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Regulation Lesson Learned from Theranos

For those who haven’t been following the Theranos drama, it’s a total mess. At first Theranos and its founder, Elizabeth Holmes, were being touted as the next major thing to happen to healthcare. They used that fame to raise $700 million (per Techcrunch) on the back of lab tests from samples as small as a few drops of blood. However, through a series of missteps, Theranos got itself in real trouble with CMS.

Today, it seems like things have gone from bad to worse as regulators plan to revoke Theranos’ lab license and to remove Elizabeth Holmes and Sunny Balwani, company president, from their positions as leaders of Theranos. You can read more in this Techcrunch story and see the letter from CMS. I’ll leave the analysis of Theranos’ future to others who are covering every detail. However, it’s worth noting that others are working on similar lab testing that uses small amounts of blood, so I’m hopeful we’ll still see that technology come to market.

Instead of focusing on Theranos’ future, I think we’re better served learning an important lesson from the Theranos experience. Government regulation matters in healthcare and you better have all your i’s dotted and t’s crossed.

There are a lot of startup companies that enter the healthcare startup world thinking that they can be rebels and succeed in healthcare. In some respects they can and I’d be the last to discourage rebels from entering healthcare. We need more rebels that fight against some of the lame status quo experiences we have today in healthcare. However, rebellion can only go so far in a massively regulated environment like healthcare. Whatever rebellion you want to lead has to fit within the constructs of regulation or it will come back to bite you.

The good thing is that the Senate is trying to make it more clear what healthcare technology will be regulated and which won’t with bills like the MEDTECH Act. However, there’s still a ways to go and there’s still some leeway for the FDA to get involved if you overstep your startup into regulated territory.

This exact problem is why many startup founders see so much opportunity in healthcare, but then shy away. I remember reading a venture capitalist that said “All the normal business mechanics that you’re use to seeing don’t apply to healthcare.” I don’t agree completely with that quote, but there’s definitely some truth to it.

I’m not saying that startups shouldn’t enter healthcare. They should, but they should think very seriously about the regulation required to participate in many parts of the healthcare system. Some will see the regulation as a downside, but remember that regulation can also be a great barrier to entry for your competitors. You have to take the good with the bad. We all know that healthcare regulation isn’t going anywhere. In fact, it’s likely to get worse over time.

April 13, 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.

Are We More Honest with Our Phones Than with Our Doctors?


This is such a great question, but like most great questions requires more than a Yes or No answer and usually leads to a depends response. If you’re asking for my short answer though, I’d say that usually yes.

Certainly there are some exceptions. There are certain people that won’t share anything on the internet and that includes their phone. So, of course they’re not going to be more honest with their phone than they are their doctor. However, social media proves that the majority of people don’t mind sharing. In fact, when you look at what people are willing to share publicly, you have to wonder what they’re sharing online privately.

From a health perspective, this can be a huge benefit as you try to track someone’s health. In the article linked above they talk about how a smart phone app was a much better way to get data from teenagers participating in their research. They described the paper surveys as homework and the mobile app as fun. No doubt that resonates with anyone that has spent time with teens.

However, that really only addresses the accessibility and ease of providing the data. There’s a disconnect from reality that happens on the phone which allows us to be more comfortable sharing some things that we wouldn’t likely share face to face with the doctor. In healthcare, we’re usually battling against this issue as we talk about Telemedicine and how it’s not the same as an in person office visit. They’re right. Telemedicine isn’t the same as an in office visit. In some ways it feels less threatening and people are more willing to share. While this “disconnect” can be a down side, it can also be used as an upside.

Like most things in life, there are pros and cons. The key as we approach digital health solutions is to understand the benefits and challenges and make the most of what’s possible.

April 6, 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.

Aggregate Fitness Tracker Data is More Valuable than Individual Results?

A recent New York Times article made an interesting conclusion about the value of fitness tracker data:

Ultimately, it is those aggregate numbers that offer the most exciting possibilities: The collective data stream from our devices amounts to by far the largest and most comprehensive observational health trial ever conducted. We have the data; now we just need to figure out what it means.

As a preface to this discussion, it’s worth letting you take a minute to read my article about the clinical relevance of FitBit data (or lack thereof). For those who don’t click over, I argue that doctors don’t care about FitBit (and other Fitness Tracker) data because it’s not clinically relevant. However, new sensors are on their way that will be clinically relevant.

