More than 100,000 health and medical apps are now on the market. Many of these connect to high-tech wireless devices that are worn, or even ingested, by consumers and patients. Apple, for example, announced this month the creation of an app that will allow users to track their vital signs and interact with their doctors’ offices. Another app wirelessly connects to a microchip that is swallowed with pills so patients and their doctors can monitor if medicine is taken correctly. Susan Page and a panel of guests discuss the benefits and risks of new wireless health technology.

Guests

  • Dr. George Savage Chief Medical Officer, Proteus Digital Health
  • Steven Posnack director, Office of Standards and Technology, Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services
  • Dr. Steven Steinhubl director of Digital Medicine at Scripps Health, affiliated with the Scripps Translational Science Institute in La Jolla, California
  • Arthur Allen editor of eHealth at Politico
  • Dr. James Giordano scholar-in-residence and chief, Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center

Transcript

  • 11:06:54

    MS. SUSAN PAGEThanks for joining us. I'm Susan Page of USA Today sitting in for Diane Rehm. Diane will be back next week. What if you could swallow a microchip the size of a grain of sand and it would tell you on your tablet computer that you'd taken your medicine correctly? Well, you can. This technology already exists. It is one of many new wireless devices that connect to mobile health apps.

  • 11:07:19

    MS. SUSAN PAGEWith me in the studio to talk about the risks and benefits of this new technology, Dr. James Giordano at Georgetown University Medical Center, Arthur Allen with Politico and Steven Posnack with the Department of Health and Human Services. And joining us by phone from California, Dr. Steven Steinhubl at Scripts Health. Welcome to "The Diane Rehm Show."

  • 11:07:41

    DR. JAMES GIORDANOThank you.

  • 11:07:42

    MR. ARTHUR ALLENThank you.

  • 11:07:42

    MR. STEVEN POSNACKThank you very much.

  • 11:07:42

    DR. STEVEN STEINHUBLThank you.

  • 11:07:44

    PAGEWe're going to invite our listeners to join our conversation with their questions and comments later in this hour. You can call our toll-free number 1-800-433-8850. Send us an email at drshow@wamu.org or find us on Facebook or Twitter. Well, Dr. Steinhubl, let's start with you. You are a doctor who specializes in digital medicine. How big a trend is this, the use of these mobile apps to monitor health?

  • 11:08:16

    STEINHUBLThank you, Susan. And I'm a cardiologist first and have, over time, in looking at -- focusing on prevention and wellness have looked at these tools and it would be fair to say it's still very much in its infancy. But it's growing rapidly just because the technologies and the apps that are available are growing. There's still a lot of work to do. But there are over 40,000 apps available on the iTunes store for example that focus on some aspect of wellness and health.

  • 11:08:51

    PAGESo Arthur Allen, my niece sent me an email this morning saying to talk but Fitbit. She called herself -- I forget what she said, obsessed with FitBit. What's Fitbit?

  • 11:09:04

    ALLENSo Fitbit is a bracelet, I guess, where, I guess, you can attach it to your body different ways and it gives you information that it can connect to a computer about your heart rate and you put in information like calorie consumption and how many -- and how many calories you're burning and various other things are fit into this and other gadgets like it.

  • 11:09:27

    PAGESo Dr. Giordano, that sounds pretty simple. Some of these, though, are pretty sophisticated devices.

  • 11:09:34

    GIORDANOThat's exactly right. Something like Fitbit, the nice part about that is it's donable and it's doffable. You can take it on and you can take it off. Where the concerns really begin to be generated is those things that are more ingestible or those things that are interventional, things that are injected, ingested, those things are in there at least for the duration if not for keeps and that's where some of the concerns really begin to arise and are generated.

  • 11:09:56

    PAGEWhat kind of concerns?

  • 11:09:57

    GIORDANOWell, you know, some of the things we're talking about here are micro scale or sensors. These are biosensors that, as I said, can be donned into the body and once they're in the body they can either occupy a hollow space or occupy an organ or just be free in the bloodstream. But, of course, the concerns here are these are, in fact, transmitting data in real time.

