Few companies have experienced such a sudden reversal of fortune as the health care technology startup Theranos. The once-celebrated brainchild of Stanford University student Elizabeth Holmes is now the target of a criminal investigation.

We should be skeptical of claims made by businesses about new products or services. But we should also be skeptical about accusations made by former employees, potential competitors, and government regulators.

I still believe there is a bright future for Theranos’s vision of making blood tests more convenient, inexpensive, and proactive. Some of the charges against the firm seem petty. Unfortunately, it’s hard to ignore the government report that says Theranos’s finger stick system failed quality control tests at an alarming rate, and in some cases the QC failures were ignored.

Betsy Mccaughey writes about the corruption institutionalized by ObamaCare at Creators.com:

Wimping Out On Repeal

Top Republican Rep. Cathy McMorris Rodgers, R-Washington, is walking back comments attributed to her that Obamacare can't be repealed. But she's not the only one suggesting that the goal should be making changes within the framework of the health law. Senate Minority Leader Mitch McConnell, R-Kentucky, says the goal is to get the law "fixed." Apparently, a lot of Republican lawmakers still haven't read the law. If they had, they'd know the framework is corrupt.

Even presidential hopeful Sen. Rand Paul, R-Kentucky, speculated on Friday that repeal is unlikely, because it will be "difficult to turn the clock back."

Nonsense. Even by the most inflated Obama administration claims, some 8 million people have signed up for exchange plans out of a nation of 318 million. Obamacare is able to be repealed and should be replaced with a plan to cover the uninsured and reduce costs.

Obamacare's authors paid lip service to these goals but had an ulterior motive: forging a permanent Democratic majority. The law creates a huge infrastructure for enrolling millions of people not just in health care but also food stamps, housing assistance and other welfare programs — and registering them to vote.

Here are the pillars of this corrupt scheme. None of the minor fixes Republicans are discussing come even close to sweeping away this corruption.

—Navigators and assisters (Section 1311): Instead of government employees promoting Obamacare and enrolling the uninsured, the law reserves these jobs for community activists, unions, community health centers and other not-for-profits. Players include the NAACP, Planned Parenthood and the Service Employees International Union. Hiring these groups is a way to fund the shadow army of the Democratic Party in between elections.

Assisters sign up the uninsured for non-health benefits and register them to vote. The National Association of Community Health Centers identifies voter registration as a key part of its mission. The whole scheme recalls the days of Tammany Hall, when local ward bosses got the poor and newly arrived whatever they needed in exchange for their votes.

Obamacare institutionalizes this corrupt model and pays for it with your premiums.

Read the entire OpEd here.

For news about reports on emerging technology markets, see Datacomm Research.

For news about next-generation high-speed wireless, see MIMO World.

I heartily recommend Freedom and Individual Rights in Medicine to anyone who wants affordable health care and the right to make their own health care decisions. FIRM "promotes the philosophy of individual rights, personal responsibility, and free market economics in health care. FIRM holds that the only moral and practical way to obtain medical care is that of individuals choosing and paying for their own medical care in a capitalist free market. Federal and state regulations and entitlements, we maintain, are the two most important factors in driving up medical costs. They have created the crisis we face today."

Here is an excerpt from an article (Moral Health Care vs. “Universal Health Care”) by FIRM's founders Lin Zinser and Paul Hsieh.

Although American scientists, doctors, and businessmen have produced the most advanced medical technology in the world, American health care is in a state of crisis. Technologically, we are surrounded by medical marvels: New “clot buster” drugs enable patients to survive heart attacks that once would have been fatal; new forms of “keyhole surgery” enable patients with appendicitis to be treated and discharged within twenty-four hours, whereas previously they would have spent a week in the hospital; advances in cancer treatment enabled bicyclist Lance Armstrong to beat a testicular cancer, which, had he lived fifty years ago, would have killed him; and so on.

