I cringe when I hear policy wonks complain about the excessive use of advanced technology in health care. Sure, advanced technology is often very expensive, but it’s usually worth every penny. Medical technology greatly enhances our ability to diagnose and treat health problems.
Wearable robots, also known as “exoskeletons,” are a great example. Someday we may learn how to cure paraplegia, but in the meantime wearable robots can dramatically improve the quality of life for many wheelchair-bound patients. If there is a way to get this technology to patients who are likely to benefit from it, then who is to say that it is too expensive?
Robotics is advancing rapidly largely thanks to the development of complex control algorithms. Also contributing are inexpensive sensors and field programmable gate arrays (FPGAs) that speed development and ensure robust performance.
I recently spoke with National Instruments, a company providing Hyundai with tools for developing wearable robotics. Hyundai is focusing on patients with knee or hip injuries, patients in rehabilitation, elderly patients, and paraplegics.
Based in Austin, Texas, National Instruments specializes in products to help scientists and engineers solve difficult problems. In this case, Hyundai needed to acquire data from multiple sensors, perform real-time analysis, and refine robot control algorithms.
At one time, it seemed like giving patients the ability to control motorized limbs required interfacing directly with nerves. Fortunately, it’s now possible to use multiple non-invasive sensors to determine the patient’s intent. With a bit of patient training and the right control algorithms, a paraplegic outfitted with a robotic exoskeleton can stand up, walk over flat ground, and sit down.
Work at The Central Advanced Research and Engineering Institute at Hyundai Motor Company is facilitated by National Instrument’s LabVIEW RIO platform. As the number of sensors and actuators increases, control algorithm complexity grows exponentially. The LabVIEW RIO platform not only eases development of complex algorithms, it employs field-programmable gate arrays (FPGAs) to essentially hardwire the algorithms so they can be executed much faster -- fast enough to exert control down to the microsecond level.
Hyundai is using wireless technology (ZigBee) to collect data about the patient’s gait -- data that can be analyzed and used to better control the wearable robot.
The Israeli company ReWalk is already selling exoskeletons in the US for roughly $50,000 each. However, it’s clear that there is a much larger market waiting to be served, so there is probably room for several competing makers of walking assistance wearable robots.
Sunday, May 15. 2016
SaniTrace and The Ministry of Ground Beef
Beginning June 20, 2016, the Food Safety and Inspection Service (FSIS) under the U.S. Department of Agriculture will require establishments that grind raw beef to keep records (for at least one year) including "supplier lot numbers and production dates"; "the date and time each lot of raw ground beef product is produced": and "the date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized." The stated purpose is to more quickly stop foodborne illness outbreaks. FSIS investigators will check retail establishments to ensure they are in compliance. It seems a safe bet that the price of ground beef will increase as a result of the new rule.
SaniTrace, LLC, a startup based in Creve Coeur, Missouri, has developed a logging and labeling solution to ease compliance and provide notifications to consumers.
Consumers can be automatically notified if the meat they purchased is recalled -- provided that they scan the QR code with their smartphone's camera or text the identifier number from the label to a local phone number.
The final rule can be found here. The record-keeping rule applies to about 70,000 establishments -- most of them small businesses.
SaniTrace, LLC, a startup based in Creve Coeur, Missouri, has developed a logging and labeling solution to ease compliance and provide notifications to consumers.
Consumers can be automatically notified if the meat they purchased is recalled -- provided that they scan the QR code with their smartphone's camera or text the identifier number from the label to a local phone number.
The final rule can be found here. The record-keeping rule applies to about 70,000 establishments -- most of them small businesses.
Saturday, May 14. 2016
Theranos revisited
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.
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.
Thursday, March 31. 2016
FDA Steamrolls Patients’ Rights, States Fight Back
My recent OpEd at The Daily Caller:
Believe it or not, there is a battle underway in the U.S. over whether terminally ill patients who have exhausted all government-approved treatments have the right to try experimental drugs. You might think that in a country founded on the principles of limited government and individual rights, citizens would be free to choose any health remedy in a last-ditch effort to save their own lives. But that’s not the way it is: Congress gave the Food and Drug Administration (FDA) exclusive power to approve drugs, and the FDA believes that even people who are dying must be protected from unproven therapies.
What makes this all the more outrageous is that while terminally ill patients don’t have the right to take experimental drugs to save their lives, they do have the right to take drugs to end their lives. The United States Supreme Court upheld a state law permitting physician-assisted suicide in 2006, and it is now legal in four states.
Heartbreaking stories about dying patients pleading for access to promising but not-yet-approved drugs forced the FDA to act years ago. The FDA created an “expanded access” program in 1987 enabling patients to apply for special permission to try investigational drugs. But there were complaints that the FDA wasn’t giving all patients a fair hearing. That led to the Food and Drug Administration Modernization Act of 1997 establishing more formal expanded access program rules.
