Although many are predicting that 2016 will be the year for Health IT, after consulting The Prophecies by Michel de Nostredame I have some wake up news to provide everyone:

1 – The death of the Meaningful Use corpse that was announced by CMS Chief Andy Slavitt during the J.P. Morgan Healthcare Conference, which took place in San Francisco from January 11th – 15th 2016, will have serious repercussions throughout Capitol Hill and will fuel one of the “bloodiest” political battles in the United States history.

The dilapidation of $31 billion that didn’t bear fruits beyond the 1st stage which only true requirement was “Use an EHR”, which proliferated the physician practices with clunky products and created the most insensible healthcare environment between doctors and their patients, will be questioned by many politicians of opposing parties and used against the ruling party.

2 – Since the failure of coming up with a sound national interoperability strategy and the lack of execution of any plan after 7 years, interoperability will take a first stage during 2016.  There is a clear acknowledgement that Meaningful Use failed because it set out interoperability requirements without having a strategy and useful standards.

A very serious national conversation will occur and action will come out of it.  There will be an honest recognition regarding that what we have as standards today will not get us where we need to be and that they have failed over and over without providing a clear path to success.  There will be participation with the most successful technology companies in the world in order to address interoperability.

There will be some surprises where some startups will rise out of the dark and offer extremely creative solutions.

3 – National Federated HIEs will be formed in order to bring together the states and other private and public HIEs that have been continuously failing, one after another.

This alone will bring about serious transformation in healthcare where a national patient identifier will finally be agreed to and a standardized format of a longitudinal electronic health record, that includes genomics and other personalized medicine information, will be defined in order to achieve true interoperability.

4 – Gadgets will be gadgets and disappear out of the healthcare landscape.  True medical devices and approved by the FDA will start appearing in the market and leaving gadget and app “pushers” behind and eating dust.

There will be innovative apps but they will have to undergo serious regulatory trials and approvals before being marketed as such.  If they claim to diagnose, detect or treat a disease or a health abnormality they will have to obtain a PMA or a 510(k).

220px-Nostradamus_by_Cesar

5 – Telehealth will continue to struggle to discover its positioning in the consumer market.  The technology is present and ubiquitous but it will have many cultural challenges to be universally adopted.

6 – Precision or Personalized medicine will start merging with Healthcare IT to discover that it will take years to become mainstream.  Although many healthcare systems with sufficient financial resources will be successful with genomics and pharmacogenomics.

7 – Big Data will finally be recognized as a fad in healthcare and a movement towards relevant, contextual and precise data, along with precision medicine, will be what the industry will follow.

8 – Merges and acquisitions will continue, companies will be flipped, but they will all be duds.  The true winners will be those that have been patient and have paid there dues while providing true service to healthcare.

The world will not end as the older prophecies revealed.

Once upon a time the U.S. Food and Drug Administration, or FDA, was a very zealous organization monitoring and enforcing the toughest quality and safety standards, for food, drugs and medical devices, which made the USA pharmaceutical and medical industry the most highly respected one in the world.

Not even European countries, which have always competed with the USA in order to demonstrate that they have higher standards, could ever surpass this country regarding quality and safety assurance for medical devices.

In South America where regulations, even though they exist, they are hardly enforced, most medical device purchases would refer to the USA FDA approval seal to ensure quality and above all safety.  Please note that this was not required by law but it was simply the right thing to do.  Even vendors would use the FDA approval as a competitive advantage to sell their products.

The FDA is an agency within the Department of Health and Human Services.

The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency’s ability to safeguard and advance public health.

The Health Information Technology for Economic and Clinical Health (HITECH) Act supports the development of a nationwide health IT infrastructure.

The HITECH Act empowers the Office of the National Coordinator for Health Information Technology(ONC) to build an interoperable, private and secure nationwide health information system and supporting the widespread, meaningful use of health information technology.

The ONC is organizationally located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS).

What could we conclude from the above HHS agencies or offices?