From an economic perspective, however, such medical treatments are increasingly out of reach to many Americans. Health care costs, as reported by the New York Times, are rising twice as fast as inflation.1 And health insurance, as reported by USA Today, “is becoming increasingly unaffordable for many employers and working people.”2 A decreasing percentage of employers are offering health insurance benefits to their workers, and many of those who are offering benefits are requiring their employees to pay a greater percentage of the costs.3 The U.S. Census Bureau reported in 2007 that nearly forty-seven million Americans had no health insurance, a sharp increase of ten million people from a mere fifteen years earlier.4 In short, there is a major disconnect between existing life-saving medical technology and the ability of Americans to afford it.

This discord is affecting doctors as well. The American Medical Association warns physicians that, due to the lack of affordable health insurance, “more patients will delay treatment and . . . doctors will likely see more uncompensated care.”5 Hence, each year doctors are working harder and harder but making less and less money, resulting in a “critical level” of stress and burnout. According to a recent survey of doctors, “30 to 40 percent of practicing physicians would not choose to enter the medical profession if they were deciding on a career again, and an even higher percentage would not encourage their children to pursue a medical career.”6

Total spending on health care in the United States amounts to nearly 17 percent of the entire economy, and this is expected to rise to 20 percent by 2015, “with annual spending consistently growing faster than the overall economy.”7 Because of skyrocketing health care costs, the U.S. federal Medicare trust fund is expected to go bankrupt in 2019, less than twelve years from now, potentially leaving millions of elderly Americans without health insurance coverage.8 American health care is in dire straits and will continue to worsen—unless Americans demand fundamental political change to reverse the trend. Unfortunately, the kinds of changes currently being proposed by politicians will only exacerbate the problem.

Politicians from across the political spectrum, including Democratic presidential candidate Hillary Clinton and Republican candidate Mitt Romney, have argued that the government should guarantee “universal coverage” to all Americans, making health care a “right.”9 And politicians are not alone; numerous businessmen, union leaders, and insurance executives are united in saying that this will solve our problems.10

It will not.

Contrary to claims that government-imposed “universal health care” would solve America’s health care problems, it would in fact destroy American medicine and countless lives along with it. The goal of “universal health care” (a euphemism for socialized medicine) is both immoral and impractical; it violates the rights of businessmen, doctors, and patients to act on their own judgment—which, in turn, throttles their ability to produce, administer, or purchase the goods and services in question. To show this, we will first examine the nature and history of government involvement in health insurance and medicine. Then we will consider attempts in other countries and various U.S. states to solve these problems through further government programs. Finally, we will show that the only viable long-term solution to the problems in question is to convert to a fully free market in health care and health insurance.

President Obama and top Democrats promoted Obamacare as a boon for people with pre-existing medical conditions. Finally, people with pre-existing medical conditions could “get health care.” However, the sales pitch ignored two key facts. No one in the United States is denied life-saving treatment just because they are unable to pay. And two-thirds of the states already had high-risk health insurance pools.

It’s hard to compare the cost of Obamacare plans to the state high-risk pool plans that are now being phased out. There are multiple plans and they are structured differently. The total out-of-pocket expenses for Obamacare plans appear to be somewhat less than the total out-of-pocket expenses for the Missouri Health Insurance Pool (MHIP) plans that I examined.

What’s interesting is that the Obamacare plans, which do not discriminate against people with pre-existing conditions, resemble the high-risk pool plans. A middle class family that doesn’t qualify for a subsidy could end up spending $20,000 per year on health care despite being insured and having no pre-existing conditions.

The Obamacare plans may hurt people with pre-existing conditions in other ways. For instance, some Obamacare plans restrict coverage to a local network. People with genetic disorders, many of which are life-threatening, need the freedom to visit out-of-network physicians who have significant experience or who are developing new treatments. There are also higher copayments for visiting specialists--something that people with pre-existing conditions are more likely to do.