Nearly 20 years later, terminally ill patients and their physicians must still jump through multiple hoops with no reliable way of predicting the outcome. To have a chance, the patient must obtain the approval of a physician and an institutional review board (IRB). The FDA estimates it takes physicians on average 100 hours to complete the forms. (The FDA has been showing a draft form that it says can be completed in just 45 minutes since February 2015, but more than one year later the miracle form still hasn’t been released.) The IRB is a local committee established to protect research subjects from physical and psychological harm. Even if the physician and IRB recommend approving the patient’s application, the FDA reserves the right to say “no.”
The deck is clearly stacked against dying patients who must find physicians willing to work many extra hours with no guarantee of success.
The FDA points to the expanded access program as proof that it is compassionate. But for some patients the program has failed spectacularly. Kianna Karnes, a mother of four children suffering from kidney cancer, requested access to two promising drugs. She didn’t qualify to participate in clinical trials. Her family lobbied on her behalf for months and finally the FDA approved her application. But it was too late: Kianna Karnes died later that day. While the FDA’s defenders complain that activists are giving terminally ill patients false hope, both of the drugs that Karnes sought access to were eventually approved by the FDA for treating kidney cancer.
How did a federal agency acquire the power to decide who lives and who dies? The FDA is an ominous example of how a government agency can gradually accumulate the power to deprive citizens of their rights and hobble entire industries.
Over most of U.S. history, citizens were free to take whatever medicines they wished. Ironically, it wasn’t until effective and often life-saving drugs appeared in the 20th century that strict regulations were introduced.
Many federal drug regulations were created in response to widely reported acts of negligence or wrongdoing. Concerns about the safety of preservatives and other additives led to the Pure Food and Drug Act of 1906. During the mid-1930s, the S.E. Massengill Company introduced a sulfa drug in liquid form. The company tested the drug for safety but forgot to test the solvent. More than 100 patients died from kidney failure. That prompted Congress to pass the Food, Drug, and Cosmetic Act of 1938, a law requiring government approval of new drugs and medical devices. A series of amendments and additional laws expanded the FDA’s power. The 1951 Durham-Humphrey amendment gave the FDA the power to require prescriptions for certain drugs.
The 1962 Kefauver Harris Amendment was the turning point, however. Enacted in response to the thalidomide tragedy in Europe, it required manufacturers to prove not only that new drugs are safe, but that they are effective. This amendment is responsible for adding years of delays and $billions in cost to life-saving drugs. Worse, it led to the misguided notion that if a new drug only cures 5 percent of patients, then it should be denied approval.
Recently, terminally ill patients and their families have been fighting back. “Right to try” laws have been passed in 25 states. These laws have many of the same requirements as the FDA’s expanded access program. The biggest difference is that a state government rather than the FDA is in charge. Right to try laws work because state governments are less conflicted about granting dying patients access to drugs that have not yet been approved, and the FDA is reluctant to challenge states’ rights.
Why is this end run necessary? The FDA has a habit of implementing reforms and creating new programs with one hand, while obstructing and delaying with the other. Darcy Olsen, President of the Goldwater Institute and author of The Right to Try, likens the FDA’s behavior to the famous gag in the Peanuts comic strip in which Lucy holds a football for Charlie Brown to kick, but pulls it away at the very last instant, leaving Charlie sprawled on the ground.
The FDA claims that it “fast tracks” approval of promising drugs. However, that’s misleading: The FDA measures approval from the time that a new drug application (NDA) is submitted, but the NDA is actually the last step in a lengthy process. Companies don’t submit NDAs until the FDA tells them that they’ve met all research, development, and clinical trial requirements. For instance, the FDA claims that it took just six months and 24 days to approve Beleodaq (for treating peripheral T-cell lymphoma), but it actually took over nine years.
According to President Obama’s Council of Advisors on Science and Technology, it takes 14 years to bring a new drug to market in the U.S. — up from eight years in the 1960s. Right to try laws passed by states enable new drugs to start saving patients’ lives much sooner.
A compelling case can be made that some drugs and medical devices should be closely monitored for safety, quality, and accurate labels. Whether federal regulations or industry self-regulation works best is a debate for another time. But one thing is clear: the effectiveness of a medical therapy may vary from one patient to another, and in no case should a government agency’s assessment of effectiveness be allowed to deprive patients, companies, and entire industries of their rights.
Ira Brodsky is the author of The History & Future of Medical Technology.
Believe it or not, there is a battle underway in the U.S. over whether terminally ill patients who have exhausted all government-approved treatments have the right to try experimental drugs. You might think that in a country founded on the principles of limited government and individual rights, citizens would be free to choose any health remedy in a last-ditch effort to save their own lives. But that’s not the way it is: Congress gave the Food and Drug Administration (FDA) exclusive power to approve drugs, and the FDA believes that even people who are dying must be protected from unproven therapies.
