Many of our leaders emphasize the need for more corporate social responsibility. Companies shouldn't just pursue profits--they should contribute to the common good. But if that's the case, why did the Obama administration with the support of congressional Democrats impose a punitive tax on makers of medical devices?

An OpEd in today's Wall Street Journal (ObamaCare's Killer Device Tax) by Henry I. Miller explains why this tax is destructive--particularly how it achieves the opposite of the administration's claimed goals by discouraging jobs, manufacturing, and economic growth.

Miller points out that the tax is especially hard on the startups and small companies that are a source of so much innovation:

Many medical device companies have to ramp up sales before they become profitable. Due to the long, draconian and sometimes unpredictable regulatory process that must be negotiated before a product can be sold, it can take from $70 million to $100 million in total sales before these businesses make their first cent of profits. Nevertheless, they would have to pay the excise tax on their revenue.

Though I have to disagree with Miller on one point:

Anticipating the excise tax, several companies already have announced layoffs or withheld investments. Recent surveys show that medical technology executives are examining a host of other undesirable options, including passing along the added costs through price increases. Even if the market would tolerate that—which is surely questionable given the current pressure to drive down costs—it would, ironically, raise the costs of medical care. That was not supposed to be an outcome of ObamaCare.

Does anyone really believe that ObamaCare was designed to make medical care less expensive? If there is one thing that economists should be able to agree on, it's that competition drives down prices. By making it harder for startups and small companies to succeed, the medical device tax will reduce competition and drive costs (and therefore prices) up.

A study published this week in Science Translational Medicine cast doubt on the value of gene mapping for the average consumer. As an article in the Wall Street Journal observes:

Sequencing can be very useful in assessing the risk of rare diseases triggered by a single faulty gene, such as the brain disorder known as Huntington's disease. With more common and more complex ailments affected by many genes and the interactions between them, the picture gets fuzzier. The study suggests, for instance, that whole-genome tests aren't especially helpful in predicting cancer in most people who don't have a strong family history of the disease.

This is more or less what I said in an earlier post. The study examined "data from thousands of twins in five countries" for 24 diseases. It found that for 23 of those diseases, gene mapping produced negative results, providing a false sense of security.

Eric Topol’s new book explains how digital technology enables individualized health care. While the book has some flaws, it’s a reasonably good introduction to a fascinating and important topic.

The book is divided into three parts: Setting The Foundation, Capturing The Data, and The Impact of Homo Digitus. Part One begins with a familiar message: the Internet and digital technology are changing everything. The next chapter reveals that many accepted medical practices are based on questionable research findings. Part One ends by discussing how consumers are sometimes misled by modern medicine—and may be misleading themselves about alternative medicine. The overall message is that the current system often causes as much harm as good, but not to worry, help is on the way.

Part Two describes new ways of harvesting health data. It’s unfortunate that Topol doesn’t cover some of the technologies in more depth. It’s even more unfortunate that he doesn’t display the same skepticism as in Part One. For example, he talks about putting sensors in automobiles to monitor the driver’s health, with the possibility of asking the driver to pull over or even automatically shutting down the car’s ignition system. If the lesson of Part One is that the current system can be hazardous to your health, the message of Part Two seems to be that the new technology merits blind trust.

Part Three argues that the U.S. health care system is too conservative and unaccountable, and how that’s about to change. As the author of a book about the history of medical technology, I can’t agree with Dr. Topol’s diagnosis. There is overwhelming evidence that new technology has repeatedly and dramatically changed our health care system. But it’s good to know that the medical profession resists change just for the sake of change. And if we want doctors and hospitals to be more accountable, then we need to start comparison shopping. Make them compete for our business, and do our own research on the Internet.

I have two major problems with Topol’s book. How could a proponent of individualized health care be so oblivious to the elephant in the room? The Patient Protection and Affordable Care Act will make our health care system more centralized, more top-down, and more bureaucratic. That doesn’t lead to individualized health care—it leads to one-size-fits-all health care.