People with pre-existing conditions will suffer disproportionately if Obamacare leads to problems predicted by some critics such as waiting lists and rationing. Some may even be denied treatment and sent home with a bottle of pain pills as a presidential candidate once suggested.

I was recently invited by the British Medical Journal to debate whether mobile medical apps should be regulated.

Mobile medical apps and hardware add-ons present a golden opportunity to make modern medicine more accessible, effective, and affordable. In fact, this could be our best chance to retool healthcare. But to make the most of it, we must ensure that entrepreneurs are free to innovate and that physicians and patients enjoy the widest choice of apps.

The FDA’s plan to regulate medical apps will only discourage investment and limit choices. By burdening developers with confusing rules and bureaucratic procedures, the FDA will drive up costs, add delays, and prevent potentially game changing products from getting off the launch pad.

Wireless gadgets offer the mobility and low price points that up to now have been sorely lacking in healthcare technology. They also lower the entry barriers for entrepreneurs with fresh ideas. Smartphones and tablet computers are relatively inexpensive platforms that come loaded with processing power, memory, and connectivity and feature developer friendly operating systems. The huge installed base of wireless gadgets offers a ready market, and online app stores provide convenient distribution. If the FDA leaves developers free to experiment, then we will surely witness an explosion of innovative, money saving products and services.

Dinosaur attitudes
Government agencies are often last to understand new technologies. When the FDA looks at wireless devices, it sees yesterday’s medical products repackaged to evade its oversight. This defensive attitude was on display in the FDA’s 2011 press release announcing draft guidelines for medical apps. The FDA emphasized that it is seeking to regulate only the “small subset of mobile medical apps” that work with devices that are already regulated or that transform wireless gadgets into devices that are already regulated. So what’s all of the fuss about?

Actually, medical apps and hardware add-ons are not the same old products in new packages. They are new tools with unique benefits. Consider Mobisante, a developer of smartphone and tablet based ultrasound imaging systems. These systems sell for a fraction of the price of the ultrasound machines found in large hospitals. Mobisante’s products are not intended to replace the high end machines. They are designed to extend the benefits of ultrasound imaging to locations such as small clinics and field hospitals.

FDA regulations create unnecessary obstacle courses for anyone bringing new medical devices to market. MIM Software introduced an app that displays diagnostic images on the iPhone in 2008 but was forced by the FDA to pull it from the market. After more than two years, including studies of the app’s performance under different lighting conditions, the company was finally granted approval. But the FDA stipulated that the app should be used “only when there is no access to a workstation.” Apparently, the FDA does not trust the judgment of trained medical professionals. But what makes FDA staff so much smarter?

Even supporters of medical app regulations urge the FDA to quit stalling and publish its final guidelines. The mHealth Regulatory Coalition, which speaks for some developers of mobile health technology, warns that uncertainty discourages investment. It should also question the propriety of a government agency putting products through the wringer when it still hasn’t told developers the rules. The coalition claims that medical app regulations are “deregulatory” because the FDA could have regulated even more types of health apps. That’s like politicians who call a smaller increase in this year’s national budget a “cutback.” No matter how it’s spun, regulating medical apps expands the FDA’s empire.

Too much power
The FDA is already too powerful. Most reasonable people agree that drugs and implants should be regulated because these products pose safety risks to ordinary consumers. But medical apps aren’t ingested or implanted and are typically used by tech savvy professionals and early adopters. Requiring FDA approval defeats two key benefits of medical apps: quick time to market and the ability to fix bugs and add features in a timely manner via downloadable updates.

The FDA was established to ensure safety but through mission creep has acquired the authority to judge effectiveness. However, we’ve learnt that specific drugs can be effective for specific people, so it’s counterproductive to evaluate drugs based on overall effectiveness. It makes even less sense to assess the effectiveness of medical apps because they are new and rapidly evolving.

FDA regulations favor large corporations over start-ups. Small developers often lack the resources and experience needed to win FDA approval. Big corporations engaged in multiple development efforts can spread the costs around. And large corporations often lobby government agencies to ensure that new regulations are in sync with their products and strategies.

