Date:
September 29, 2016

Source:
North Carolina State University

Summary:
An efficient, semi-printed plastic solar cell has now been created without the use of environmentally hazardous halogen solvents.

 

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Schematic illustration and chemical structure of semi-printed plastic solar cells in air, using food additive o-MA as solvent.
Credit: Long Ye, NC State

 

 

Researchers from North Carolina State University and the Chinese Academy of Sciences have created an efficient, semi-printed plastic solar cell without the use of environmentally hazardous halogen solvents. These solar cells can be manufactured at room temperature, which has implications for large-scale commercial production.

Plastic solar cells, or organic photovoltaics, are popular because they are lightweight, flexible, transparent and inexpensive to manufacture, making them useful in multiple applications. Unfortunately, the halogen-containing solvents used in their manufacture are an obstacle to large-scale commercialization. These solvents are key to making sure that the solar cell’s morphology, or structure, maximizes its energy efficiency; however, they are environmentally hazardous. Additionally, the use of these harsh chemicals requires a controlled environment, which adds to production costs.

Long Ye, a postdoctoral research scholar in physics at NC State and lead author of a paper describing the work, wanted to find out if nontoxic solvents could provide equally efficient morphology in the manufacturing process. Ye and his colleagues developed a proof of concept semi-printed plastic solar cell that utilized o-methylanisole (o-MA) as the solvent. O-MA is a commonly used flavoring agent in foods, and is nontoxic to humans.

The researchers used soft X-ray techniques to study the morphology of their solar cell. They found that the o-MA based solar cell had similar morphology, crystalline features and device performance to those produced by halogenated solvents. The solar cell’s overall efficiency rating was around 8.4 percent. Furthermore, their cell could be produced via blade coating at ambient, or room temperature. Blade coating is a process that uses a glass blade to spread a thin layer of the photovoltaic film onto either a rigid or flexible substrate, and the process is compatible with large-scale commercial manufacturing.

“Two of the key requirements for mass producing these solar cells are that the cells can be produced in the open air environment and that the process doesn’t pose health or environmental hazards,” Ye says. “Hopefully this work can help pave the way for printing solar cells in ambient air.”

The work appears in Chemistry of Materials.


Story Source:

Materials provided by North Carolina State University. Note: Content may be edited for style and length.


Journal Reference:

  1. Long Ye, Yuan Xiong, Huifeng Yao, Abay Gadisa, Hao Zhang, Sunsun Li, Masoud Ghasemi, Nrup Balar, Adrian Hunt, Brendan T. O’Connor, Jianhui Hou, Harald Ade. High Performance Organic Solar Cells Processed by Blade Coating in Air from a Benign Food Additive Solution.Chemistry of Materials, 2016; DOI:10.1021/acs.chemmater.6b03083

 

Source: North Carolina State University. “Food additive key to environmentally friendly, efficient, plastic solar cells.” ScienceDaily. ScienceDaily, 29 September 2016. <www.sciencedaily.com/releases/2016/09/160929111717.htm>.

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Date:
September 28, 2016

Source:
Technical University Munich

Summary:
Researchers have achieved unprecedented transmission capacity and spectral efficiency in an optical communications field trial with a new modulation technique. The breakthrough research could extend the capability of optical networks to meet surging data traffic demands.

 

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TUM researchers (l-r) Fabian Steiner, Georg Böcherer, and Patrick Schulte with the statue of Claude Shannon, father of information theory.
Credit: Denise Panyik-Dale/Alcatel-Lucent

 

 

Nokia Bell Labs, Deutsche Telekom T-Labs and the Technical University of Munich (TUM) have achieved unprecedented transmission capacity and spectral efficiency in an optical communications field trial with a new modulation technique. The breakthrough research could extend the capability of optical networks to meet surging data traffic demands.

In an optical communications field trial, Nokia Bell Labs, Deutsche Telekom T-Labs and the TU Munich showed that the flexibility and performance of optical networks can be maximized when adjustable transmission rates are dynamically adapted to channel conditions and traffic demands. As part of the Safe and Secure European Routing (SASER) project, the experiment over a deployed optical fiber network of Deutsche Telekom achieved a net transmission rate of one Terabit.

This is close to the theoretical maximum information transfer rate of that channel and thus approaching the Shannon Limit of the fiber link. The Shannon Limit was discovered in 1948 by Claude Shannon, Bell Labs pioneer and the “father of information theory.”

Novel modulation approach

The trial of the novel modulation approach, known as Probabilistic Constellation Shaping (PCS), uses quadrature amplitude modulation (QAM) formats to achieve higher transmission capacity over a given channel to significantly improve the spectral efficiency of optical communications.

PCS modifies the probability with which constellation points — the alphabet of the transmission — are used. Traditionally, all constellation points are used with the same frequency. PCS cleverly uses constellation points with high amplitude less frequently than those with lesser amplitude to transmit signals that, on average, are more resilient to noise and other impairments. This allows the transmission rate to be tailored to ideally fit the transmission channel, delivering up to 30 percent greater reach.

Maximal transmission capacity

It was 50 years ago when optical fiber was introduced. With the promise of 5G wireless technology on the horizon, optical transport systems today continue to evolve to help telecommunications operators and enterprises meet network data traffic growing at a cumulative annual rate of up to 100 percent.

PCS is now part of this evolution by enabling increases in optical fiber flexibility and performance that can move data traffic faster and over greater distances without increasing the optical network complexity.

The research is a key milestone in proving PCS could be used in the future to extend optical communication technologies. The results of this joint experiment will be presented at the European Conference on Optical Communication (ECOC) 2016 in Düsseldorf, Germany on September 19.

Transmitting data faster, further, and with unparalleled flexibility

“Increased capacities, reach and flexibility over deployed fiber infrastructures,” said Bruno Jacobfeuerborn, Director Technology Telekom Deutschland and CTO Deutsche Telekom. “Deutsche Telekom provides a unique network infrastructure to evaluate and demonstrate such highly innovative transmission technologies for example. Furthermore, it also supports higher layer test scenarios and technologies.”

