Smartphones Revive the Black Bag for Doctors: A Mixed Blessing?

Introduction
As recently as the early ‘60s, doctors commonly made house calls carrying a black bag with the basic tools of their profession: stethoscope; thermometer; tongue depressor; otoscope; blood pressure cuff; an assortment of bandages; needles and surgical thread; and a variety of pills. House calls gradually became the rare exception instead of the rule, and the tools of the profession expanded beyond the bag to sophisticated devices housed in labs and operated by trained specialists. These tools included ECG tests, high tech imaging exams such as ultrasound, blood and urine tests, blood oxygen saturation, and others.

All of these high tech tests were ordered by the physician, performed in the hospital or clinic, and the results were sent back to the physician as part of determining the diagnosis and care plan. This process involved several steps from the initial office visit, ordering the tests, scheduling the tests, which may or may not be done that day, getting the test results, scheduling another office visit to discuss the results and the subsequent plan with the patient. The process became another reason for the physician to stay in the office.

However, the iPhone with specialized attachments and other mobile diagnostic devices allow the diagnostic process to be streamlined and free physicians to diagnosis on the road. It has become possible to carry a black bag again, a more powerful bag. The new bag now carries an iPhone, some attachments, and small mobile diagnostic devices. Many of these devices are available now, and more are coming. Here is just a sample of what the new “black bag” may carry.

Tricorder
There are variety of sensors available that measure various vital signs and send the readings to a smart phone for recording. One of the more intriguing is the Scanadu Scout, a palm sized device that measures vital signs in 10 seconds by pressing it against a forehead. Initially it will measure temperature, heart rate, respiratory rate, and blood pressure and send the results to an app on a smart phone. More measurements are being developed, and the initial release is planned for March 2014.

Kinsa Smart ThermometerThermometer
Available sooner than the Scandu are a variety of sensors and apps to take and record vital signs. Temperature can be measured and recorded with the Kinsa smart thermometer, coming in November 2013. The thermometer plugs into the iPhone audio jack to power the thermometer and transmit the results to the phone. Other thermometers are in the works that employ non-contact infrared technology.

Withings Blood Pressure MonitorBlood Pressure
Blood pressure and heart rate can be obtained with blood pressure cuffs, such as the Withings BP monitor, that plugs into the iPhone. An app inflates the cuff, measures the blood pressure and heart rate and records the results.

iHealth Pulse Oximeter
Pulse Oximeter
A wireless pulse oximeter is available from iHealth Lab that measures the SpO2, pulse rate, and stores the results in an app on an iPhone. iHealth also has wireless blood pressure monitors and a scale.

Withings Smart Scale
Smart Scale
Smart scales measure weight and calculate BMI sending these measurements to an iPhone app using a Bluetooth connection. The scale from Withings is about the size of a laptop computer.

Sanofi Glucose Monitor
Blood Glucose Monitoring
Glucose testing is a difficult issue due to the need to test glucose levels multiple times a day and keep a diary of the results, associated meal times, exercise and other variables. Sanofi’s iBGStar is an iPhone attachment and app that greatly simplifies the testing and data logging process.

When plugged into the phone, the phone recognizes an inserted blood glucose strip and opens the app. After 6 seconds, the result is displayed on the screen and color coded to emphasize hyperglycemia and hypoglycemia conditions.

Biosense Technologies Urine Analysis SystemUrine Analysis
A urine analysis system from Biosense Technologies uses the iPhone’s camera to automatically read commercial urine dipsticks using a peripheral, the cuboid and a color mat to standardize the reading conditions. It is intended to perform analysis of 10 common analytes in urine listed on their web site. Processing takes about 30 seconds once the strip is in the mat and placed in the cube. It is available in several countries in Europe, the middle East and Asia and is awaiting FDA clearance in the U.S.

Blood Tests
Mobile blood tests are rather limited at the moment but a new development by Sharp Laboratories of Europe promises to change that in the next few years. Microfluidics allows the development of a lab-on-chip about 4-5 cm that is a mobile lab. Results are now known in minutes instead of hours, and it requires just a drop of blood. The goal is to move this to commercialization in the next few years.