None of this means that the FDA can’t play a positive role. The FDA could work with app developers, physicians, and patients to promote high standards, voluntary testing, and accountability. Rather than imposing regulations on all developers, the FDA could serve as a watchdog, taking action only when warranted.

Physicians and patients don’t want medical apps that meet stodgy government standards—they want medical apps that deliver exciting new capabilities at attractive prices. Developers free from constraints will give them what they want and retool health care for the 21st century.

Ira Brodsky is author of The History and Future of Medical Technology.

Two years ago, I wrote about the FDA's draft guidance concerning regulation of mobile medical applications. The medical apps community is still awaiting final guidance, and some are getting anxious. Last month, opposing coalitions petitioned the government, one urging it to take its time on regulation and the other calling for the prompt release of final guidance.

A recent report from medical software resource Software Advice takes a closer look at the two sides of the debate.

According to the report, stakeholders on both ends of the spectrum claim to have patients' interests in mind, but they are also looking out for their own business interests.

On the one hand, the report says, provider associations and large IT companies point out that FDA regulation could discourage new market entrants, delay apps getting to market for patient use, and cost app makers time and money.

On the other hand, according to the report, a group consisting largely of mobile companies and app developers are calling for decisive action quickly, pointing out that clear guidance from the FDA will encourage investment in the app space and give developers the confidence to continue developing apps. However, some larger and more experienced app developers and medical device makers feel they can gain an advantage from FDA regulation as many smaller developers lack the resources and experience to achieve compliance in a timely fashion.

Should the FDA regulate mobile medical apps? Read the report at Software Advice and vote in the poll.

The words most often used to denote the retooling of health care—“Health 2.0,” “Digital Health,” and “eHealth”—say next to nothing. Apparently that’s how some people want it to be.

I call it Personal Health Tech because empowering individual consumers (and caregivers, too) is a huge opportunity. It’s desperately needed because health care in the US is becoming increasingly bureaucratic and expensive. The good news is that Personal Health Tech is enabled by stuff that’s within reach of virtually everyone: smartphones, apps, and cloud services. Hopefully, what’s currently happening in US health care will prove analogous to the rise of the personal computer.

Unfortunately, many health care pundits downplay the personal empowerment angle. They apparently feel that most people are uninterested in or incapable of personal empowerment. They believe that it is enough for patients to participate in their own care. They scoff at solutions touted by sophisticated early adopters. But that’s generally how successful technologies get their start.

The most common criticism of my Op-ed last week, Obamacare and the vanishing medical miracle, was that government meddling in citizens' personal health care decisions under ObamaCare is a right-wing myth.

That would be reassuring--if only it were true. The first question that needs to be asked is: Why would the President of the United States offer his opinion about a personal health care decision ("Maybe you are better off not having the surgery, but taking the painkiller") if he didn't believe that it is an appropriate topic of public policy?

The lead editorial in today's Wall Street Journal provides further evidence. Cheesecake Factory Medicine fingers several of ObamaCare's intellectual gurus and demonstrates that they really do believe that government is most capable of reducing waste, that decisions about what gets paid for and what doesn't should be made by an Independent [sic] Payment Advisory Board, and that medical treatments should be standardized. So just forget all of that talk about personalized health care.

One of the gurus is former White House budget director Peter Orszag:

So get a load of Mr. Orszag's Tinker Bell alternative, which he called the "most important institutional change" after ObamaCare passed in 2010: the Independent Payment Advisory Board composed of 15 philosopher kings who will rule over U.S. health care.

Who are these Orszag 15? Well, nobody knows. The board was supposed to be up and running by the end of September, but the White House is avoiding naming names for Senate confirmation until after the election. No one knows, either, what this group of geniuses will propose, but that too is part of the grand Orszag plan.

