The Digital Health Update by Paul Sonnier ⋅ Sep 9, 2017 ⋅ #291

I made this announcement to 58,177 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. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here.

The Digital Health Update by Paul Sonnier ⋅ Sep 9, 2017 ⋅ #291

Dear Group,

I’ve published two issues of my newsletter since last week’s group announcement. You can read both newsletters via the following links. The full text of each is also included below.

The Digital Health Newsletter for Sep 5, 2017

The Digital Health Newsletter for Sep 9, 2017

Also, please note that I’m seeking a direct role with a company or organization that would, ideally, complement and leverage all that I’ve built and am doing, including my keynote speaking, weekly newsletter, Digital Health LinkedIn group management/curation, and contributing editor role at Innovation and Tech Today. My professional bio is viewable here. Please contact me if you see a potential fit or would like to advertise in my announcements, newsletter, and website.

The Digital Health Newsletter for Sep 5, 2017

In an interview in Men’s Health, Apple’s director of fitness for health technologies, Jay Blahnik, claims that over the past five years the company’s fitness lab has collected more data on activity and exercise than any other human performance study in history. To date, there have been over 10,000 unique participants (contrast this with a typical clinical trial of less than 100 enrollees), who have completed 33,000 sessions and generated more than 66,000 hours of data. Apple employees exercise in group classes, on rowing machines, treadmills, cable machines, and even swim in an endless pool, all while 13 exercise physiologists and 29 nurses and medics monitor the data from the Apple Watch, metabolic carts, ECGs, and a mask that tracks calorie burn, oxygen consumption, and VO2 max. There are also rooms with microclimates that simulate Arctic conditions (subfreezing) and desert heat (100°F-plus). All of this work is intended to optimize the health of users of the company’s apps and devices, like the Apple Watch, which will soon be upgraded to WatchOS 4 and include high-intensity interval training and wireless connection to gym cardio machines. Apple’s next launch event is Sept 12.

In what has become a common theme of the digital revolution, a new self-learning algorithm leveraging data from wearable devices could add a new layer of activity monitoring that fills in the gaps missed by current tools. Scientists at the University of Sussex have developed a machine learning system that can detect and record daily activities in real-time and fill in the missed motion that current systems don’t account for or accurately label. For example, the algorithm could track you while you are lying down, sitting still, or doing some activity or notable trend and identify what you’re doing, including if it’s related to another activity.

LIVING AND SOCIETY

Verizon has a new system called Hum, that features an app and two component devices: One that plugs into your car’s On-board Diagnostics (OBD) port and anther that clips onto your sun visor, doing double duty as a speaker phone. The system includes vehicle diagnostics, a WiFi hotspot (upgraded system only), and can automatically call emergency services if it detects an accident and even send help. You can also connect to emergency services at the push of a button. As I tweeted to Joel Winston, I am curious about what Verizon does with the data it collects.

Bosch’s concept X-Spect stain scanner device can detect what you spilled on your clothes and can tell what type of fabric its on in order to help you better wash your clothes. Future applications could also include analyzing your food for consumption, like whether or not it’s ripe.

One of Samsung’s new washing machine leverages AI and other techniques in order to wash clothes faster. The companion Q-rator app incorporates a virtual assistant to help you plan your laundry based on various factors (like fabric types), make suggestions, and can alert you to issues.

WEARABLE TECH

Samsung has announced its new Gear Sport smartwatch, a new version of the Gear Fit fitness band, and new Gear IconX wireless earbuds. The buds are not just for listening to music, but can also be used to track workouts. The Gear Sport smartwatch comes with improved heart-rate monitoring, automated activity tracking, and apps from its partner Under Armour. While it is waterproof, unlike the new Fitbit, it doesn’t track breathing or oxygen consumption.

REGULATION

The FDA has published its final guidance for “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” ( PDF). In ablog post by Bakul Patel, Associate Director for Digital Health at the FDA’s Center for Devices and Radiological Health, Bakul points out that the final guidance outlines the agency’s recommendations for smart, safe, and secure interactions among medical devices and other information systems. He also lists the following recommendations for all medical device manufacturers:
  • Design their devices with interoperability as an objective
  • Conduct appropriate verification, validation, and risk management activities
  • Clearly specify the relevant functional, performance, and interface characteristics to the user

The FDA has also released its final guidance on the “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices” (PDF). The agency states that this will clarify how it evaluates Real-World Data (RWD) to determine whether it is sufficient for generating the types of RWE that can be used in FDA regulatory decision-making for medical devices. This guidance is applicable to all devices, as that term is defined in the FD&C Act, including software that meets the definition of a device. It adds that RWD are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, including electronic health records (EHRs), claims and billing data, data from product and disease registries, patient-generated data (including in home-use settings), and data gathered from other sources that can inform on health status, such as mobile devices.

 

The Digital Health Newsletter for Sep 9, 2017

With the inroads being made to reduce costs and improve care via digital health (for example, Kaiser Permanente’s achievements, include providing 52% of patient interactions via digital tools and a continuing reduction in heart attack rates among its Northern California members), it’s a shame to see pharmaceutical companies doing things that keep costs unnecessarily high in the name of profits over patients. The latest example is by drug maker Allergan, which has made a deal to transfer its patent for the drug Restasis to the the Saint Regis Mohawk Tribe in New York state. The result is that Allergan gets to maintain the patent protection (from which the company derived $1.5 billion in worldwide sales of the drug last year), and the Native American Tribe—which is a sovereign entity immune from patent reviews—gets $15 million/year plus upfront money of $14 million. And consumers—plus other payers—get to pay more than they should for an important eye care drug.