Well, one acts as a traffic cop for medical devices, among other things, and the other one has orders to push technology at a fast rate.  Apparently, we have put a traffic cop in the middle of an NASCAR race.  There seems to be a conflict of interests here.

Albeit an unintended consequence, since the FDASIA clearly expands the FDA’s authorities and strengths, the FDA seems to have a weakened authority to enforce the adequate processes that manufactures should adhere to in order to build, release  and advertise medical devices to the market.

Congress has pressured the FDA in order to not contribute to the stifling of the technological advancement.

We have a situation where an enforcing agency [FDA] is unable to act due to external political pressures.

Meanwhile, many have been abusing this weakened authority and lack of autonomy.  The press is chalk-full of news regarding “digital snake oil“.

But, what exactly is a medical device?

Per the FDA a medical device is: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Many mobile medical apps are claiming to do precisely what medical devices are for, that is, detect or diagnose a disease or other conditions.

For the FDA it’s easy to control medical devices that have to go through rigorous processes in order to be marketed.  Even if they are being manufactured overseas they have to go through certain “physical” gateways before they are promoted and marketed in the USA.  The conventional devices have to be transported,traverse customs, acquire other permits and clearances (e.g.; FCC), before they reach the distribution channels.

The FDA can also audit or request the companies in the US soil to prove that they follow a quality control process following international standards for quality management systems, such as: ISO-13485.

Before a medical device is even marketed in the US, that is, the simple announcing it to the public with the intent of selling it, the product must obtain a FDA Premarket Approval (PMA) or a 510(k) Clearance.

Medical apps on both Android and Apple platforms have become ubiquitous, these are classified as Mobile Medical Applications by the FDA.

Even controlling the Apple or Google stores by requiring them to act as proxies by enforcing regulations could be easily circumvented.  And from a layman’s perspective this seems like a legal impossibility.

Apple has some control over the apps you download but you can do anything on an Android.  And if medical device apps get blocked by Apple most of those interested more in the apps than the niche segment, will just move to the competitors.

But how would the FDA control the “manufacturing” of mobile medical apps when they can be delivered through the Internet from any location in the world.  The user could simply download the app and install it on their phone or tablet.

The FDA has no authority outside of the USA.  How can the FDA stop a mobile health app being developed in Eastern Europe or in China from being downloaded into a smartphone here in the USA?

Another fact is that entrepreneurs move fast, and technology is changing at a speed never witnessed before and this is only going to get much more aggressive in the near future.  On the other hand, the FDA moves slowly, and most times with the best intentions in mind.  The FDA was created to protect the American People from harm produced by inadequate and untested medical devices or drugs.

Entrepreneurs have on their side congress members like Rep. Chris Collins (R-N.Y.).

These technology advocates understand that if the FDA becomes a hindrance for American entrepreneurs, the USA is going to lose its technological vantage point to other countries that impose little or no restriction on mobile medical apps.

This may be the reason why the FDA has been performing more the role of guidance than of enforcement relating to mobile medical apps.

Postmarket Management of Cybersecurity in Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff

If the FDA pushes too hard on this recent technological rising, the USA will lose ground to foreign competition and our market will not be protected unless the Internet is closed to the outside world and we know this will never happen.

The fact of the matter is that this is not an easy problem to solve.

Could it be that the FDA has gone obsolete?

Performing tests with a drop of blood is nothing new.

Diabetics have been doing this on their own for over two decades with a blood glucose meter or glucometer that uses a an electro-chemical strip where the sample drop is placed in a spot that contains glucose oxidase, an enzyme that reacts to glucose by forming gluconic acid, this acid then reacts with another chemical on the strip called ferricyanide forming ferrocyanide.

When this chemically activated strip is inserted in the glucometer it completes a circuit through an electrode where a current is induced.  The higher the glucose in the blood the higher the reading provided by the meter due to the variation of the resistance proportional to the ferrocyanide level.  The process described in this paragraph is denominated the amperometric method.

There is another method that differs from the one explained above which is called the colorimetric method.