While I fundamentally believe that current FitBit data isn’t that interesting to the individual, it’s worth considering if the aggregate FitBit data is going to provide some clinical and health insights. My reaction is that the aggregate FitBit data is likely to provide a much larger benefit than the individual data. Although, that’s not saying too much since I just said that I didn’t think it was that clinically relevant for an individual.

I do think the aggregate data will tell an interesting story about the population as a whole. If we get enough data (and this will likely require all fitness tracking companies to work together), then we could look at some interesting trends that happen across various regions and shifts in activity over time.

One of the big complaints about value based reimbursement efforts is that there’s no baseline that will allow a doctor to say that their patient population is sicker than another doctor’s population. However, under this new model, we’re planning to reimburse them based on how well they keep the population healthy. We can all see how this isn’t fair and could lead to doctors only working with the most healthy patients.

Could a baseline of personal health tracking data (yes, it will likely need to be more than just step trackers) allow us to understand in a really detailed way the health or sickness of a physician’s patient population?

Yes, this all gets quite messy very quickly. However, it also gets quite exciting. Could enough data help us understand what doctors have said for years, “My patients are more sick!”? I think it could. It won’t be perfect, but it will be better than what we have today.

Of course, the solutions to actually improving the health of patients is a whole other challenge. However, understanding the health of a population as compared to other populations and how their health changes over time is going to be very valuable to the future of healthcare as we know it.

March 30, 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.

Samsung CMO Uses Gear S2 to Monitor Passed Out Patient on Plane

This post is sponsored by Samsung Business. All thoughts and opinions are my own.

I’m always impressed by stories of doctors doing amazing things on airplanes. So, you can imagine my interest in this tweet from Dr. Rhew, Samsung’s Chief Medical Officer.

A doctor doing something to help someone who’s sick on a flight is nothing new. Some of you might remember that Colin Hung wrote about how Dr. Rasu Shrestha helped a passenger during his flight to HIMSS. Eric Topol is also famous for saving someone’s live on a flight and for averting an emergency landing after using his AliveCor ECG to help a man who lost consciousness.

Each of these stories should be applauded. I can only imagine how grateful these people were to have a doctor on their flight that could help. Although, the stories about Dr. Topol and the one from Dr. Rhew from the tweet above are particularly interesting to me since they both used a piece of mobile health technology to assist them in their work with the patient. In Dr. Topol’s case it was an Alivecor ECG and in Dr. Rhew’s Case it was the Samsung Gear S2 watch.

I’ve actually heard from doctors that the medical kit on an airplane is surprisingly good. However, they no doubt don’t have an ECG or heart rate monitor. So, it’s pretty amazing that each of these doctors had these tools at their disposal and that each of us could easily be carrying one of them around with us now with no trouble at all. In fact, in the case of the heart rate monitor, a lot of us are already carrying one around.

This will get even more exciting as more sensors go mainstream and are able to monitor other parts of our health. Of course, use of these sensors doesn’t have to be on a plane. It could just as well have been on a soccer field at your kid’s soccer game. In that case, you may not even need one of the other parents to be a doctor. Your cell phone could quickly Skype/Facetime in an emergency response doctor who could walk you through what was needed and assist you with the injured child. Plus, that doctor could remotely see the vital sign readings coming from sensors on/in your phone and on/in the injured person.

We’re not there yet organizationally and politically with some of what I described, but the technology is definitely there for everything I described. It’s just a matter of time for it to become a reality.

It’s an exciting time to be working in healthcare.

For more content like this, follow Samsung on Insights, Twitter, LinkedIn , YouTube and SlideShare

Update: Here’s a nice little postscript from Dr. Rhew:


I agree with the passenger. That is so cool!

March 24, 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 Key to Successful Health Wearables and Apps

Yesterday I took part in the Dell #DoMoreHIT Healthcare Think Tank event. This was my 4th year participating in the event which always provides a rich discussion of important health IT topics.

This year, one of the topic areas was around wearables and how wearables are part of healthcare. We had a great discussion including insights from Stacey Burr, Digital Sports Managing Director at Adidas, which I found very helpful in my understanding of how a brand like Adidas is approaching wearables.

As the discussion progressed, I made the comment that I’ve come to realize that for a wearable or health app to be extremely successful it’s going to require one of two things: Fun or Invisible.

