The Digital Health Newsletter by Paul Sonnier
July 27, 2017
New featured event: CNS Summit 2017!
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Today the U.S. FDA announced its " Digital Health Innovation Action Plan" and the launch of its " Software Precertification (PreCert) Pilot Program". According to the FDA: "Digital health technology has become a new health care revolution that empowers consumers to make better-informed decisions about their health. At the FDA, we recognize this revolution and are reimagining our oversight of digital health technology to help provide patients with timely access to high-quality, safe, and effective digital health products. We’ve provided details and timelines for our digital health efforts in our Digital Health Innovation Action Plan, and one important piece of this plan is a new pilot program for software developers." The FDA is hosting a webinar (Aug 1 at 1pm EST) to provide industry with the opportunity to discuss and answer questions about the PreCert program.

In an exclusive, MIT Technology Review reports that the  first known attempt at creating genetically modified human embryos has occurred in the United States. A team of researchers led by Oregon Health and Science University's Shoukhrat Mitalipov used the CRISPR gene-editing technique to change the DNA of a large number of one-cell embryos. Known as “germline engineering”, this method can correct or eliminate genes that cause inherited disease. It also means that a genetically modified child can pass any gene changes on to subsequent generations via their own egg and sperm germ cells.
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"Digital health is the convergence of the digital and genomic revolutions with health, healthcare, living, and society." - Paul Sonnier

In other big CRISPR-related news, see the challenge to the USPTO's decision on relevant patents in the GENOMICS section below.
Following months of speculation on whether it would find a buyer,  WebMD has agreed to a $2.8B buyout by KKR. WebMD has been a public company for 12 years and has about 75 million users per month. Private equity firm KKR will also acquire a majority stake in nutritional supplements maker Nature's Bounty, adding both companies to its portfolio of health-related investments, which also includes Air Medical Group Holdings and Arbor Pharmaceuticals.
US-based startup Hinge Health has raised $8 million in Series A funding. The company is focused on alleviating chronic pain due to musculoskeletal disorders in hopes of intervening before surgery or painkillers are prescribed. The company supplies patients with health kits comprised of wearable tech and a tablet with its software. 
Belfast-based biometric authentication tech company B-Secur has raised £3.5m from two investment funds. The startup has developed biometric technology that authenticates a user's identity using their heart beat's electrocardiogram (ECG).
New York-based startup Maven has raised $10.8M in Series A funding. The company is working to transform women's health and is also working with companies to deliver improved maternity and family benefits for working parents.
Gurugram-based startup 1mg has landed $15M to continue growing its medicine database that provides information on drug side effects and the best alternatives. The startup's platform also offers telehealth doctor consultations, lab tests/diagnostics, diabetes care products as well as Ayurveda and homeopathy products..
A restaurant in Chicago's Conrad Hotel has partnered with Macallan, maker of the famous single malt Scotch whisky, to deliver a $95 virtual reality scotch cocktail using the Oculus headset. While staffers explain the distilling process, guests are virtually transported to Macallan’s distillery in Moray, Scotland. Oddly, customers apparently only get to smell the drink being mixed during the VR journey and get to drink it after their session is over.
The "Objective Zero" app connects military veterans in crisis with other veterans who are willing to talk. Veterans in distress can use the app for voice, video, or text, and broadcast a “distress signal” to other veterans who have volunteered to be ambassadors. The VA’s mental health services and resource info are also available in the app. Interestingly, the Headspace meditation and mindfulness app is offering its $150 services free-of-charge to veterans registered using Objective Zero. Also, Comeback Yoga, which focuses on relieving PTSD, is providing free videos in the app.
Comedian JP Sears posted a hilarious video in response to the American Heart Association's recent “presidential advisory”  declaring that coconut oil causes heart disease. In addition to Sears, others like Nina Teicholz, who penned an op-ed in the LA Times " Don't believe the American Heart Assn. — butter, steak and coconut oil aren't likely to kill you", feel that the "evidence shows that when it comes to heart attacks or mortality, saturated fats are not guilty."
It's great to see the pharmaceutical industry's growing focus on digital health. But ironically, GSK's new Chief Digital & Technology Officer doesn't seem to be on Twitter. This is a general observation about pharma, more than anything, as I see it as emblematic of their inward-looking approach to leveraging digital. My point being that understanding technology and consumers entails using and engaging on digital platforms in order to better identify opportunities of all types. 
In a new technology partnership, Apple and Cochlear have enabled iPhone, iPad, and iPod audio streaming to implanted hearing devices which are specifically made for use with the iPhone. The implant, which was approved by the U.S. Food and Drug Administration in June, contains a processor that's controlled by the phone itself and does not require an app to be downloaded from the iTunes app store. The system also allows users to control and customize the sound from their Apple devices. 
Researchers at Microsoft and the University of Washington are working on creating super fast computations using DNA molecules as processors. The method used involves organizing DNA molecules in intervals on a DNA origami surface. This approach offers a way of creating DNA logic gates including the interconnects between them.
Helix has finally launched their DNA app store. The $100M startup will sequence your exome ( 20,000 genes plus some other "bits") for $80 and serve as a platform for third-party app developers (including hospitals, like Mayo Clinic and Mount Sinai Health System) to sell you access and information related to it. The platform, allows for the mixing of consumer tests (e.g. lifestyle, nutrition, and wellness tests, which can have " little or no scientific backing"), and " medically serious" tests, like genetic disease carrier status. The risk of this "fuzzy line" between the two, according to Daniel MacArthur, a human genomicist at the Broad Institute and Massachusetts General Hospital, is that it may inflate customer expectations and undermine consumer confidence in "genuinely clinically useful genetic tests.”
The California University System, the University of Vienna, and Dr. Emmanuelle Charpentier have filed an appellate brief seeking reversal of the U.S. Patent Board's decision on CRISPR/Cas9 gene editing
The group claims that the PTAB's determination in Feb that the UC's patent claims did not make the Broad's patent claims obvious is based on a "misapplication of controlling legal standards established by U.S. Supreme Court and Federal Circuit precedent," and "in its decision, the PTAB had concluded that UC's claims covering CRISPR/Cas9 single guide gene editing technology and its application in any cellular or non-cellular setting did not make obvious Broad's claims covering application of the same technology limited to use in eukaryotic cellular settings."

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