Another is Atul Gawande:

...the surgeon and influential New Yorker magazine writer Atul Gawande, has further instructions for the medical masses, this time from—believe it or not—the Cheesecake Factory, the chain restaurant.

Dr. Gawande's point is that medicine would function better if care were delivered by huge health systems that can achieve economies of scale, like commercial kitchens. Care ought to be standardized like preparing a side of beef, with a "single default way" to perform each treatment supposedly based on evidence, with little room for personalization.

The editorial notes that in preparation for these changes the US health care industry is undergoing major consolidation. Hospitals and health insurance companies are merging to better grapple with anticipated new layers of bureaucracy and regulations.

Here is precisely the kind of thing that we should worry about:

The immediate danger of the Orszag-Gawande-Obama vision is that layer on layer of new regulation will lock in less-than-best practices. This makes the status quo worse, because too-big-to-fail oligopolists have less incentive to innovate to reduce costs and improve quality.

The longer-run danger is that Mr. Orszag's cost board starts to decide what types of care "work" for society at large and thus what individual patients are allowed to receive. One way or another, health costs must come down. And if Mr. Ryan's market proposal is rejected, then government a la Orszag will do it by brute political force.

A murderer's row of liberal health-care gurus—Zeke Emanuel, Neera Tanden, Don Berwick, David Cutler, Uwe Reinhardt, Steve Shortell, Mr. Orszag, many others—recently acknowledged as much in the New England Journal of Medicine. They conceded that "health costs remain a major challenge" despite ObamaCare. That would have been nice to know in, oh, 2009 or 2010.

Anyhow, their big idea is the very old idea of price controls that are "binding on all payers and providers," much as post-RomneyCare Massachusetts is already doing. When that strategy fails as it always has, and the public denies further tax increases, the Orszag payment board will then start to ration or prohibit access to medical resources that it decides aren't worth the expense.

My opinion piece at the Daily Caller:

Obamacare is an imminent threat to people with life-threatening medical conditions.

People with serious medical conditions often achieve miraculous results in the U.S. thanks to a private health care system that gives them the freedom to track down and go to doctors with the right knowledge and experience. These people, who have the greatest and most urgent health care needs, will be stymied by Obamacare’s new layers of bureaucracy. Instead of swiftly obtaining the right diagnosis and treatment, they will lose precious time submitting forms and filing appeals.

As every physician knows, it’s important to arrive at a correct diagnosis as soon as possible because medical conditions are most treatable in their early stages.

A recent article in The Wall Street Journal illustrates the point. “Facing Lifesaving Heart Surgery, Twice” bemoans the plight of people who had heart surgery as children only to experience further heart problems as adults. Doctors were often baffled because their hearts had been reconfigured during childhood. In some cases, the best course of action proved to be going back to the pediatric hospitals and surgeons who performed the original operations. This is possible in a private health care system because patients are correctly viewed as customers. Under Obamacare — a system that perceives people with serious medical conditions as financial burdens to a government already deeply in hock — these patients are more likely to find themselves boxed in by rules designed to contain costs.

Read the rest here.

Now New York City's technocrats want to control what residents and visitors eat and drink: Health panel talks about wider food ban

Businesses and individuals will find ways around all such rules. And what about individuals who need high calories? This is really about doing away with individualism.

At the meeting, some of the members of board said they should be considering other limits on high-calorie foods.

One member, Bruce Vladeck, thinks limiting the sizes for movie theater popcorn should be considered.

"The popcorn isn't a whole lot better than the soda," Vladeck said.

Another board member thinks milk drinks should fall under the size limits.

Why stop there? Why not track and regulate each person's food intake, exercise, and other habits?

It's sad to see the US drifting further and further toward liberal fascism. Are we willing to sacrifice individual freedom and choice so that perhaps there will be less obesity? Could such policies have negative unintended consequences? Are one-size-fits-all solutions healthy for society? Isn't it better to let people make mistakes--isn't that how important lessons are learned?

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.