  • 11:10:15

    GIORDANONow, there's great positives that go along with that. You're able to acquire tons of information, select information and parse this information so that it almost takes the user, the individual out of whose body it is, out of the loop, which then provides great data information to clinicians and a variety of different clinical services. But there's an interesting risk.

  • 11:10:33

    GIORDANOWe're really walking right down a center line. This is personalized medicine probably at one of its most sophisticated, but we also have to worry about protection and privacy. Who's gonna get a hold of this information? How will this information be used and is this, in some way, hackable?

  • 11:10:45

    PAGESo Arthur Allen, one of the things that people are concerned about, so you use one of these mobile apps to monitor something. Can this data be gathered and sold to third parties?

  • 11:10:58

    ALLENIt can and it is being sold. Someone at FTC recently did a study and I think it showed roughly a third of these kind of apps, the companies that are selling them, that provide them, are, you know, selling the data to other, you know, to data companies. And it's no clear how it's being used. I mean, it doesn't seem that, in most cases, it's being used to sort of personally target the people who are using it. It's more sort of gathering data that will be used in other ways.

  • 11:11:31

    ALLENBut the potential is there for it to be very invasive of people's privacy.

  • 11:11:35

    PAGESteven Posnack, you're director of the Office of Standards and Technology at the Office of National Coordinator for Health Information and Technology, which is a mouthful, at the Department of Health and Human Services. So what about the federal government's regulatory role here? Are there rules about what devices can be marketed and also how the data can be used?

  • 11:11:54

    POSNACKSure, yeah. And the FDA, Food and Drug Administration, plays a large role in this area, as well as my office, among other agencies that Arthur mentioned. The Federal Communications Commission, we're talking about wireless data being transmitted, this concept of the medical body area networks that involve, you know, the use of these ingestible types of devices and sensors that are providing information back and forth, as well.

  • 11:12:22

    POSNACKThe FDA has been playing a role in this area. They release guidance on mobile medical applications and which ones they were going to focus and prioritize their oversight as well as areas where they're not going to be focusing their oversight as well to allow for greater innovation in the marketplace.

  • 11:12:36

    PAGEWhere are they not doing oversight, so it's like the marketplace rules?

  • 11:12:39

    POSNACKSo currently, they have a subset of mobile medical applications that they call related to medical devices and these involve devices that are already regulated by the FDA so if you've miniaturized a device that currently exists on the market that FDA currently regulates to make it work with an iPhone, that would be something they continue to regulate.

  • 11:13:02

    POSNACKSo the platform on which this functionality exists doesn't change the fact that it continues to be regulated. But a lot of the, you know, pedometers, calorie-intake, normal health kind of just understanding about ourselves is not something that the FDA is focusing on.

  • 11:13:16

    PAGESo Dr. Steinhubl, these are some of the risks. Talk about some of the benefits. How can you use this in a way to help people be aware of their own health or make their own health better that they couldn't do before?

  • 11:13:30

    STEINHUBLWell, it really allows to better engage patients and really empower them. And there's going to be different degrees of that of how an individual's desire of empowerment and we know that from studies, that every patient has different levels of activation. But what the tools end up being is not any direct answer in itself, but rather something to build a system around where you can really communicate with the patient.

  • 11:13:58

    STEINHUBLAnd just, as a very quick example, hypertension, which happens to be our most common chronic disease in the United States and only half of U.S. individuals are adequately treated for their hypertension, yet it explains about 50 percent of our risk for heart attacks, 80 percent of our risks for strokes. And the typical hypertension treatment is come into the office, measure your blood pressure, maybe start a medication, bet lifestyle changes.

  • 11:14:21

    STEINHUBLCome back three months later and then, you know, we'll measure it again or sometimes measure it at home. And instead, with some of the wireless devices, some are just wireless blood pressure cuffs that can transmit and track the data, others that are being developed are wrist watches that continuously measure your blood pressure beat to beat, that now you can, the next day or two days later, your blood pressures are automatically transmitted back to your physician's office.