“Information theory is the mathematics of digital technology, and during the Claude E. Shannon centenary year 2016 it is thrilling to see his ideas continue to transform industries and society,” said Professor Gerhard Kramer, Head of the Institute for Communications Engineering at Technical University of Munich.

“Probabilistic constellation shaping, an idea that won a Bell Labs Prize, directly applies Shannon’s principles and lets fiber optic systems transmit data faster, further, and with unparalleled flexibility,” added Prof. Kramer. “The success of the close collaboration with Nokia Bell Labs, who further developed the technology, and Deutsche Telekom T-Labs, who tested it under real conditions, is satisfying confirmation that TUM Engineering is a label of outstanding quality, and that TUM teaching gives our students the intellectual tools to compete, succeed and lead globally.”

Marcus Weldon, president Nokia Bell Labs & Nokia CTO, said: “Future optical networks not only need to support orders of magnitude higher capacity, but also the ability to dynamically adapt to channel conditions and traffic demand. Probabilistic Constellation Shaping offers great benefits to service providers and enterprises by enabling optical networks to operate closer to the Shannon Limit to support massive datacenter interconnectivity and provide the flexibility and performance required for modern networking in the digital era.”


Story Source:

Materials provided by Technical University Munich. Note: Content may be edited for style and length.

 

Source: Technical University Munich. “Optical fiber transmits one terabit per second.” ScienceDaily. ScienceDaily, 28 September 2016. <www.sciencedaily.com/releases/2016/09/160928154945.htm>.

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Date:
September 27, 2016

Source:
University of Washington

Summary:
Engineers have devised a way to send secure passwords through the human body using smartphone fingerprint sensors and laptop touchpads — rather than over the air where they’re vulnerable to hacking.

 

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Potential applications for on-body transmissions include securely sending information to door locks, glucose sensors or other wearable medical devices.
Credit: Vikram Iyer, University of Washington

 

 

Sending a password or secret code over airborne radio waves like WiFi or Bluetooth means anyone can eavesdrop, making those transmissions vulnerable to hackers who can attempt to break the encrypted code.

Now, University of Washington computer scientists and electrical engineers have devised a way to send secure passwords through the human body — using benign, low-frequency transmissions generated by fingerprint sensors and touchpads on consumer devices.

“Fingerprint sensors have so far been used as an input device. What is cool is that we’ve shown for the first time that fingerprint sensors can be re-purposed to send out information that is confined to the body,” said senior author Shyam Gollakota, UW assistant professor of computer science and engineering.

These “on-body” transmissions offer a more secure way to transmit authenticating information between devices that touch parts of your body — such as a smart door lock or wearable medical device — and a phone or device that confirms your identity by asking you to type in a password.

This new technique, which leverages the signals already generated by fingerprint sensors on smartphones and laptop touchpads to transmit data in new ways, is described in a paper presented in September at the 2016 Association for Computing Machinery’s International Joint Conference on Pervasive and Ubiquitous Computing (UbiComp 2016) in Germany.

“Let’s say I want to open a door using an electronic smart lock,” said co-lead author Merhdad Hessar, a UW electrical engineering doctoral student. “I can touch the doorknob and touch the fingerprint sensor on my phone and transmit my secret credentials through my body to open the door, without leaking that personal information over the air.”

The research team tested the technique on iPhone and other fingerprint sensors, as well as Lenovo laptop trackpads and the Adafruit capacitive touchpad. In tests with 10 different subjects, they were able to generate usable on-body transmissions on people of different heights, weights and body types. The system also worked when subjects were in motion — including while they walked and moved their arms.

“We showed that it works in different postures like standing, sitting and sleeping,” said co-lead author Vikram Iyer, a UW electrical engineering doctoral student. “We can also get a strong signal throughout your body. The receivers can be anywhere — on your leg, chest, hands — and still work.”

The research team from the UW’s Networks and Mobile Systems Lab systematically analyzed smartphone sensors to understand which of them generates low-frequency transmissions below 30 megahertz that travel well through the human body but don’t propagate over the air.

The researchers found that fingerprint sensors and touchpads generate signals in the 2 to 10 megahertz range and employ capacitive coupling to sense where your finger is in space, and to identify the ridges and valleys that form unique fingerprint patterns.

Normally, sensors use these signals to receive input about your finger. But the UW engineers devised a way to use these signals as output that corresponds to data contained in a password or access code. When entered on a smartphone, data that authenticates your identity can travel securely through your body to a receiver embedded in a device that needs to confirm who you are.

Their process employs a sequence of finger scans to encode and transmit data. Performing a finger scan correlates to a 1-bit of digital data and not performing the scan correlates to a 0-bit.

The technology could also be useful for secure key transmissions to medical devices such as glucose monitors or insulin pumps, which seek to confirm someone’s identity before sending or sharing data.

The team achieved bit rates of 50 bits per second on laptop touchpads and 25 bits per second with fingerprint sensors — fast enough to send a simple password or numerical code through the body and to a receiver within seconds.

This represents only a first step, the researchers say. Data can be transmitted through the body even faster if fingerprint sensor manufacturers provide more access to their software.


Story Source:

Materials provided by University of Washington. Original written by Jennifer Langston. Note: Content may be edited for style and length.

 

Source: University of Washington. “Secure passwords can be sent through your body, instead of air.” ScienceDaily. ScienceDaily, 27 September 2016. <www.sciencedaily.com/releases/2016/09/160927134838.htm>.

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Date:
September 26, 2016

Source:
Johns Hopkins University

Summary:
A layer of iron and other elements deep underground is the evidence scientists have long been seeking to support the hypothesis that the moon was formed by a planetary object hitting the infant Earth some 4.5 billion years ago, a new study argues.

 

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A new paper uses laboratory simulations of an Earth impact as evidence that a stratified layer beneath the rocky mantle — which appears in seismic data — was created when the Earth was struck by a smaller object. The authors argue this was the same impact that sent a great mass of debris hurtling into space, creating the moon.
Credit: © Gudellaphoto / Fotolia

 

 

A layer of iron and other elements deep underground is the evidence scientists have long been seeking to support the hypothesis that the moon was formed by a planetary object hitting the infant Earth some 4.5 billion years ago, a new study led by Johns Hopkins University scientists argues.

