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The regulation of medical devices is specific to each country. Currently different versions of Stethophone are recognized as a medical device in the USA and Ukraine. This means that Stethophone is available for residence of these countries. We are working on offering Stethophone in more countries in the future.

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Bring your own medical data – how patient gathered data could change healthcare
Jan 03, 2023

Imagine seeing a specialist and bringing six months of your own cardiac and pulmonary data to go along with your concerns of light headedness and headaches

Healthcare has historically been an inconvenient and expensive service to access. Even basic or primary care has numerous barriers; not the least of which is booking appointments, taking time off work, waiting in waiting rooms, being sent for test-after-test etc.  The effects are magnified if you happen to feel ill or are symptomatic.  At the same time, millions of people in the US live in medically underserved areas in states like California, Texas and Illinois[i]; making this process almost insurmountable.

The fact remains that when we feel sick we want answers fast. One of the main questions that crosses our minds is – should I go (to the doctor), when do I go and what information do I bring with me so that I get the right care. People have to make these decisions all the time, for themselves and their loved ones. Depending on the situation, medical history and social determinants many people wind up in a cycle of multiple visits and unnecessary tests, while others don’t get help until their conditions advance to more acute levels. Both scenarios cost the medical system billions and severely affect the quality of life and outcomes for patients.  Arming the population with a way to make this better seems like something we should have had by now.  At the very least people should be able to do more to assess if they are sick or not – because today 65% of them ask Google. Our minds jump to technology that could easily scan and record vital signs at home, detect any red flags and then share that information with medical professionals.

Medical care has increased in leaps and bounds and with it the need for more screening, diagnosis and triage. Yet patients seeing doctors are answering the same questions and describing their symptoms the same way we did a hundred years ago. Patients can and should  be a bigger contributor to the process. Imagine seeing a specialist and bringing six months of your own cardiac and pulmonary data to go along with your concerns of light headedness and headaches. Getting more diagnostic information earlier has never been controversial in the medical industry. It was simply assumed that people were incapable of collecting their own medical data without specialized training. The same of course, used be said about making your own investments, booking your own travel, or even pumping your own gas.

Patients gathered health data (PGHD) are defined as “data created, recorded, and gathered by and from patients” often using technology such as smartphones and wearable devices.  It’s all part of what you would expect from any basic physical examination needed to even begin the process of determining if you are having a panic attack or is ischemic event, the flu or necrotizing fasciitis.  Back in 2011, Dr Gregory Abowd from the school of interactive computing at Georgia Tech gave a keynote to the American Medical Informatics Association on the near-future importance of PGHD. He predicted that the vast majority of information that a doctor might use to determine how a patient is doing will be things that are collected outside of that doctor’s office and that much of the data relevant to the medical records of an individual is going to be accumulated in their homes and elsewhere.

Since Dr. Abowd’s seminal prediction, wearable devices and specialize connected devices that record certain vitals or help you manage conditions have flooded consumer markets.  At the same time, there are now more ways that people gain electronic access to their medical records, test results, X-rays etc. Up until recently, however, the adoption of PGHD to support clinical decisions by doctors has been relatively slow. The pandemic did a lot to move healthcare institutions, medical practitioners, and insurers forward on this front. By way of example, over 500 health institutions now support Apple Health Records[ii], which enable patients to view important data such as immunizations, X-rays, and lab results in the Health app. In 2019, Tim Cook famously stated “I do think there will be a day when people looking back will say Apple’s greatest contribution to the world was healthcare.”  The promise here is that patients will ultimately have greater custody over their medical information, carrying it with them where they go. The ability for a patient to transmit this information instead of waiting for in-person visits or forwarding the information to specialists, means better access with fewer steps in a lot of cases. It also puts the patient in more control, something we are now used to in our consumer lives.

The question remains, however, how will patients record and share things like a lung sound or heartbeat in a way that is medically useful, accessible, and convenient? Will the general public  start purchasing specialized new consumer medical appliances for the home?  Some might, however, on the whole it may not be necessary.  The use of smartphones has hit an inflection point that is relevant to this question. Analysts today put smartphone adoption in the US at 88%, with almost 75% adoption in the 65 and older demographic[iii].Today, there are no comparable physical technologies that we interact with more. One study stated the average person touches their phone 1500 times week[iv].  The evolution of these devices have been guided by our desire to use them as proxies for our own senses: ultra-high-resolution video, stereo audio recording and playback capable of selective noise cancelling, physical feedback through haptics, geolocation, gyroscopes and more.  This is extremely important because it allows our smartphones to be applied as an extension of a doctor’s ability to touch, listen, see, measure and record anytime.

If all it took was a software download to transform a smartphone into a medical device, the convenience factor and accessibility for the consumer would skyrocket.  Consumerization and convenience have driven huge changes in how we manage finances, make important decisions and shop; healthcare is next. A recent study surfaced that now 60% of consumers expect a healthcare digital experience to mirror that of retail[v]

People using their personal devices as medical instruments to assess their health does not seem far-fetched; in fact it will likely become as normal as using a banking app instead of standing in line. Patient gathered data applied correctly would invariably fuel intelligent systems that could help both patient and doctor do a better job of making decisions outside of the structure of the traditional clinical environment.  As we have recently been reminded, a population’s overall health is heavily tied to the health of the economy.  Both employers and insurers benefit from people’s ability to be more proactively involved in their own health. At the same time, democratizing elements of the screening and assessing process and moving those partially into the patient’s control seems daunting.  Does the medical system get overwhelmed with consumers demanding attention because their phones told them they were sick?  Do employees gravitate to medical software on their devices in the hopes it will tell them they need more time off work?  At the very least companies would need to consider overhauling policies related to health, especially when every employee can now bring-their-own medical device to the office.

It’s easy to argue that the current balance does not need to shifted. But it’s important to remember that a large number of people, who have chronic illnesses or conditions, already manage their own care to a large degree every day.  For them, getting the best outcomes almost always has to do with being proactive, having the right information, tracking the progression of their conditions themselves and using this to navigate the medical system wisely.  It’s also a big part of the psychology of living with conditions and mentality around recovery.  People have always been capable of sound decisions about their own health when they know what they need to know.  Transforming the devices in our pockets into medical grade diagnostic tools refined for consumer use seems like something people are ready for.

The quadruple aim of healthcare as developed by the Institute of Healthcare Improvement (IHI) “advocates for: improving patient experience, reducing cost, advancing population health, and improving the provider experience.” Connecting the right expertise at the right time and place—utilizing technology that is highly familiar to the population—holds promise as a big step towards achieving this aim.

[i] US Health Resources & Services Administration 2020 report

[ii] https://techcrunch.com/2020/10/07/apple-brings-health-records-to-iphone-in-the-uk-and-canada/

[iii] Mercator Advisory Group : truth and data https://www.paymentsjournal.com/smartphone-adoption-in-the-u-s-by-age-group/

[iv] https://www.dailymail.co.uk/sciencetech/article-2783677/How-YOU-look-phone-The-average-user-picks-device-1-500-times-day.html?ito=social-twitter_mailonline#ixzz3FTEdxnvq

[v] Customer Experience Trends in Healthcare, 2018; NTT DATA Services

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