  • 11:14:48

    STEINHUBLYour physician's office, not specifically the physician, but the office can give you feedback and to -- this is working well or these numbers are well, and the less, you know, the less (unintelligible) your therapy was not. And in studies, not specifically of mobile devices, but of that very close follow-up at home, we've found that we can almost double the rate of individuals who achieve a goal of adequate blood pressure control.

  • 11:15:11

    PAGEI wonder if there's any risk, Dr. Giordano, I'm thinking of one of my kids who's kind of a hypochondriac, if he had a device like that, I could see him obsessively monitoring his blood pressure in a way that wouldn't necessarily maybe be what you'd be looking for. Is there a risk that people become overly concerned if they have all this information?

  • 11:15:29

    GIORDANOWell, I think it goes both ways. I think that on one side, what it does is it actually takes the individual out of the loop because it allows direct transmission to healthcare providers. So to essentially mirror and very apropos for Dr. Steinhubl, say, is it is a very useful clinical tool because it provides real time information that can be either select or generalized to a healthcare provider not only for monitoring, but if we increase the sophistication of some of the indwelling devices, which are then able to do is get closed loop.

  • 11:15:56

    GIORDANOSo, in fact, what could actually happen is you monitor the parameters, certain biometrics of blood pressure or chemistry and then it'll actually also signal, for example, an indwelling device to release certain chemicals or to actually activate, for example, an alert network that would then allow someone to come to the house, emergency services, so it is useful.

  • 11:16:14

    GIORDANOThe question then become is this also accessible to patients and how they will then use that information or misuse the information.

  • 11:16:19

    PAGESo should they generally?

  • 11:16:21

    GIORDANOI think that's a debatable issue. Obviously one of the things you're talking about is their personalize information and by virtue of an ethical law of autonomy, this is something that the patient would want to have right and access to. But then, this opens a proverbial can of worms because then that patient has access to a host of information that they may not be able to interpret.

  • 11:16:40

    GIORDANOAnd this increases, in many cases, the workload that clinicians may have to interpret.

  • 11:16:44

    PAGEDr. Steinhubl, what do you think about that?

  • 11:16:46

    STEINHUBLI completely agree. I think that's often the unknown side of this, that isn't talked about enough. But we see it all the time in routine practice now where we'll send a patient an actual copy of a lab report that comes with all of the highs and lows and other information. And I know just from experience with not only my patients but my own family members who have value that may be close to the abnormal low or high and it panics them and they wonder what's going on.

  • 11:17:13

    STEINHUBLAnd so empowering patients and providing them with their data -- and it's their data and they deserve that and deserve to choose how that's used, I believe -- but it's incumbent upon us to give it to patients in a understandable, meaningful way and not just dump all the data on them and say, good luck with this now.

  • 11:17:31

    PAGEArthur Allen, what kind of reaction have you heard from people about these devices?

  • 11:17:35

    ALLENWell, I mean, the thing is, these devices -- there's a movement called the quantifiable self movement which uses these things called fit and to me, it's a subculture that's very fascinated by these bits of data, by trying to figure out exactly how they can lose, you know, a pound a week by eating exactly so many peas and potato chips. And those aren't really the people that medicine cares about and yet, they're the most avid users of these technologies, I mean, because often these are not people who are really in bad health. They're younger people.

  • 11:18:07

    PAGEThey're probably people in the best health.

  • 11:18:09

    ALLENExactly. So there's that issue and then, I think the question of, you know, misuse of information or just there being so much data and so much information and it can be misused. I mean, this makes me think often of the use of VAERS data, which is vaccine adverse event data that's misused all the time.

  • 11:18:28

    PAGEWe're going to take a short break. When we come back, we'll continue our conversation about these incredible new health apps and we'll take your calls. Our phone lines are open, 1-800-433-8850 is our toll-free number. Or send us an email at drshow@wamu.org. Stay with us.