Published in the current issue of the journal Nature Geoscience, the paper uses laboratory simulations of an Earth impact as evidence that a stratified layer beneath the rocky mantle — which appears in seismic data — was created when Earth was struck by a smaller object. The authors argue this was the same impact that sent a great mass of debris hurtling into space, creating the moon.

“Our experiments bring additional evidence in favor of the giant impact hypothesis,” said Maylis Landeau, the lead author of the paper, who was a post-doctoral fellow in Johns Hopkins’ Department of Earth and Planetary Sciences when the experiments were conducted. “They demonstrate that the giant impact scenario also explains the stratification inferred by seismology at the top of the present-day Earth’s core. This result ties the present-day structure of Earth’s core to its formation.”

Landeau, now a Marie Curie Fellow at the University of Cambridge, co-wrote the paper with Peter Olson, research professor in the Department of Earth and Planetary Sciences, Benjamin H. Hirsh, who was an undergraduate at Johns Hopkins, and Renaud Deguen of Claude Bernard University in Lyon, France.

Olson said the giant impact argument for the formation of the moon is the most prevalent scientific hypothesis on how Earth satellite was formed, but it is still considered unproven because there’s been no “smoking gun” evidence.

“We’re saying this stratified layer might be the smoking gun,” said Olson. “Its properties are consistent with it being a vestige of that impact.”

Their argument is based on seismic evidence of the composition of the stratified layer — believed to be some 200 miles thick and lie 1,800 miles below Earth’s surface — and on laboratory experiments simulating the turbulence of the impact. The turbulence in particular is believed to account for the stratification — meaning a mix of materials in layers rather than a homogeneous composition — at the top of the core.

The stratified layer is believed to consist of a mix of iron and lighter elements, including oxygen, sulfur and silicon. The very existence of this layer is understood from seismic imaging, as it lies far too deep underground to be sampled directly.

Up to now, most simulations of the impact have been done numerically, and have not accounted for impact turbulence, Olson said. Olson said turbulence is difficult to simulate mathematically and no computer model has yet done it successfully.

The researchers in this experiment simulated the impact using liquids meant to approximate the turbulent mixing of materials that would have occurred when the planetary object struck when Earth was just about fully formed — a “proto-Earth,” as scientists call it.

Olson said the experiments depended on the principle of “dynamic similarity.” In this case, that means a way to make reliable comparisons of fluid flows without replicating the scale, materials and force of the original Earth impact, which would be impossible. Instead, the experiment was meant to simulate the key ratios of forces acting on each other to produce the turbulence of the impact that could leave behind a layered mixture of material.

The researchers conducted more than 60 experiments in which about 3.5 ounces of saline or ethanol solutions representing the planetary projectile that hit Earth was dropped into a rectangular tank holding about six gallons of fluid representing the early Earth. In the tank was a combination of fluids in layers that do not mix: oil floating on the top to represent Earth’s mantle and water below representing Earth’s core.

The analysis of the impact showed that a mix of materials was left behind in varying amounts, and also that the distribution of the mixture depended on the size and density of the projectile hitting the “Earth.” The larger the projectile, the more likely the entire core of Earth, and not just a layer, would be a mix of material. The authors argue for a smaller moon-forming projectile, smaller or equal to the size of Mars, a bit more than half the size of Earth.


Story Source:

Materials provided by Johns Hopkins University. Note: Content may be edited for style and length.


Journal Reference:

  1. Maylis Landeau, Peter Olson, Renaud Deguen, Benjamin H. Hirsh. Core merging and stratification following giant impact. Nature Geoscience, 2016; DOI:10.1038/ngeo2808

 

Source: Johns Hopkins University. “Scientists’ finding supports moon creation hypothesis.” ScienceDaily. ScienceDaily, 26 September 2016. <www.sciencedaily.com/releases/2016/09/160926115339.htm>.

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Les Jordan Joins Target Health as Vice President, Chief Product Evangelist

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As part of Target Health’s commitment to the paperless clinical trial, we welcome Les Jordan to Target Health as Vice President and Chief Product Evangelist. Les’ mandate is to provide overall software product vision, architectural and technical guidance to our esteemed software development teams, and support for sales and marketing. Les brings to Target Health almost 20 years of Life Science industry experience and over 25 years of IT and IS management experience. His particular expertise includes systems that support clinical trials, and a passion for bringing patient engagement technologies to clinical trials.

 

Les spent 10 years as the CTO for Microsoft’s Life Sciences Industry Unit, where he was responsible for providing Life Science industry guidance to internal product teams particularly around regulatory compliance, and working with the largest Life Science companies on how to use Microsoft products to solve industry problems. He also served as Microsoft’s representative to industry standards groups, including CDISC, IHE and HL7.  After he left Microsoft, Les spent two years with Quintiles where he was responsible for sales and marketing for their IT Consulting Practice and 5 years with Webridge (now part of Huron Consulting) where he was responsible for launching their now market-leading suite of products into clinical trials and research compliance automation.

 

Les started his career at Boston Biostatistics (now part of Icon) as the IT Director and fourth employee, working with our good friend and colleague Dr. Phil Lavin. His responsibilities included the design and development of electronic data capture systems, installing client-server based clinical trials systems at many of the largest pharmaceutical and life sciences companies, and consulting with customers on the implementation of CANDA systems supporting drug filings to FDA.

 

Outside of pharmaceutical and life sciences companies, Les served six years in the financial services industry, with most of the time as an officer at State Street Bank, a Fortune 500 financial services firm, managing large IT projects and setting direction in the messaging and collaboration space. His efforts have resulted in invitations to speak at numerous conferences, events, and webinars on life science topics, as well as numerous interviews and articles published in publications including BioInform, ClinPage, Pharmaceutical Manufacturing, BioIT World, Applied Clinical Trials and Applied & Translational Genomics.

