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Scanadu to Shut Down Scout Medical Device Per FDA Regulation

Posted on December 14, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The famous Qualcomm Tricorder prize winner and IndieGogo crowdfunding success, Scanadu, has just hit some major bumps in the road. In fact, you might say they lost their engine completely. After winning the X Prize foundation’s tricorder competition, they went on to raise more than $1.6 million on IndieGogo from 8509 backers.

After shipping the product, Techcrunch just broke the news that Scanadu was now planning to disable the Scout’s functionality. Yes, that’s right. People paid $149-269 for the Scanadu Scout and now Scanadu is going to brick all of the devices. Here’s their official comment to Techcrunch:

“From the beginning of the campaign, this was an investigational device that was part of a study which has now reached its endpoint with data collection for the study ending in November 2016. FDA regulations require that all investigational studies be brought to closure and their respective devices be deactivated. As a result, we will deactivate the Scanadu Scout® devices by May 15, 2017.

Interestingly, the Scanadu website, Twitter, Facebook, etc are all quiet. In fact, most of them have been quiet since April. What hasn’t been quiet is customers anger towards Scanadu. That’s true on social media, but also in the IndieGogo comment section where Scanadu had raised $1.6 million.

You can imagine people’s anger. Their expensive device will now be useless. As one commenter pointed out, someone bought 100 of them. That person will now essentially have 100 expensive bricks. In the comments, people are calling for a class action lawsuit, refunds from IndieGogo and outrage at the company doing this to them. The most salient point is that it’s hard to imagine anyone ever buying a product from Scanadu again after something like this occurs. One commenter suggested the following:

The consent doc also says: “If you have any questions about your rights, call the Scripps Office for the Protection of Research Subjects at (858) 652-5500. ” [Note: Scripps is performing the study based on the Scanadu data.]

Some people in the comments are even commenting that there’s no such FDA regulation. I’m not an expert on FDA regulation, but my gut tells me there’s more to this story than we know today. I could easily see how there could be an FDA regulation that required a company to shut down devices that made claims they couldn’t achieve and therefore put people’s health in danger. I’m not sure if this is what’s happening with Scanadu, but when there’s smoke there’s usually fire.

I think we all loved the romanticized idea of a medical tricorder. Haven’t we all wanted one since we first saw it portrayed on Star Trek? Scanadu was trying to make it a reality, but it seems their efforts have fallen flat. This is a good warning to everyone else out there. FDA compliance is no joke. Even winning an X Prize, a successful crowd funding campaign, and raising $35 million in funding doesn’t guarantee success.

Innovation in healthcare is hard!

How Much of Healthcare Business is Healthcare?

Posted on January 27, 2014 I Written By

Kyle is CoFounder and CEO of Pristine, a VC backed company based in Austin, TX that builds software for Google Glass for healthcare, life sciences, and industrial environments. Pristine has over 30 healthcare customers. Kyle blogs regularly about business, entrepreneurship, technology, and healthcare at kylesamani.com.

Editor’s Note: We’re excited to welcome Kyle Samani, Founder of Pristine, as a regular blogger here on EMR and HIPAA. I first met Kyle when he was a high school student working at his father’s EHR company. It’s amazing how far we’ve both come since then. You can find all of Kyle’s EMR and HIPAA posts here.

In The Great Re-Bundling of Healthcare, I argued that healthcare will be rebundled along new dimensions because technology will break assumptions that predicated bundling in the analog era of healthcare delivery.

In that post, I noted that a few industries have been completely dismantled and rebundled by technology:

The print publishing industry – newspaper and magazines – thought that their unique value was in their core product – news, editorials, and classifieds. But the unique value they delivered was in printing and distribution. When the Internet reduced the cost of printing and distribution to effectively $0 and free news became the standard, their businesses collapsed. Print publishers are left servicing the paper news market, which is a fraction the size of the overall digital news market.