What makes this all the more outrageous is that while terminally ill patients don’t have the right to take experimental drugs to save their lives, they do have the right to take drugs to end their lives. The United States Supreme Court upheld a state law permitting physician-assisted suicide in 2006, and it is now legal in four states.
Heartbreaking stories about dying patients pleading for access to promising but not-yet-approved drugs forced the FDA to act years ago. The FDA created an “expanded access” program in 1987 enabling patients to apply for special permission to try investigational drugs. But there were complaints that the FDA wasn’t giving all patients a fair hearing. That led to the Food and Drug Administration Modernization Act of 1997 establishing more formal expanded access program rules.
Nearly 20 years later, terminally ill patients and their physicians must still jump through multiple hoops with no reliable way of predicting the outcome. To have a chance, the patient must obtain the approval of a physician and an institutional review board (IRB). The FDA estimates it takes physicians on average 100 hours to complete the forms. (The FDA has been showing a draft form that it says can be completed in just 45 minutes since February 2015, but more than one year later the miracle form still hasn’t been released.) The IRB is a local committee established to protect research subjects from physical and psychological harm. Even if the physician and IRB recommend approving the patient’s application, the FDA reserves the right to say “no.”
The deck is clearly stacked against dying patients who must find physicians willing to work many extra hours with no guarantee of success.
The FDA points to the expanded access program as proof that it is compassionate. But for some patients the program has failed spectacularly. Kianna Karnes, a mother of four children suffering from kidney cancer, requested access to two promising drugs. She didn’t qualify to participate in clinical trials. Her family lobbied on her behalf for months and finally the FDA approved her application. But it was too late: Kianna Karnes died later that day. While the FDA’s defenders complain that activists are giving terminally ill patients false hope, both of the drugs that Karnes sought access to were eventually approved by the FDA for treating kidney cancer.
How did a federal agency acquire the power to decide who lives and who dies? The FDA is an ominous example of how a government agency can gradually accumulate the power to deprive citizens of their rights and hobble entire industries.
Over most of U.S. history, citizens were free to take whatever medicines they wished. Ironically, it wasn’t until effective and often life-saving drugs appeared in the 20th century that strict regulations were introduced.
Many federal drug regulations were created in response to widely reported acts of negligence or wrongdoing. Concerns about the safety of preservatives and other additives led to the Pure Food and Drug Act of 1906. During the mid-1930s, the S.E. Massengill Company introduced a sulfa drug in liquid form. The company tested the drug for safety but forgot to test the solvent. More than 100 patients died from kidney failure. That prompted Congress to pass the Food, Drug, and Cosmetic Act of 1938, a law requiring government approval of new drugs and medical devices. A series of amendments and additional laws expanded the FDA’s power. The 1951 Durham-Humphrey amendment gave the FDA the power to require prescriptions for certain drugs.
The 1962 Kefauver Harris Amendment was the turning point, however. Enacted in response to the thalidomide tragedy in Europe, it required manufacturers to prove not only that new drugs are safe, but that they are effective. This amendment is responsible for adding years of delays and $billions in cost to life-saving drugs. Worse, it led to the misguided notion that if a new drug only cures 5 percent of patients, then it should be denied approval.
Recently, terminally ill patients and their families have been fighting back. “Right to try” laws have been passed in 25 states. These laws have many of the same requirements as the FDA’s expanded access program. The biggest difference is that a state government rather than the FDA is in charge. Right to try laws work because state governments are less conflicted about granting dying patients access to drugs that have not yet been approved, and the FDA is reluctant to challenge states’ rights.
Why is this end run necessary? The FDA has a habit of implementing reforms and creating new programs with one hand, while obstructing and delaying with the other. Darcy Olsen, President of the Goldwater Institute and author of The Right to Try, likens the FDA’s behavior to the famous gag in the Peanuts comic strip in which Lucy holds a football for Charlie Brown to kick, but pulls it away at the very last instant, leaving Charlie sprawled on the ground.
The FDA claims that it “fast tracks” approval of promising drugs. However, that’s misleading: The FDA measures approval from the time that a new drug application (NDA) is submitted, but the NDA is actually the last step in a lengthy process. Companies don’t submit NDAs until the FDA tells them that they’ve met all research, development, and clinical trial requirements. For instance, the FDA claims that it took just six months and 24 days to approve Beleodaq (for treating peripheral T-cell lymphoma), but it actually took over nine years.
According to President Obama’s Council of Advisors on Science and Technology, it takes 14 years to bring a new drug to market in the U.S. — up from eight years in the 1960s. Right to try laws passed by states enable new drugs to start saving patients’ lives much sooner.