The other problem is that the book is brimming with clichés. In fairness, Topol warns in the title that this is a book about “creative destruction” (if not “the democratization of medicine”). This is more than just annoying, however. For example, Topol pays obligatory homage to “crowdsourcing.” In my opinion, the “wisdom of crowds” is an oxymoron. According to a popular anecdote, when a large number of fair-goers were asked to guess the weight of an ox, their individual guesses were wrong but the average guess was remarkably accurate. Sorry, but this does not show that crowds possess wisdom. It merely illustrates how people’s false judgments are sometimes evenly distributed around the truth.

Topol boasts that in 2011 he tweeted: “Tunisia… Egypt… American medicine?” Last I heard, Egypt was on the verge of handing power over to the bigoted and anti-democratic Muslim Brotherhood. And a year after the Tunisian revolution, there are reports of journalists being arrested.

Topol’s book contains many interesting ideas and facts. And I’m sure it’s an accurate reflection of what many digital health care entrepreneurs are thinking. But the “Arab spring” is not a good model for health care reform. Not by a longshot.

comScore reports that the number of mobile users accessing health information from mobile devices more than doubled over the past year. During the 3 month period from Sep 2011 to Nov 2011, there were 16.9 million mobile health information users. comScore also reports that 60% of the users were under age 35. Unfortunately, the post doesn't say anything about the type of information accessed.

It's good to see health technology playing a bigger and bigger role at the Consumer Electronics Show (CES) in Las Vegas. However, you can tell this is an emerging market because most of the attention is focused on business opportunities rather than consumer solutions.

Dan Munro reports on CES at Forbes. Though he mentions personal health care products and services on display by Zeo, Fitbit, Qualcomm (sponsor of the "Tricorder X Prize" contest), the Continua Health Alliance, and Carnegie Mellon University, he's most excited about Life Technologies' Ion Proton Genetic Sequencer that, it is claimed, can sequence an entire human genome for around $1,000.

UnitedHealth Group, a major health insurance company, not only participated in CES, they created a special website for their CES presence. But is this because they are excited about the emerging opportunities or worried that private insurance will be driven out of the market by proponents of "single payer" (i.e., zero choice, zero competition) health care?

CES also featured the Digital Health Summit, a conference for "developers, manufacturers, distributors and service providers." Sessions included "Data Liberation: Making Health Data Intelligible for the Consumer" and "Is Technology Changing the Doctor-Patient Relationship?" Again, the agenda suggests an industry that is in search of a market breakthrough.

Personal health technology isn't going to take off until we free consumers to act as self-directed buyers of health care products and services and free the health care industry to compete for those buyers. Unfortunately, we are moving rapidly in the exact opposite direction.

I recently wrote an article for the Commonwealth Secretariat's magazine, Global Briefing. The article identifies four areas in which technology can drive down the cost of health care--provided we let it:

Everyone wants the best medical care that money can buy. Diagnostic imaging systems let doctors peer inside the body – often detecting health problems in their earliest, most treatable, stages. Implantable pacemakers and defibrillators restore the heart’s proper rhythm. Cochlear implants help many people hear, and retinal implants are just a matter of time. But the best medical care that money can buy involves some costly technology.

In fact, sophisticated medical equipment is widely seen as one of the chief reasons that today’s health care is so expensive. While consumers want access to the latest advances, critics say we have become too dependent on expensive technology and that people in wealthy nations are over-diagnosed and over-treated. Given the high cost of medical technology, a number of policy-makers have concluded that we should ration access to the most aggressive treatments.

But exactly why is medical technology so expensive? There are several reasons. Patients insist that the health care industry performs flawlessly, so we subject new medical systems and devices to a phalanx of certifications, regulations and clinical trials – all of which add cost. But the main reason is that the industry has been so busy integrating computers and communications into medical products that the technology is only now beginning to stabilise and mature.

Developments in four key areas will drive down the cost of health care: high-end medical systems are being equipped with productivity-enhancing features; remote solutions that let specialists apply their skills at a distance are being deployed; mobile solutions that enable physicians to save time and money are coming to market; and personal health technology that helps consumers stay healthy and manage chronic medical conditions is starting to take off.

You can read the entire article here.

There was a highly misleading article by David B. Agus, a professor at the University of Southern California, in this weekend's edition of the Wall Street Journal. A Doctor in Your Pocket suggests that "tiny health monitors" and "tailored therapies" will lead to a future in which people will live disease-free lives up to age 100 or older. Agus exaggerates personal health technology's near-term potential to promote a greater role for government in health care.

