Free EMR Newsletter Want to receive the latest news on EMR, Meaningful Use, ARRA and Healthcare IT sent straight to your email? Join thousands of healthcare pros who subscribe to EMR and HIPAA for FREE!!

23andMe Gets FDA Authorization for Consumer Genetic Health Risk Reports

Posted on April 11, 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.

The big news about 23andMe’s FDA approval came out last week when I was holed up at a conference.

That’s right. 23andMe can now directly offer consumers a genetic health risk report that’s FDA approved. This is a big step for 23andMe when you consider that they’d previously gotten their hand slapped by the FDA.

23andMe got what’s called a de novo authorization from the FDA. This is something we’re likely to see more of and something that I’m sure many people aren’t familiar with. Here’s a description of what a de novo authorization is from the 23andMe announcement:

What does it mean to be granted a de novo authorization?
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option, which provides an alternate pathway to classify novel devices of low to moderate risk. The de novo process is used by the FDA to grant marketing authorization for devices that are new and unlike any other on the market. In addition de novo marketing authorization means that 23andMe met the FDA’s premarket requirements to demonstrate the following: accuracy, validity and user comprehension.

I’m glad that the FDA has created this new form of authorization for companies like 23andMe. This story also stands in stark contrast to other FDA related stories like Theranos. I’m sure that 23andMe would hate the comparison. However, there are some similarities. They both got slapped by the FDA. However, their response to the FDA’s notices was completely different. That’s why 23andMe seems to still be thriving and now have FDA approval. Theranos is floundering with reports that their founder now owes the company $25 million.

Needless to say, if you’re a healthcare startup, make sure you know the FDA regulations that apply to your startup.

Theranos “Punks” the Scientific Community In First Public Presentation at AACC

Posted on August 2, 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.

Elizabeth Holmes made her first public appearance at #AACC2016 where most thought that she would address the concerns (I’m being nice) around the Theranos products and practices. While most believed that Holmes would not go into much detail, I didn’t see anyone predict that she would not only avoid the controversy, but she also decided to launch a new product. I use the phrase “new product” lightly since it’s similar to lab equipment on the market today, but smaller.

I think this image and tweet describes most people’s reaction to this bait and switch by Theranos and Holmes:
Theranos Punks AACC in First Public Appearance

It’s too bad she chose not to address the controversy before trying to sell another product. Are there any labs out there that will buy this new product until they do address the controversy? I’d hope not. Theranos will have to address it, but for some reason they’re putting it off.

This tweets seems to have captured the sentiment that most will likely feel about any product that Theranos tries to deliver:

Regulation Lesson Learned from Theranos

Posted on 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.

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.

How Will Quick Labs Change Healthcare?

Posted on September 23, 2015 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 was struck by the news that HealthSpot was planning to bring the 7 minute blood test to their retail pharmacy clinics. For those not familiar with HealthSpot, they provide a kind of kiosk setup that allows for a telemedicine visit with a doctor. However, what makes them unique is that the kiosk is staffed by an MA who can assist the patient. Plus, the kiosk has a bunch of medical devices which the remote doctor can make available to the patient as part of their treating the patient.

While I find it fascinating that HealthSpot is taking this all to the next level with a 7 minute blood test, it also made me start to think about the impact of these quick lab tests on healthcare in general. We’re seeing much of this work pioneered by Theranos’ lab efforts. The HealthSpot announcement above seems to indicate that a whole wave of new quick labs are heading to the market.

We like to talk about the lab result workflow when it comes to EHR software. If you have an interface between your EHR and the lab, then the results can automatically appear in the EHR. Over the years I’ve heard a lot of debate and discussion around whether the lab results should be automatically shared with the patient or not. The arguments against sharing revolve around the patient misreading the diagnosis or the patient getting a bad result without a medical provider there to help them deal with the bad result and put it in context.

On the other side of the coin is the patients who say that it’s there data and they should have access to their data. Plus, they argue that waiting a few extra days for a normal result causes days of extra worrying while the patient waits for the doctor to get back to them with the normal result. The most common thinking is that normal results are fine to share in real time and the abnormal results are best delivered by someone to the patient. Of course, smart patients realize that if they don’t hear from the doctor soon, then it’s bad news which means the doctors have to stay on top of calling back even the abnormal results.

Now let’s reframe this discussion when it only takes 7 minutes to get the lab results. All of the above discussion doesn’t matter. The patient waits at the office for 7 minutes, the doctor has the results and can share the results with the patients immediately with the doctor present. No more phone tag. No more worrying while the patient waits for the results. No more issues with automatically sharing the results with the patients electronically. It’s really quite beautiful.

Of course, we won’t be able to do this for all lab results. Some lab results just take time. However, these quick labs are going to change a lot of things about how we interact with patients and that’s a good thing.

$10 Finger Stick Blood Tests Illustrate New Quantified Future

Posted on July 3, 2015 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 often talked about the variety of health sensors that are quantifying everything about us and how that’s going to change healthcare as we know it. As we have more information about ourselves, it’s impossible for us to keep doing the same things we’ve been doing. One of the challenges we’ve faced with this change is that we need access to the blood to really do quality testing. No one wants to do a venous blood draw to regularly monitor their health data.

This is why I’m so interested in what the quite secretive Theranos is doing with their finger stick blood tests. Yesterday, the big news hit that Theranos got their first FDA clearance for their herpes simplex 1 virus IgG test. Although, as MedCityNews notes, this is the first of 100 pre-submissions they have underway with the FDA.

This is exciting news, but this part of the MedCityNews article is even more exciting for me:

Its HSV-1 test costs $9.07 – one of 153 tests the company says it makes that cost less than $10.

This is a great price point for a lab test and we’d all benefit from this massive decrease in price. I’m still not sure Theranos should have a $9 billion valuation. They still have a long way to go with the FDA, but if they’re able to execute then maybe that valuation isn’t that crazy after all.

Regardless of how Theranos does as a business, I think we’re going to see hundreds of companies like Theranos that continue to make testing more affordable. That’s going to change how we approach healthcare.