A compelling case can be made that some drugs and medical devices should be closely monitored for safety, quality, and accurate labels. Whether federal regulations or industry self-regulation works best is a debate for another time. But one thing is clear: the effectiveness of a medical therapy may vary from one patient to another, and in no case should a government agency’s assessment of effectiveness be allowed to deprive patients, companies, and entire industries of their rights.
Ira Brodsky is the author of The History & Future of Medical Technology.
Sunday, December 20. 2015
Big data and the future of healthcare
Healthcare solutions built around smartphones, cloud computing, and big data have the potential to cut through bureaucracy and put power back in the hands of consumers and their doctors.
I recently caught a glimpse of the future of healthcare at an open house at CIC in St. Louis. CIC provides office space, lab facilities and other resources tailored for startups. The 20 participants included three types of businesses: companies developing tools to help healthcare providers diagnose and treat illnesses, companies developing products to help healthcare providers interact more efficiently and effectively with patients, and companies developing healthcare products for consumers.
Several of the startups are leveraging smartphones, cloud computing and big data to create innovative and potentially disruptive solutions. Today’s healthcare consumers often feel overwhelmed when dealing with big insurance companies, large hospitals and mammoth government agencies. Fortunately, smart phones and Internet access have the potential to empower consumers by making healthcare more direct, personal, and timely.
Sparo Labs’ Wing
One intriguing startup is Sparo Labs. The company has developed Wing to help asthma patients manage their condition. Asthma is a chronic lung condition in which the airways become inflamed causing wheezing, coughing, and shortness of breath. Asthma is a serious and incurable disease that affects approximately 25 million Americans.
Wing enables patients to monitor their asthma daily to better understand and control it. Normally, asthma patients’ lung performance is only assessed during doctor visits (typically months apart) or when they show up at the emergency room. Wing uses the smartphone’s microphone, a hardware add-on and an app to measure FEV1 (how much air the user can exhale in one second) and peak flow (how fast the user exhales). This information can be used to detect and stop asthma attacks before they cause symptoms, to determine how well medications are working and to identify things in the environment that trigger attacks. For example, using the phone’s locating technology, lung performance can be linked to factors including temperature, humidity and pollen count.
By giving patients a tool that they can carry with them, and by linking the app to servers in the cloud, it will become increasingly possible to treat asthma proactively rather than reactively. The app enables patients to track and visualize their lung performance. The more it is used, the more it learns about the individual user’s asthma. A simple “stoplight” signals green, yellow or red to ensure the patient understands their current status. All in all, Wing could lead to a better understanding of what triggers attacks, which therapies are effective at stopping attacks, and how to manage asthma.
Sparo has received $1.25 million in seed funding. However, the firm will need to obtain FDA approval before it can make Wing available for purchase by consumers. Sparo believes that Wing will also prove useful for patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis and pulmonary fibrosis, as well as athletes, singers and musicians who play wind instruments.
Ultradia’s Chrona
Another interesting company, Ultradia, has developed a product that transforms an ordinary pillow into a “smart pillow.” The device, Chrona, slips between the pillow and pillow cover with a foam insert and enhances the quality of sleep by emitting different sounds at specific times during the sleep cycle. Chrona also features a haptic alarm that gently vibrates to wake the user without disturbing their partner.
While the precise physiological function of sleep is still studied and debated, it’s clear that the quantity and quality of sleep affects a person’s health and sense of well-being. Sleep disorders can lead to high blood pressure, depression, and other problems. Ultradia points to research that shows acoustic stimulation can be used to enhance certain features of rapid eye movement (REM) sleep and non-rapid eye movement sleep (NREM). Specifically, low frequency sounds have been found to boost deep sleep, while higher frequency sounds help prepare the user to wake up by promoting light sleep.
The Chrona device connects wirelessly to a smartphone via Bluetooth low energy. The smartphone can be used to check sleep score, change sleep optimization settings and set the haptic alarm. The Chrona device’s built-in accelerometer is used to quantify movement while sleeping. The Chrona app communicates with Ultradia’s cloud-based servers and, in theory, could be used to conduct long-term sleep studies involving large numbers of people. The Chrona unit is powered by a lithium-ion battery that must be recharged about once per week.
Data Dog Health’s Mindset
The third startup using smartphones, the cloud and big data is Data Dog Health. The company’s first app, Mindset, is described as a “toolkit for mental performance.” Mindset monitors stress throughout the day and automatically provides behavioral intervention when needed. Data Dog Health believes that managing stress is essential to helping users maximize performance at work, at play and at home. This can be accomplished by learning to turn distress (bad stress) into eustress (good stress such as experienced while exercising). Bad stress can cause problems including headaches, sleeplessness and irritability. Chronic bad stress is associated with greater susceptibility to viral infections.