 

In his spare time, Les volunteers as a music teacher working with inner city children, designs web sites for local non-profits, and has served for almost 10 years as the Tournament Director for his local youth soccer association.

 

We are now setting up partnering meetings with large and small pharma companies, large and small CROs and independents to truly transform the industry. Our paperless and web-based solutions, with no need for any dedicated devices, include 1) direct data entry (eSource) at the time of the office visit, 2) integration with the electronic medical record (EMR), 3) electronic Informed Consent and 4) multiple clinical trial features, all at one website. Thus, the former, together with our expertise in drug and device development, and Target Health and 8 clinical sites passing FDA inspections of our software, and especially one FDA marketing approval, says it all.

 

No study is too small. We will pilot for those who just want to dip their toes in the water.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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Are Wearables Safe as They Alert Us to Our Present State of Health?

 

For those interested in some of the regulatory implications of wearables please see a paper we wrote for Applied Clinical Trialsthis year.

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Greatly magnified, close-knit fabric, wired for wearable device. Source: Wikipedia Commons

 

Sometime over the last few years, wearable electronics have become the norm. Whether it’s a cell phone attached to a holster at the hip, a smart watch on the wrist, or sensors on and sometimes woven into clothing, these technologies are part of everyday life. Along with this trend, many of the devices are also now collecting and transmitting health information. That is certainly convenient, but the question with any kind of health care device, including wearable medical technology, has always been and continues to be: is it safe? With that in mind, experts are taking a hard look at new advances in medical-related wearable 1) ___and textiles to help ensure that while attempting to do good, the technology isn’t doing any harm, as some believe. In the US, the FDA is the primary regulatory agency overseeing wearable medical technology is the FDA which evaluates how well these devices and associated software applications do their jobs. The FDA issued its guidelines, Mobile Medical Applications Guidance for Industry and FDA Staff, in early 2015 to clarify its focus on wearable technologies with important medical implications. The document spells out the FDA’s emphasis on technologies that:

 

1. present “a greater risk to patients if they don’t work as intended.“ An app on a smartphone that monitors 2) ___ pressure for an individual who has a heart condition would fall under this description, whereas a device that a patient uses to record when he or she wants to light up a cigarette in a smoking cessation program would not.

2. impact “the functionality or performance of traditional medical devices,“ which would include new technologies that are designed to take the place of older medical technologies.

 

An electrocardiograph (ECG or EKG) is an example of the second focus. Early ECG machines were bulky instruments, but over time, they have been downsized to fit on a rollable cart and, more recently, onto hand-held devices. Today, smartphone-connected mobile apps are taking on the task of performing ECGs. Regardless of their format, all of these tools must perform similarly when it comes to capturing physiological data and performing the ECG-type functions.  FDA is looking at the functionality of the product as opposed to the platform of the technology or the size of the product. The FDA steps in and has an opinion when it doesn’t work as it’s intended. The FDA’s accentuation of functionality will remain constant into the future. According to FA, they want technology to evolve, but, at the same time, they want to be sure that we have very informed guiding principles so that people have a clear view of what we consider a medical device and when patient safety and public health are important. Accordingly, the FDA is continuing to hone its guidelines and add additional examples to reflect innovative technologies.

 

Wearable devices and textiles could potentially impact health on several fronts, including possible inaccuracies in the measurements they take, but exposure to electromagnetic 3) ___ is not an issue, according to Kenneth R. Foster, professor of bioengineering at the University of Pennsylvania. Foster feels that the U.S. Federal Communications Commission (FCC) also has some regulatory jurisdiction over wearable technologies, but, so far, its guidelines remain a bit behind the times. The FCC regulations were set up decades ago, when portable devices transmitted several watts of power, and it was necessary to keep them away from the body to ensure that FCC safety limits were maintained. He notes that the wearable devices today, however, operate at far lower power levels, but the regulations have not been updated. “This has led to strange situations, such as the instructions that came with my Pebble smart watch that say I should keep my watch 2.5 cm from my body.“ He speculates that a misunderstanding of FCC regulations may have led to the warning and notes that the warning has been removed from the instructions for the Pebble 2 watch.

 

If heat is not a problem and the FDA is overseeing functionality, what are the concerns with wearables? “There’s a lot of interesting discussion about many of the body-sensing applications and whether they are entertainment, sports, or clinical devices. It’s becoming a bigger issue, especially as people get more access to their own health data, because sports/ entertainment devices are not necessarily evaluated rigorously,“ says Lucy Dunne, director of the Wearable Technology Lab at the University of Minnesota. She describes the laboratory as developing innovative smart textiles that are soft, flexible, loose-fitting, and “aesthetically normal“ as compared to everyday clothing. Scientists and engineers understand where variations arise between traditional devices and wearable technologies, Dunne says, because they know “how messy it is to accurately sense something in the wearable environment.“ Consumers on the other hand, see a nice, shiny interface on a device and assume the data it conveys is correct. She explains, “Some of these devices do fall under FDA approval, so they are clinically validated, but the problem in the marketplace is that it’s really hard for the general public to know which is which. And while some of the consumer devices do actually publish their accuracy data, not all of them do.“

 

The drawback to sports/entertainment devices arises when consumers use the data that devices collect for medical purposes. For instance, people who need to lose 4) ___ for health reasons may look to their devices for accurate estimations of the number of calories they are expending and the number of steps they are walking so that they can manage their diet and exercise. “The technology is so new that we just sort of take data at face value without being too concerned about how they were validated or whether they’re correct,“ Dunne says. “As the power of these devices increases, I think it will become more important to know whether you can trust what a device or interface is telling you.“ Foster counts accuracy concerns as one of the three major issues facing wearable devices. The second on his list is that devices can be distracting, particularly when individuals are doing something that demands their full attention. “I have a smart watch, and every time I get an e-mail, including junk e-mails, my wrist vibrates. I just can’t resist looking at the thing,“ he says. A similar display that continually updates health data would be no different. “I think this is equally as dangerous as texting while driving. It may be just a momentary distraction, but it’s a serious potential problem,“ he says. “Nobody’s really explored the ergonomics of these wearable devices. I see an awful lot of hype in the literature about all of the wonderful things that these technologies are going to do to protect health, but it remains to be seen exactly how useful they are going to be and what the problems are going to be as they get introduced.“ Dunne believes consumers are sometimes mistaken about the accuracy of wearable textiles and devices designed for sports/entertainment purposes. Such smart technology is not required to meet the same high standards as that designed for clinical uses.

