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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.

4 Key Pillars of Effective Mobile Health

I loved this tweet from HP Healthcare on the 4 Key Pillars for effective mobile health.

 

Here are the 4 pillars for those who might not see the embedded tweet:

  • People
  • Places
  • Payment
  • Purpose

As I look through these pillars, the one that I think we’re missing most is purpose. This isn’t that we have a purpose. All of the apps have the purpose of improving someone’s health. That’s a noble purpose and they all have that as their goal. This purpose in my book means that the app actually achieves the intended purpose.

As I wrote previously, there are so many apps and so few users. The solution to this problem is creating apps that are effective at achieving their goals. An app that can move the needle, change behavior, or somehow provide tangible value to the user is one that will get many, many more users. We’re just not there yet.

Some people are concerned by this fact. I’m not. I’m excited about the potential of it all along with the amazing number of intelligent people that are working to find a solution. We’re still early in this iteration of mobile health companies and I believe we’ll see some major breakthroughs in how we look at health. However, we aren’t there yet.

February 3, 2014 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.

Some Perspective on Mobile Health

This holiday weekend with family has been really interesting. It’s been fascinating to hear what my relatives and friends have to say about the mobile revolution that’s happening in healthcare and in every part of our lives. The most interesting observation is how little many of my relatives know about what’s really happening in mobile and definitely in mobile health.

Offhand I’ve mentioned a few of these topics to my relatives to see how they respond. As is often the case, it’s met with a general silence based on their lack of understanding of the subject. They certainly listen intently, but they know so little about the subject that they have very little to add to the conversation.

Of course, I’m dealing with a relatively small sample, but I think there’s a lesson there for those of us who live, eat, and breathe this stuff every day. A huge shift is happening, but most of the people out there know nothing about it.

I’m not sure this is a bad thing. While they know very little of the high level stuff, my wife, her sisters and mother did go wait in line for the $199 iPad mini deal today. So, there’s definitely interest in the devices. Although, I think few of them have any idea of how important all of these devices will be to their lives in a few years. They did however introduce me to a pointless, but addictive game called Space Team. At least they know about the most important things.

November 28, 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.

Scan What’s In Your Food – TellSpec

I recently came across an IndieGogo campaign for a product called TellSpec. They describe TellSpec as “A revolutionary hand-held device that tells you the allergens, chemicals, nutrients, calories, and ingredients in your food.”

The concept is really interesting and they’ve already raised $116,826 from 650 people, surpassing their goal of raising $100,000 and they still have 24 days left for their campaign. Given those numbers, I guess many others are interested in this as well.

While I think the concept is beautiful, I’m a little skeptical of how good it will actually work. I’m interested to see if it really can produce the results that they describe. If it can, then no doubt there will be many interested in using such a product.

I do wish that it would identify both the chemicals and the portion sizes. If it could do both, then it would take food tracking to a much higher level of tracking. Maybe this will be an opportunity for TellSpec to partner with another company that has portion identification using something like a picture. The combined functions would make TellSpec interesting for a much larger market than just those interested in identifying chemicals in their food.

Another major challenge with what they’ve created is that it’s a separate device. One day this or something like it will be built into our cell phones. I don’t have to explain why people don’t want to carry two devices. Once it’s integrated with the smart phone I can already see the pre-meal ritual being to scan your food so that what you’re eating is captured and tracked.

I once heard someone say that one of the biggest factors influencing our health is the food we put in our body. Maybe TellSpec combined with other mobile health applications will get us closer to understanding the relationship between the foods we eat and are health.

November 6, 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.

Will Mobile Health Devices Become Mandated Care?

I was really intrigued by this article from Sam Stern titled “Coming Next: Mandated Mobile and Digital Medical Devices for Chronic Conditions.” In it he discusses a bit of Obamacare and then looks across the pond for what he believes will be the future for healthcare in the US. He uses this quote from NHS England as an illustration:

Everyone with a long-term condition or disability must have a digital personalised care plan accessible online or via a mobile phone app by 2015.”

It’s a strong point that’s worthy of consideration. As the government starts paying for more and more healthcare (no doubt they’re already a large payer of healthcare), will they start to mandate mobile health devices so they have more data on the care they’re providing?

I believe the answer to this question is yes. In fact, they’ve always wanted this data, but mobile health and a new wave of consumer sensors are finally going to be able to deliver the data.

Coming from the perspective of someone from mobile health, this is a really great development. While it will take a little while for all of this to happen, you can be sure that those mobile health companies that can supply the data are going to be richly rewarded.

As a consumer, I’m a little torn on if I like it or not. When I think about this, I’m reminded of the car insurance companies putting a little monitor on my car’s computer. A part of me loves this, because then they could possibly give me lower rates when they see I don’t drive as much and that I am a safe driver. Although, the big brother aspects of it are also a little disconcerting. When someone can make money from that data they will. I’m not sure exactly how, but you can be certain it will happen.

