to take full advantage of the opportunities offered by technology. Bentley says it can not launch a range of new applications due to regulations is outdated.

"It is much easier to develop the technology to get permission to use it, " he assured. "I am able to create a mobile ultrasound scanner and an application to measure the blood oxygen level, but the legal regulation prevents me. We are not allowed to turn the phone itself into a medical instrument and that means precisely that today there is a gray area in terms of legal regulation. This is the only reason we're not still attending an invasion of such devices. "

Professor Ian Wells, chief scientific computing section of the Physics Department of the Royal Hospital Medicine County Surrey, Guildford, southern England, shares the view that innovation is being hampered by legislation "still in diapers."

Nova Science Pub Inc Medical Devices and the FDA: Regulation, User Fees and Tort Claims (Biomedical Devices and Their Applications; Laws and Legislation)
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2010-01-18 11:40:06 by sweet_simplicitys

ACLU challenges US laptop border searches

Privacy campaigners are continuing a legal challenge against random laptop border searches by US customs amid concerns there may be a racial bias in those delayed and inconvenienced by stop and search powers introduced as part of the war on terror.
The ACLU also argues that searches of mobile phones by US border agents in the absence of any reason to be suspicious also pose a unwarranted invasion of privacy while delivering few tangible benefits.
Customs and Border Protection agents searched over 1,500 electronic devices at the US border over a period of nine months between October 2008 and June 2009, according to documents obtained by the ACLU as part of a Freedom of Information Act lawsuit and published on Thursday

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