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ObamaCare And Regulatory Lock-In Threatens The Biggest Healthcare Tech Revolution In History

July 17, 2013

By Mark P. Mills


We are entering an era of big government medicine. Few could claim that ObamaCare hews to the market principles of Adam Smith, or state’s rights, or individual choice. And Silicon Valley’s DNA of unbridled innovation? Not so much.

In the swirl of issues surrounding the rollout of the Affordable Care Act, the most important one is largely in the backwater: A massive regulatory apparatus always has the effect, both intended and unintended, of locking-in existing technologies and stifling the advance of the new. Given the new tech-centric health revolution that is brewing today, there could hardly be a worse time to lock-in today’s technologies of healthcare.

Before reviewing the evidence of the emergent health-tech revolution that is unlike anything in history, first permit an analogy. Imagine a similar technology lock-in arising from regulatory, tax and stimulus policies, but associated instead with transportation 120 years ago. In 1893, the world was deep in the thrall of a peak age of mass transportation by steamship and rail. That year George Westinghouse publicly worried that the potential demand for wood for railroad ties could denude America’s forests. That year also saw, in Massachusetts, America’s first gasoline-powered car take to the road, the Duryea Motor Wagon. No one then imagined the rapid transformation to hyper-personalized transportation. Yet just 20 years after the Duryea, Henry Ford built the first automobile assembly-line.

Such pivots in history are rare. We are entering another with the emergence of hyper-personalized healthcare. In order to see the shape of this new revolution we have to start with the iPad � continuing the analogy, the equivalent to the dawn of the internal combustion engine � and how its technological ecosystem is creating the transformative superstructure.

Billions of people around the world will soon own an iPad or its cousin the iPhone and their imitators. Tablet sales alone, according to IDC Research, reveal that a Rubicon has been crossed: more tablets will be purchased this year than notebook computers, and in two years, tablet sales will blow past desktops and notebooks combined. In fact, for two consecutive years now, tablets have driven the PC market into negative growth territory for the first time since the dawn of the PC.

In an era where fast growth of tech stuff is taken for granted, no one (perhaps with the exception of Steve Jobs) foresaw the unprecedented rise of the 21st century’s new computing ecosystem �� mobile broadband, anchored in the tablet/smartphone and App economy. (A smartphone of course is essentially a tinier tablet, since �phone� is a euphemism for a device where phone calls comprise a trivial share of data traffic.) Wind the clock back just five years to the dawn of the iPhone, two years before the iPad’s launch, and you cannot find a single article forecasting the torrid expansion of this new mobile computing platform and its complementary revolution in software, the App. The world has gone from zero Apps to installing 50 billion in just five years. No product, software or otherwise, has been so rapidly adopted.

The embrace of the tablet/smartphone, using mobile broadband, is happening for a simple reason. Computing is finally entering an era where it is intuitively useful. Clunky desktop PCs and notebooks, fat keyboards, jumbles of wires and connectors, and confusing software that entangles you in do-loops of frustration evaporate with the elegant interface of the tablet/smartphone. And, courtesy of the advent of broadband wireless (itself only a few years old), you can easily, everywhere and practically for free, reach beyond the limits of a PC and tap into the Cloud.

Consider then the three salient features of the mobile broadband revolution, all remarkable, but in combination revolutionary. And it is the combination that creates the superstructure that transforms healthcare.

First, there is the universal access to the Cloud’s warehouse-scale supercomputing where you can personally use computing horsepower and big data analytics that utterly dwarf what governments deemed a national, classified asset a decade ago. And it keeps getting better. It is hard to overstate how much more powerful computing has become. A single iPad has 10,000 times the compute power of the vaunted IBM mainframe of 1980, and a single data center today (of which there are tens of thousands) contains tens of thousands of iPad equivalents. That’s where we find not only the long sought artificial intelligence that enables the commercial appetites of Amazon and Facebook (or perhaps the malfeasance of NSA), and Google Maps, or Siri Voice, and also the medical diagnostics capabilities of IBM’s Watson. (For more on Watson see here, and on big data analytics, here.)

The second feature is the ability to hyper-personalize your tablet/smartphone via Apps and accessories, whether for business, entertainment, or healthcare. The �personal� computer wasn’t so much personal, but distributed to lots of persons. It was a highly commoditized distribution of general purpose computing. PCs allowed computing to be taken outside of cloistered mainframe computer rooms and put it in every home. But everyone used the same software from a limited suite of standardized options (spreadsheets, word processing, email, Web access). It was a big deal, but it wasn’t very personal.