I’m all for using mobile health to improve the health care I receive. I just think we have to be careful how and when we use it. Plus, we have to make sure we have proper privacy regulations on that data. Otherwise, we could find ourselves with a lot of unintended consequences.

November 4, 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.

The Shift from PC to Mobile

One of my favorite hospital CIOs is a man named Will Weider, CIO of Ministry Health Care. He’s also a fellow blogger that started blogging about the same time I did at Candid CIO. He sent out this tweet which provides a pretty amazing insight into the shift that’s happening with PCs.

Think about what it means that 4 years ago only 25% of PCs were mobile and now 50% of them are mobile. I expect that the users of those systems would probably like that number to be even higher, but replacement cycles take time to circulate out the old PCs that aren’t mobile.

I’d be interested to see what the stats are for the mobile PCs. How many are laptops, tablets, carts on wheels, etc. I assume when he says PC he doesn’t include smartphones in that number. Although, if trends continue as they are, your smartphone could become your future PC.

The idea of point of care computing in healthcare is a really important topic and trend. There’s nothing stopping it. It will absolutely be the future of healthcare. Are we ready to embrace it?

October 25, 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.

5 Reasons Future Healthcare Will Be Mobile

Melissa Thompson takes an interesting look at mobile healthcare in her Huff Post article about Frictionless Health. First I love the concept of frictionless healthcare. There is almost nothing about healthcare today that’s frictionless. There are points of friction everywhere in healthcare. Sometimes by necessity, but more often because of the culture of healthcare.

Here’s Melissa’s 5 reasons why the future of healthcare will be mobile:
1. Evolution: Mobile phones, are just “phones.”
2. Mobile empowers us…
3. and it empowers our healthcare providers
4. A New Dimension: Contextual Healthcare
5. Better, Faster, Stronger

I would take a simpler approach to explain why mobile health will be the future of healthcare. Our phone will become the central gathering point of all our health information. It will receive and transfer all the information from our sensors, from our medical providers, and any other health information. The phone will become our healthcare brain. It will know everything about our healthcare.

To me this isn’t a question of if, but when.

October 17, 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.

Mobile Health Tool Matrix

I came across this really cool mobile health tool matrix by BJ Fogg. Here it is embedded below:

I think this is an interesting way to look at mobile health tools. Although, the most powerful part of this matrix is it shows the breadth of mobile health tools. The possibilities are nearly endless. In fact, it makes it a challenge to cover because the idea of mobile health is so broad.

May 17, 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.

Thirty-Five Percent of Americans Consult Internet For Health Information

Every  morning before I get out of bed, I look at all the headlines on my news widget. The last section I usually look at is the health news. Today, a headline caught my attention — it said something about thirty-five percent of American adults consult “Dr. Google” to diagnose illness. This definitely sounded like something up my alley, so I read it, and wanted to share the information here.

I couldn’t find the article that I originally read, but this one from CBSNews.com provided the same information. Just today, findings from The Pew Research Center’s Internet and American Life Project were published. Here are some of the most interesting findings:

  • 59 percent of adults using the Internet have looked online for health info in the past year
  • 35 percent have sought out information online, specifically trying to diagnose theirs, or someone elses’, medical condition
  • After apparently finding out what their condition was online, 46 percent felt they should seek help from a health provider, 38 percent felt they could treat it at home, and 11 percent said it was in between.
  • 41 percent had a doctor confirm the condition, thirty five percent didn’t consult a physician, and 18 percent were corrected by their physician on what the condition was.

I thought this was all pretty interesting. The study also found that women are more likely to look information up online about health. That sounds about right to me — I don’t think my husband has EVER looked up something about a medical condition online, while I probably do every other day.

I think the fact that almost half of those that looked up information were able to have the condition they “diagnosed” themselves with confirmed with a physician shows how information found online is getting better. The authors did say this though, about these findings:

It is important to note what these findings mean — and what they don’t mean. Historically, people have always tried to answer their health questions at home and made personal choices about whether and when to consult a clinician. Many have now added the internet to their personal health toolbox, helping themselves and their loved ones better understand what might be ailing them. This study was not designed to determine whether the internet has had a good or bad influence on health care. It measures the scope, but not the outcome, of this activity.

What I think this study does show, however, is that it’s now more important than ever to make sure there’s good, reliable information out there for people to consult. A decent percentage of the people surveyed didn’t seek medical attention after their self-diagnosis, and it would be unfortunate if someone got incorrect information and really did need to see a doctor.

If anything, I’m just happy to see that there are others who consult Dr. Google as much as I do!

January 16, 2013 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.