Agus claims that with enough information we can either prevent diseases or catch them early enough to nip them in the bud. I agree that the more we know about diseases the better equipped we will be to prevent them or at least catch them during the earliest, most treatable stages. I also believe that new technologies will enable us to gather and analyze much more health data than was previously practical. But we are a very long way from being able to prevent most diseases and cure those that can't be prevented. Agus admits as much when he acknowledges that his strategy will only work up to about age 100. What he doesn't acknowledge is that people begin aging much earlier.

The point of the article seems to be that we must let government gather and use all available health data. Agus complains that privacy concerns are getting in the way: "...we can't expect the health care industry to continue to innovate and grow if we continue to hoard health information." Since Medicare pays over half of our country's medical bills, Agus reasons, then letting Medicare harvest and analyze its patients' data would enable Medicare to improve public health.

Agus argues that if we knew more about the body then we could put more emphasis on preventive medicine as opposed to diagnostic medicine. That's a popular view among people who want to see more government involvement in health care, but it assumes that most if not all diseases can be prevented. Agus also says he is a "big proponent" of genetic profiling for consumers, but as I discussed here these services offer most people little more than entertainment.

It's what Agus doesn't say that really worries me. Surely he knows that people don't always choose the healthiest alternative even when presented with ample information. In a free society, individuals have the right to eat and drink what they want, exercise or not exercise as they prefer, and make other tradeoffs that involve health risks. And there are, contrary to Agus, legitimate reasons for keeping private health data private.

Worse, Agus seems unaware that most health care innovation comes from private individuals and companies--not government. His vision of bringing all health databases together in a "centralized network" could actually discourage innovation.

The Wall Street Journal is on a roll--at least in terms of technology reporting. The cover story in this weekend's Review section, Citizen Scientists, discusses people who are demanding the right to control their own medical data and are even conducting their own research. Also known as "health hackers," these individuals are challenging the claim that their genomic data belongs to the laboratories who do the DNA testing and that only trained professionals should be able to perform clinical trials.

The article is particularly ironic given that just yesterday (see below) the Wall Street Journal ran a piece about academic labs producing findings that commercial labs are unable to reproduce. Sure enough, the Science Establishment is responding to the citizen scientists by circling its wagons: They are amateurs. Their data collection methods are not sufficiently rigorous. Their sample sizes are too small. And worst of all, the work of citizen scientists isn't supervised by the Food & Drug Administration (FDA).

Unfortunately, some of the activists want to take things to the other extreme. They want to create an Information Commons that would for all intents and purposes abolish intellectual property rights. It's one thing to suggest that my genetic information belongs to me, and it's another to suggest it belongs to everyone. Getting scientists to agree to share data will discourage innovative research. It's also a form of bullying: if the Information Commons catches on, then you can bet there won't be many jobs for scientists who decline to sign an agreement to share their data.

Some of the organizations mentioned in the article are Genetic Alliance, Center for Connected Health, and Sage Bionetworks (That'sMyData! project).

There is an important article today on the front page of the Wall Street Journal: Scientists' Elusive Goal: Reproducing Study Results.

Two years ago, a group of Boston researchers published a study describing how they had destroyed cancer tumors by targeting a protein called STK33. Scientists at biotechnology firm Amgen Inc. quickly pounced on the idea and assigned two dozen researchers to try to repeat the experiment with a goal of turning the findings into a drug.

It proved to be a waste of time and money. After six months of intensive lab work, Amgen found it couldn't replicate the results and scrapped the project.

Contrary to what most people think, government funding is a bad influence on science research. It encourages people to perform research and present findings that are pleasing to the agencies that dispense the funds. Research at private universities and companies is generally more honest and, overall, far more beneficial to society.

The UK Daily Mail reports on a "computerized contact lens" that might one day be used to stream information and gather physiological data:

...scientists have developed a prototype lens that could one day provide the wearer with all kinds of hands-free information.

It could also be used to display directions and TV programmes.

The lenses, which would be inserted and removed like normal contacts, could also be handy if you are indeed enjoying the great outdoors, allowing you to zoom in on distant views.

