Sunday, September 25, 2011

"Doctor Cell Phone" will get nursed along by the FDA

Could your phone cut the umbilical cord as well? That seems easy enough.
    (Sept. 25, 2013) Oh great: Today, the Food and Drug Administration will officially begin approving some cell phone apps as medical devices without requiring authentication. This would be welcome news, if the FDA hadn't shown itself to be totally incompetent. And these are apps, the federal agency admits, that pose "moderate" or "high" risks to users. WTF? Could the woman pictured above, who just pounded her baby with sonar, have caused some harm? Who knows?
    In three previous blog posts, we have documented the appalling failure of the FDA's approval process for  medical devices that multibillion-dollar multinational corporations spent years developing. Time after time, despite a protocol that requires extensive clinical trials and "documentation" by these profit-crazy firms, the devices that the FDA has enshrined as "safe and effective" have proven to be unsafe and ineffective. Its "overworked and overextended" staff has a similarly dismal record in its drug-approval charade.That's why we have all those warning letters, recalls and class-action lawsuits: The FDA is a big-time bungler.
   Now they're going to "clear" cell phone apps, with no studies or authentication? Fasten your seatbelts.

Predominant symptoms of app overload: Dizziness. And blurriness.
    Don't you think cell phones are doing enough multi-tasking already, without taking on complex, life-and-death responsibilities? Do we really want to mix our twerky "Blurred Lines," our tweets, our kitty pics, porn and gaming, with functions that involve sensors, leads, electrodes and "intricate physiological parameters"? Blurred lines indeed! They slice, they dice, they compile your grocery list, and administer your "friendships" with the greatest of ease. Then they inform you, in a soothing Siri-like voice, that you have pancreatic cancer.
    For years, without fanfare, cell-phone apps have been using "built-in features such as light, vibrations, camera, and similar sources to perform medical device functions (e.g., apps that could be used by a licensed practitioner to diagnose or treat a disease)," the FDA acknowledges. 
    Yikes! Who knew?
    There are both moderate-risk (Class II) and high-risk (Class III) mobile medical apps, the FDA says.
    Will someone please tell us which ones are HIGH RISK?? Does it seem CRAZY to anyone but me that we are placing HIGH RISK medical devices in the hands of any customer of any age, without proper education or monitoring? 
   What could some smart young hacker do with a HIGH RISK medical app?
    Are we at risk only if we own the phone and we're doing something, knowingly, to ourselves? Or can someone with a "high-risk" app endanger our health somehow -- by targeting another person's pacemaker, for example, or shooting some kind of waves or rays in our direction?

    The agency has cleared about 100 mobile medical applications over the past decade, with about 40 of those cleared in the past two years, according to the New York Times ( They include ultrasound imaging systems, real-time ECG monitors and arrhythmia detectors, multi-gas monitors (?), remote patient monitoring, various blood pressure and blood glucose aids, "ingestion monitoring systems," vestibular analysis, body guardian systems and "asthmapolis systems."

    What about all the other health-oriented apps that are on the market, unregulated? There's a bit of a backlog: Approximately 1,000 new programs are released each month, and there will be 142 million annual downloads and 500 million worldwide users by 2016, according to a study published in the August issue of Insights into Imaging. The number of medical imaging-related apps in the marketplace has tripled since January, the European web site HealthCare Informatics reported last month.
    This deluge cries out for oversight, but it also cries out, "Mission Impossible!"
    Before you know it, we'll be able to press a phone to each temple and give ourselves electroshock treatments. What a cuckoo's nest that will be, courtesy of free enterprise and the U.S. government. 
Oh, what a relief it is!
    Effective today -- after all these years of freewheeling medical-app development -- the FDA has issued Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff  (
    The agency uses brisk, confident language in explaining its purview: 
    "The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of  'device' and that are intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device," it states on its web site. "Our focus (is) only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices" (italics mine).
An EGC is an ECG, even if it's in your phone, the FDA says.
     "Risk-based approach" is such a nice way of putting it. How risky is too risky? How many malfunctions, injuries and deaths are acceptable? The FDA hasn't gotten that straight when it comes to big-time devices and drugs, so one has to wonder how well they'll manage the apps issue. The agency's focus is "only on the apps that present a greater risk to patients if they don’t work as intended." Greater than what? Than not having a phone at all, and walking around with both hands free, like people did not so long ago? And where were we -- and the medical establishment -- when these bright, charming apps starting popping up and "impacting the functionality" of the medical machinery we've come to rely upon?
Can we really take this little guy seriously?
    It's a good thing these phones are so "smart." They have  insinuated themselves deeply into the already unwieldy health-care system. In plowing through the services they can provide, one has to admit that it's an astonishing effort, reflecting great innovation and enterprise.
    Unfortunately, the appearance of these applications on the market wasn't a plan that unfolded in an orderly way, under the supervision of medical personnel.
    It was an explosion of wild-and-crazy, scattered, unfettered entrepreneurship -- which can be quite interesting if your life isn't at stake -- that flooded the globe with these intriguing and empowering products. Nobody said "buyer beware." They just said, "BUY."
    Mobile apps span a wide range of health functions. "The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices," its site explains. That is about the most disturbing remark this hapless agency could possibly make.
    Since the agency has cleared quite a few apps already, it is difficult to discern what has changed, starting today, except that we finally are being informed about the seriousness of this issue. None of the apps that the FDA has already cleared was required to go through "costly regulatory hurdles like clinical trials," the Times article noted.
    And yet, they pose "moderate" to "high" risk. Isn't there something incongruous about this?