Simple, right?  Not so, these blood drop tests have a lot of technology behind them.  And the glucose meter is probably one of the most technologically simplest that exists.

There are other devices that use a drop of blood to provide measurements of some sort.

The A1C, or hemoglobin A1c, is a blood test that provides information about a person’s average levels of blood glucose over the past 90 days.  Today, a diabetic can also perform this test at home with a small meter and a drop of blood.

Another common home test device that uses a drop of blood is the cholesterol meter.  Although the home test is limited to overall cholesterol and it doesn’t distinguish between LDL, HDL and triglycerides.

For this discussion let’s set aside the true clinical efficacy of all of the aforementioned devices.  Let’s assume that they are all clinically accurate in the same way as the ones of the general diagnostic laboratories.

What’s important to consider is that drop blood tests are not innovative or new.  They’ve been around for several decades.

But let’s not get further into the science and technology (S&T) of this topic.  Hopefully, and if I did a good job at explaining, you got the point.

What is going on with Theranos has very little to do with the S&T and more to do with the regulatory and business aspects around startups and especially for those that may become unicorns.

But what do the above mentioned devices have in common?  They are all FDA approved medical devices.  That means that they have been rigorously tested for quality, reliability and accuracy.  Or they should have, we hope.

A FDA approval of a medical device is a seal of legality to be able to market and sell it.

From what I’ve been able to read in the media, Theranos only has the FDA approval for what appears to be a CLIA waiver to perform a test that detects the presence of the sexually transmitted disease known as herpes simplex virus (HSV-1) outside of a controlled laboratory environment.

Theranos is also seeking the FDA approval, in the same fashion according to the media information, for 120 more tests.

In their website they list more than 120 tests even with pricing: Theranos Test Menu.  Talk about transparency!  This is one of the most transparent organizations I have witnessed in the USA healthcare system!  It gives me “I feel good!” goosebumps!

But one important activity that Theranos has not been performing is manufacturing their medical device(s) using a quality control system that is required by the FDA for medical device manufacturers.  Elizabeth Holmes, CEO of Theranos, claimed that they had been using a laboratory standard instead of the one typically used by medical device manufactures, the ISO-13485 based quality control system.

For a company valuated at 9 billion dollars I find it rather intriguing that they weren’t doing the things that medical device manufactures typically perform.  Did they have the wrong counseling?  Was it a strategic approach to preserve secrecy as much as possible?

If it was a strategic approach then somehow they didn’t account for the media debacle that ensued.

Theranos is in a serious situation even if they come out of the regulatory scrutiny unscathed.  Healthcare is unforgiving to missteps and negative media.

Partners have distanced themselves from Theranos.  Building these partnerships takes years and rebuilding them is almost impossible.

If you are an entrepreneur that is running a startup in the healthcare space, read carefully:

  • It’s not easy to know when you are entering the space of a medical device
  • When you learn that you have, it’s almost too late to do the right thing if you hadn’t prepared for it
  • You only get one shot in healthcare, there’s no double-dipping here
  • It’s not hard to do the right thing and don’t let process-adverse employees dissuade you – Implementing an ISO-13485 based control system is like cooking with a recipe – It’s not hard at all

Only time will tell how Theranos and Elizabeth Holmes will overcome the conundrum in which they’ve fallen into.  Elizabeth is a very smart person and this is obvious by observing her in the media throughout the ordeal she’s been involved in.

But you, dear entrepreneur, may not be as lucky.  Get your act straight from the beginning.

And believe me, many of you in Health IT are indeed manufacturing software as a medical device and you don’t know it.  You’re even in denial because many of you have heard it personally from me.

Telemedicine is not new to me.  I led a project deploying telemedicine technology in the Amazon jungles of Venezuela and other rural and critical access places in both the State of Bolivar and the Federal District of the Amazons, located in the Southern part of the oil-rich country.

This project occurred during the mid 90s and it was funded by a government grant spurred by the outbreak of the dengue fever.