I want to be careful on the fun angle. I’m not talking about an app that applies gamification. Sure, gamification might be part of it, but people want to have fun. If a wearable or health app can’t make something fun, then more people are going to use it. In our current society we’re spoiled by so much stimulus and so we’re always interested in new ways to have fun. If you can incorporate some health or wellness into that, then we’ll like it even more. However, we’ll keep doing it because it’s fun, not because of the health and wellness benefits.

The other option is for the wearable or health app to be invisible. Say what you want about society (and there are some notable exceptions), most people don’t care about their health. At least they don’t care enough to really do something about it. Sure, we all want to be healthy, but not enough to inspire action. I’ve seen it over and over again with apps. That’s why the health wearable or app has to be invisible and do its work without the need of intervention by the human.

Dr. Wen Dombrowski (Better known as @HealthcareWen) argued that there were other reasons too and then explained that her GPS wasn’t fun or invisible, but she used it. I think she’s right that there could be some areas where an app could provide a specific utility that could become popular. I just have yet to see that happen in the health space. Plus, what I find interesting about her GPS example is that GPS has tried to become more and more invisible as well. I love that my phone now knows my calendar and the GPS to where I’m going and tells me that I’m late and gives me an easy link to get the navigation. So, even GPS is heading the direction of invisible as well.

March 16, 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.

HIMSS 2016 Moved from Mobility to Devices

Thinking back on a week at the HIMSS Annual Conference, I think it’s fair to say that the industry has moved beyond the smart phone and moved on to new devices. That’s not to say that mobile doesn’t matter, but mobility has just become a feature of most software the same way we talk about a cloud application. No one buys cloud, but they might look at whether the application is a cloud application. The same is true for mobility. You don’t buy mobility, but you might want to know if the application is available on mobile devices.

With that said, there are still many that use the term mobile health to describe any devices that could be used in your health. That’s a pretty broad definition since it could include apps on your smartphone, the watch on your wrist, the Fitbit in your pocket, or some other sort of sensor attached to your body in some way. This leaves off ingestibles and implantables which I guess could apply to this broad definition of mobile health as well.

I believe 2016 was a breakout year for consumer health device companies at HIMSS. While in previous years I might see a number of these consumer health device companies at CES, very few of them really had any presence at HIMSS. HIMSS 2016 had a lot of these device manufacturers with much larger presences. This includes large companies like Philips (who killed it on the #HIMSS16 hashtag) and Qualcomm (of course they acquired CapsuleTech which has always had a good presence at HIMSS), but also a large smattering of smaller device companies scattered throughout the HIMSS 2016 exhibit hall floor.

I can’t say that I saw anything new from these companies, but HIMSS isn’t really the place for them to launch new products. Most of these companies save product launches for other events like CES or Mobile World Congress. Instead, their presence at HIMSS shows an interesting evolution in the journey of these generally consumer focused health devices. HIMSS is about the healthcare enterprise. What’s still not clear to me is how many of these consumer health devices can find a foothold in the enterprise healthcare world. However, it’s notable that so many are trying.

March 9, 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.

Should We Be Looking to Children to Learn About Remote Patient Monitoring?

This post is sponsored by Samsung Business. All thoughts and opinions are my own.

In a recent blog post, Taylor Mallory Holland wrote about how “Remote Patient Monitoring Isn’t just for Adults” including the following:

Remote patient monitoring has become a popular way for healthcare providers to ensure that patients stay healthy at home. More than two-thirds of hospitals and health systems have already deployed these solutions, according to Spyglass Consulting, mostly to monitor adults with chronic diseases.

She then went on to talk about how Children’s Health in Dallas is using Vivify Health’s care management platform and Samsung Galaxy tablets to get children out of the hospital faster, but still be able to remotely monitor their patients.

While it’s true that home health monitoring is a hot topic with the chronic, elderly patient, it might behoove us to spend a lot more time exploring the opportunities that are available with children as well. It turns out that patients that are children can teach us a lot about how to design the right software and systems to truly make a patient’s life better.

Lately it seems like every health IT solution wants to talk about patient engagement. Remote patient monitoring is the epitome of patient engagement, no? You’re literally engaging with the patient in one of their most sacred places: their home. However, one of the biggest challenges related to patient engagement is that far too many patients don’t care enough to actually engage.

This is why remote patient monitoring with children is so powerful. As a parent of four, I can attest to you that there’s nothing a parent won’t do for the health of their child. The duty and responsibility you feel for your child’s health is real. This often gets the bad rap of helicopter parent (which can be bad if taken too far), but in a healthcare situation you want a “helicopter” parent that’s totally involved in the care of their child. In fact, if we really believe in patient engagement, then we need parents that are involved and participating in the care their child receives. Luckily, most parents are totally engaged in their child’s health and that provides a tremendous opportunity for healthcare.