  • 11:20:02

    PAGEWelcome back. I'm Susan Page of USA Today, sitting in for Diane Rehm. We're joined from Redwood City, California -- actually we're joined from La Jolla, California by Dr. Steven Steinhubl, who's director of digital medicine at Scripps Health. He oversees clinical trials of wireless health technology at the affiliated Scripps Translational Science Institute. I'm sure I butchered that. And here with me in the studio, Steven Posnack, director of Office of Standards and Technology at the Health and Human Services Department.

  • 11:20:33

    PAGEArthur Allen, he's editor of eHealth at Politico, and Dr. James Giordano, scholar-in-residence and chief of the Neuroethics Studies Program at Georgetown University Medical Center. Well, Steve Posnack, you're here from the government. What has the government -- the federal government found necessary to kind of crackdown or limit when it comes to this explosion of health and medical apps?

  • 11:20:56

    POSNACKSure. And there has been some areas where the representation of the apps and what they can do for patients using some medicine, diet, that's one area there. There have been other instances where the convergence of the ability and mobility of the technology has led to the use of the mobile apps in different contexts that weren't necessarily approved by the FDA. So, you know, one example being a urinalysis type of assessment where it would measure the use on a stick color-coding that relied on visual.

  • 11:21:31

    POSNACKUsing eyesight to determine the type of effects that glucose protein, ketone levels that were part of the person's urine. And the FDA said, you know, if you're using a mobile application, that you're taking a picture of this. The comparative analysis and the algorithms behind that need to be viewed in a different light.

  • 11:21:52

    PAGEAre you concerned that companies are pushing too far too fast on this? Or do you think this is a good thing to have happening?

  • 11:22:00

    POSNACKWell, I think we are very much in favor of encouraging innovation in this area. I think we do need to be careful where the technology gets close to the edge of making decisions for us. And that's really one of the risks where, I think, you know, we are most concerned about or interested in when the technology can potentially independently act on the patient's behalf, whether it'd be distributing drugs or alerting your doctor that, you know, you're having a heart attack or something along those lines. Very much important and very much cutting-edge. This is 21st century care. But it also bears, you know, new risks that we're not familiar with.

  • 11:22:31

    PAGEDr. Giodarno?

  • 11:22:32

    GIORDANOLet me just mirror what Steve said here. He used the magic word, actually two. He used the word convergence and he used decision technologies. So our group is actually looking to both of these issues in great detail. And they have great promise, the idea of convergent sciences, bringing together, for example, micro and nano-sciences together with cybertechnology and information technology offers huge vistas and possibility.

  • 11:22:54

    GIORDANOThese can also be linked to things called decision technologies that then utilizes various computational algorithms to actually make decisions about what type of care is necessary, what vectors of care, who gets notified, what gets notified. So decisions are being made. But, of course, all these things are also (word?). With every positivity, there's a negativity. So we have to be very, very careful about how these things are utilized and what controls are put into them.

  • 11:23:15

    PAGEWe're joined by phone now from Redwood City, California by Dr. George Savage. He's chief medical officer of Proteus Digital Health. This is a company that manufactures an ingestible sensor that tracks if you are taking your medication. Thanks so much for being with us, Dr. Savage.

  • 11:23:33

    DR. GEORGE SAVAGEGood morning.

  • 11:23:34

    PAGEGood morning. So tell us about this ingestible sensor and how it works.

  • 11:23:39

    SAVAGEYeah. What we're aiming to do is to connect drug therapy to the internet. And the reason for that is that fewer than half of all patients are taking their medicines at all correctly. And the reason for this isn't an affirmative decision just to go their own way, but that they just can't keep with the regimen and the doctor doesn't know what's going on and so forth. So what we've created is a very tiny microchip.

