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I’m delighted to announce a new featured event: DPharm & Mobile in Clinical Trials Conference: 7th Annual , which is taking place Sept 6-8 in Boston, MA. Organized by the Conference Forum, DPharm is the premier event focusing on disruptive digital and mobile innovations in clinical research. Keynote speakers include leaders from Pfizer, Janssen, and Duke Research. Digital Health group members receive a 10% discount by using code PSL when registering on the conference website.
A new bill in the California State Assembly would require Medi-Cal to cover continuous glucose monitors. Patients without these devices are much more likely to experience complications of diabetes like stroke, kidney disease, amputations, and blindness. If passed into law, the bill would enable better healthcare for tens of thousands of diabetics (many of whom are senior citizens, low-income, and/or disabled). It would also help to lower healthcare costs, which are more than two times higher for people with diabetes. California taxpayers already cover 75% of all hospital costs for patients with diabetes.
According to two separatereports published in JAMA, many drugs and most high-risk medical devices that have been granted accelerated approval by the FDA lack clear evidence of safety and effectiveness. Accelerated approval makes potentially promising investigational medicines and devices available for use before all the typical data has been provided confirming safety and effectiveness.
Regarding drugs granted accelerated approval, Dr. Huseyin Naci of the London School of Economics and Political Science states that “We have found numerous situations in which required confirmatory studies with rigorous designs and outcomes are not pursued or are not completed in a timely fashion, and in these cases, we are concerned that regulators appear to accept data that would not otherwise meet FDA standards.”
And for high-risk medical devices, Dr. Rita Redberg at UCSF says that “We were surprised to discover that relatively few studies were randomized or blinded, which means that it is not known if the device was better than an alternative treatment (or better than no treatment), and whether any purported beneficial effect was actually due to the well-documented placebo effect of procedures and devices. I think the public assumes that medical devices currently on the market, particularly high-risk devices, have been approved based on a high standard to show safety and effectiveness before doctors can recommend and implant them. Our findings show that this assumption is often incorrect.”
Apple has been granted a patent for using the front camera and other smartphone sensors (e.g. light and proximity), to monitor a user’s emotional state, blood pressure, and body fat, plus potentially perform electrocardiogram (ECG) readings, monitor breathing, and even detect circulatory conditions.
A patent has been granted to Global Kinetics Corp for their wearable-based system that objectively measures symptoms of Parkinson’s Disease. The application pertains to Bradykinesia, or slowness of movement, which is one of the most common symptoms and a defining feature of Parkinson’s disease. The capacity to continuously measure this movement symptom underpins the company’s Personal KinetiGraph system.
LIVING AND SOCIETY
Startup ‘Function of Beauty’ is using an online questionnaire to customize shampoo and conditioner hair products. The process begins with customers filling out an online quiz that includes information regarding their hair profile, hair goals, color, and scent preferences. They then receive personalized products in the mail. The video by Business Insider is pretty funny. This is not a product I need myself. 😉
A survey report “Trends in Consumer Mobility “, by Bank of America and Convergys contains interesting digital health items. The report explores “timely mobile trends and forward-looking consumer behaviors that increasingly impact our everyday lives. The latest iteration includes the youngest generation – Generation Z – to better understand the future of mobile and the next era of banking.”
The ‘cop button’ feature in Apple’s new iOS 11 smartphone operating system has the added benefit of helping users with a Medical ID protect their data if they are unconscious. In the event that bystanders or emergency personnel assisting someone in distress access the Medical ID on their iPhone, the system will then block the phone-unlock feature that uses the phone owner’s fingerprint placed on the Touch ID sensor.
RESEARCH AND INNOVATION
Illustrating yet again that truth can be stranger than fiction, scientists have hacked into a mouse brain and were subsequently able to remotely control the animal’s body movements. Physics professor Arnd Pralle, PhD, of the University at Buffalo College of Arts and Sciences used a technique called magneto-thermal stimulation, which entails implanting DNA strands and nanoparticles that attach to specific neurons in the brain. This allows the brain to be remotely controlled with an alternating magnetic field that heats up the particles and causes the neurons to fire.
In a study comparing the accuracy of GPS monitors and smartphone apps to measure physical activity, investigators have concluded that there is evidence for the validity of GPS-based physical activity monitors and smartphone applications for measuring distance traveled while walking and running. The authors noted that the Runkeeper app stood out in terms of acceptable error. However, they point to the limits of these tools in monitoring energy balance and for use as weight management tools.
In a Digital Biomarkers interview of Dr. William Marks, Jr., Head of Clinical Neurology at Verily Life Sciences, Dr. Marks describes the use of the Verily Study Watch, an investigational device developed by the company for medical research that unobtrusively collects physiological and environmental data from individuals over long periods. As Dr. Marks explains, “data from these types of devices could go a long way to establishing outcomes for studies that have more relevance to patients, rather than some of the subjective approaches that we currently use to categorize whether somebody’s responding to a treatment or not. For Parkinson’s, in particular, we have a real unmet need that we can now begin to fill with the advent of these technological advances.”
M&A AND FUNDING
Phil, Inc. has received $10M in Series A funding to be used for its planned national expansion. The startup provides an end-to-end prescription management and delivery service that connects patients with local pharmacies and aims to solve the problem of drug adherence.