     The newly announced FDA program will liberate the market even more, according to Dr. Joseph M. Smith, chief medical and science officer at West Health Institute. "This is very welcome news for the innovator and investment community," he said. 
    Brace yourselves, health-care consumers. Fools will be rushing in, right along with the guys who know what they're doing.
    And, as "medical devices," the apps presumably will be under the umbrella of the federal "doctrine of pre-emption," which protects them from legal liability if they injure, disable or kill a user.
    The HealthCare Informatics site studied the FDA's process of assessing cell-phone medical apps, noting that it is only advisory -- "not a full regulatory process." The site discovered that only a small minority of the apps claims to have had a medical professional involved in the development of its product. And it found that deceptive language is widespread in the marketing of these apps. This is typical of how the imprimatur of the FDA is abused by profiteers, without penalty.
    "The increased accessibility of apps has obvious benefits, but there are concerns about the accuracy of content in medical apps, especially considering the low level of medical professional involvement," HealthCare Informatics added. "Also, potential app users cannot determine the accuracy of the program's content prior to purchase." 

    "App stores do provide short descriptions written by the developers, as well as customer ratings and comments, and a selection of screen shots, but most (61 percent) of the apps in the study didn't have ratings," the researchers noted. "Also, 69 percent of those rated were based on fewer than 10 ratings, reducing the reliability of the customer feedback."
    The HealthCare Informatics study concluded, "Expert medical input in the development of medical apps may improve reliability, and this input should be clearly stated in the advertising material to allow potential users to make an informed assessment of an apps reliability prior to purchase."
    Thank you, Europe, for providing the only serious, science-based examination of our glorious federal process for protecting the health and safety of the American public!
     For the time being, you have to wonder if that vibration in your pocket means you've got mail, or you're headed into a diabetic coma. And did you know that if you've got wrinkles (and don't we all?) there's an app for that?  (Uh oh, it can remove hair, too. So when someone says "You never know where that phone has been," you know what he means.) 
We're blurring too many lines!!!!
    I personally would like to see e-cigarettes assume some of the burden we have imposed on cell phones. I have noted that the mouthpiece might be used to monitor the levels of stress hormones and bacteria in your mouth ( If you're indicating a bit of anxiety, a teensy pouf of soothing lavender or a benzodiazepine could automatically be included in your inhalation. Maybe if the gingivitis germs reach a certain level, your e-cig could thoughtfully squirt antiseptic mouthwash into your oral cavity. Or perhaps the vapor itself should provide a steady stream of nutrients, antimicrobial agents, cognitive enhancers and "mood brighteners."
     The trusty little e-cig, covered by a special "condom," could peek up your nose, down your throat, and into your ears, and then transmit the photos and chemical data to the clinic. The light on the tip would provide very nice -- even flattering -- illumination. One hesitates to mention this, but the cig could even provide a pelvic exam -- in the privacy of our own homes, thank god -- and gather data on the health of our intestinal ecosystems. I'm not trying to gross you out! I just think our e-cigs should take some of the pressure off our phones, those poor workhorses!
    But just today (when it rains, it pours) 40 state attorneys general petitioned the FDA to start regulating e-cigarettes. Of course, it needs desperately to be done. But the FDA can't do everything. I'm not sure it can do anything.
    We shouldn't allow our cell phones to do everything, either. Let's be reasonable! And careful! You know the old saying (if you're Boomer-plus): A jack of all trades is a master of none. 

(Today – Oct. 17, 2013 --  the government shutdown has ended, and the medical-device industry, which waged an intense lobbying campaign, says it has garnered enough support to achieve a full repeal of the excise tax by early next year. Medical-device manufacturers allocate only a sliver of profits to research and development  The industry’s enormous profits are a result of anticompetitive practices. Exorbitant prices fuel enormous profits — profits that dwarf both the medical-device tax and the industry’s investments in research and development. The United States spends about 50 percent more on the top five medical devices, compared with Europe and Japan, leading to $26 billion annually in excess spending, according to Topher Spiro, vice president for health policy at the Center for American Progress. )

American doctor patents a smartphone device that aims to provide professional-quality testing and analysis for a variety of conditions, including thyroid disease, HIV, syphilis, diabetes and kidney disease. It can also test cortisol in saliva, a key indicator of stress levels. Pretty cool -- or is it more deranged multitasking?