Cellscope OtoscopeEar Test
In addition to vital signs apps and attachments, there are a variety of more specialized tests available with Iphone attachments. Cellscope makes a smartphone otoscope attachment that captures photos or videos of the ear. The stored images allow diagnosis, remote consultation, and tracking of changes over time. Pediatric ear infection is one common ailment that is targeted by Cellscope.

GE UltrasoundUltrasound
Ultrasound exams can be done with a pocket, flip phone scanner such as the Vscan from GE Healthcare. The Vscan has the capability to provide at quick look abdominal, urology, fetal/OB, and cardiac anatomy. This can speed diagnosis and subsequent treatment. Currently an ultrasound exam is ordered, scheduled, and performed in lab. With a hand held scanner, it can be done immediately as part of a physical exam.

AliveCor ECG System
Cardiology
The cardiologist has been a big beneficiary of mobile technology with just two devices: an attachment for the iPhone to generate, display and store ECG’s and mobile ultrasound devices that are more effective than just relying on the stethoscope for an initial work up. The Alivecor Heart Monitor was cleared by the FDA in November of 2012 and is now available for both the iOS and Android smartphones. It generates a single lead ECG that can be annotated, stored, and reviewed. The device is available for physicians and can be prescribed for patients to record intermittent events and send the ECG to their cardiologist.

GE Cardiac Ultrasound ExamThe GE Vscan portable ultrasound also performs 2D echocardiograms including color flow for assesment of the valves, left ventricle, and pericardium. Both devices can be used in the cardiologists office for a more complete initial assessment and anywhere else the cardiologist happens to be.

Dr. Eric Topol, chief academic officer at Scripps Health has used the AliveCor twice on airplanes. Answering the call “is there a doctor on board”, he used the AliveCor as part of his diagnosis. Once he recommended an emergency landing to get immediate treatment and the other time, an emergency landing was not necessary.

Dr. Topol no longer does a formal cardiogram. He uses his iPhone to get the ECG and if indicated, prescribes an AliveCor device for the patient to record intermittent events. He also says that he hasn’t used a stethoscope for 2 years. Instead Topol pulls out his Vscan and does a full echo of the patient’s heart.

Sleep-wearable Physiological RecorderSleep Apnea
Watermark Medical has developed a device to diagnose obstructive sleep apnea at home. The WM Sleep Portal and integrated home sleep technology replaces a more expensive overnight stay at a hospital’s sleep laboratory.

After vetting the candidate patient as appropriate for the study, the wearable device is either provided to the patient by their physician or is mailed directly to the patient’s home. Upon completion of the study, the information is uploaded, auto-processed, undergoes a QA audit and professional interpretation by a Watermark network board certified sleep physician. The report is then sent to the ordering physician. All this is done within 48 hours.

EyeNetra Refraction SystemEye Test
EyeNetra has under test a refraction system, NetraG, for a smartphone that will generate a prescription for eyeglasses and contact lenses. It corrects for nearsightedness, farsightedness, and astigmatism and measures the distance between the eyes.

The Netra is an inexpensive clip-on eyepiece that goes on top of a cell phone. The user looks through this eye piece and interactively aligns the displayed patterns by clicking the buttons. The number of clicks required to bring the patterns into alignment indicates the refractive error. The device is not available commercially yet and is currently being optimized with eye care professionals. However, its target market is the developing world where the need is great.

Mixed Blessing
The new black bag presents problems as well as opportunities for physicians. The mobile diagnostic devices described here barely scratch the surface of what is available. The number of devices makes choosing a set for a physician’s black bag an imposing task.

The number of manufacturers is almost as large as the number of devices. All of these manufacturers will have different database schema. Pulling all this disparate data into an EMR is a daunting prospect. At least one company is addressing the problem of mobile device interoperability. Qualcomm Life, a Qualcomm company, has developed a platform, 2net, which is a set of wireless heath solutions.

The 2net Platform is a cloud-based system designed to be universally interoperable with different mobile medical devices and applications. Qualcomm Life says that 2net will enable end-to-end wireless connectivity and allow both device users and their physicians to easily access biometric data. The 2net solution set supports secure socket layer (SSL). It is listed as a Class I Medical Device data System in the U.S, CE listed in Europe, and Class I in Canada and is installed in several European countries.