Now, however, if there’s not a specialized software tool, an App, for everything, there soon will be. The precision specificity of Apps, combined with their low cost (many free) and intuitive ease of use, finally offers not just an easy human-computer interface, but one that is customized and specific to any task, whether as mundane as controlling a DVR or house thermostat, or as complex as assisting a doctor’s diagnostic or mapping your blood chemistry. Apps make it simple to do more than shop and read newspapers. They are increasingly the default means to present and interface with any complex industrial, commercial � and medical � information system. (For more on Apps, see Next Innovation Hypercycle.)

The third feature of the new mobile broadband ecosystem is the ability to use the tablet/smartphone as a platform for omnipresent and broadband sensing and situational awareness. The PC was and is in every sense, blind. Mobile broadband computing is not just sighted but situationally aware. In the PC era, information inputs were all about typing. The only contextual or circumstance-specific information the computer could work with, say your location or your heartbeat, came from either the act of typing, or plugging into clunky devices and then typically only in specialized settings.

Your tablet/smartphone has a highly adaptable native suite of other sensor inputs: microphone, accelerometer, camera, GPS, and the touch screen. Each of these sensors can be repurposed; cameras can be used to image a lesion or recognize a face, microphones to identify stress in a voice, or the GPS to correlate your location with some service including, for example, whether you’ve been in a place that’s a vector for a flu epidemic.

The tablet/smartphone platform also offers a gateway for separate but complementary smart sensors (e.g.,Nike’s FuelBand) linked with ubiquitous wireless Bluetooth connectivity. The sensor possibilities are nearly limitless, and their costs keep collapsing, from wearables (tape-on heart monitor) to embedded (blood glucose), to swallowable (FDA has already approved an ingestible wireless feature for medicine). Now the wireless broadband connection to the Cloud can do more than answer Siri-voice verbal requests, and more than crunch data to map your trip, but map instead your state of health, in real time.

This synergistic ecosystem is inspiring hundreds of hardware, software and analytics start-ups. And the likes of IBM [NYSE:IBM] have focused their considerable intellectual prowess on artificial intelligence in the Cloud for medical analytics. Then there’s one of the core enablers of the tech ecosystem, Qualcomm [NASDAQ:QCOM], with its sponsorship last year of an X-Prize to spur development of a medical �Tricorder,� an idea from Star Trek now imminently possible.

The iPAD/iPhone paradigm has upended global IT markets, unleashed new productivity capabilities, changed lives with respect to convenience and entertainment, and now education and training around the world. But what exactly does one build on such a platform of ubiquitous, hyper-personalizable sensing with connectivity to supercomputing artificial intelligence? Well, an iPOP. An integrative Personal Omics Profile.

In the foreseeable future everyone will want and eventually get their own. The advent of the ubiquitous iPOP will do more for medicine, for our individual health, than anything since the discovery of germ theory and antibiotics.

What is an iPOP? To really understand and to get a peek under the hood of the iPOP machinery and what it will mean, I highly recommend you include in your summer reading my friend and colleague (and co-author with me of The Bottomless Well) Peter Huber’s monograph (here) about the emergence of digital molecular medicine. It’s a teaser for his new book out this September, The Cure in the Code.

Huber’s monograph, unsurprisingly lucid and persuasive, comes from someone capable of unraveling and explicating the intersection of three domains that make possible the iPOP revolution: the science of molecular medicine, information technology, and the regulatory apparatus that can enable it all, but is now holding it back. As Huber writes:

  • The formerly blind doctors now have keen molecular vision, too. In early 2012, scientists at Stanford University described how they had spent the previous two years tracking DNA, RNA, cell proteins, antibodies, metabolites, and molecular signals� some 40,000 biomarkers that yielded billions of data points�in the body of geneticist Michael Snyder, the team’s senior member, to create the first-ever �integrative Personal �Omics’ Profile�: an �iPOP.� Though Snyder had no family history or conventional risk factors, the data revealed a genetic predisposition to type 2 diabetes. Later in the study, the data tracked the onset of the disease in what has been described as �the first eyewitness account�viewed on a molecular level�of the birth of a disease that affects millions of Americans.� Then the iPOP team watched the diabetes markers revert to their normal state in response to treatment.
  • The technologies for designing and mass-producing the diagnostic biochemicals that power the iPOP, along with many less ambitious molecule sniffers already on the market, have been mastered. Arrayed on chip-size, micro-electro-mechanical laboratories, sniffers are now becoming complete bio-scanners that can, for a few dollars a whiff, search a cheek swab or a drop of blood for hundreds�and soon, thousands�of genes, proteins, and other biomarkers. Sensor chemicals on the surface of plastic or paper cards mounted in a breathalyzer can detect lung cancer, tuberculosis, and 100 other biomarkers associated with other disorders. More complex sequences of assays are now performed by automated banks of compact diagnostic machines that can quickly and cheaply diagnose germs, genes, and biochemical imbalances of every kind�in as many specimens of bodily fluids or tissues as anyone cares to supply.