On one side there was a tribe of Arawakan (Yanomamis) natives as patients, which were suffering from complications of the dengue fever outbreak, along with a small group of physicians, paramedics and engineers, and on the other side, 12 driving hours away, a university hospital with specialists of varied disciplines and a large group of medical students.

The video technology was used to provide the means to allow the university hospital doctors to assess the complications and provide requests for specimens, treatments or recommendations.

The program didn’t last long.  The grant dried out and it was too expensive to sustain for any practical means.  There were political agendas fighting a tug war behind the scenes, dengue fever became commonplace throughout the Americas and was no longer confined to the jungles which had attracted international media due to its mysterious appeal.

The technology in those days wasn’t by any means primitive but it wasn’t perfect; it was costly and it required a lot of technical overhead to maintain operating adequately in remote areas where even the electricity had to be transported along with it.

Let’s quickly transport ourselves forward quarter of a century through time.

Video technology has advanced significantly in speed and resolution and you can view more detail at a tolerable speed.  Tablets and phones came around and video chatting has been readily available from the get-go.

There’s Apple’s FaceTime and Google’s Hangouts which have been popular among the least-aged population.  These applications lend themselves to personal video chats.

We have other services that have provided ubiquity and ease of access to video calls and conferencing, such as: Skype, LifeSize, Biscotti, Zoom and Oovoo, among many, that have a presence in some homes and companies.

But despite all of these technologies and the ubiquity and ease of access the consistent adoption is not that high.  The use is rather sporadic and capricious.

I am a big fan of technology, reason why I’m a technology engineer and architect.  In my house there are 9 computers immediately accessible with video technology.  Each one of my 9 TVs has a video camera.  Yes, I have a TV in each and every room with the exception of the dining room.  Technology is not allowed in the dining room with the exception of the light fixtures.  Most of the technology is Skype or Biscotti.  I acquired Biscotti to be able to integrate with H.323/SIP based systems.  If you did the math, and include the smartphones and tablets, my family and I have access to 25 video capable devices!

For the past 6 years I’ve dwelled at more than one abode so I installed the sophisticated network of video cameras throughout the homes to keep in touch with my family in a personable way, or at least that was my thinking.

Albeit I spent a fortune in video technology it seldom gets used if at all.

So it’s not the technology and the ubiquity of it, it’s the lack of culture of use that impedes its adoption, in my opinion and from my direct experience along with my family.  It’s easier to just pick up the phone and call or send a text message.  When my family and I communicate from a distance, video conferencing is the last thing that comes to our mind.  When we do use it, it has more to do with showing me some new garment or the latest cool trick one of our four legged hairy family members just learnt.

But for some reason, maybe just money, I don’t really know, there are companies out there that are touting telemedicine or telehealth as the next BIG thing in healthcare.

I will not deny that it has an appeal to it but the arguments that the technology promoters use are mostly flawed:

Doctors will have more time to attend patients is a common argument and the most flawed of them all, in my opinion.  First of all, the doctors time is finite whether in person or via telemedicine.  If you have been a patient lately you must have witnessed that a typical visit consists of several encounters with various clinicians. The attention span of the primary physician you are visiting is similar to that of a squirrel.  I’ve clocked this and out of the hour long visit, my primary physician or the specialist interact with me a couple of times in micro-instances of less than 3 minutes each. The physicians in their practice offices attend several patients in the window of an hour.  With telemedicine the accustomed orchestrated workflow of the physician and the clinicians comes to a stand-still with a slot of time frozen between the physician and the patient participating in the video link.

This is one more area where physicians view technologists as out of this world, and not in a good sense, and they have a right to have an opinion of that nature!

Just because its beautiful in technology and it looks cool in movies like Star Wars doesn’t mean it will work and fit in a real medical setting.

Another silly claim is that telemedicine can integrate with the EMR and the patients electronic health record.  First of all, doctors walk around their practices with the EMR laptop in their hands while moving from patient to patient in the attempt to maximize the results of the orchestration of the entire practice in order to attend as many patients as possible in a specific time frame.

