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Google And Fitbit Partner On Wearables Data Options

Posted on May 7, 2018 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Fitbit and Google have announced plans to work together, in a deal intended to “transform the future of digital health and wearables.” While the notion of transforming digital health is hyperbole even for companies the size of Google and Fitbit, the pairing does have plenty of potential.

In a nutshell, Fitbit and Google expect to take on both consumer and enterprise health projects that integrate data from EMRs, wearables and other sources of patient information together. Given the players involved, it’s hard to doubt that at least something neat will emerge from their union.

Among the first things the pair plans to use Google’s new Cloud Healthcare API to connect Fitbit data with EMRs. Of course, readers will know that it’s one thing to say this and another to actually do it, but gross oversimplifications aside, the idea is worth pursuing.

Also, using services such as those offered by Twine Health– a recent Fitbit acquisition — the two companies will work to better manage chronic conditions such as diabetes and hypertension. Twine offers a connected health platform which leverages Fitbit data to offer customized health coaching.

Of course, as part of the deal Fitbit is moving to the Google Cloud Platform, which will supply the expected cloud services and engineering support.

The two say that moving to the Cloud Platform will offer Fitbit advanced security capabilities which will help speed up the growth of Fitbit Health Solutions business. They also expect to make inroads in population health analysis. For its part, Google also notes that it will bring its AI, machine learning capabilities and predictive analytics algorithms to the table.

It might be worth a small caution here. Google makes a point of saying it is “committed” to meeting HIPAA standards, and that most Google Cloud products do already. That “most” qualifier would make me a little bit nervous as a provider, but I know, why worry about these niceties when big deals are afoot. However, fair warning that when someone says general comments like this about meeting HIPAA standards, it probably means they already employ high security standards which are likely better than HIPAA. However, it also means that they probably don’t comply with HIPAA since HIPAA is about more than security and requires a contractual relationship between provider and business associate and the associated liability of being a business associate.

Anyway, to round out all of this good stuff, Fitbit and Google said they expect to “innovate and transform” the future of wearables, pairing Fitbit’s brand, community, data and high-profile devices with Google’s extreme data management and cloud capabilities.

You know folks, it’s not that I don’t think this is interesting. I wouldn’t be writing about if I didn’t. But I do think it’s worth pointing out how little this news announcement says, really.

Yes, I realize that when partnerships begin, they are by definition all big ideas and plans. But when giants like Google, much less Fitbit, have to fall back on words like innovate and transform (yawn!), the whole thing is still pretty speculative. Just sayin’.

More Ways AI Can Transform Healthcare

Posted on April 25, 2018 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

You’ve probably already heard a lot about how AI will change healthcare. Me too. Still, given its potential, I’m always interested in hearing more, and the following article struck me as offering some worthwhile ideas.

The article, which was written by Humberto Alexander Lee of Tesser Health, looks at ways in which AI tools can reduce data complexity and detect patterns which would be difficult or even impossible for humans to detect.

His list of AI’s transformative powers includes the following:

  • Identifying diseases and providing diagnoses

AI algorithms can predict when people are likely to develop heart disease far more accurately than humans. For example, at Google healthcare technology subsidiary Verily, scientists created an algorithm that can predict heart disease by looking at the back of a person’s eyes and pinpoint early signs of specific heart conditions.

  • Crowdsourcing treatment options and monitoring drug response

As wearable devices and mobile applications mature, and data interoperability improves thanks to standards such as FHIR, data scientists and clinicians are beginning to generate new insights using machine learning. This is leading to customizable treatments that can provide better results than existing approaches.

  • Monitoring health epidemics

While performing such a task would be virtually impossible for humans, AI and AI-related technologies can sift through staggering pools of data, including government intelligence and millions of social media posts, and combine them with ecological, biogeographical and public health information, to track epidemics. In some cases, this process will predict health threats before they blossom.

  • Virtual assistance helping patients and physicians communicate clearly

AI technology can improve communication between patients and physicians, including by creating software that simplifies patient communication, in part by transforming complex medical terminology into digestible information. This helps patients and physicians engage in a meaningful two-way conversation using mobile devices and portals.

  • Developing better care management by improving clinical documentation

Machine learning technology can improve documentation, including user-written patient notes, by analyzing millions of rows of data and letting doctors know if any data is missing or clarification is needed on any procedures. Also, Deep Neural Network algorithms can sift through information in written clinical documentation. These processes can improve outcomes by identifying patterns almost invisible to human eyes.