While the amount of information that could appear in front of our faces is tantalising, the researchers insist all the components are tiny and the normal field of vision will not be obstructed.

The super-lenses are the brainchild of Professor Babak Parviz, a contact lens-wearing engineer who specialises in making parts on the nanoscale, thousands of times thinner than a human hair.

So far, he has created a lens which is implanted with tiny components, including a single LED light, an antenna that picks up power and information through a wireless connection, and an electronic circuit.

This device is a long way from being practical. And that's a good thing, because it could be used to either empower or enslave individuals.

The article is followed by another about a retinal implant for people suffering from a specific form of blindness that has reportedly produced "astonishing" results in small-scale trials.

The U.S. Food and Drug Administration (FDA) is hoping to extend its regulatory fiefdom to mobile medical applications. The agency released its draft guidelines on July 19, 2011 and will accept comments until October 19th.

The FDA portrays the guidelines as uncontroversial. "These are the devices we have been regulating all along and just because they are on a mobile platform doesn’t mean we should be regulating differently,” the FDA's Dr. Jeffrey Shuren told MobiHealthNews. It's telling that the FDA doesn't cite examples of anyone being harmed.

However, the FDA’s argument that it is merely being consistent can also be used against the proposed guidelines. As the same article in MobiHealthNews pointed out, in 1989 the FDA proposed guidelines for regulating PC-based products but was forced to abandon the effort when the number and variety of such products quickly mushroomed.

The FDA also downplays the guidelines’ significance by pointing out that only a small percentage of mobile health apps would be affected. To wit, the guidelines only apply to apps that are used to diagnose and treat medical conditions. These include mobile apps that work with already regulated medical devices, mobile apps that turn handhelds into medical devices, and mobile apps that issue recommendations about a patient’s diagnosis or treatment.

The FDA's Bakul Patel commented, "We are starting off with the very small tip of the pyramid"—implying that we should be grateful that fitness and wellness applications are not included. He offered the hypothetical example of an app that transforms an iPhone into a stethoscope. Since stethoscopes are regulated, apps that turn iPhones into stethoscopes should also be regulated.

I challenge the wisdom of regulating stethoscopes in the first place. If physicians aren’t smart enough to purchase decent quality stethoscopes, then they probably aren’t smart enough to use them properly. Besides, I see no evidence that the FDA is smarter than most physicians, and the risks associated with regulating stethoscopes are arguably as great as the risks associated with not regulating them.

Patel explained the FDA is focusing on new risks posed by mobile platforms including small screen size, lower contrast ratio, uncontrolled ambient light, and use of the apps by ordinary consumers. However, all products have limitations, and the idea that a government agency can somehow eliminate them creates a dangerous illusion. Besides, these limitations are rather obvious. I would rather that physicians and consumers be mindful of the limitations than be denied affordable and timely products.

Instead of scheming to establish new regulations, the FDA would be wiser to take the opportunity afforded by mobile medical apps to test a completely different approach. The FDA could better serve the public by testing and reviewing mobile medical apps while subscribing to the highest standards of objectivity. This would enable the FDA to earn immense credibility while permitting physicians and consumers to make their own choices. I would hate to see this exciting new industry handcuffed by burdensome regulations.

Smartphones and tablets are booming, and their impact on health and fitness is just beginning to be felt. So which platforms should app developers target?

MyVirtualHealthCheck's announced launch of its Windows 7 version caught my eye. The app was already available for the iPhone and Android, so Windows 7 must have seemed like a natural next step. MyVirtualHealthCheck appears genuinely excited about the added functionality of Windows 7's user interface.

MyVirtualHealthCheck offers a single app for recording and sharing vital signs. It also provides access to a nutritional database and its chronic disease management website. There is even a location-based "Healthy Spots" feature that identifies nearby health food restaurants (among other healthy things).

The iPhone and Android versions are safe bets. I'm not as sure about Windows 7. Microsoft has been chasing the smartphone market for about as long as anyone—and with little success. Apple and Google just marched right in and swept everyone else aside. Microsoft's announced strategic alliance with Nokia is not so much a coup as a swan song. Nokia is the world's leading maker of mobile phones, but everyone knows that they are a has-been.