Taxi companies thought that their local, retail, administrative, and regulatory overhead was necessary to solve the get-from-point-a-to-point-b problem. Using the Internet, Uber, Lyft, and SideCar proved that none of those overhead functions matter, enabling a new era of get-from-point-a-to-point-b solutions. Taxi companies are left servicing the I-haven’t-heard-of-Uber and there-aren’t-enough-Uber-drivers markets, both of which are rapidly shrinking.

Hotels thought constructing buildings and staffing employees was the only way to solve the get-a-place-to-stay-for-the-night problem. Using the Internet, AirBnB proved that anyone can solve the get-a-place-to-sleep-for-the-night problem for anyone else. Hotels are left servicing the high-end, premium service market in the get-a-place-to-stay-for-the-night business.

These examples beg the question: when healthcare is completely rebundled around digital delivery, what businesses will healthcare providers really be in?

In the examples above, the Internet empowered laymen to circumvent legacy establishments. Using the Internet, laymen performed the same tasks more affordably than traditional retail businesses.

With Watson-like self-diagnostics; an army of cheap, connected, sensors; and a wealth of freely available information on the web, laymen will increasingly self-diagnose and self-medicate whenever and however possible. This process will start at the low end – the simple stuff such as common colds, simple bumps and bruises – and increasingly move up market.

Over time, tri-corders (such as Scanadu), smartphone EKGs (such as AliveCor), smartphone ultrasounds, CTs, MRIs, and blood tests will empower patients to gather all of the necessary diagnostic information without ever visiting a retail medical facility. Patients will send data to providers electronically and consult with providers via video conference. The web will obviate the need for most retail overhead, capital expenditure, and labor cost associated with most care delivery.

Medicine will be disrupted from the bottom up. Hospitals won’t completely go away, but they will be left servicing the high-end of the market – ICUs, surgery, labor and delivery, and other high-acuity conditions – just as hotels, print publications, and taxis service the most expensive segments of their respective markets. The vast majority of care will be delivered as virtually and cost effectively as possible.

By circumventing retail establishments, medicine will centralize as geography loses relevance. Just as the hotel and taxi industries consolidated around mega-platforms such as Uber and AirBnB, healthcare will consolidate around provider hubs that service enormous populations. The mega healthcare systems will have the tools to centrally manage populations and interact with them contextually. The major health systems of the analog era that were bounded by geography will battle to become national behemoths as geography becomes irrelevant. Mayo Clinic, Cleveland Clinic, and others are already doing this by establishing virtual clinics across the country.

Why did the publishing industry, taxi industry, hotel industry, and travel agency industries collapse? Why will all of the old practices of medicine collapse? Cost. The most costly aspects of delivering care are labor and retail overhead. As increasingly small, localized, connected computers gather an increasingly large amount of data, computers will help patients self-diagnose and self-medicate without the need for expensive retail or labor overhead. Computers will automate inherently repetitive processes.

So how do I answer the question I posed in the title of this post? I’ll do some high level math. About 15% of the cost of delivering care is associated with billing and administrative overhead. About 40-50% is provider labor. There’s another 5-10% is spent on other miscellaneous expenses. And the remainder of costs are in capital expenditures including retail overhead. I suspect that 50-60% of total healthcare costs could be cut when healthcare is fully digital.

Scanadu Closes $10.5 Million for Medical Tricorder

Posted on December 16, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

As most of you know, I’m a big fan and deep supporter of Vegas Startup companies. In fact, I’m an adviser to a healthcare focused secure healthcare messaging startup called docBeat. As such, I’m extremely interested in any healthcare related startup company becomes part of the Vegas family.

The latest entrant is a company called Scanadu that was just funded by the Vegas Tech Fund and others in a $10.5 Series A round of financing. This comes after raising $1,664,574 on Indiegogo. Here’s a description of what they’re trying to accomplish with Scanadu:

While Scanadu is equipping the Scout with off-the-shelf sensors, each needs a 501(k) clearance from the FDA, as do any groups of sensors working in conjunction with each other. That’s the whole point of the Scout: it combines existing trackers into one handy device.

“This is a device that comes out of nothing,” Scanadu CEO Walter De Brouwer said. “There was nothing that you could build on. You put all sorts of sensors together in a small package and make it do stuff that it hasn’t done before.”

