Smartphone Diagnosis and Health Devices: Legal and Clinical Implications

Hansa Bhargava, MD; Daniel L. Kraft, MD


March 31, 2016

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Show-and-Tell: Health Devices

Hansa Bhargava, MD: I'm Dr Hansa Bhargava from WebMD, and [I am] Medscape's advisor for pediatrics. Dr Daniel Kraft joins me today to discuss new devices.

Daniel L. Kraft, MD: I'm a physician trained in internal medicine and pediatrics. I'm the chair of medicine at Singularity University, and I am the founder and chair of a program called Exponential Medicine, where we look at the future of healthcare through the lens of where technology can take us.

Dr Bhargava: We would love to hear about these interesting devices you have here.

Dr Kraft: A lot is happening in healthcare as we move from the "sick care" equation to healthcare, and from intermittent and reactive to continuous and proactive care. Some of the tools and technologies I have on the table are already here and will reshape health and medicine.

One of them is a medical "tricorder." Almost every consumer and parent will have this kind of technology in their home in a couple years. You hold it to your forehead, and it tracks your temperature, heart rate, and oxygen saturation, and calculates your blood pressure. These are currently in clinical trials, but will eventually replace the digital thermometer. We're going to see the integration of these technologies at home, which provide data that will upload through your smartphone to your clinician.

We will have smart point-of-care lab tests, which require you to spit in a tube or dip a strip in your urine. An app on your phone will analyze the data and send the influenza screen or urinalysis results to your clinician or pediatrician. There will be many ways for consumers to be empowered to use these at home.

Or if you want to send a patient with a cardiac condition, for example, home from the hospital early, there are smart Band-Aids®, such as this one, that have an intensive care unit in a patch. This will send real-time EKG information, temperature, position, heart rate, stress level, or caloric burn through the Web to any clinician or pediatrician in the world. That's a lot of data. We're going to be able to use those in the inpatient and outpatient settings.

We're in an era of quantified self-help, using patches and other devices that can track your breath to determine your blood alcohol level, or the quality of your breath. These also can track your hydration level, and we will use these to pick up disease early. Devices can track your voice. Smartphones can be used as a sensor for detecting mental health.

Dr Bhargava: That would be a great device for a child at home who has gastroenteritis.

Dr Kraft: This can be used for gastroenteritis, tracking peak flow in asthma, picking up diseases—even lung cancer can be detected through breath assessment.

We can even start to quantify our brains. There is a new set of brain computer interfaces that are consumer-based. You wear this device and perform mindfulness training or meditation. I could prescribe this to a patient who might have depression or anxiety. Instead of giving a pill, I would prescribe 10 minutes of mindfulness training every day. This can provide guidance and feedback, and "gamify" it.

Is This Atrial Fibrillation?

Dr Kraft: Cardiac patients will have a smartphone case with an EKG, which is already US Food and Drug Administration (FDA)-approved. You can buy this online for less than $50, and it enables you to track an EKG anywhere. The app can even tell the difference between atrial fibrillation (AF) and a normal rhythm, which is useful for triage or screening, or for a patient with a particular condition.

Dr Bhargava: That is convenient for the patient and the physician, because the data are at your fingertips.

Dr Kraft: Right. A patient calls you with a fluttering chest at 2 in the morning, and with this app, you can see whether the patient is in AF.

We are pediatricians, and we see many children with ear infections. Rather than bringing in a screaming 2-year-old for an ear check, parents of children with ear infections can use a smartphone case with an otoscope. With a little training, they can take a picture or video and send the data to the pediatrician. Eventually, the app will be able to analyze the eardrum and determine whether it's infected.

We will be applying machine learning to a lot of the data that we can already collect, and the apps will be able to make a diagnosis using heart sounds, respirations, EKG, and more.

Another example is dermatology. You can take a standard camera or a dermatoscope and take a picture of a skin lesion. Instead of having to make a dermatology consult and possibly wait for months, you can send the image directly to a dermatologist, and they can tell whether it is a melanoma or a mole. Soon, new applications with machine learning will be able to tell whether the lesion is dangerous and track the lesion over time. Such fields as dermatology, pathology, and radiology, which are all based on pattern recognition, are going to be shaped, and in some cases disrupted, by technology.

We are in the era of 3D printing, which is being applied to hearing aids and braces, for example. Patients can now 3D print their own tumors. This is an example from a patient who printed his own tumor. He created this actual life-size version to help his surgeons remove and resect his tumor.

These technologies—which are getting faster, cheaper, and better at an exponential rate—are going to shift the spectrum of healthcare from home-based diagnostics and screening to managing such diseases as depression, anxiety, and cardiology.

Legal Implications of the Smartphone Diagnosis

Dr Bhargava: Now I'm going to be the devil's advocate. What are the legal implications of this technology? Are the data accurate? Can we make a diagnosis using these data? Is that going to be an issue?

Dr Kraft: A lot of these devices are going through FDA approval processes right now. It's one thing if an app tracks your steps, but it's another thing if it's calculating your blood pressure or blood sugar levels.

These devices are moving to FDA clearance, and physicians will be able to prescribe them to track diabetes and wellness, or optimize a patient's diet, for example. Some of these are available as consumer versions today, but we'll eventually use them to diagnose psychiatric or neurologic conditions early.

We don't need to wait for everything to be FDA approved, but many of these are moving in that direction and can give us continuous data to enable us to be more proactive and smart about prevention, fine-tuning diagnostics, and personalized therapy.

Dr Bhargava: So in the next 5 or 10 years, we're going to get more reliable information from these devices and apps, which can make our lives as physicians better and increase the convenience of consulting with patients. More important, patients' lives will be improved.

Dr Kraft: Right. No one wants to have an app for every single one of these, and eventually, the data will flow through our smartphones, and in some cases directly to our EMRs. When you prescribe a wearable device, and say, "I want you to exercise" or "I want you to track your blood glucose," those data will flow back to you as the clinician.

These systems might be able to nudge patients, alerting them to see their doctor, that their blood pressure is too high, or to adjust their medication dosage on the fly. We may be delivering medications by drone pretty soon. Many things are converging in this exponential age, and it's up to us to reimagine healthcare and integrate devices, smart data, low-cost genomics, and beyond.


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