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Monday, April 27, 2015

Gadgets Put Medical Diagnostics Into The Hands (Smartphones) of Consumers

Gadgets Put Medical Diagnostics Into The Hands (Smartphones)
of Consumers

A growing number of Americans are taking control of their medical information, obtaining electronic records from their health-care providers so they can more easily keep track of their care and discuss it with their doctors.

But originating health information through lab tests is still mostly under the control of doctors. Aside from a few tests that can be done at home, like those for pregnancy or HIV infection, lab tests typically require a doctor’s order.

Some consumer advocates want to change that, arguing that people have a right to decide what information they want about their health—and how to act on it—without the expense and hassle of first consulting a doctor. Opponents argue that a doctor’s input is needed to ensure that the right tests are ordered to keep a patient healthy and that the results are interpreted correctly.

Michelle De Mooy, deputy director of the Privacy and Data Project at the Center for Democracy and Technology, wants consumers to be able to order their own lab tests. Roy Benaroch, a pediatrician in Roswell, Ga., says testing without a doctor’s supervision isn’t the best way to keep people healthy and can be dangerous.

YES: People Should Have More Control Over What Gets Tested
By Michelle De Mooy

Consumer-ordered lab tests, without a doctor’s involvement, are a natural evolution of patient-centered health. They offer convenience, access and control, giving people the power to decide when to test, what information they want, and whether and how to share it. This is a no-brainer, and it’s long overdue.

What we can learn about our bodies from lab tests is astonishing—stats on pregnancy, cholesterol, glucose levels, HIV status, indicators for disease and thyroid functioning, to name a few. This is not data that has to belong to hospitals or doctors or insurance companies. It’s ours. And by taking control of it, we can increase our involvement in our own care, which studies have found can significantly improve our health.

Some providers have publicly worried that patients will be befuddled by tests that may have false positives or negatives or those that need medical expertise to be understood. The fact is that most people who order tests will already be talking to a doctor, certainly if there is a need to discuss treatment options, and the limitations of tests can be communicated fairly easily.

Indeed, on-demand testing is not a replacement or proxy for a provider or for quality care—it supplements them. And there is plenty of information available to assist people in monitoring their own health. Lab Tests Online, for example, was developed by lab professionals to help patients and providers navigate the nuances of testing.

Control over lab tests and their results not only gives us a chance to make more-informed choices about our health but also can make it easier for us to avoid mishandling of our test results by health-care providers. Studies have shown that a high percentage of providers fail to inform their patients of abnormal lab test results, leading in some cases to disastrous outcomes. With self-ordering, consumers at least can avoid that pitfall by having the results sent to them directly.

There are cost issues as well. For the millions of Americans who struggle to make ends meet, control over testing means not having to travel to and from a doctor’s office to order and receive test results—something that not only can be expensive but also is particularly difficult for those who depend on other people or public transportation to get around or the availability of child care to free up time.

Self-ordering also means not being hit with as many copayments for office visits or being compelled to share sensitive information with a provider.

Lab testing on demand isn’t perfect. Some of the tests are expensive, most aren’t covered by insurance, and some overpromise on the value of tests or technology. Data leakage is also a risk when information passes through different vendors, from the test maker to the drugstore that sells test kits to the lab that ultimately tests a blood sample. The data-security practices of these entities should be governed by more than flimsy corporate privacy policies or scattered state laws as they are now.

In addition, the Food and Drug Administration should require test companies to include easy-to-understand notices that explain the benefits and risks of testing, as well as when a health-care provider should be involved, and require test makers to publicly list prices.

Consumer lab tests are not risk-free, but they are protected by a constellation of regulations and guidelines that monitor quality, safety, even deceptive or fraudulent practices by companies. On-demand tests benefit all of us by giving us more control over our information and allowing us to play a larger role in our health.

Ms. De Mooy is deputy director of the Privacy and Data Project at the Center for Democracy and Technology. 

NO: Access to Results Is One Thing; Control Is Something Else 

By Roy Benaroch

Making your own medical diagnosis has a certain appeal. You can Google a list of symptoms, see what matches, and make a good guess right from your computer or smartphone. In a way, it’s fun to be a detective, unraveling the mysteries of your own illness. There are practical benefits, too. Being your own doctor can save time, money and hassle. And it can help preserve your privacy.