The goal is to have the commercial device available to consumers by the winter of 2014 or Q1 of 2015. Before that, the Scout will ship to the 8,000 people who preordered through the Indiegogo campaign in March. Scanadu will be doing usability testing on volunteers from that cohort in order to glean how exactly consumers will use the Scout: how many times a day they check it and what metrics they are most interested in tracking, for instance.

I think it’s ambitious of them to go after the FDA clearance, but it probably necessary. There’s a lot of money and time involved in getting FDA clearance. However, once you do it, your competition has to deal with those barriers in the future.

I hope Scanadu uses the money they’re getting to bring on someone who’s very good at getting through the FDA clearance process. It’s a beast and it’s a real advantage to work with someone who’s done it before.

On a broader level, Scanadu is just one of MANY devices that are coming out like this. It’s an exciting time for these types of devices. In the next couple years there are going to be a wave of these devices that help us better track our health. This is just the start.

App Created to Connect Patients With Doctors Immediately

Posted on June 25, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

Have you heard of Consult a Doctor? Well, if you haven’t, here’s a little bit of an overview:

MYHEALTHPLAN24/7 is Consult A Doctor’s revolutionary cloud-based telemedicine platform that offers health plans the freedom to dramatically improve access for their members, and offer a significant convenience and revenue benefit to their provider network, all while reducing cost of care by ensuring that members stay healthier with the right care, in the right setting as soon as possible.

Consult a Doctor offers cloud-based telemedicine services to its users. It teams up with hospitals, providers, employers, and consumers to provide affordable health care and advice to everyone. Patients connect with their doctors via the Internet and are able to get care faster, easier, and less expensive over all. On June 6th, Consult a Doctor announced their new app, iDr 24/7. Anyone who is currently subscribed to Consult a Doctor, either through their employer or health plan. iDr 24/7 is the first of its kind is available for the iPhone. Users will have the opportunity to be instantly connected with a doctor, no matter where they are. The press release from Consult a Doctor described the app:

The mobile app will enable members to connect with network physicians via phone and secure messaging for live, on-demand medical consultations, including medical diagnosis, treatment, and if appropriate, prescriptions to certain medications to treat non-emergent conditions.

Sometime this year, the app will be available to other groups as well, including providers and patients.

It’s pretty incredible how far seeking medical attention has come. I mean, someone used to have to ride horseback miles and miles just to find a doctor, and now a doctor can be reached almost instantaneously. While yes, in a true emergency, you should go to the emergency room, I think this is a great option for those just needing to talk to a doctor about some basic concerns, or who needs to get a prescription filled. Last week, David talked about a tricorder being developed called Scanadu, which also would give medical advice instantly. I wonder what type of technology will be developed next to make reaching a doctor even easier.

Consult a Doctor offers both individual and group plans. Pricing for the plans can be found here. Beyond access to iDr 24/7, membership benefits are:

  • Licensed physicians available 24/7/365.
  • 100% Approval — No one is ever turned down!
  • No Limitations on Usage
  • Great alternative for the uninsured or underinsured
  • Store and share your EMRs (Electronic Medical Records)
  • Immediate access to Consult a Doctor’s health related interactive tools/service
  • HIPAA-compliant

A free trial is available, and enrollment can be done here or by calling 1-800-362-2667.

Tricorder Devices, REC Numbers, and EHR Photo IDs: This Week in HealthCare Scene

Posted on June 10, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

John’s Note: As regular readers know, I usually reserve the Sunday post to do a Twitter round up. The Sunday post on EMR and EHR has been a Healthcare Scene round up post written by Katie. I decided to mix things up a little bit. Each week I’ll swap which site does the Twitter round up and which site does the Around Healthcare Scene.

If all of this is confusing, don’t worry. Just subscribe to the emails for EMR and HIPAA & EMR and EHR and you’ll be all set. Now sit back and enjoy a look around the Healthcare Scene network.