  • 11:24:04

    SAVAGEIt's made out of silicon, it's made out of some essential dietary minerals. In fact, everything that's in it is found in your diet. When you swallow it, as part of a pill, it will send a signal in your body only, very privately, with a unique ID code. It sends that ID code for about five minutes and then it goes inert. And we also make a Band-Aid, one of these wearable monitors that records that signal and monitors your activity and your heart rate and certain other factors, and then relays that via the phone to the internet.

  • 11:24:36

    SAVAGESo the idea is you can have an accurate picture as a patient. Your family can have an accurate picture, the physician, of how you're using your medicines and how that behavior is affecting your therapeutic response.

  • 11:24:47

    PAGESo to make sure I understand this, so the little microchip would be a part of the pill, basically, that you take. Right?

  • 11:24:54

    SAVAGEThat's right.

  • 11:24:55

    PAGEAnd it would transmit information to a Band-Aid that you'd wear.

  • 11:24:58

    SAVAGEThat's correct.

  • 11:25:00

    PAGEAnd then the Band-Aid sends the information to the internet.

  • 11:25:03

    SAVAGEThat's right, yep.

  • 11:25:05

    PAGEWhat's the information that it's telling whoever's listening?

  • 11:25:09

    SAVAGEYeah. The information is primarily about what you took and when you took it. And then also the Band-Aid is monitoring other parameters that are very common nowadays in terms of your sleep, your activity, your step count, your gait, your heart rate, various other biophysical parameters. When the data get to the internet, of course, you can associate that with other information from other censures made by other companies.

  • 11:25:35

    SAVAGEBut the goal here is to begin to build some rich information around how patient's therapeutic decisions are affecting their health. Right now, there's a lot of misinformation on the part of physicians working with patients to take their medical therapy. If I ask a patient are you taking your drugs, the inevitable response is yes. And I'm thinking, do you have a steady blood level of a therapeutic agent? Pharmacokinetics, that kind of thing. The patient is often thinking, am I a good person and did I take my drugs this morning. And, of course, that's a different question.

  • 11:26:08

    PAGEI can see how if you had, say, an Alzheimer's patient or an older person who was living alone that this could be especially suited for them.

  • 11:26:19

    SAVAGEAbsolutely. Patients with cognitive impairment or important areas of need, particularly for family members who are helping to deal with these patients, giving family members a picture with permission from the patient. Dr. Giordano earlier made the point about patients being out of the loop. And here what we're trying to do is the opposite. We're trying to put the patient in the center of the loop.

  • 11:26:42

    SAVAGEIf you think about drug therapy nowadays, typically, in between doctor visits the feedback a patient gets is all negative. I have complexity. I have to remember to take a lot of medicines. I have cost. I have side effects. I feel scared if I look at my pill bottle I'm reminded of a diagnosis of a chronic illness that may worry me appropriately. I've got nothing positive in it for me.

  • 11:27:06

    SAVAGEAnd one of the issues that we're trying to address with digital technology is this fact that drugs are designed by doctors primarily for other doctors. And that's a great first step. But if we think about computers from 20 years ago, we used to sell computers that were built by engineers for other engineers, how fast did the processor run, that kind of thing. And part of the mobile phone revolution has been to change that paradigm by making computing relevant to everyone else.

  • 11:27:32

    SAVAGEAnd we're trying to do more of that with drug therapy to get out this misuse of medicine that is really swamping the therapeutic benefits that patients could get.

  • 11:27:41

    PAGEProtheus' ingestible chip was the first smart pill approved by the FDA in 2012. How widely is it used now?

  • 11:27:48

    SAVAGEWell, we're in early commercial use in both United Kingdom and the United States. We're working to integrate the technology into patient care. And we have certain, you know, requirements that we're really looking at. And that is it can't just be another widget, it has to fit into the way care is delivered. It has to have privacy and protection, where the patient controls their data first. And what we're trying to do is to create new business models.

  • 11:28:15

    SAVAGEWhereas instead of the current pharma model, which involves selling chemicals by weight for high prices that could work, having business models where you get paid, if you're a company, for delivering value. Value that the patient can see in terms of an outcome. Value that the payer can see. And we believe these digital technologies have the potential to do that. So that involves us partnering with integrated health networks to try to fit this into practice in a way where we can demonstrate that.