Your personal �omics� profile comes from the biological domains ending in the suffix -omics such as genomics, interactomics, proteomics, metabolomics (all your metabolites), lipidomics (the totality of lipids), spliceomics (protein splicing), mechanomics (an organism’s mechanical operation), and more. It’s about everything that comprises the machinery of you. And technology’s ability to sense, measure, monitor, track across all these �omics� is already vast and expanding rapidly, and because it is all related to information and silicon technology, getting cheaper fast.

Huber describes what the advent of big data tools and analytics means when combined with our stunning gains in understanding molecular biology � the potential for, as he puts it, �molecular scalpels� that will allow hyper-personalized therapeutics. By knowing nearly everything about your particular illness, and your particular body, and producing molecular drugs specifically tailored not just to your disease, but how an invasion operates in your unique biosystem, health care enters an era unlike anything before. It is no small thing, and no coincidence that both the physicians and our �personal� computers are no longer blind.

Healthcare is by definition hyper-personal, and to be effective requires scads of information about everything you’ve done and where you’ve been (situational awareness � voluntarily) and most importantly everything about the staggeringly complex biochemical molecular machinery that is uniquely yours. This latter task is astronomical in scale, and emerging computing power is finally measuring up.

To say this is a big deal doesn’t come close. But, also as Huber writes, �Washington remains focused on why ordinary citizens should not be permitted to read their own biochemical scripts,� and he lays out a prescription not just for why the regulatory apparatus of Washington has to change, but how it should change. The future of medicine, not just for your children and grandchildren, but for you, can improve profoundly. And it could be soon, if we let it happen with the speed of Silicon Valley instead of Pennsylvania Avenue.

Ultimately the iPOP becomes a product for anyone, and most everyone will want it too. Like any tech �product,� it is created from a constellation of components. And you can be sure consumers will purchase iPOPs at a pace likely to dwarf the adoption of the iPAD.

Knitting all of this together is the use of a new class of big data analytics based on Bayesian mathematics, which Huber illuminates and for which I cannot do justice here. But simplistically put, Bayesian analytics lets you perform computational tasks that stump traditional statistical analysis with the many disparate and orthogonal variables that comprise the real world. And no world is more real than the human body. �Bayes’ theorem is an algorithm for combining prior experience with current evidence,� writes Stanford mathematician Bradley Efron in Science. It’s the statistical tool that got Nate Silver famous for so accurately predicting the last presidential election outcome. It would be much more useful � albeit much more difficult � to predict the outcome of the use of a particular drug to address your particular molecular malady.

The technology now in hand and emerging takes us to the world of hyper-personalized medicine. The suite of (voluntarily and personally collectable) biological data is exploding from future FuelBand-esque tools you can wear, glue on or swallow, to those that will talk to and give eyes to you tablet/smartphone. People will want, not just embrace, the opportunity when, inevitably, it becomes cheap and easy to collect all the real-time data about our day-to-day state of health not just at the macro but also soon at the molecular level � the latter first by accessory and later by implantable lab-on-a-chip.

With all this data, and with modern molecular medical science and Bayesian tools, we will precisely identify and engineer therapeutics for individuals, and the costs of healthcare will collapse. More importantly, the effectiveness of healthcare and therapeutics will soar. Today’s drug paradigm will look in our near future as dated as blood-letting with leaches does to us today. But, as Huber summarizes, that new era is already being impeded by the old era’s regulatory regime, with its epicenter in the FDA’s laws anchored in the pre-vacuum-tube era.

Today the technologies that make hyper-personalized medicine possible are all in place � and even obvious. There’s one difference compared to the century-old transportation revolution. The pace with which we can implement today is, as demonstrated by recent silicon and algorithm history, far faster than in the old steel and oil world.

First millions, then billions of people will want and have individual iPOPs. And we will vault from what Cisco [NASDAQ:CSC] labels today’s zettabyte era of big data, into one beyond yottabytes (the next, and last named big number). The assembly lines of the future will be molecular, and very personal.

And while the iPad has made a lot of people happier, the iPOP will make many healthier. The world will be more productive too as silicon-enabled molecular medicine eviscerates health care costs in ways ObamaCare cannot.

So the race is underway between Silicon Valley and Pennsylvania Avenue, between Big Data Medicine and Big Government Healthcare. It’s a race between the old regulatory apparatus, and the innovators and citizens. It is a battle between the sclerotic reflexes of the bureaucratic machinery and the torrid appetite of markets. And in this case it is the market that matters most to everyone. The longer the bureaucracy prevails the more that many lives will be, at a minimum, less pleasant, and for many too short.

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