 

A third issue Foster sees is the integration of all of these newly collected data into the 5) ___ care system. He feels it is such an important consideration that he brings up the topic during one of his graduate-level courses. “We talk about apps that detect atrial fibrillation. First of all, the question is: how accurate are these things, given that it’s hard to make high-quality measurements with an app? And then we talk about integration.“ Last semester, Foster and his class heard from a medical doctor who said he’s terrified that he’ll have hundreds of anxious patients constantly sending him data from their apps. He describes the collective potential drain on medical professionals, device-related distractions, and accuracy misunderstandings by users as “serious potential issues that have safety implications and medical-usefulness implications, and these are really big problems.“ More work is definitely needed on integration. Some of this miniaturization that you can wear everyday on your fabrics or on yourself has great potential, and we are very excited about that because it’s now going to give us insights into and more information about the health care process. Concurrently, however, people need to start thinking about the importance and relevance of those data. FDA looks forward to more research into the process and utility of incorporating wearable-collected data into the health care stream. That includes the interoperability of medical devices. This kind of research is going to be very important not just from an FDA safety perspective but also from a health care perspective because (these new technologies) have the potential to bring the whole ecosystem of health care to a better place and change the paradigm of how we look at the 6) ___ body.

 

Exposure to electromagnetic (EM) radiation has been in and out of the news for decades, as concerns – justified or not – about microwave ovens, then cell phones, and now wearable devices have been aired. When it comes to wearable devices, most scientists, engineers, and health care agencies take the stance that they emit such low levels of EM radiation (typically two orders of magnitude less than a cell phone) that they pose no health risks at all. Some, however, still harbor a cautionary view. “Compared to the medical accuracy issues and the driver safety issues, why worry about a hypothetical risk from some tiny exposures?“ Foster asks. “My smart watch has a low-power Bluetooth transmitter. It’s inconceivable to me that these tiny, 2-milliwatt Bluetooth transmitters are going to cause any exposure problems, particularly when they transmit a small fraction of the time. And besides, everyone in the world is now using cell phones, which may transmit at levels 100 times higher, so the issue of radio-frequency (RF) exposure from relatively much weaker devices is moot.“

 

Editor’s note: There should be a study that calculates how many devices exist in a given area, like a town or a city. Then another calculation of the amount of RF energies and EM exposures in each area and the effect on all the humans living in that radius. There should be a long term view on this topic, otherwise, we’ll end up with another catastrophic man-made error, like those that have given us Global Climate Change, with all of its ramifications.

 

People have been looking for hazards associated with RF energies since World War II, when people were worried about RF exposure from military communications systems. Later, they were worried about radiation from cell phones. All along, major health agencies have done comprehensive reviews of the literature and written 1,000-page reviews of thousands of articles and other reviews, and they all say the same thing: they don’t see any clear sign of a problem aside from too much heating, which is already regulated by the FCC.“ It is true that heat is the only universally adopted guideline in health-related exposure regulation, but engineers and researchers should do everything they can to limit EM exposure beyond the mandated limits, says Gert Cauwenberghs, a professor of bioengineering at the University of San Diego Jacobs School of Engineering, codirector of the university’s Institute for Neural Computation, and cofounder and chair of the scientific advisory board for San Diego-based Cognionics, Inc., which is developing wearable technology. “There are studies that have clearly shown other effects of EM fields (EMFs) on body activity,“ Cauwenberghs says. “And if you think about it, this makes perfect sense because radiation doesn’t just get absorbed as heat. Absorption can also have a clear effect on transitions between energy states of 7) ___, such as proteins and DNA, and those transitions could have some life-impacting effects.“ Such transitions can occur even at very low intensities, he asserts, so wearable technologies should be scrutinized. EM radiation can also affect cells from an electrical perspective, Cauwenberghs says, noting that small variations in electrical fields can disrupt the firing of neurons in the brain. “Just a few millivolts of radiation-induced local field potentials are enough to change the activity of neurons,“ he says, adding that EM devices producing intermodulation interference in the 4- to 13-Hz range can directly impact 8) ___ waves. Cauwenberghs readily admits that evidence linking low-level EM radiation and health dangers is less than definitive. “There have been some studies suggesting biological effects of low EM exposure, and not all studies have been rigorously performed – as occurs in every field of study – so there is controversy. However, there are studies that have established some clear effects, and they should be taken seriously,“ he remarks. He points to the Bioinitiative report, which was written by proponents of lowering EM exposure and includes references to some of these studies. “As engineers and scientists, we have to separate the science from the advocacy in this report,“ he says, but he also notes that a number of scientists, particularly from Europe, participated in the report and asserts it has scientific merit. To shed more light on the biological effects of low EM exposure, more research is needed, Cauwenberghs says. That includes theory-guided experiments to understand the bioelectrical mechanisms at play, especially in relation to brain waves.