But when it comes to ordering your own lab tests, patients need to beware of some serious potential pitfalls that outweigh all those benefits. Certainly, patients should have access to their health information and lab results. But control is a different story.

There’s a reason physicians go to medical school. There is a huge and bewildering quantity of tests that can be ordered, often with overlapping, technical names that vary between labs. Ordering the correct test, itself, requires technical knowledge.

Even assuming the correct test is done, the perspective of a medical professional may be needed to understand and interpret what the results mean. There is no certainty that consumers will seek out that perspective if they order their own tests, and the result can be a dangerous lack of attention to a serious medical condition.

For example, one of the most commonly ordered tests in any medical office is a CBC, or complete blood count. Any one of the dozen or so results in a CBC can be outside what is considered the normal range. And an abnormal result may mean absolutely nothing, or may be a harbinger of a very serious problem. A low hemoglobin count, for instance, may mean you’re not getting enough iron in your diet, or that you’re losing blood in your gut from a benign or cancerous tumor. Or it may be a normal variant for you. A high (or low) white count might mean you are fighting off a minor viral infection, or it may mean you have a serious infection or cancer.

Even “normal” values don’t always reflect good health. A component of a routine body-chemistry test is your creatinine level, a measure of kidney function. If your creatinine rises from 0.5 to 1, it’s still in the normal range—but it means your kidneys are failing.

Lab results need to be interpreted in context, not just against a list of normal values.

How about testing for a common condition like allergies to foods or pollens? Even the best allergy blood tests yield at least as many false as true results—it may make as much sense to flip a coin. Without the patient’s whole clinical history, including family history and what sort of exposure history fits the case, allergy testing cannot be interpreted in a useful or reliable way.

As for avoiding miscommunication or lack of communication about test results, self-ordering, with all its own pitfalls, isn’t the solution. If you have a blood test—or X-ray, or any medical testing—you should ask when to expect the results, and contact the provider if you don’t hear from them. Staying engaged with your doctors is the best way to avoid poor communication.

The push toward self-ordering is a boon for laboratories. But unlike health-care professionals, labs don’t have any responsibility for making sure that the correct tests are ordered, or that tests are interpreted correctly.

If you want to understand what your tests mean, you’re going to need a doctor or other professional who knows your story. You’ll be better equipped to understand your own health if tests are ordered by a physician.

A Silicon Valley startup wants to bring the doctor’s office to the home.

The company is hoping to sell to consumers simple-to-use devices that, with the help of a smartphone app, could analyze vital signs with a quick scan of the forehead. Another gadget could measure a blood or urine sample like a medical lab does, feeding the information to a doctor or even diagnosing an illness, such as a kidney infection.

It may sound like Star Trekian science fiction. And the path toward acceptance is rife with regulatory hurdles and technical challenges, plus there is the imposing obstacle of changing consumer and doctor habits.

Their first device is a $199 hockey-puck sized disc, is pressed to the forehead and measures body temperature, heartbeat and blood pressure.

Related Article:

Scanadu, which is announcing it has raised $35 million in funding from investors including Tencent Holdings Ltd., is one of the companies helping to lead a home-diagnostics movement that is gaining wider recognition as software drives down the cost and improves the accuracy of results. The Food and Drug Administration has shown a willingness to allow diagnostics to be sold straight to consumers, provided they can prove their accuracy.

To get the Scout off the ground, the company raised nearly $1.7 million on crowdfunding site Indiegogo in 2013.


While there are a number of mobile and wearable health trackers on the market today, Scanadu aims to be the first company to offer a cuff-less blood-pressure monitor straight to consumers.

Down the road, the company aims to be the first to offer full blood- and DNA-sample diagnostics on consumers’ mobile phones.

The Scout uses sensors to monitor vital signs. Among its features are reflective light-emitting diodes that can measure blood pressure by shining a light on the side of the user’s forehead. Other sensors inside the Scout—including electrodes, gyroscopes, accelerometers and infrared thermometers—track heart rate, temperature and even oxygen in the blood.