Google’s Verily unit has acquired Senosis Health, maker of a suite of medical condition monitoring and measurement apps that rely upon a smartphone and its sensors. The startup’s apps focus on measuring and monitoring newborn jaundice (camera), blood hemoglobin (camera), lung function (microphone), and bone strength (accelerometers).
Doctors at Nationwide Children’s Hospital in Columbus, Ohio, along with the backing of Sarepta Therapeutics and Parent Project Muscular Dystrophy, are planning to use gene therapy to treat boys with muscular dystrophy (MD), a muscle-wasting disease caused by mutations in the dystrophin gene. MD affects one in a few thousand boys, results in most teenage boys being unable to walk, and often leads to death once they reach their 20s. There are very few treatment options, so doctors hope that the so-called ‘mini-gene’ therapy will result in only a mild handicap.
An Australian bodybuilder has died as a result of drinking too many protein shakes while not knowing she had a genetic condition called urea cycle disorder, which prevents the body from breaking down protein in a normal manner. While the article doesn’t mention it, I discovered that GeneDx appears to offer a test for this genetic condition and there may be other companies offering it as well. It bears noting that there are other, non-DNA testing methods for identifying this condition.
The Apple Watch — which affords an important wearable digital health platform at consumer scale (read as “population health”) — is set to achieve even larger unit sales growth. While not reported publicly, sources in the Apple Watch supply chain are indicating that total sales this year may reach 15 million units and increase 33% next year, achieving 20 million units for all of 2018 . The third-generation Watch, which will have LTE cellular connectivity built in (untethering it from reliance upon the iPhone’s Internet connection) is expected to launch in Sept. Cumulative lifetime sales are reportedly around 30 million units since its introduction in April of 2015, and may hit 50 million by 2019.
Tom Gruber, the co-creator of Apple’s Siri personal assistant, presented a powerful TED Talk on the value of ‘humanistic-AI’.
Tom illustrates his point through poignant examples of current and emerging AI applications providing utility in the areas of human enablement, the practice of medicine, improving our social lives, and enhancing our memory. Basically, his whole talk is a feature on the AI component of Digital Health.
LIVING AND SOCIETY
Due in large part to the digital revolution —aka the information age — we now receive five times as much information every day as we did in 1986. Studies have demonstrated that your brain is not designed to be alert and stimulated for a majority of the day and can only focus for 90-120 minutes at a time. And t he faster your brain moves the more time off you may need. Consequently, it’s important to incorporate brain breaks within your day.
New guidance in the UK would result in online hate crimes being treated as seriously as abuse committed face-to-face. The revised guidance includes offences against bisexual people for the first time. According to Director of Public Prosecutions Alison Saunders, online abuse can fuel dangerous hostility and a hate crime is an offense motivated by a hostility or prejudice, including racism, sexism, or homophobia.
The Facebook Safety Check feature will now have a dedicated section on the Facebook app and website. You will be able to see when your friends use Safety Check plus learn about incidents happening around the world. The companion Community Help feature, which allows users to provide assistance, will also display which of your friends are contributing.
If you Google “depression” on your smartphone, the search engine will now present you with a link to a questionnaire to help you identify your symptoms and ascertain whether or not you should seek professional help. It would be great if the search giant went a step further and integrated this with online, telephone, or text-based mental health services.
On Friday, President Trump signed the Medical Device User Fee Agreement (MDFUA) reauthorization bill, which officially funds the new digital health unit within the FDA’s Center for Devices and Radiological Health (CDRH). Under the MDFUA user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency as well as whenever they submit an application or a notification to market a new medical device in the United States.
Scientists from Daegu Gyeongbuk Institute of Science and Technology (DGIST) and Northwestern University have developed a new electronic skin that uses a web of springy coils that improve flexibility for wearable applications. The design will also allow for more compact devices that can track heart rate, respiration, muscle movement and wirelessly transmit the data to a smartphone.
In a case of a real-life Iron Man suit (hyperbole alert!), Amazon’s Alexa can now steer exoskeletons. Startup Bionik Laboratories is enabling people with spinal injuries to control the company’s Arke lower-body exoskeleton using their voice. The support exoskeleton is also intended to assist people with stroke and traumatic brain injuries.
Researchers from Stanford have developed a method of protecting genetic privacy by encrypting`DNA with a cryptographic “genome cloaking” method, which may help to overcome the scientifically self-defeating means of stripping the DNA data of all identifying details. The cloaking is accomplished by converting genome variations into linear values. Once this is done, analyses can still be performed on just the genes that are revealed and are pertinent to the investigation at hand.
A bill passed the Senate and House last week that would expand the use of Rapid DNA Analysis to analyze DNA samples in 90 minutes, versus several days. Citing one law enforcement example, former FBI Director James Comey said that this allows for booking stations around the country, if someone is arrested, to know instantly — or near instantly — whether they have detained the criminal in question before releasing them on bail. It can also show if they’re not the person suspected of the crime.
CNS Summit 2017
Nov 16-19 in Boca Raton, FL
Digital Health World Congress 2017 (Winter Edition)
Nov 29-30 in London, UK,
XPOMET Convention 2018
March 21-23 in Leipzig, Germany
Copyright © 2017 Paul Sonnier
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