As Kaiser Permanente CEO Bernard Tyson wrote in a Forbes piece Why Pharma Must Change Its Model , “Every part of the industry has been shaken up by this new era of doing better for less. Countless industries outside of health care have already gone before us, understanding that technology and productivity gains must be passed along to the consumer for businesses and our nation to remain competitive. The pharmaceutical industry remains our lone holdout, and we cannot succeed without it. If the cost of new drugs continues to rise at this rate, any progress we make in other parts of the health ecosystem will be irrelevant.”

Alternatives to the current system of higher prices due to drug patent monopolies exist, including one suggested by economist Dean Baker that involves replacing patent supported drug research with direct public funding.

report in STAT News states that the IBM Watson AI system is nowhere close to creating a revolution in cancer care. Ironically, while Watson is a cloud-based computing system designed to analyze large data sets, treatment recommendations are currently based on human data entry of information related to patients and how they should be treated. Also, as of this time, Watson has not published any independent, third-party studies (save one) for the oncology application in peer-reviewed journals. With over 7,000 employees, revenue for IBM’s “cognitive solutions” division, which Watson is part of, has fallen from last year, though the company claims that it remains on an upward growth trajectory in this projected $200B segment of the digital health market.

FUNDING

Kirkland, WA-based Cardiac Insight has raised $4.5M to speed up sales and production of its disposable wearable ECG heart monitoring system. Their Cardea Solo system provides diagnostic insights to physicians following a week-long monitoring period. A key benefit it provides is detecting transient symptoms, including periodic lightheartedness and chest pains.

Stockholm, Sweden-based Aifloo, which sells a wearable wristband to help in the care of elderly people, has raised $6M. TheAifloo system leverages data and AI to help elderly people live independently for longer, plus it provides peace of mind for relatives and caregivers.

NYC-based Talkspace has raised $31M to accelerate the growth of its online therapy service which, to date, has provided mental health care to more than 500,000 people, 70% of whom had never received therapy previously. According to Talkspace, clinical research has established that online therapy can sometimes be better than face-to-face therapy, not to mention that users are often more satisfied with its increased convenience, affordability, and the timeliness of receiving help.

Mountain View, CA-based 23andMe is raising about $200 million. The genetic testing and analysis company now has a $1.5 billion pre-money valuation. The money will be used to expand the company’s genetics research arm, develop new products, and grow its revenue without the pressure (from Wall Street) of going public.

UK-based Antidote has raised $11M to expand its clinical trial recruitment platform. The company has already matched more than 14,000 patients to clinical trials. Its revenue model is based on referral fees from pharmaceutical companies and licensing fees received from health organizations.

LIVING AND SOCIETY

It turns out that Facebook says it can reach 25 million more people in the U.S. than the census shows actually exist. This is according to a Pivotal Research Group analyst, who said that this could restrain Facebook’s growth in video ad sales as the company expands its offering to include premium episodic shows. According to a Facebook spokesperson, “Reach estimations are based on a number of factors, including Facebook user behaviors, user demographics, location data from devices, and other factors. They are designed to estimate how many people in a given area are eligible to see an ad a business might run. They are not designed to match population or census estimates. We are always working to improve our estimates.”

Oracle has broken from other tech giants in backing legislation aimed at preventing online human trafficking. The proposed bill by the U.S. Senate would allow for penalizing websites that are sometimes used by online sex traffickers. Oracle’s endorsement of the new legislation is in contrast to other tech companies, which oppose it because it may thwart digital innovation and lead to endless litigation. The National Center for Missing and Exploited Children states that child sex trafficking has surged in recent years due in part to Internet platforms. Tech industry companies oppose the bill and changes to Section 230 of the Communications Decency Act, saying that it is one of the most important federal protections fostering technology innovation.

911 operators in Washington state are set to get an improved locator software system from RapidSOS. In areas where cell towers are spaced widely apart, it can be difficult for callers and 911 to determine the caller’s location. The new system will be both faster and improve accuracy to within 5-10 meters by pinging your cell phone the same way that Uber or Domino’s Pizza does when they provide services directly to your location. A free app must also be downloaded by cell phone users.

According to New York State governor Andrew Cuomo, facial recognition technology has helped lead to more than 4,000 arrests since 2010. Governor Cuomo further stated that “The use of this facial recognition technology has allowed law enforcement to crack down on fraud, identity theft, and other offenses—taking criminals and dangerous drivers off our streets and increasing the safety of New York’s roadways.”

An AI system developed by researchers at Stanford and used in a study published in the Journal of Personality and Social Psychology was able to accurately guess whether people are gay or straight from a photograph. In analyzing images on a dating site, the tool distinguished between gay and straight men 81% of the time. It was accurate 74% of the time for women. This system raises serious ethical and privacy concerns.

REGULATION

The FDA has launched a Digital Health Entrepreneur-in-Residence program to support and help develop their Software Precertification (PreCert) Pilot Program,which is part of the Digital Health Innovation Action Plan, announced on Aug 8. EIR Fellows will work several days per week as embedded members of the agency’s Digital Health Unit team located at the White Oak campus in Silver Spring, MD.

—END—

FEATURED EVENTS
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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Paul Sonnier
Social Entrepreneur ⋅ Speaker ⋅ Consultant
Contributing Editor, Innovation & Tech Today
Founder, Digital Health group on LinkedIn ⋅ 50,000+ members
Creator, Story of Digital Health
Facebook: StoryOfDigitalHealth
Instagram: @StoryofDigitalHealth
Twitter: @Paul_Sonnier
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