Ned Anderson: The Digital Health Update by Paul Sonnier ⋅ Dec 11, 2017 ⋅ #304

I made this announcement to 59,968 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. I also send out my Digital Health Newsletter, which you can sign up for and receive for free, here.

The Digital Health Update by Paul Sonnier ⋅ Dec 11, 2017 ⋅ #304

Dear Group,

I was interviewed by Phil Howard on his Telecom Radio One show. The recording is available here.

I’ve published one issue of my newsletter since last week’s group announcement, which you can read below and via the following link: The Digital Health Newsletter for Dec 8, 2017

Also, please note that I’m available to deliver my keynote address at conferences and corporate events. You can also advertise in my group announcements, newsletter, and on my website. My professional bio is viewable here and my full list of services is viewable here. I can be contacted via my LinkedIn profile.

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The Digital Health Newsletter for Dec 8, 2017

I was interviewed by Phil Howard on his Telecom Radio One show. The recording is available here. Also, the Digital Health LinkedIn group is less than 100 members away from 60,000 total. The 60,000th member will receive a free copy of my book.

The FDA has released three new digital health guidance documents: Software as a Medical Device: Clinical Evaluation; Clinical & Patient Decision Support Software; and Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. The agency posted these on its Guidances with Digital Health Content web page. FDA associate director of digital health Bakul Patel (@_bakulpatel) also tweeted a link to a statement from FDA Commissioner Scott Gottlieb (@SGottliebFDA) regarding the agency’s position on advancing new digital health policies to encourage innovation, bring efficiency, and modernization to regulation.

In response to the new digital health guidances, Morgan Reed, Executive Director of ACT – The App Association, stated that: “It’s now clear that if a doctor makes the decision and diagnosis, and uses software to make more informed decisions about treatment, that software would not be regulated.”

In contrast to Reed’s perspective, Bradley Thompson, head of the Clinical Decision Support Coalition writes: “I was expecting a guidance that focuses on risk, rather than simply explaining the statutory language in slightly greater detail. What I think many of us in industry were hoping for was an effort by FDA to distinguish high from low risk as a basis for regulation. We didn’t get that. Worse, it appears based on the guidance that FDA is not interested in drawing that line.”

Engineers at MIT have created a living tattoo made up of live, genetically programmed bacteria cells that are 3-D printed, adherable to skin, and light up differently in response to specific chemical or molecular compounds. These living materials can be used for wearable flexible patches and stickers acting as sensors and interactive displays. They may also one day be used to manufacture drug capsules and surgical implants that contain, for example, glucose-producing cells for therapeutic use. According to co-author Xinyue Liu, “They can be engineered to produce drugs within a 3-D scaffold, and applications should not be confined to epidermal devices. As long as the fabrication method and approach are viable, applications such as implants and ingestibles should be possible.” The video at right provides an overview of the new technology.

WOMEN’S HEALTH

New mammogram technology from GE Healthcare features a wireless remote allowing patients to control the amount of compression. This means that mammograms can be less painful since the patient knows how much pressure they can tolerate. According to Barbara Rhoden, GE Healthcare’s director of marketing and sales for women’s health in the U.S. and Canada: “Women weren’t as compliant as we thought they were. More than half of women weren’t showing up for their mammogram. What can we do? How can we engineer comfort in this new platform? That is what we have here with Pristina.”

Estrella Jaramillo is the cofounder of B-wom, a digital coach focused on women’s health that creates a personalized self-care plan to help women manage and prevent symptoms of incontinence and sexual pain or discomfort. According to Jaramillo, the company is “building a culture around communication and sexual education. We need to be able to communicate about our sexual health with others. It’s about taking charge of all the changes that your body experiences as a female, about not being afraid or ashamed to discuss them with whoever can support you, and take action so that you can feel at your best.”

LIVING AND SOCIETY

Facebook is offering a controversial new messenger app for children under age 13 named “Messenger Kids”. Children don’t need a Facebook account and can communicate with regular Facebook Messenger and Messenger Kids users that their parents sign-off on. Critics say it takes more from families than it gives them and that it’s all about the data that Facebook obtains from the kids. Moreover, the pitch to parents relies first upon scaring them: “For the first time, Facebook is opening up to children under age 13 with a privacy-focused app designed to neutralize child predator threats that plague youth-focused competitors like Snapchat.” As privacy lawyer Joel Winston ( @joelwinston)tweeted, “Data is the new credit report. Do parents have any responsibility to protect children from corporate data mining?” And “Success of Facebook Messenger Kids depends on parents not reading the +8 different legal consent disclosures.” and “You agree that Facebook can collect, use & share your child’s content & info…WE MAY TRANSFER INFO TO 3RD PARTIES”

So-called video game “loot boxes’ are being criticized as gambling for kids. Loot boxes are random collections of in-game abilities that remain a mystery until purchased by kids. Hawaii State Rep. Chris Lee described “Battlefront II” as an “online casino designed to lure kids into spending money. The fact that some of the games on there mimic slot machine mechanics is incredibly worrisome for a lot of the folks we’re talking to once they realize just how accessible and absolutely unregulated some of these potentially dangerous mechanics are.” As Zaid Jilani writes in The Intercept, “in the game “Battlefront II,” a loot box costs between 83 cents and $1.80, and it’s not uncommon for a player to buy dozens and dozens of boxes in an attempt to unlock a particular character or capability. One popular YouTuber, for example, bought 85 boxes for around $90 and amassed, along with various in-game upgrades, 18,700 credits — just under half as many needed to unlock marquee character Darth Vader. Remember that the game itself retails at a suggested price of $59.99.”