“This is consumer medicine, the likes of which we have never seen before,” said Eric Topol, the founder of the Cleveland Clinic Lerner College of Medicine and a director of the Scripps Translational Science Institute.

Mr. Topol’s institute is studying whether users of the Scout will make changes to their health routine after getting access to ongoing blood-pressure monitoring results.

The Scout has been approved by the FDA as an “investigational device,” meaning it can be used in a study of its effectiveness as a vital-sign tracker. Scanadu is shipping thousands of devices to its 8,500 Indiegogo supporters, who must agree to allow the FDA to study how they are being used.

One of those backers is Dr. Don Rice, an emergency-room physician and a Nebraska official responsible for directing the state’s emergency medicine. Dr. Rice said he was intrigued by the idea of a cuff-less blood pressure monitor and a less-invasive heart monitor, so he bought 10 Scouts and handed nine out to colleagues and patients.

Dr. Rice says the data is “pretty accurate” compared with conventional instruments, but it can be difficult to get a clean read. “You have to apply it to the forehead just right,” he said. “But once you get it done, you get a full scan in 10 seconds.”

Walter De Brouwer, who co-founded Scanadu with his wife, Sam, in 2010, said the idea for the technology grew from the year he spent in hospitals after his 5-year-old son was gravely injured in a fall from a window in 2005, damaging his brain. Months of waiting for updates in hospitals spurred the De Brouwers to empower consumers with medical information, alleviating doctor visits and freeing up doctors’ time in the process.

The De Brouwers are awaiting final word from the FDA about whether they can more widely sell Scouts to consumers as a vital-sign tracker and blood-pressure reader to manage hypertension.

Scanadu, based in Mountain View, Calif., is also developing a urine test to pair with the Scout that would connect to a smartphone app and analyze the urine’s content.

The color-coded strips would check for signs of ailments like kidney disease or bladder infection. Scanadu says it is starting up a 1,000-patient trial in China and a 275-patient trial in the U.S. in a bid to get a consumer urinalysis product on the market by the end of next year.


Scanadu eventually wants to make a blood-sample and nucleic-acid diagnostic device that would give consumers access to information about their blood-cell count and genetic markers, information that can indicate the threat or presence of health problems. The results of those future tests may need to be interpreted by a doctor.

To be able to reach the market, Scanadu would have to prove to the FDA the validity of the test results for each diagnostic test, said Bakul Patel, associate director of digital health at the FDA’s medical-devices office.

Wireless Camera Finder

Though the FDA has kept some diagnostic devices off of the market, it does allow home pregnancy tests, iPhone-enabled heart-rate monitors, mobile blood-glucose meters and other diagnostics to be sold over the counter or on the Web.

Another challenge will be getting doctors on board with the idea of patients bringing them information from home. Dr. Topol said doctors will need to trust the information is a unified platform, rather than a collection of odds and ends gathered by patients with smartphones.

“The platform,” Mr. De Brouwer said, treats electrical signals from the body as one data stream. “Urine is just another data stream, and blood is another data stream…Scout is going to be that platform.

Scanadu has short- and long-term goals that go beyond the other wireless health trackers on the market today.

From its current goal of providing cuff-less blood pressure monitoring and other vital-sign tracking to its longer term goal of providing detailed blood, urine and DNA analysis, it will be up to Scanadu every step of the way to prove that its algorithms can provide diagnostic information just as accurately as the legacy systems in use in hospitals today.


Dr. Michael Blum, a cardiologist and professor at the University of San Francisco and the director of its Center for Digital Health Innovation, said doctors have already begun to accept diagnostic information from patients with mobile devices, and that this trend is likely to continue.

But in order for Scanadu to convince the medical community it can accurately diagnose health problems by analyzing blood or DNA with a smartphone, the company has a lot of work ahead.

“Scanadu has a lot of bold marketing claims,” he said. “What they are going to need is a lot of validation. Can they deliver? I’m skeptical until I see it proven with very thorough analysis.”

Your questions and comments are greatly appreciated.

Monty Henry, Owner


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