Just to make the above claim true the interoperability requirements are of a maturity level that is way beyond what exists today and probably for the next decade.

Telemedicine will bring the costs down is the one that sounds like a used car salesmen line.  Physicians have been fighting for parity laws so that if they are forced to use telemedicine they will be able to be compensated in the same way as if it was an in-person visit.  Costs will not go down and efficiency will not improve.

There will be cases where patients would require telemedicine and there should be services that do provide it.  But these are special cases and not related to the mass adoption that technology vendors have been trying to push.

I have also observed that physicians use telemedicine or telehealth to capture new patients and attract them to their practices.  The story usually unfolds with a patient requiring a prescription and the doctor indicating that he/she can provide the order but for a short period of time and that if the patient requires constant refills he/she must have an in-person visit.  Hooked.

But what will happen once the practice has a steady flow of patients.  Will the doctor continue fishing for patients via phone or video?  I doubt it.  Busy doctors don’t have time for petty video-chats.

Technologists will continue pushing technology for the sake of itself.  Investors will continue seeking the next unicorn.  Some doctors love technology and evangelize it even if they don’t practice anymore.  Startups will come and go.  All in all, dreams are good for the economy.

So, who wants to video-chat with me today?  Doctor?

 

Clarification note:  Telemedicine is referred to in this article simply in the context of audio/video-conferencing that takes place between a physician from the practice site to the home of the patient as the originating site.  It is not the intent of the article of stating that the use of telemedicine between practitioners at different locations isn’t valuable.  Like I indicated in a paragraph above, there are cases where telemedicine has a lot of value and patients will require this type of service.  But mass-consumer scale telemedicine has a long way to go, in my opinion.

The National Health Information Technology Interoperability Manifesto

NHITM

A Call To Support and Participate

January 22nd, 2016

Harrisburg, PA

Today, January 22nd, 2016 a call to support and participate is published to invite all interested corporations, companies and individuals to help define the National Health Information Technology Interoperability Manifesto or NHITM.

Up to a maximum of 20 persons will be selected to define the Manifesto.  It is important that each one of the 20 persons represent a unique area of healthcare.

Once the Manifesto is defined we will then craft the governing principles.  We will craft less than 15 principles.

To participate please use a valid Twitter account and send a tweet with the following message:

“I @twitter_handle, pledge to contribute to and support the National HIT Interoperability Manifesto. #NHITM #HealthIT #HITsm”

The first 20 persons that represent valid segments of healthcare will be selected as participants to help craft the Manifesto.

Thank you for your support to help create a National Health Information Technology Interoperability plan, strategy and approach.

Michael Planchart (@theEHRGuy)

Enterprise Healthcare IT Architect

Are you ready for this year’s Independence Day #HIT100 event?!

Let the fun begin!

Remember, this is not a vanity contest but a means to allow our community to learn about each other and follow each other.  We have referred to it as a #HealthIT and #HITsm #FollowFriday on steroids.

This year there are some changes, hopefully all good for everyone.  Some rules will change so that we can leverage the analytical tools put in place for this year’s event.

ANALYTICS PLATFORM:

I’ve assembled a real-time, or near real-time, analytical platform to capture the #HIT100 stream with other associated hashtags.

I did this to avoid what happened in 2014 where I had some personal issues and I was unable to keep up with the effort.

This analytical platform has been assembled in the cloud using AWS Kinesis Firehose, Elasticsearch Service, a Lambda Python function and S3 (integrated with a node.js JavaScript client application that captures the Twitter stream and sends through Firehose to S3).  The discovery, viewing and all analytical magic is enabled by Kibana.

To learn more visit: Building a Near Real-Time Discovery Platform with AWS by Assaf Mentzer.