Lee is so bullish on AI that he believes we can do even more than he has described in his piece. And generally speaking, it’s hard to disagree with him that there’s a great deal of untapped potential here.

That being said, Lee cautions that there are pitfalls we should be aware of when we implement AI. What risks do you see in widespread AI implementation in healthcare?

LEVL – Measuring Fat Burning

Posted on March 9, 2017 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.

I’ve been sitting on this story since CES and just hadn’t had the time to write it. Plus, it dives into some deep biology and chemistry that really isn’t my wheel house, but I think the concept is too interesting not to write about it. Plus, I think this is an illustration of the larger trend I’ve been writing about which is that sensors are arriving to measure every aspect of our body.

While at CES, I had the chance to talk with LEVL. LEVL creates a device which measures the acetone level in your breathe. Here’s the science they shared with me about why the level of acetone in your breathe matters:

Previous clinical research demonstrates a correlation between the amount of acetone detected in the breath and body fat burned, giving you a reliable indicator of fat loss. LEVL is designed to detect trace amounts of acetone in your breath when your body is burning fat. LEVL Clinical Scientist, Joe Anderson Ph.D. emphasizes the significance of breath acetone measurement as it applies to the weight loss in his review, Measuring Breath Acetone for Monitoring Fat Loss in Obesity – A Research Journal.

If you want more details of how this should work, check out this video that LEVL created:

I’ll admit that the science seems interesting, but not totally definitive. Especially when it comes to actually moving the needle on people using weight. LEVL is still early in the process of figuring out how to take the data and make it actionable for the consumer. However, the concept of being able to answer the question “Are your actions helping you burn fat?” is a very interesting take that I think could be effective for many people if it’s framed the right way.

I asked the person I met from LEVL which things influenced acetone and he said “The things you’d expect” and then listed off fatty foods, sugar, no exercise, etc. Not really shocking since we have so much experiential data that knows the impact of those things on weight. That said, I could see the LEVL data being another element that at trainer or health coach could use to help motivate a patient. In fact, personal trainers are one of their big target markets to start.

It looks like LEVL is currently only available in Seattle and they are offering a LEVLhome and a LEVLpro device. The former is obviously for home use and the later is for health and wellness professionals. The product isn’t cheap. The home version is $699 and $49/mnth and the pro version is $699 + $149/month. That includes the device, app, sensor refills and calibration gas. The pro version also includes a client dashboard, training and education, and special support.

As I mentioned at the start, this is some pretty heavy science that I’ll leave to other people with more experience. However, the concept is quite interesting and I still expect we’ll see a wave of these types of devices that measure every aspect of our health.

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!

Aggregate Fitness Tracker Data is More Valuable than Individual Results?

Posted on 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.

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.

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

Posted on 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.

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!

Google Fit and Other Fitness Trackers

Posted on 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.

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?

The Fitness Wearable Nobody Knows About

Posted on January 27, 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.

I ran across a great article from Techcrunch that looked at the top 3 wearable vendors and they pointed out that most of us have probably never heard of the #3 wearable on that list. For those following along at home, the top 3 are Fitbit, Apple Watch, and Xiamoi Mi Band.

Everyone in the US has heard about Fitbit and the Apple Watch. However, my guess is that few in the US know about the Xiaomi Mi Band since 97% of its sales are in China. Here’s a look at the breakdown of wearable market share per the Techcrunch article linked above:

According to IDC, market leader Fitbit shipped 4.7 million wearable units in the third quarter, taking a 22.2 percent market share. Apple shipped 3.9 million units, for a 18.6 percent market share, while Xiaomi shipped 3.7 million units, or 17.4 percent of the market.

For all intents and purposes, the Xiaomi product line is very similar to the Fitbit product line. Some might even call it a knock off. The Mi Band originally started with steps, hours of sleep, and calories burned. Now the Mi Band Pulse also does heart rate. Have we heard this story before?

It’s really easy in our US centric minds to forget about what else is happening around the world. That’s particularly true of China which is one of the fastest growing wearable markets out there. I saw that first hand when I met all these Chinese digital health companies at CES. What will be interesting to watch is if and when some of these successful Chinese companies come to the US. We’ll see how they do.

Consumer Health Devices versus Medical Devices

Posted on January 20, 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.

