Along with the invention of smart phones, an entire medical mobile application (app) industry has cropped up, promising patients enhanced connectivity, health data collection, and overall care quality at lower costs. Last year the FDA put a damper on the app industry’s quick-profit hopes by announcing that it intends to regulate certain medical apps as medical devices. In other words, if the app is used to connect with a medical device or to turn a smart phone into such a device (whether it can check your blood sugar, blood pressure, heart rhythm, etc. or suggest diagnoses), it must undergo safety and efficacy checks by the FDA before it can be brought to market. That process is likely to inflate app development costs exponentially, thus creating a chilling effect on the industry.
I actually think that FDA oversight is a good thing in this case, since it could protect patients from potentially misleading health information that they might use to make treatment or care decisions. But more importantly, I wonder if a lot of this fuss is moot for the largest, sickest, segment of the U.S. population?
For all the hype about robo-grannies, aging in place technologies, and how high tech solutions will reduce healthcare costs, the reality is that these hopes are unlikely to be achieved with the baby boomer generation. I believe that the generation that follows will be fully wired and interested in maximizing all that mobile health has to offer, but they’re not sick (yet) and they’re also not the proverbial “pig in the python” of today’s healthcare consumption.
I’m not saying that mobile health apps have no role in caring for America’s seniors – their physicians and care teams use tablets and smart phones, their kids do too, and a small percent of seniors may adopt these technologies, but I’m a realist when it comes to massive adoption by boomers themselves. Wireless connectivity, texting, personal digital health records, and asynchronous communication is just not in their DNA. Take away a teenager’s smart phone and he or she is likely to be completely flummoxed by reality. Now give that phone to a baby boomer and the flummoxing will be roughly equivalent, but centered upon the device. The teen can’t live without the constant phone/internet connection, and the senior is overwhelmed by the lack of human interface and unfamiliar menus.
What makes me so sure of my pronouncements? I just spent a month making house calls to almost 70 different Medicare Advantage members in rural parts of this country. And I can tell you that almost none of them used any sort of smart phone app to manage their health. These “odd creatures” actually enjoyed face-to-face human contact, they used their phones almost exclusively to talk to people (not surf the Internet), and they took hand-written notes when it was important for them to remember something. They even had paper calendars that they used to schedule their physician appointments and keep records of their medications and procedures. How “weird” is that?!
When I asked one of the seniors if she’d be interested in using a cell phone to check her blood pressure and have that automatically uploaded to her doctor’s office she replied,
“I’m too old to learn that stuff, dear. I’m lucky if I can find my slippers in the morning.”
The reality is that the average app user isn’t sick, and sick people don’t see a need for apps… yet. So our challenge is to meet seniors where they are instead of trying to change their habits. House calls are the best way I know of to get a full appreciation for individual quirks, compliance challenges, and health practices. If we are really serious about reducing healthcare costs in our aging population, it may take some low-tech solutions. As un-sexy as that may be, it’s time that we put down the iPhone and practiced some good old-fashioned medicine.
The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
*This blog post was originally published at iMedicalApps*
Tim Cromwell’s mother-in-law is 86 years old. Her husband is a Korean War veteran who developed Alzheimer’s disease, and receives care from both the VA and private healthcare providers. Because she and her husband take so many medications, they actually replaced their dining room table centerpiece with a collection of orange and white pill bottles. Mrs. Spencer keeps a hard copy of all of her husband’s medical records in a large file box that she carries with her on a cart with wheels. She has no alternative for keeping all her husband’s providers up to date with his complex care, and lifting and transporting the records has become more difficult for her in her eighth decade.
If this story sounds all too familiar, then you’ll be glad to know that the government is facilitating electronic medical and pharmacy records portability. One day it may be possible for Americans to dispose of those hard copy files, knowing that any provider anywhere can access their records as requested.
Tim Cromwell is passionate about alleviating his mother-in-law’s need to carry medical records around, and believes the way to do this is through the US Department of Veterans Affairs’ participation in the Nationwide Health Information Network (NHIN). Working in compliance with NHIN standards, the Federal Health Architecture group recently oversaw the creation of software (called CONNECT) that creates a seamless, secure and private interface with hospitals, and over 20 federal agencies’ medical records systems (including the Social Security Administration, Department of Defense, Veterans Affairs, the Centers for Disease Control and Prevention, and the National Cancer Institute).
On April 6, 2009, NHIN released the CONNECT software necessary to make Electronic Medical Records systems interoperable. The software is “open-source” and free to all who’d like to incorporate it into their EMRs. Those who add the free software will be able to share data with NHIN’s member groups, which include early adopters like the Cleveland Clinic, Kaiser Permanente, Beth Israel Deaconness Medcial Center, and MedVirginia.
This means that if Mrs. Spencer and her husband receive their care from participating hospitals and federal programs, they’ll never have to tote paper records again. But it may take some nudging from patients and healthcare professionals like you to grow the network. If you’d like your hospital to participate in the NHIN network, encourage them to view the NHIN website here.