Mindset collects data such as heart rate (from an optional wearable heart rate monitor), location (from GPS or another locating technology), motion (using the smartphone’s accelerometer) and time. An algorithm learns to detect when the user is exercising, resting, meditating or stressed out. When the app detects that the user may be stressed, it informs the user and suggest remedies such as relaxation. When the user feels stress coming on, he or she can open the app’s cognitive behavioral therapy tool. Like other smartphone-based health apps, data can brought back to the cloud for aggregation, analysis and visualization.
Big data is a big deal
There are three exciting things about the new breed of smartphone-based health aids. First, they enable consumers to detect health problems in their earliest stages, giving them a chance to take corrective action before symptoms become pronounced. Second, smartphone-based health aids treat the user as a unique individual: They learn what factors cause problems for the user, and what therapies work best for the user in specific situations. And third, smartphone-based health aids give the medical industry the unprecedented ability to observe millions of people day-in and day-out. This should help identify factors that contribute to the development of specific medical conditions, detect the presence of specific medical conditions earlier, and develop more effective treatment and management strategies.
None of these products claim to replace doctors, clinics, and hospitals. But they give consumers tools that they can apply to their daily lives, and give healthcare professionals tools they can use to observe patients outside of the clinic setting.
This commentary by Ira Brodsky first appeared at Computerworld. Brodsky is a Senior Analyst with Datacomm Research and is the author of five books about technology. Brodsky focuses on mobile solutions for payments, retail automation, and health care.
I recently caught a glimpse of the future of healthcare at an open house at CIC in St. Louis. CIC provides office space, lab facilities and other resources tailored for startups. The 20 participants included three types of businesses: companies developing tools to help healthcare providers diagnose and treat illnesses, companies developing products to help healthcare providers interact more efficiently and effectively with patients, and companies developing healthcare products for consumers.
Several of the startups are leveraging smartphones, cloud computing and big data to create innovative and potentially disruptive solutions. Today’s healthcare consumers often feel overwhelmed when dealing with big insurance companies, large hospitals and mammoth government agencies. Fortunately, smart phones and Internet access have the potential to empower consumers by making healthcare more direct, personal, and timely.
Sparo Labs’ Wing
One intriguing startup is Sparo Labs. The company has developed Wing to help asthma patients manage their condition. Asthma is a chronic lung condition in which the airways become inflamed causing wheezing, coughing, and shortness of breath. Asthma is a serious and incurable disease that affects approximately 25 million Americans.
Wing enables patients to monitor their asthma daily to better understand and control it. Normally, asthma patients’ lung performance is only assessed during doctor visits (typically months apart) or when they show up at the emergency room. Wing uses the smartphone’s microphone, a hardware add-on and an app to measure FEV1 (how much air the user can exhale in one second) and peak flow (how fast the user exhales). This information can be used to detect and stop asthma attacks before they cause symptoms, to determine how well medications are working and to identify things in the environment that trigger attacks. For example, using the phone’s locating technology, lung performance can be linked to factors including temperature, humidity and pollen count.
By giving patients a tool that they can carry with them, and by linking the app to servers in the cloud, it will become increasingly possible to treat asthma proactively rather than reactively. The app enables patients to track and visualize their lung performance. The more it is used, the more it learns about the individual user’s asthma. A simple “stoplight” signals green, yellow or red to ensure the patient understands their current status. All in all, Wing could lead to a better understanding of what triggers attacks, which therapies are effective at stopping attacks, and how to manage asthma.
Sparo has received $1.25 million in seed funding. However, the firm will need to obtain FDA approval before it can make Wing available for purchase by consumers. Sparo believes that Wing will also prove useful for patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis and pulmonary fibrosis, as well as athletes, singers and musicians who play wind instruments.
Ultradia’s Chrona
Another interesting company, Ultradia, has developed a product that transforms an ordinary pillow into a “smart pillow.” The device, Chrona, slips between the pillow and pillow cover with a foam insert and enhances the quality of sleep by emitting different sounds at specific times during the sleep cycle. Chrona also features a haptic alarm that gently vibrates to wake the user without disturbing their partner.
While the precise physiological function of sleep is still studied and debated, it’s clear that the quantity and quality of sleep affects a person’s health and sense of well-being. Sleep disorders can lead to high blood pressure, depression, and other problems. Ultradia points to research that shows acoustic stimulation can be used to enhance certain features of rapid eye movement (REM) sleep and non-rapid eye movement sleep (NREM). Specifically, low frequency sounds have been found to boost deep sleep, while higher frequency sounds help prepare the user to wake up by promoting light sleep.
The Chrona device connects wirelessly to a smartphone via Bluetooth low energy. The smartphone can be used to check sleep score, change sleep optimization settings and set the haptic alarm. The Chrona device’s built-in accelerometer is used to quantify movement while sleeping. The Chrona app communicates with Ultradia’s cloud-based servers and, in theory, could be used to conduct long-term sleep studies involving large numbers of people. The Chrona unit is powered by a lithium-ion battery that must be recharged about once per week.