EMR and EHR
The Shift From Expensive Technology to Cost Saving Technology

For years, medical technology came with a hefty price tag. While many of these investments were a miracle worker of sorts, it left hospitals and medical practices with a large bill. Fortunately, in recent years, the technology being released, such as EHR, are trying to make health care less expensive. While it is up for debate if software like EHR really is less expensive, there is a definite shift in the costs of medical technology.

Photo IDs as Part of the Patient Record — Flashy Trend or Future of Medicine?

Unfortunately, errors do occur in hospitals. However, putting photos on a patient record may help prevent some of these problems. Children’s Hospital in Colorado is currently trying this out. The number of mistaken orders dropped from 12 in 2010 to 3 in 2010 since the hospital started using photo IDs. So the question is, are photo IDs worth the time and effort?

Hospital EMR and EHR
Make Consumers Want Their PHR

More PHRs seem to be popping up, but are any of them really convincing people to use them? Anne Zeigler doesn’t think she. In this post, she lists several different ideas on how to get people “excited” about PHRs with tips such as good marketing and rewarding the user. If companies want consumers to use their PHR, many things should be taken into consideration.

EMR Thoughts

REC Numbers for REACH (Minnesota and North Dakota Doctors)

REACH is a nonprofit federal Health Information Technology Regional Extension Center that aims to help hospitals and medical practices through Minnesota and North Dakota implement EHR or optimize the current system. It had many goals in mind when it started, and recently, many of these goals have been met or surpassed. REACH serves 4,749 priority primary care providers across these two states.

EHR and EMR Videos

Dr. Eric Hartz’s EHR Story from the 2012 HIMSS Conference

At the recent HIMSS Conference, Dr. Eric Hartz shared his thoughts on EHR. He discussed the benefits of EHRs and gave tips on participating in incentive programs. He also talked about how to use EHR across a number of different hospitals.

Smart Phone Health Care

Is the Tricorder Device a Reality?

Is that rash on your child something serious, or nothing to worry about? Or is that fever from a UTI? Scanadu, a tricorder-like device, supposedly will use social media to help make healthcare more immediate and accessible. The machine will allow people to take a picture or sample of something worrisome, and immediately find out what action needs to be taken. The world of social medicine is quickly expanding, and a tricorder is becoming an actual possibility.

Pajamas Created to Monitor an Infant’s Vital Stats, Sends Mobile Alerts

Wearable monitors are popping up throughout the health care world. The latest? Pajamas for an infant to wear. It monitors an infant’s vital stats and sends mobile alerts to the parents. Great idea, or just another gimmick to sell to paranoid parents? Read more and decide for yourself.

Is the Tricorder Device a Reality?

Posted on June 4, 2012 I Written By

Back in January, Qualcomm and the X-Prize Foundation announced a contest that offered $10 million to anyone that could develop a tricorder similar to the one that was used in Star Trek.  I wrote back then that I didn’t think it was that unrealistic, and after reading a recent article, I am even more convinced that we will see such a device in the very near future.

The article was written by Mark Mills of Forbes.com who addresses how social media will lead to the next revolution: Social Medicine.  I’ve written about the use of social media and how beneficial it can be to healthcare on so many levels, but he describes it better than I ever could.

The company that he talks about, Scanadu, definitely seems to have the write idea in terms of using social media to make the tricorder a reality.  You can see a short video below that gives a great visual of what they are trying to accomplish in making healthcare more accessible and efficient for everyone.

How awesome would it be to be able to take pictures of a rash or injury that your kid had, add a few details of how they are feeling, and within seconds get a pretty good idea of what is wrong with them.  If it was an emergency you would know quickly and be able to get them the help they needed.  In general, an emergency is relatively obvious, so to me the greater value is in preventing unnecessary trips to the doctor when the condition will simply pass with time.

In this world of instant gratification it would be awesome to to be able to get more regular updates on your health.  The one major risk here is that people will rely solely on their smartphone and attached devices rather than going to a professional when they really need it.  The beauty there is that it would be super easy to send an email or phone message to the patient’s doctor letting them know what is going on with their patient so they could step in if needed.

It will be incredibly exciting to see how Scanadu and other companies develop modern technology into the social medicine of the future.  Do you think there is any limit to what is possible in the future of healthcare?