 

Regardless of the debate about whether the radiation emitted by wearable sensors and other smart technologies could cause health problems, Cauwenberghs believes engineers and researchers should continually strive to reduce the levels of EM radiation emission and to develop the lowest-powered devices possible. “As engineers, we’re starting to really look into energy efficiency of many systems, but it is slow moving. Even so-called Bluetooth low-energy isn’t what the name implies. What we need is much more energy-efficient technology, and there is still a lot of work that can be done to really improve these wireless systems,“ he says. He describes the typical metric used to measure wireless systems as the energy required to send 1 bit of information a certain distance, and the energy to transmit is proportional to the distance squared. “The best that can be done today is in the lower to upper femtojoule range per bit transmitted over 1 m distance,“ Cauwenberghs says. “If circuit designers can really go after this metric in the same way that processor circuit designers have gone after the femtojoule per multiplier accumulator unit?a measure of how much work a computer does?we can really make some progress and reduce the radiation emitted as well as the footprint of wireless radiation on the environment, which is another important consideration.“ Minimizing the power consumption of wearable devices is desirable, but the primary reason to do so is to prolong battery life. The limit on radiated power depends both on how far the device has to throw a signal to be useful, and the rate at which data must be transmitted. A lot of engineering effort has already been invested in minimizing 9) ___ consumption for the kinds of Bluetooth interfaces that wearable devices typically use, but there is undoubtedly room for further improvement. Irrespective of the reason for the drive to generate low EM and power in smart devices, there will be a push sooner or later to make wearables more efficient, and electrical engineers are able to make a real difference.

 

Additional work to make technology more efficient will likely always be a goal, but, at this point, studies into health risks of low EM wearable devices simply aren’t necessary, in comparison to studies addressing health concerns about the use of mobile phones and other higher-powered equipment. In an article coauthored with engineer and philanthropist Lorne Trottier, Foster describes the Bioinitiative report as “an egregiously slanted review of health and biological effects of EMFs“ that disregards the fact that, as Foster and Trottier wrote, “the overwhelming majority of scientists see no good evidence for health effects“ at levels below international exposure guidelines, which are similar to FCC safety limits. Because of public concern about cell phone radiation, there have been many studies looking at the effects of cell phone RF signals that are in roughly the same frequency range as Bluetooth and Wi-Fi, and there’s been no clear evidence of any problem,“ Foster says. Since smart devices have transmitters some 100 times less powerful than cell phones, he remarks, “Health agencies say that there are scientific issues regarding RF energy that need to be clarified, in particular the weak connection that has been reported between heavy use of cell phones and brain 10) ___. However, it is ludicrous to worry about possible health risks from the tiny RF exposures from wearables when you read your e-mail on your smart watch while driving.“ (Editor’s note: We hope he meant, in a driverless car!)

 

As wearable technologies become increasingly popular and begin to make their way into everything from watches to clothing, an increasingly higher percentage of the world’s population will have at least one device -and probably multiple devices – somewhere on their bodies. This presents enormous opportunities and challenges for engineers and other researchers to study the ways people use them, evaluate how their data is or isn’t integrated into medicine, and, ultimately, create the best and safest devices that do the most to improve health care.

 

Sources:

1. U. S. Food and Drug Administration. (2015, Feb. 9). Mobile medical applications guidance for industry and Food and Drug Administration staff. [Online].

2. K. R. Foster, “Biological effects of radiofrequency energy as related to health and safety,“ to be published.

3.  K. R. Foster and L. Trottier. (2013, Feb. 15). Picking cherries in science: The Bioinitiative report, science based medicine.[Online].

4. Pulse.embs.org/january-2016/by Leslie Mertz

5. Wikipedia

6. ScienceDaily.com

 

ANSWERS: 1) devices; 2) blood; 3) radiation; 4) weight; 5) health; 6) human; 7) molecules; 8) brain; 9) power; 10) cancer

 

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Life, Liberty and the Pursuit of Happiness is Good for Your Health

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By Machine Elf 1735 – Public Domain: Commons.Wikimedia.org

 

 

In 2005 a study conducted by Andrew Steptow and Michael Marmot at University College London, found that happiness is related to biological markers that play an important role in health. The researchers aimed to analyze whether there was any association between well-being and three biological markers: heart rate, cortisol levels, and plasma fibrinogen levels. Interestingly, the participants who rated themselves the least happy had cortisol levels that were 48% higher than those who rated themselves as the most happy. The least happy subjects also had a large plasma fibrinogen response to two stress-inducing tasks: the Stroop test, and tracing a star seen in a mirror image. Repeating their studies three years later Steptow and Marmot found that participants who scored high in positive emotion continued to have lower levels of cortisol and fibrinogen, as well as a lower heart rate. In Happy People Live Longer (2011), Bruno Frey reported that happy people live 14% longer, increasing longevity 7.5 to 10 years and Richard Davidson’s bestseller (2012) The Emotional Life of Your Brain argues that positive emotion and happiness benefit long-term health. Consistent results are that “apart from good health, happy people were more likely to be older, not smoke, have fewer educational qualifications, do strenuous exercise, live with a partner, do religious or group activities and sleep for eight hours a night.“ Happiness does however seem to have a protective impact on immunity. The tendency to experience positive emotions was associated with greater resistance to colds and flu in interventional studies irrespective of other factors such as smoking, drinking, exercise, and sleep.

 

“Life, Liberty and the pursuit of Happiness“ is a well-known phrase in the United States Declaration of Independence. The phrase gives three examples of the “unalienable rights“ which the Declaration says have been given to all human beings by their Creator, and which governments are created to protect. The United States Declaration of Independence was drafted by Thomas Jefferson, and then edited by the Committee of Five, which consisted of Jefferson, John Adams, Benjamin Franklin, Roger Sherman, and Robert Livingston. It was then further edited and adopted by the Committee of the Whole of the Second Continental Congress on July 4, 1776. The second section of text in the Declaration contains the phrase “Life, Liberty and the pursuit of Happiness“.

 

We hold these truths to be sacred & undeniable; that all men are created equal & independent, that from that equal creation they derive rights inherent & inalienable, among which are the preservation of life, & liberty, & the pursuit of happiness;

 

A number of possible sources or inspirations for Jefferson’s use of the phrase in the Declaration of Independence have been identified, although scholars debate the extent to which any one of them actually influenced Jefferson. Jefferson (1743-1826) declared himself an Epicurean during his lifetime: this is a philosophical doctrine that teaches the pursuit of happiness and proposes autarchy, which translates as self-rule, self-sufficiency or freedom. The greatest disagreement comes between those who suggest the phrase was drawn from John Locke (1632-1704) and those who identify some other source.