I think there’s a major confusion in the current health app and device marketplace right now. The problem stems from consumers who draw conclusions even though claims aren’t really being made. I’ll use an example from my Healthcare Scene blog network.

I get asked all the time what I do for a job (like I’m sure most of you). I usually say that I’m a blogger and people then ask me what I blog about. I usually answer that I blog about healthcare IT. While people’s minds are blown by the fact that I’m a professional blogger, I can see in their eyes and often hear in their response that they didn’t really understand what it meant to blog about healthcare IT.

The most common interpretation is that I blog about health and wellness. I guess in some ways I tangentially blog about health and wellness, but no doubt in these people’s minds they’re picturing me writing about nutritional supplements, diet, fitness, and other health and wellness topics that they read in their magazines or favorite blogs online.

I never told them that I blogged about health and wellness, but they often interpret it that way since they don’t know the term healthcare IT to know what I really mean. When I try to clarify it for them, I often say that I write about how doctors use technology. That usually gets them closer.

I’ve found the same thing is happening with many consumer health devices. When you say that something is a consumer health devices they immediately draw their own conclusion that it must be a medical device that can be used by consumers. Unfortunately, the reality today is that consumer health devices are very different from medical devices.

As I’ve thought about the differences, I’ve come to realize that there’s one major difference that causes a lot of problems for those that misinterpret what they’re using. A medical device produces clinically relevant data that would be accepted and trusted by a medical professional. A consumer health device might or might not. We don’t know and therefore many medical professionals won’t use that data.

I don’t think it’s a problem that these consumer health devices don’t put out clinically relevant data. There seems to be a great business model for consumers to take a peak at their health data (regardless of how accurate it is). Plus, there are plenty of anecdotal stories about how this has helped individuals. That’s great.

The problem however comes in when we try to say that a consumer health device is something that it’s not. I think we’ll see this come into sharp focus over the next few years. Consumers will finally start to understand that not all devices are created equal. They’ll realize that some devices are clinically relevant (ie. their doctor will want and care about the data) and other devices are more for fun and intrigue than they are actually improving their health. Unfortunately, it’s just going to take us a while to get there.

Fitbit Lawsuit and Lumosity Settlement Shine Important Light on Making Health Claims

Posted on January 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.

2 big announcements came out around CES that shined a light on all the pomp and circumstance that you hear at a show like CES and the Digital Health Summit. The first was Lumosity’s $2 million in refunds to settle Federal charges with the FTC for deceptive marketing practices.

The FTC commented:

“Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection. “But Lumosity simply did not have the science to back up its ads.”

Lumosity commented:

The company said in a statement that the FTC’s charges and the resulting settlement stem from “marketing language that has been discontinued” and that the company’s focus “has not and will not change.”

In related news was the lawsuit against Fitbit’s wrist activity tracker and its ability to track heart rates. Here’s an excerpt as reported by CBS (or you can read the full complaint):

The lawsuit filed in federal court this week claims that the wrist-based activity tracker is consistently misrecording users’ heart rates by a “very significant margin.” It also takes aim at Fitbit commercials with slogans like “Every Beat Counts” and “Know Your Heart.”

“Far from ‘counting every beat,’ the PurePulse Trackers do not and cannot consistently and accurately record wearers’ heart rates during the intense physical activity for which Fitbit expressly markets them,” the lawsuit states.

Here’s Fitbit’s response:

Fitbit stands behind our heart rate technology and strongly disagrees with the statements made in the complaint and plans to vigorously defend the lawsuit.

Some of you might have read my article where I wrote that Fitbit’s data isn’t clinically relevant. The challenge is that they give the impression that it is clinically relevant. It’s a fine line you walk when you don’t want to take the time and spend the money to do the clinical studies and FDA clearance that’s needed to make clinical claims. Anecdotal results isn’t enough. Plus, the media can take and make whatever claims they want even if you are very careful with your words.

This discussion is going to become really important as clinically relevant devices that have gone through the clinical studies and can make the claims start to hit the market. It just takes years for these studies to see the light of day. Many would argue that it’s not fast enough. They’re right. It takes forever, but you’re walking a fine line in the claims you make while you wait for the results to be published.

While we wait, Doctors will continue to use and share these various digital health solutions and offer their first hand experience using the products. It’s just a really hard balancing act when the company starts to promote these stories.

Watch for this discussion to really come into focus in 2016. Count on legislation which clarifies what’s acceptable and what’s not as well.