  • 11:28:43

    PAGEAnd how much does it cost?

  • 11:28:45

    SAVAGEWell, that's the beauty of the system. We're leveraging semiconductor-base technology. So the more we make, the less expensive it is. So as a rubric internally here, we assume the product is free. And, of course, it does cost something, but it's into the pennies for the sensor level already. And as I make more and more of them, it gets cheaper. So what we're really trying to do is not to say here's my pill, please pay a lot of money for it.

  • 11:29:13

    SAVAGEThat's the current model. We're trying to say, here's my treatment system, here's how I'm going after this 50 percent misuse of medicine out there due to a lack of information. How can we, in therapeutic area after therapeutic area, demonstrate value and then share in the value we're helping to realize.

  • 11:29:31

    PAGEDr. George Savage, thanks for joining us on "The Diane Rehm Show."

  • 11:29:35

    SAVAGEThank you.

  • 11:29:36

    PAGEDr. Savage is the chief medical officer of Protheus Health. So this idea, Arthur Allen, how important is it when you think about the way our health system work? Is it kind of a shiny object or is it something that would make a great deal of difference to a lot of people?

  • 11:29:53

    ALLENWell, the first impression I have from that conversation is that they're trying to figure out how they can make money on it and that is not going to be easy. When people start talking about value-based care, I mean, that's kind of the buzz word of today and it's important I'm sure. But it sounds like it would need a lot of development because if it's just a matter of putting these objects in pills and they don't cost anything, maybe that's difficulty -- there's a difficulty there getting paid for it.

  • 11:30:22

    ALLENBut, I mean, in principle, it sounds like it could be useful addressing this problem. I'm sure there are other ways of addressing the problems of people not taking their drugs. For example, there are pillboxes that are wired where if you open up the pillbox, you know, a sensor goes off and shows that you've gone in to get your medicine out of it. And that can be sent to an electronic device and alert someone.

  • 11:30:49

    ALLENAlso, all of this has to be integrated into medical system so that there's somebody at the doctor's office who's looking at this every day, right? So it's all part of a system. And I think that's an issue with a lot of these devices that are being invented is that there isn't really a medical system that they're being integrated into. And if there isn't, then there's just going to be a lot of venture capital, money put into these things. So they aren't going to go anywhere useful. I mean, that's a really big issue, I think.

  • 11:31:16

    PAGEDr. Steinhubl, what do you think?

  • 11:31:18

    STEINHUBLI couldn't agree more. And I think that's one of the biggest challenges of really taking advantages of these technologies. The Protheus pill is a tremendous advantage to how we care for patients. In particular patients who just we have to make 100 percent sure they take their medicines, hepatitis C treatments, schizophrenia patients, you had mentioned Alzheimer's patients.

  • 11:31:41

    STEINHUBLBut we don't have the systems built around that. And what is -- what is so exciting about the mobile technology is that we have to, to make them successful, we have to change our systems of care. And most everybody would agree -- maybe not at face value -- that that's a good thing. But, you know, physicians or providers and service are for the most part the vast majority are unhappy in their current situation.

  • 11:32:08

    STEINHUBLPatients are unhappy. We're unbelievably expensive. And in a recent Commonwealth Fund Survey, we ranked 11th out of 11 countries in terms of our quality of health care. So we need that kind of rebooting of our systems of care. And we can use these technologies to take advantage of that. But Arthur is completely right. If we don't change our systems of care, they're not -- there's going to be no benefit.

  • 11:32:32

    PAGEI'm Susan Page, and you're listening to "The Diane Rehm Show." Dr. Giordano, do you agree with that? I mean, does there need to be kind of a broader-reaching integration in systems of care before some of these devices will make sense?