Data Dog Health’s Mindset
The third startup using smartphones, the cloud and big data is Data Dog Health. The company’s first app, Mindset, is described as a “toolkit for mental performance.” Mindset monitors stress throughout the day and automatically provides behavioral intervention when needed. Data Dog Health believes that managing stress is essential to helping users maximize performance at work, at play and at home. This can be accomplished by learning to turn distress (bad stress) into eustress (good stress such as experienced while exercising). Bad stress can cause problems including headaches, sleeplessness and irritability. Chronic bad stress is associated with greater susceptibility to viral infections.
Mindset collects data such as heart rate (from an optional wearable heart rate monitor), location (from GPS or another locating technology), motion (using the smartphone’s accelerometer) and time. An algorithm learns to detect when the user is exercising, resting, meditating or stressed out. When the app detects that the user may be stressed, it informs the user and suggest remedies such as relaxation. When the user feels stress coming on, he or she can open the app’s cognitive behavioral therapy tool. Like other smartphone-based health apps, data can brought back to the cloud for aggregation, analysis and visualization.
Big data is a big deal
There are three exciting things about the new breed of smartphone-based health aids. First, they enable consumers to detect health problems in their earliest stages, giving them a chance to take corrective action before symptoms become pronounced. Second, smartphone-based health aids treat the user as a unique individual: They learn what factors cause problems for the user, and what therapies work best for the user in specific situations. And third, smartphone-based health aids give the medical industry the unprecedented ability to observe millions of people day-in and day-out. This should help identify factors that contribute to the development of specific medical conditions, detect the presence of specific medical conditions earlier, and develop more effective treatment and management strategies.
None of these products claim to replace doctors, clinics, and hospitals. But they give consumers tools that they can apply to their daily lives, and give healthcare professionals tools they can use to observe patients outside of the clinic setting.
This commentary by Ira Brodsky first appeared at Computerworld. Brodsky is a Senior Analyst with Datacomm Research and is the author of five books about technology. Brodsky focuses on mobile solutions for payments, retail automation, and health care.
Thursday, October 22. 2015
Using the FDA as a Club against Competitors
Blood testing startup Theranos is in trouble with the FDA. As I pointed out in this essay at American Thinker, it is hypocritical (and cynical) to ask the FDA to relax regulations that get in your way while advocating new regulations to thwart your competitors:
Most conservatives believe that mountains of government regulations drive up prices, discourage innovation, and crush small businesses. So why aren’t businesses united in their opposition to oppressive regulations? Because many have discovered that they can use regulations as a weapon to fend off competition.
Consider the example of Elizabeth Holmes, the founder and CEO of Theranos, a Silicon Valley health care technology firm. Ms. Holmes boldly proposes that consumers should be able to get diagnostic blood tests without waiting for prescriptions from their doctors (How to Usher in a New Era of Preventive Health Care, Wall Street Journal, July 28, 2015). That’s an excellent idea for at least three reasons: the earlier medical conditions are detected the easier they are to treat, blood tests (like those developed by Theranos) that use a fingerstick rather than poking a vein with a needle are extremely safe, and eliminating unnecessary regulations benefits both consumers and entrepreneurs.
However, in the very same guest column Ms. Holmes recommends that all lab tests should be reviewed by the Food and Drug Administration (FDA). While Ms. Holmes wants to make it easy for consumers and partners to do business with Theranos, she wants to make it hard for anyone to compete with Theranos, calling for regulations that protect her company’s head start.
Theranos was founded to make blood tests simpler, less expensive, and more accessible. For example, Theranos has partnered with Walgreens, the largest drugstore chain in the United States, to make blood tests available at neighborhood stores during evenings and weekends (when most outpatient hospital labs are closed).
Traditional blood tests have drawbacks: they take too much time, are expensive, and there is a small but real risk of injury when blood is drawn from a vein using a needle. Requiring doctor’s prescriptions may avoid unnecessary blood tests, but it also prevents patients from being proactive. As Ms. Holmes explains, “…many of us get lab tests only when we’re showing symptoms, which means we may already be sick. And too many of us find out we’re sick when it’s too late to change the course of these conditions.”
Ms. Holmes understands that blood tests have consequences. She points out that a doctor may recommend the patient take medication, undergo a medical procedure, or be admitted to the hospital based on the results. Weighing the benefits against the risks, Ms. Holmes concludes that we should treat consumers like intelligent and responsible adults, letting them exercise their own judgement about when to get blood tests.