An additional challenge for physicians and their IT departments is that almost all of the mobile health devices are not only available to patients but are being marketed to patients. Patients can show up at the office with symptoms and data to be analyzed. Getting that data from the patients smartphone into the doctor’s hands and potentially the EMR, is another issue the Qualcomm Life platform may be able to solve. It will be an interesting transition for physicians when patients start arriving with their own personal medical record collected from the patients’ monitoring devices and stored on their smartphones.This entry was posted in GeneralMobile HealthPersonal Medicine. Bookmark the permalink.← Patients Do More than Engage — They Can Take ControlLook at the Dark Side of the Cloud Before Using it for Archiving Images →

2 Responses to Smartphones Revive the Black Bag for Doctors: A Mixed Blessing?

Patients Do More than Engage — They Can Take Control

While CMS is focused on patient portals in EHRs to engage patients, patients have been engaging themselves with the aid of smartphones.  Smartphones have been supplemented with a variety of external sensors which track health parameters, providing information for the patient to manage their healthcare. These devices attack chronic health issues such as obesity, noncompliance with medication, diabetes, and heart disease.

The first step to improvement is to measure the condition.  The first measurement establishes a baseline and continued measurements track how well the program is progressing.   “If you cannot measure it, you cannot improve it.” – Lord Kelvin.  The mantra is embodied by the Quantified Self movement which promotes “self knowledge through numbers”.  This web site serves the QS user community with forums and international meetings.   You name it and someone in the QS community has tracked it and reported on it.  From weight, fitness, sleep, moods, stress, to reading habits, nothing seems to be left out.

Fitbit Flex Wristband

The number of fitness and weight loss apps are legion. Wearable and not wearable sensors aid in measuring and tracking fitness goals.The Fitbit Flex is a wristband that tracks steps, distance, food intake and calories burned during the day and sleep quality at night. It is water resistant and handles laps in the pool.

The Flex automatically syncs the stats wirelessly to computers and smartphones allowing real-time monitoring of progress. It does more than track. Lights on the band show how close one is to reaching the daily goal and when that goal is reached, it vibrates. As motivation, progress can be shared and compared with friends. The wrist band itself is a tangible reminder about fitness and occasionally blinks and vibrates to say stop sitting and move.

Withings Smart Scale

In the not wearable category for fitness tracking are the smart scales such as the one from Withings which not only measures weight, but body composition, heart rate and air quality. It measures the body fat percentage and calculates BMI. Standing heart rate is an indicator of improved fitness if it drops over time. Indoor air quality measures temperature and carbon dioxide and sends an alert when it is time to clear the air.

The scale automatically syncs wirelessly to smartphones and tablets to a Withings Health Mate app or several others such as My FitnessPal. The app tracks progress towards goals, sets reminders to weigh in and offers encouragement.

Medisafe Virtual Pill Box

Medication adherence is one of the largest and most expensive problems in healthcare. It is estimated that 50% of the US population take medication on a regular basis and of those, only half take their medications as prescribed. Healthcare costs, caused by improper and unnecessary use of medicines, exceeded $200 billion in 2012, according to the IMS Institute for Healthcare Informatics.

A variety of apps and mobile health tools address the issue of medication noncompliance. Medisafe is a smartphone app that creates a virtual toolbox that holds medications, instructions and refill reminders for regular medications.

uBox Smart Pill Box

Abiogenix has developed a smart pill box, the uBox, that pairs with a smart phone or computer. The box is locked until it’s time to take the medication when it and/or the phone sends a reminder to take the medication and the box is unlocked allowing it to advance to the next dose. The uBox tracks medications taken and notifies family members about missed doses. The locking feature on smart pill boxes combined with the dispenser prevents over dosing

Blood Glucose Monitoring System

Diabetes management is a difficult issue due to the need to test glucose levels multiple times a day and keep a diary of the results, associated meal times, exercise and other variables. Sanofi’s iBGStar is an iPhone attachment and app that greatly simplifies the testing and data logging process.