 

Editor’s note: After reading about Epicurus (341-270 BCE) and John Locke, and knowing that Jefferson, an avid reader, would have read both philosophies in depth, we feel that he was greatly influenced by both. We are impressed with how long the concept of happiness, has taken to become rooted in human consciousness; and eventually understood to be a human value, that makes life worth living. Achieving a state of happiness, not necessarily constant, requires equal opportunities for all and brings about sustained global peace. Retracing: the concept of happiness was first written about in approximately 290 BCE. This brilliant idea was revived during the Age of Reason in Europe and the Age of Enlightenment in America. Finally, the concept of happiness rose from a philosophy of a few to a political understanding of more, when it became incorporated in the American Constitution, in 1776. In the 21st Century, this idea finally, reached global status when the United Nations, in 2013, declared March 20 as the International Day of Happiness as a way to recognize the importance of happiness in the lives of people around the world. Look how long it’s taken for humans to pass this concept onto a planetary level to be taken seriously; approximately 2,316 years.  Often misunderstood as soft, pursuit of happiness is a value, so serious, it will enable humans around the world to work together on important issues and to reach much needed solutions.

 

John Locke

In 1689, Locke argued in his Two Treatises of Government that political society existed for the sake of protecting “property“, which he defined as a person’s “life, liberty, and estate“. In “A Letter Concerning Toleration,“ he wrote that the magistrate’s power was limited to preserving a person’s “civil interest“, which he described as “life, liberty, health, and indolency of body (absence of pain); and the possession of outward things“. He declared in his Essay Concerning Human Understanding that “the highest perfection of intellectual nature lies in a careful and constant pursuit of true and solid happiness“. According to those scholars who saw the root of Jefferson’s thought in Locke’s doctrine, Jefferson replaced “estate“ with “the pursuit of happiness“, although this does not mean that Jefferson meant the “pursuit of happiness“ to refer primarily or exclusively to property. Under such an assumption, the Declaration of Independence would declare that government existed primarily for the reasons Locke gave, and some have extended that line of thinking to support a conception of limited government. Benjamin Franklin was in agreement with Thomas Jefferson in downplaying protection of “property“ as a goal of government. It is noted that Franklin found property to be a “creature of society“ and thus, he believed that it should be taxed as a way to finance civil society. If, in reality, “courage and a heart devoted to the good of mankind are the constituents of human felicity, the kindness which is done infers a happiness in the person from whom it proceeds, not in him on whom it is bestowed; and the greatest good which men possessed of fortitude and generosity can procure to their fellow creatures is a participation of this happy character. If this be the good of the individual, it is likewise that of mankind; and virtue no longer imposes a task by which we are obliged to bestow upon others that good from which we ourselves refrain; but supposes, in the highest degree, as possessed by ourselves, that state of felicity which we are required to promote in the world.“

 

The 17th-century was an enlightened period of history in which some philosophers began promoting that the well-being of our fellow humans is essential to the “pursuit of our own happiness“. William Wollaston’s The Religion of Nature Delineated describes the “truest definition“ of “natural religion“ as being “The pursuit of happiness by the practice of reason and truth“. An English translation of Jean-Jacques Burlamaqui’s Principles of Natural and Politic Law prepared in 1763 extolled the “noble pursuit“ of “true and solid happiness“ in the opening chapter discussing natural rights. Comparable mottos worldwide include “liberte, egalite, fraternite“ (liberty, equality, fraternity) in France; “Einigkeit und Recht und Freiheit“ (unity, justice and liberty) in Germany and “peace, order, and good government“ in Canada. It is also similar to a line in the Canadian Charter of Rights: “life, liberty, security of the person“ (this line was also in the older Canadian Bill of rights, which added “enjoyment of property“ to the list). The phrase can also be found in Chapter III, Article 13 of the 1947 Constitution of Japan, and in President Ho Chi Minh’s 1945 declaration of independence of the Democratic Republic of Vietnam. An alternative phrase “life, liberty, and property“, is found in the Declaration of Colonial Rights, a resolution of the First Continental Congress. The Fifth Amendment and Fourteenth Amendment to the United States Constitution declare that governments cannot deprive any person of “life, liberty, or property“ without due process of law. Also, Article 3 of the Universal Declaration of Human Rights reads, “Everyone has the right to life, liberty, and security of person“.

 

The World Happiness Report is a landmark survey of the state of global happiness. The first report was published in 2012, the second in 2013, and the third in 2015. The World Happiness Report 2016 Update, which ranks 156 countries by their happiness levels, was released in Rome in advance of UN World Happiness Day, March 20th, 2016. Leading experts across fields of economics, psychology, survey analysis, national statistics, health, public policy and more, describe how measurements of well-being can be used effectively to assess the progress of nations. The reports reviews the state of happiness in the world today and shows how the new science of happiness explains personal and national variations in happiness. This report with its, Happiness Index, reflects a new worldwide demand for more attention to happiness as a criteria for government policy. The widespread interest in the World Happiness Reports, of which this is the fourth, reflects growing global interest in using happiness and subjective well-being, as primary indicators of the quality of human development. Because of this growing interest, many governments, communities and organizations are using happiness data, and the results of subjective well-being research, to enable policies that support better lives.

 

This year, for the first time, the World Happiness Report gives a special role to the measurement and consequences of inequality in the distribution of well-being among countries and regions. In previous reports the editors have argued that happiness provides a better indicator of human welfare than do income, poverty, education, health and good government measured separately. In a parallel way, they now argue that the inequality of well-being provides a broader measure of inequality. They find that people are happier living in societies where there is less inequality of happiness. They also find that happiness inequality has increased significantly (comparing 2012-2015 to 2005-2011) in most countries, in almost all global regions, and for the population of the world as a whole. The year 2015 was a watershed for humanity, with the adoption of Sustainable Development Goals (SDGs) by heads of state at a special summit at the United Nations in September 2015. Many countries in recent years have achieved economic growth at the cost of sharply rising inequality, entrenched social exclusion, and grave damage to the natural environment. The SDGs are designed to help countries to achieve a more balanced approach, leading to higher levels of well-being for the present and future generations.