  • 11:32:46

    GIORDANOWell, I'm going to call the wolves out of the den, if I could. I certainly think that the Protheus system is nascent, it's great. I think what it does is it speaks to the old adage that says the only drugs that work are those that the patient will take. So what this does is imparts a particular level of control. And we can go one step further. If we do look at a close loop system, where you not only have a sensor, but you also have a delivery device.

  • 11:33:06

    GIORDANONow when certain blood chemistries change and metrics change, it's not a question of notifying anyone, it's a question of notifying the device that the drug is delivered. So it creates a very, very close loop integrated system. But you and I both know, actually, well, our listeners that control can be a two-edge blade. And so the issue here is, what level of control, what drugs, who will be doing the control and what are we looking to control.

  • 11:33:28

    GIORDANOSo there is the other ethical issue that says this thing imparts a level of control, medical control over a patient's body to where the patient may not be able to be compliant or non-compliant. And of course this can also be directed by intent. And this does in fact call the wolves out of the den, not to be negative against the technology.

  • 11:33:44

    PAGENow when you say that, what does that mean?

  • 11:33:46

    GIORDANOWell, I mean, if we look at something that, say it's an app, one that can be internally or externally controlled, we can then have drug delivery from either an internal or external source. So if certain parameters within this patient changed, certain blood levels of a chemical changed, certain physiological parameters changed, we can then cause the release of a particular drug to control their physiology or I'll go one step further their behavior inclusive of their thoughts or their emotions.

  • 11:34:09

    GIORDANOAnd this can be very, very useful in patients who are, in fact, suffering from things like dementia or schizophrenia. But this also opens the door for some other possibilities. And, as I said, this is the negativistic side where we now look at the possibility of even dual use. Can we now see this providing perhaps behavioral control, thought control, physiological control. As I said, this is really calling the wolves out of the den.

  • 11:34:31

    GIORDANOThis is the negative side of the Pandora's box. This is wonderful technology and shows great promise to really allow medical care and personalization. But, of course, we have to be pragmatic and prudent about it.

  • 11:34:42

    PAGEAnd I guess it also raises the question who decides? Who decides what's appropriate, who puts limits if limits are needed. Steve Posnack, how big a debate is that in the government?

  • 11:34:53

    POSNACKIt is -- it's quite a big debate. And we have recently been, with my colleagues in the FDA and other agencies engaging stakeholders across the nation, innovators, Silicon Valley, venture capitalists. We had a three-day workshop a few weeks ago to discuss these issues and how the government can play a role in promoting patient safety as well as innovation.

  • 11:35:16

    PAGEYou know, Arthur Allen, there was a new device put out by Apple -- announced by Apple this month that allows patients to share data with doctors. Talk about this new operating systems called HealthKit.

  • 11:35:31

    ALLENYeah. I mean, my understanding of it -- and I'm not a -- I don't know all the details, but that it offers a lot of the same kind of monitoring information that other systems offer. You know, monitoring your sleep and heart rate and, you know, activity and so on. One thing that was new about it was that they announced that they were going to have an arrangement with the big electronic health record, a company called Epic, which covers about 100 million patients in this country.

  • 11:36:02

    ALLENAnd so the idea there was that it would have sort of a more of a practical side rather than just being a device that's kind of out there in the universe and you can add new functions to it and that would eventually be of a more used sort of medically. I mean, I think one of the issues with these devices, I mean, the wolves coming out of the den are really fascinating and it's a very scary and a cool image.

  • 11:36:26

    ALLENBut it's also just a practicality -- I mean, if you -- if your body -- if you take this pill and electronically it registers your heartbeat going up, you have to have a human being there to know that the patient didn't also just fall down the stairs after they took the drug and that their heart rate has nothing to do with the drug, but is also -- I mean, there's a lot of practical implication, you know, questions that go around these devices also.

  • 11:36:54

    GIORDANOAnd I couldn't agree more. And Arthur has actually raised an interesting point. In some of his previous in electronic medical records, they said the theoretical concept is not the same as actual use. And he's right. I mean, as a concept, the idea of self-monitoring systems is ideal because it does provide that level of clinical control. It also provides a bit of safety. I mean, it takes the I fall and I'd just get up.