Citing safety risks due to their integrated lithium ion batteries, U.S. airlines are making moves to ban smart luggage. An American Airlines announcement states that “the bags pose a risk when they are placed in the cargo hold of an aircraft. Beginning Jan. 15, customers who travel with a smart bag must be able to remove the battery in case the bag has to be checked at any point in the customer’s journey. If the battery cannot be removed, the bag will not be allowed. If the customer is able to take the bag into the cabin with them, the customer will be able to leave the battery installed.”

Smart bag maker Bluesmart issued its own press releas e stating that its “products meet DOT, FAA, FCC and UN38.3 regulations. We are aware that the International Air Transport Association (IATA) which proposes standards for the airline industry and some airlines have recently made their own regulations with tighter requirements than the industry regulators.”

The company adds that it has “organized meetings with the world’s leading airlines to make sure that your Bluesmart will be exempt from such rulings. During these meetings we will be demonstrating how our products meet all safety requirements and regulations.”

Above is a Facebook video of a carry-on bag called ‘Modobag’ that you can sit on and ride around the airport.

A study using 4D ultrasound scanning to analyze the movements of the hands of fetuses in the womb was able to predict with accuracy ranging from 89% to 100% whether a child would be left- or right-handed. The researchers state that this knowledge could be used to inform predictions about depression, schizophrenia, and autism spectrum disorders due to the relationship between hand preference and dominance of one brain hemisphere over another.

A new video from Freethink Media ” Our Cyborg Future is Coming (And That’s Not a Bad Thing)” features Adam Piore, author of ” The Body Builders: Inside the Science of the Engineered Human“. Adam argues that “incorporating tech into our biology has, and probably will continue to be, a good thing. His book looks into the field of bioengineering—which can be used to reverse engineer, rebuild, and augment human beings—and paints a vivid portrait of the people at its center. He chronicles the ways new technology has retooled our physical expectations and mental processes.”

Even though Amazon’s CEO Jeff Bezos owns The Washington Post, Geoffrey Fowler writes in the media publication that “Amazon wants a key to your house. I did it. I regretted it.” The $250 Amazon Key, he says, “isn’t just about stopping thieves. It’s the most aggressive effort I’ve seen from a tech giant to connect your home to the Internet in a way that puts itself right at the center.”

Unfortunately, Geoffrey’s experience with Key was disappointing in that Amazon missed four of his scheduled in-home deliveries and charged him (in addition to his Prime membership fee) for the Key smart lock that sometimes jammed. He also noted that the app was awkward to use when trying to “share” his door with people, apps, services, and other retailers.

HEALTHCARE

A 9-month long qualitative pilot study of Facebook as a tool for patients found that the social network provided benefits in regard to patient engagement and satisfaction. According to the abstract, “Despite the potential benefits of social media, health care providers are often hesitant to engage patients through these sites. Our aim was to explore how implementation of social media may affect patient engagement and satisfaction.” The authors concluded that: “This pilot study indicates that the integration of social media into clinical practice can empower surgeons to synthesize effectively a patient support community that augments patient engagement and satisfaction.”

GENOMICS

Daniel Rodríguez-Leal, a fellow with The Pew Charitable Trusts, is using the CRISPR gene editing tool to manipulate sequences within the promotor of genes that are important to the overall yield of tomatoes, particularly fruit size. As Kara Coleman, director of The Pew Charitable Trusts’ biomedical programs states: “Global crop yields are increasingly vulnerable to changing climate and air quality. To combat future environmental threats and increased population growth, scientists are seeking new ways to engineer plants that can withstand harsh and unpredictable environments, and produce more food.”

Google has released its DeepVariant AI tool, which can reportedly build a more accurate picture of a human genome from sequencing data. According to Brendan Frey, CEO of Deep Genomics, “The gap that is currently blocking medicine right now is in our inability to accurately map genetic variants to disease mechanisms and to use that knowledge to rapidly identify life-saving therapies.” DeepVariant is able to automatically identify small insertion and deletion mutations and single-base-pair mutations in sequencing data in repetitive portions of a genome.

Emails obtained via a Freedom of Information Act request indicate that the U.S. military agency DARPA is investing$100M in genetic extinction technologies that could be used to wipe out malaria-carrying mosquitoes, invasive rodents, or other species. But UN experts are warning of possible military uses, e.g. via bioweapons, and other possible unintended consequences of these efforts. One unnamed UN expert told the Guardian that: “You may be able to remove viruses or the entire mosquito population, but that may also have downstream ecological effects on species that depend on them. My main worry is that we do something irreversible to the environment, despite our good intentions, before we fully appreciate the way that this technology will work.” The United Nations Convention on Biological Diversity (CBD) will reportedly debate whether to impose a moratorium on the gene research next year.

The FDA has approved Foundation Medicine’s FoundationOne CDx test that is capable of looking for mutations in hundreds of cancer genes at once. CMS is also proposing coverage of this first “breakthrough-designated test to detect extensive number of cancer biomarkers.” This would lead to private insurers covering the test as well. According to the FDA, “Compared to other companion diagnostics previously approved by the FDA that match one test to one drug, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer. Additionally, based on individual test results, the new diagnostic can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and health care professionals access to all of this information in one test report, avoiding duplicative biopsies.”

CRISPR gene editing and viruses that attack bacteria could be used to knock out superbugs that have developed antibiotic resistance. According to the U.S. Centers for Disease Control and Prevention (CDC), each year these drug-resistant bacteria infect more than 2 million people nationwide and kill at least 23,000.

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Paul Sonnier
Author ⋅ Speaker ⋅ Technologist ⋅ Social Entrepreneur
Book: “The Fourth Wave: Digital Health”
Contributing Editor, Innovation & Tech Today
Founder, Digital Health group on LinkedIn
Creator, Story of Digital Health
Twitter: @Paul_Sonnier
San Diego, CA, USA