The tweets stream, which will start being collected today at noon, is filtered with the following hashtags:

Required hashtags:

(Each nomination should have all of these)

  • #HIT100 or #HIT99 (One or the other is required)

Optional hashtags:

(Please use only one of them so that the analytics have value)

  • #HealthIT (Optional but helps filter unwanted noise)
  • #HITsm (Optional but helps filter unwanted noise – please do not use on Friday’s between 10:30 AM and 12:30 PM Central Time)
  • #FHIR (Optional)
  • #Interoperability (Optional)
  • #PersonalizedMedicine or #PrecisionMedicine (Optional)
  • #Genomics

Some rules will change this year due to the analytical tools being put in place for the first time:

NOMINATION RULES:

  1. Nominations start Friday July 1st 2016 at 6PM and end on Friday July 8th at 6PM
  2. Only one person at a time may be nominated.  Multi-nominations in one tweet will not be counted though they might form part of the analytical information base
  3. Only direct nominations will be counted.  Retweets will not be counted though they may be analyzed for further enjoyment
  4. Favorites will not be counted though they may be analyzed for further entertainment
  5. There will only be one cycle of nominations.  No delegates or super-delegates here
  6. I reserve the judgement to disqualify a nomination that I find suspicious for any reason
  7. You are encouraged to include one of the optional hashtags above so that we can process with analytics to get some statistics about each one of them
  8. You can add a sentiment to the end of the nomination
  9. You must have fun and please follow each other as you discover new members of our community

I’ve been receiving a couple of messages in public about the “accuracy” and “transparency” of how the #HIT100 votes are counted.  I’ll explain this further below.

Just to be crystal clear, the stack and ranking is just the entertainment and part of the fun of #HIT100.

The spirit of #HIT100 is to introduce community members to each other and it’s not a competition for a first place prize or anything of that nature.

We do want to recognize the influencers in both our #HealthIT and #HITsm communities or channels.  That’s why we do the stack and ranking.  But it’s not the essence of it.

Over the years I’ve witnessed some people reach the top of the list and they weren’t what I would consider “influencers”.  I’ve also witnessed some of the most influential people in healthcare IT be beyond the bottom of the list.  This proves that this order is not what is significant and relevant regarding the spirit of #HIT100.

There are some that have created the notion of an official list and unofficial lists.  These are artificial artifacts that have no purpose in the community.

The truth is that I have never published a list!  You will not find a list on my blog or any other website I own and operate.

The lists have been published by community members and others interested in spreading the fun and building of our communities.

For example:

  • HIT100 2011 was published by Motorcycle_Guy on his blog and by NateOsIT on his blog
  • HIT100 2012 was published by Healthcare IT News
  • HIT100 2013 was published by Healthcare IT News
  • HIT100 2014 was published by Healthcare Scene (they called it the “unofficial” list and there is no such thing as an official list)
  • HIT100 2015 was executed by others with another hashtag named HIT99
  • HIT100 2016 has been published in a novel way:
    • The Top 5
    • The Top 6-10
    • The Top 11-25
    • The Reverse List with a countdown from 100 to 50 in a #FollowFriday format (inspired by MandiBPro’s HIT100 video)
    • A final list that will be published soon

The truth is that every year has been different.  Every year everyone has fun and enjoys it.

I do the tallying in a simple way.  This year I simplified it even more with some simple algorithms.

  1. Complex nominations, which I consider those that have multiple handles or URLs or other artifacts were excluded from the list.  The exclusion list removed 257 complex nominations. Some care was taken with the top 25 to make sure close ties could be verified and validated.  Duplicate nominations were also removed.  This produced a “curated” list.  The curated list ended up having 2417 valid nominations.
  2. With a simple SQL grouping select statement the tweets with the unique nominee handle were grouped and summed.  This created a sequential list organized alphabetically with hundreds of nominees.  The top 100 of the list were the ones that have been in the announcements.

The nominations were being captured near real-time and the analytics were being continuously published.

The best effort was performed to be transparent and accurate but that doesn’t mean that artificial intelligence was performed on all the tweets.  Some tweets got filtered for not meeting the basic syntax that was required.

The spirit of #HIT100 is not the stack and ranking but the building and bringing of a community together.

Read more here