However, Ms. Holmes is more inflexible and one-sided regarding policies that affect competitors. She writes, “The FDA sets the gold standard for quality assurance. Its review is data-driven, objective and uniquely rigorous.” Yes, there is a legitimate argument for taking steps to ensure that lab tests are reasonably accurate and reliable. However, it’s not clear that a federal bureaucracy is best qualified to review lab tests. An industry that is constantly developing new tests and improving old tests probably knows more about the underlying technology. And an industry association with participants from regulatory agencies, competing vendors, and patients’ groups is likely to be fairer than a government bureaucracy targeted by lobbyists and politicians. Nor is it clear that a federal agency is most capable of striking the right balance between cost, time-to-market, and consumer safety.
Few people would deny that there is a role for federal regulations addressing the safety of health care products and services. For instance, physicians and consumers should be confident that any pharmaceutical marketed in the U.S. contains the type and quantity of active ingredients advertised. It’s also reasonable to require disclosure of all other ingredients to avoid adverse interactions and to protect patients with allergies.
However, there is reason to be skeptical of FDA regulations concerning effectiveness. In fact, it’s only through mission creep that the FDA became involved in determining effectiveness. Yet there is growing evidence that regulating effectiveness is counterproductive. Traditionally, the FDA gauged the effectiveness of a drug by studying its effect on a large population of patients. We’ve learned in recent years that some drugs may be ineffective for most patients but very effective for specific groups of patients. This has led to the common sense conclusion that it’s wrong to reject a drug merely because it is only effective for a small group of patients -- and has given rise to the new field of personalized medicine.
Ms. Holmes’ faith in the FDA’s lab test review process is misguided. There is no universally recognized standard by which lab tests can be evaluated. All diagnostic tests are subject to measurement errors and there is always a risk of false negatives and false positives. And lab tests are evolving. That’s not to suggest that blood tests shouldn’t be reviewed. But it does say that no one has a corner on objective and rigorous lab test reviews, and it’s reasonable to take speed and cost into account when deciding who should perform the reviews. Even if the FDA bureaucracy turned out to be most objective and rigorous, it is notoriously slow and expensive.
There is a troublesome explanation for why Ms. Holmes is so eager to have the FDA perform the reviews. As she states in her guest column, “…Theranos, the company I founded, voluntarily committed to submit all of its lab tests for review starting in 2013. On July 2 [2015], the FDA cleared the first of those tests, for herpes simplex virus 1, and the associated finger-stick blood-test technology and underlying system on which our tests are run.” If Theranos began submitting its lab tests in 2013 and received its first FDA approval in mid-2015, then it seems fair to conclude that a competitor submitting its tests for review today might not gain its first approval until 2017.
Government regulation works best when it is simple and direct. Even then, most of the responsibility for inspecting, reviewing, and certifying should be delegated to outside contractors who can be quickly replaced when there is evidence of negligence, incompetence, or corruption. Too much regulation drives up costs, delays new products and services from coming to market, and discourages innovation. Worse, convoluted regulations can be used by powerful companies as a club against their smaller or less experienced competitors. If Elizabeth Holmes trusts consumers to prescribe their own blood tests, then she should trust the health care industry to review lab tests provided that the review process is transparent and accountable.
Sunday, May 18. 2014
Restaurants and Nutrition Information
A new report from Datacomm Research Company (which I co-authored along with David Strom) details how restaurant chains are using consumer-facing connected technology to promote their brands, engage customers, and provide superior customer experiences. In recent years, virtually all major restaurant chains have added nutrition information to their websites. Some simply provide tables with entries for each of their menu items. Others provide ingredients used in specific products and additional information for those with allergies or diabetes.
Several restaurant chains (such as McDonald’s, Chick-fil-A, and KFC) provide meal nutrition calculators. This is very helpful, because it often allows consumers with dietary restrictions to identify acceptable combinations of menu items. And chains including McDonald's, Wendy's Chick-fil-A, Red Robin, and Steak n Shake also provide nutrition information in handy mobile apps that consumers can consult in the restaurants' stores.
Though the report (Good Food and Drink and Connected Technology, 2014-2019) focuses on restaurant chains' use of consumer-facing connected technology, it predicts that the technology will increasingly play a major role in other retail segments, and suggests that the other segments would do well to study the restaurant chains' experiences. Though there is already quite a bit of effort going into the development and marketing of consumer-facing connected technology for health and fitness, the use of this technology by restaurant chains provides important lessons regarding what does and doesn't work, how to optimize its use, and how to avoid common pitfalls.
Another new resource that may be of interest to readers of this blog is MIMO World. This site provides news, analysis, and resources regarding 4G and coming 5G wireless technologies.
Several restaurant chains (such as McDonald’s, Chick-fil-A, and KFC) provide meal nutrition calculators. This is very helpful, because it often allows consumers with dietary restrictions to identify acceptable combinations of menu items. And chains including McDonald's, Wendy's Chick-fil-A, Red Robin, and Steak n Shake also provide nutrition information in handy mobile apps that consumers can consult in the restaurants' stores.