The attachment plugs directly into the iPhone, reads the test strip, and reports the result on the attachment and on the phone. The attachment can be used independently from the phone to read the test strip, but connecting the attachment to phone, provides the real benefits.

When plugged into the phone, the phone recognizes an inserted strip, opens the app, and plays a video demonstrating proper sample application technique. After 6 seconds, the result is displayed on the screen and is color coded to emphasize hyperglycemia and hypoglycemia conditions.

The result is auto-tagged for time of day and noted for post breakfast, pre dinner based on meal time pre-sets entered by the patient. Notes can be added to the result by selecting from those on the app, e.g., “light exercise”, “fatty meal” or manually entered. Similar screens allow for entering carbs, insulin and manual blood glucose readings.

Data can be viewed on a trend chart, logbook, or presented as average results over various time periods. Results can be quickly emailed to the healthcare team.

Blood Pressure Cuff for iPhone

Monitoring heart disease can be done with devices attached to smartphones that can also communicate results to the healthcare team. Blood pressure cuffs controlled by a smartphone app, such as Withings blood pressure monitor, automatically take blood pressure and heart rate and save it to the iPhone or iPad stamped with the time and date. The measurements history can be emailed to a physician for advice.

AliveCor ECG System

For more advanced monitoring, the AliveCor Heart Monitor device snaps onto an iPhone like a back and takes a single lead ECG by either placing one’s thumbs on the senors or by placing on the chest. The Heart Monitor sends the ECG wirelessly to the phone where it is displayed and can be sent to an AliveCor server for review by a cardiologist. This device is being prescribed by cardiologists to patients with intermittent events and being used by cardiologists as part of a patient’s exam.

Owlet Baby Monitor
Many more monitoring apps with sensors have been released. One of the more ambitious devices aimed at consumers is the Owlet baby monitor. The Owlet monitors heart rate, blood oxygen levels, temperature, sleep quality, and provides rollover alerts. All this data is collected with a “smart sock” worn by the baby, sent to a smart phone or PC app that syncs with an Owlet server proving access via any web browser.

Another patient engagement phenomena, that may be even more far reaching, is growing use of “peer-to-peer” social networks allowing patients to share data about treatments, how well they worked, and other tips about their specific disease. These networks range from the very specific, e.g., Crohnology for Crohn’s disease with 4200 members to networks with a broad scope of many diseases, such as Patients Like Me with 220,000 members. These sites allow patients to access real data as to what works in the real world and obtain more data than a single physicians experience allows.

The wealth of health and wellness apps and sensors combined with social networks allows patients to collect and monitor more data about their specific conditions and goals than ever before. Plans for management of their disease or for achieving wellness goals can be individually tailored. The result is patients not just engaging in their healthcare, but taking control of their healthcare.

Patients will be better informed and equipped to engage their healthcare team with more data about their condition that any single visit to the office could ever provide. Patients can collect detailed healthcare records and analyze different therapies based on what has worked in their social network. This could level the playing field of the doctor patient relationship.

HIMSS13 Highlights: mHealth and Data Analytics

There were many events that captivated me at the recent HIMSS meeting in New Orleans. Here are a few of my favorites, some of which I had run across before, and some surprises.

A major highlight was Dr. Eric Topol’s keynote address, “On the Democratization of Medicine”. The mantra, “Nothing about me without me”, encapsulated the themes of patient engagement and participation

alivecor2

Topol showcased and, in some cases demonstrated, a host of mobile diagnostic apps and devices, almost all of which are based on the smart phone. He has been an early adopter of the AliveCor ECG app for the iPhone as he showed in this video on his blog in 2011.

Dr. Topol has now used iPhone ECG twice on airplanes to diagnose passengers in distress during flight. The first time was on a flight from Dulles to San Diego when the “is there a doctor on board” announcement came over the intercom. Topol put his iPhone ECG on the passenger’s chest, diagnosed myocardial infarction, recommended that the plane land, and the passenger was treated and survived.

The second time Topol used the iPhone device on airplane was on the way back home from the recent HIMSS meeting. This time the passenger was diagnosed with atrial fibrillation, on a flight from New Orleans to Houston. He calmed and stabilized the patient, and the plane landed without further incident.