I’m not suggesting that we shouldn’t be working on remote monitoring tools for patients in every age group. Remote patient monitoring can be a valuable thing regardless of age. However, we may want to spend a bit more time looking at the way patient engagement happens with younger patients since their parents are already interested and engaged. No doubt we can apply some of those lessons and learnings to the older patient populations as well.

For more content like this, follow Samsung on Insights, Twitter, LinkedIn , YouTube and SlideShare

February 24, 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.

#HIMSS16 Mobile Health Roundup

HIMSS 2016 (or as many prefer #HIMSS16) is just around the corner. The Twitter stream for #HIMSS16 is alive and well. In fact, it’s pretty much overwhelming. However, there are nuggets full of amazingness being shared by incredible people. With that in mind, I thought this week’s post could look at interesting mobile health related tweets shared on the #HIMSS16 hashtag.


The very best mobile health apps will realize this truth. Downloads is great because it illustrates potential. However, value is created by persistent use and improved outcomes.


Unfortunately, I’m not seeing much of a culture shift in this regard. Most in healthcare are afraid to fail. In some ways that’s a good thing. In other ways, it’s hindering our progress.


My gut tells me that most mobile health vendors would fail a HIPAA audit. What do you think?


Changing behaviors is the holy grail of mobile health in my opinion. Although, it’s much harder to do it than to write about it.

February 17, 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.

Google Fit and Other Fitness Trackers

I’ve always been intrigued by the various fitness trackers. I’ve never been that excited about their pure healthcare value, but I do believe that the amount we move (or don’t move) matters to our health. So, it makes since to track how much we move as one element of your health.

The problem I’ve had with all the fitness trackers I’ve used is that they end up in a drawer far too quick. In fact, I could never reliably wear one. My wife did better and made it a few weeks, but I just hated having a device attached to me. So, it never worked for me. (Side Note: HIMSS16 has a fitness challenge and they’re even accepting donations of fitness tracker devices you have gathering dust in your drawer.)

The closest I’ve come to a fitness tracker working for me is my cell phone. I was excited when my Samsung Galaxy S5 had the S Health app loaded on it and would track my steps and it could even do my heart rate. It was novel to see my step counts and see the trend over time. I was always excited when I’d go dancing and my step count would go through the roof and blow away all the goals that it had set for me.

I’ve since switched to the Google Nexus phone which has Google Fit built in. It has a similar step tracker and I definitely turned on Google Fit when I started with the phone. However, then I never heard or saw any notifications about it. I did’t really even realize it was on. Then, this week I got the notification from it that Google Fit was going to be disabled to save my battery since I hadn’t opened it in a long time (I can’t remember how many months they said).

What can I say? I totally forgot that it was even tracking me and it didn’t tell me that it was doing it. I do remember getting a notification or two that I’d had an active hour or something, but I’d just give myself a pat on the back and swipe off the notification. I guess that’s not considered using the app.

The other reason I probably didn’t care as much about the Google Fit tracking is that I knew that it was only tracking a small part of my movement since the cell phone is often with me, but not always. I work from home and so when I’m home I take my cell phone out of my pocket and it sits on my desk all day. That means it’s not tracking any of my movement during most days. I also play a lot of sports and I don’t want my cell phone in my pocket while I play. I guess that’s why all the Fitness trackers are these little devices that you could potentially wear while playing. Although, that feels like work and for what value?

Many have been dealing with this for years. What’s interesting is that I’ve been watching it for years as well and not much has changed. Is it nice that Google Fit is tracking my activity with almost no effort from me? Definitely, but with all the gaps in data it’s collecting, is that data really all that meaningful?

Would love to hear other people’s experiences with these trackers. Is there something new that’s changed your perspective on things?

February 10, 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.

Health App Millionaires

The market research firm research2guidance put out this really interesting graphic of the profiles of mHealth companies. Although I find it even more interesting that they grouped the mHealth apps into Millionaires and Low Earners. Take a look:

mHealth App Millionaires Chart

The motivation section of the chart is what is most scary. The low earners want to help people and reduce costs. The mHealth millionaires want to increase sales and improve brand awareness. Is this disturbing to anyone else. I think there’s a balance of the two that can be achieved. What are your thoughts and experiences?

February 3, 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.