Though the report (Good Food and Drink and Connected Technology, 2014-2019) focuses on restaurant chains' use of consumer-facing connected technology, it predicts that the technology will increasingly play a major role in other retail segments, and suggests that the other segments would do well to study the restaurant chains' experiences. Though there is already quite a bit of effort going into the development and marketing of consumer-facing connected technology for health and fitness, the use of this technology by restaurant chains provides important lessons regarding what does and doesn't work, how to optimize its use, and how to avoid common pitfalls.
Another new resource that may be of interest to readers of this blog is MIMO World. This site provides news, analysis, and resources regarding 4G and coming 5G wireless technologies.
Wednesday, May 14. 2014
Why ObamaCare Must Be Repealed
Betsy Mccaughey writes about the corruption institutionalized by ObamaCare at Creators.com:
Read the entire OpEd here.
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.
Two New Websites
For news about reports on emerging technology markets, see Datacomm Research.
For news about next-generation high-speed wireless, see MIMO World.
For news about next-generation high-speed wireless, see MIMO World.
Monday, March 31. 2014
What The US Can Learn From the Australian Health Care Debate
Dr. Paul Hsieh writes about the health care debate in Australia, where very modest co-pays ($6) have been proposed for visits to general practitioners and (to keep people from routinely choosing ERs over GPs) emergency rooms.
Hsieh says the Australian debate offers two lessons for the US. The first is that once a government program is put into place it's very hard to reverse. You would think that a $6 co-pay would not be particularly controversial. But it is. Opponents argue that people should be able to go to the ER and not worry about paying anything. Never mind that visits to the ER are not free and are paid for through higher taxes.
The second lesson is that there needs to be a conversation about the proper role of government in health care. Namely, does ensuring that everyone has access to health care justify giving a government bureaucracy the power to determine "who can receive what services and when"?
Hsieh is heartened by the debate in the US over domestic surveillance. Most people believe there should be limits on what government can do surveillance-wise. Shouldn't there also be limits on how much the government can interfere with personal health care decisions?
Hsieh says the Australian debate offers two lessons for the US. The first is that once a government program is put into place it's very hard to reverse. You would think that a $6 co-pay would not be particularly controversial. But it is. Opponents argue that people should be able to go to the ER and not worry about paying anything. Never mind that visits to the ER are not free and are paid for through higher taxes.
The second lesson is that there needs to be a conversation about the proper role of government in health care. Namely, does ensuring that everyone has access to health care justify giving a government bureaucracy the power to determine "who can receive what services and when"?
Hsieh is heartened by the debate in the US over domestic surveillance. Most people believe there should be limits on what government can do surveillance-wise. Shouldn't there also be limits on how much the government can interfere with personal health care decisions?
Monday, January 6. 2014
Smartphone vision for the blind
An Israeli professor (Zeev Zalevsky) is developing a special contact lens that could give vision to the blind. The contacts stimulate the cornea, an area of the body that is more sensitive to tactile sensations than even the fingertips. Rather than restoring vision, the system provides a form of sensory substitution.
Several articles about Zalevsky's invention appear to be inaccurate. They suggest the sensations are somehow picked up by the wearer's retina. However, Zalevsky suggests his approach could be useful for people who do not have normal retinas. And he says his approach offers greater resolution than the artificial retinas under development. Plus, artificial retinas require surgery and that involves risks.
The lenses contain a grid that acts like 10,000 tiny electrodes. The lenses work in combination with a digital camera or the digital camera in a smartphone. Though this is an early-stage technology, it's a wonderful example of the potential medical applications for smartphones.
Several articles about Zalevsky's invention appear to be inaccurate. They suggest the sensations are somehow picked up by the wearer's retina. However, Zalevsky suggests his approach could be useful for people who do not have normal retinas. And he says his approach offers greater resolution than the artificial retinas under development. Plus, artificial retinas require surgery and that involves risks.
The lenses contain a grid that acts like 10,000 tiny electrodes. The lenses work in combination with a digital camera or the digital camera in a smartphone. Though this is an early-stage technology, it's a wonderful example of the potential medical applications for smartphones.
Thursday, December 12. 2013
Even More Truth About Obamacare
Data from the National Association of State Comprehensive Insurance Plans shows that the high-risk pools in 35 states cost a grand total of $2.6 billion to operate--slightly more than half of which was paid by enrollees through premiums. Most of the remainder was paid by the insurance companies in the form of "assessments."
See in particular the tables Total Revenue by Pool (2011) and Total Expenses by Pool (2011).
Therefore, the pools cost 35 states a grand total of $125 million per year. Note that the Healthcare.gov website, alone, has cost taxpayers about five times as much.
See in particular the tables Total Revenue by Pool (2011) and Total Expenses by Pool (2011).
Therefore, the pools cost 35 states a grand total of $125 million per year. Note that the Healthcare.gov website, alone, has cost taxpayers about five times as much.