 

Editor’s note: You can be sure that it was stunning to hear, last week, on Bloomberg radio, a discussion about GDP, capitalism, profit, and definitions of American and world values, and the illuminating suggestion that along with all other values, we should add happiness as a highly important bottom line. Along with GDP, reporters are now adding GHP. It’s been a long journey, from 290 BC to 2016, the concept of happiness has traveled from ancient Greece to Bloomberg radio. Time to celebrate!

 

World Happiness Index’s official site.

 

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Depression in Early Pregnancy Linked to Gestational Diabetes

 

Gestational diabetes is a form of diabetes (high blood sugar level) occurring only in pregnancy, which if untreated may cause serious health problems for mother and infant. According to a study published online in Diabetologia (19 September 2016), a two-way link has been identified between depression and gestational diabetes.

 

The authors analyzed pregnancy records from the NICHD Fetal Growth Studies-Singleton Cohort, which tracked the progress of thousands of pregnancies, to understand the patterns of fetal growth. The study enrolled 2,334 non-obese and 468 obese women in weeks eight to 13 of pregnancy. The women responded to questionnaires on symptoms of depression when they enrolled in the study, again between the 16th and 22nd week of pregnancy, and then six weeks after giving birth. The authors also reviewed the women’s records to identify who had developed gestational diabetes.

 

According to an analysis of pregnancy records, women who reported feeling depressed during the first two trimesters of pregnancy were nearly twice as likely to develop gestational diabetes. Persistent depression from the first to second trimester set women at even greater risk for gestational diabetes, and that women who had the highest scores for depression in the first and second trimesters, about 17%, had nearly triple the risk for gestational diabetes when compared to women who had lower depression scores. Conversely, a separate analysis found that women who developed gestational diabetes were more likely to report postpartum depression six weeks after giving birth, compared to a similar group of women who did not develop gestational diabetes. Although obesity is known to increase the risk for gestational diabetes, interestingly, the likelihood of gestational diabetes was higher for non-obese women reporting depression than for obese women with depression. In fact, depression did not appear to increase the risk for gestational diabetes among obese women. In contrast, non-obese women with high depression scores had nearly triple the risk for gestational diabetes than the other women in the study. The authors added that the results suggest it would be a good idea for clinicians to pay particular attention to women with high depression scores when evaluating the risk of gestational diabetes. The authors also found a higher risk for postpartum depression among the women who had gestational diabetes. Of the women who developed gestational diabetes, nearly 15% experienced depressive symptoms after birth, which was more than four times that of women who had not had gestational diabetes.

 

Currently, the American College of Obstetricians and Gynecologists recommends that physicians screen patients at least once for depression during the perinatal period (22 weeks of pregnancy through 7 days after birth.)

 

The authors stressed that the study was not able to prove a cause and effect relationship between symptoms of depression and gestational diabetes, but noted that earlier studies have shown that depression is associated with impaired glucose metabolism that may lead to higher blood sugar levels. Similarly, high blood sugar levels may lead to inflammation, hormonal, and other changes that could lead to symptoms of depression.

 

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Statins Are Associated With Reduced Mortality in Multiple Myeloma

 

The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) have activity in one of the pathways influenced by nitrogen-containing bisphosphonates, which are associated with improved survival in multiple myeloma (MM). As a result, a study published online in the Journal of Clinical Oncology (19 September 2016) was performed to evaluate the association between statin use and mortality in a large cohort of patients with MM.

 

For the study, patients were identified from the Veterans Administration Central Cancer Registry who were diagnosed with MM between 1999 and 2013. The authors defined statin use as the presence of any prescription for a statin within 3 months before or any time after MM diagnosis. The authors identified a cohort of 4,957 patients, of whom 2,294 received statin therapy. Results showed that statin use was associated with a 21% decrease in all-cause mortality (P < .001) as well as a 24% decrease in MM-specific mortality (P < .001). This association remained significant across all sensitivity analyses. In addition to reductions in mortality, statin use was associated with a 31% decreased risk of developing a skeletal-related event.

 

The authors stated that the findings suggest a potential role for statin therapy in patients with MM and that the putative benefit of statin therapy in MM should be corroborated in prospective studies.

 

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Ilaris Approved for Expanded Indications in 3 Rare Diseases

 

Editor’s Note: Target Health Inc. is very active in the rare/orphan disease area with FDA marketing approvals in Gaucher disease and Cystic Fibrosis. Dr. Jules Mitchel, President of Target Health Inc. will be participating in a panel at the NORD meeting in Washington October 17-18, 2016

 

The FDA has approved Ilaris (canakinumab) for 3 new indications for the following rare and serious auto-inflammatory diseases in adult and pediatric patients:

 

Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS);

Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); and

Familial Mediterranean Fever (FMF).

 

All three syndromes are hereditary diseases that are characterized by periodic attacks of fever and inflammation, as well as severe muscle pain. There are no previously approved therapies for TRAPS or HIDS/MKD.

 

Ilaris was previously approved for another periodic fever syndrome called Cryopyrin-Associated Periodic Syndromes (CAPS) and for active systemic juvenile idiopathic arthritis. Approvals for the new indications were based on clinical studies, including safety, efficacy and pharmacokinetic data. The most common adverse reactions for these indications are injection site reactions and being more susceptible to catching colds.

 

Ilaris can cause serious side effects, including increased risk of serious infections as iIlaris can lower the immune system’s ability to fight infections. Other serious side effects include decreased ability to fight infections (immunosuppression) and allergic reactions. Patients experiencing any symptoms of an allergic reaction should call their healthcare provider, including: rash, itching and hives, difficulty breathing or swallowing, and dizziness or feeling faint. Patients should not get live vaccines if receiving Ilaris. Patients should not receive Ilaris if they are allergic to canakinumab or any of the ingredients in Ilaris.

 

Ilaris is manufactured and distributed by Novartis Pharmaceuticals Corporation, of East Hanover, New Jersey.

 

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