50963-hi-Vscan-closeup-sm

Topol also pulled out of his coat pocket a hand held ultrasound unit, the Vscan by GE Healthcare which he has also demonstrated several times as in this video. Dr. Topol uses the Vscan instead of the stethoscope for initial patient examinations of the heart. He said that it is about time the stethoscope, invented in 1916, was replaced.

visimobile

Topol pulled up the sleeve of his jacket to show that he was wearing a mobile monitor on his wrist. The Visi Mobile by Sotera is a stand alone monitor currently FDA cleared for monitoring of 3-lead or 5-lead ECG, heart rate/pulse rate, SpO2, respiration rate, non-invasive blood pressure, and skin temperature. It transmits the information wirelessly to a monitoring station. The Visi Mobile provides “monitoring in motion” whether the patient is in or out of bed or in transport. Dr. Topol discusses the Visi Mobile on this NBC video. The Visi Mobile was on display at HIMSS13 in the Intermountain Health booth which had a marked increase in traffic after Topol gave them a shout out in his keynote address.

The HIMSS Analytics booth featured CapSite’s products and services. Capsite is a health technology research and consulting firm that was acquired by HIMSS Analytics in the fall of 2012. Capsite presents actual pricing and discount data in 160 different HIT categories across 1600 vendors drawn from public information. In addition to the pricing data, the actual contracts, proposals, and RFP’s are available as well, making this a unique resource.

The M*Modal Catalyst products take transcription beyond reporting into analytics. I was intrigued by the Catalyst for Radiology demo which first creates a structured report from an unstructured radiologist’s dictation, then the structured data is utilized to create real time feedback to the dictating radiologist or “guidance” in M*Modal’s terminology. This guidance can point out addition information required to meet coding requirements, achieve PQRS measures, or other compliance needs. Future possibilities are fascinating to contemplate.

And for those who missed it, here is Eric Topol’s keynote closing. The video parody of the famous scene from the Jerry Maguire movie with Topol and his staff doing the voice overs to make it, “Show Me the Data!”

ECG Receives Attention from Apps Developers

A series of current iPhone apps and those in development, offer a set of sophisticated diagnostic tools for cardiology. Here is a sampling of ECG apps.

Alivecor has developed a ECG device that turns an iPhone into a ECG machine. A case with a sensor clips onto the iPhone and shows & records a ECG strip. One either places the index fingers on the sensors or places it on the chest to get an ECG strip.

The strip can be transmitted wirelessly during acquisition, saved, and emailed for review by a cardiologist. A patient with intermittent events can use this to record one and send it out for review. Watch a video here.

A cardiologist can use this in the office to get an instant look at a patient’s condition.
Today’s alternative is to order a ECG test from a lab in the hospital or clinic which may take several hours to schedule, perform the test and send the results back to the physician for review.

AliverCor is currently in the FDA clearance process for this device and expects to market the device for less than $100.

The Embedded Systems and Telecommunications Circuits Lab at EPFL has developed a ECG monitoring device for long term monitoring up to 150 continuous hours for to identify heart rate anomalies. The monitor consists of 4 electrode senors attached to the skin which are linked to a radio module and processor that clips onto the patient’s belt.

Data is fed to the user’s smart phone where it can be transmitted, viewed in realtime and stored. Algorithms identify any abnormalities and send the associated data via an email picture attachment to the patient’s physician. A demonstration is at http://www.youtube.com/watch?v=yIv14jZ83E0

AirStrip Technologies is marketing an FDA-cleared platform that allows mobile device access to 12 and 15 lead ECG data. Full 10 second data is presented on the mobile device with access to previous ECG’s from the ECG management system.

Physicians can scroll through the data to choose the beats for analysis. Calipers are provided as is dynamic ECG layout functionality.

Classically, ECG’s are either faxed or sent as a pdf file for remote viewing which presents a static view of a few beats. The dynamic access to all the data provided by AirStrip Cardiology app with touch zoom and scroll represents a quantum improvement. This app has been named the best US medical application for the iPhone as part of Ap Store Rewind 2011. It is in use at the Texas Health hospitals amongst others. A video demonstration is at http://www.youtube.com/watch?v=Mn8AFw27JSU