  • 11:37:16

    GIORDANOCrank it up to one whole new level. It's like, well, my blood chemistry is changing and I need my medication. Well, it can be delivered. But, you know, I think the other issue there too is that there are decisions that are contingent on this and we have to ask who's making the decisions and what's the level of decision making.

  • 11:37:30

    PAGEWe're going to take a short break. When we come back, we're going to go to the phones and take your calls and comments, 1-800-433-8850. Stay with us.

  • 11:40:01

    PAGEWelcome back. I'm Susan Page of USA Today, sitting in for Diane Rehm. And with me in the studio this hour, Arthur Allen, editor of E-health at Politico, Steven Posnack who works for the Department of Health and Human Services and Dr. James Giordano from Georgetown University Medical Center. And joining us by phone from California, Dr. Steven Steinhubl at Scripts Health.

  • 11:40:23

    PAGEWe're gonna take your calls and questions. Let's go first to Fred. He's calling us from Syracuse, New York. Fred, you're on the air.

  • 11:40:30

    FREDHi. It sounds like I'm listening to NSA meets medicine. Anyways, I was told to be brief. Here's my story. I'm a physician. I'm a podiatrist in the Syracuse area and a year and a half ago I got diagnosed with diabetes, called the night before that, my A1C was 9.9, my blood sugar was 440. The oncall doctor said, Fred, I want you to go to the hospital.

  • 11:40:54

    FREDI said, who do you want me to see? They said, nobody. You have to go in 'cause you're sick. And I said, well, I feel okay. So I went in the next day and I got what I consider poor medical care because the doctor looked at me, said you're diabetic. We're gonna put you on some Metformin. And as a commercial pilot and a doctor, I said, whoa. Can't do this because I got to talk to the FAA and I don't want to do that.

  • 11:41:17

    FREDSo we went on diet and exercise. Happy to say I lost 45 pounds. I have an A1C of under five and my sugars run between 80 and 100. What you need is informed consumers, people who understand and manage their chronic disease. I think we need fewer bells and whistles. If we spent more time educating our patients (word?) how to manage their chronic diseases, we would have much happier and healthier people.

  • 11:41:46

    FREDAnd over the past year, I'm happy to say, in my practice, I probably caused people to lose over 10,000 pounds.

  • 11:41:53

    PAGEAll right, Fred.

  • 11:41:54

    FREDAnd that's all I got to say.

  • 11:41:56

    PAGEAll right, Fred, thanks so much for your call. Let's take another caller, Bridget's calling us from Cincinnati, Ohio. Bridget, you're on "The Diane Rehm Show."

  • 11:42:02

    BRIDGETHi. Thank you for taking my call and I wish this could be kind of a four-hour discussion because it's so intense. But let me give you my brief questions and then I can listen off air. First of all, I agree with Fred in terms of the we need more informed patients. And personalized to me means one on one with my doctor, not one on one with a device that goes to my doctor.

  • 11:42:25

    BRIDGETBut that being said, my two questions have to do with medical aspects of this and what attempt is there to get medical ethics onboard studying this, looking at this from two standpoints. What do you do with noncompliant patients? Can care be refused? Can it be that they only get one more shot at it and then -- or three strikes and the you're out because now, all of a sudden, their routine and their compliance is being monitored?

  • 11:42:51

    BRIDGETAnd the other thing is how does this affect the roles of POAs, of guardians, of children who want to deny care of execute care? So those are my questions and I will take my answers off air. And I admire the panel for what they're doing.

  • 11:43:08

    PAGEBridget, thanks so much for your call. Well, Dr. Giordano, these are some things you were talking about. What to do, for instance, if you've been diagnosed as a schizophrenic and there's a device that monitors whether you've taken your medicine and if you haven't, it dispenses it without your express permission?

  • 11:43:26

    GIORDANOWell, it raises a very interesting question, the question of what am I consenting to when I give informed consent. We're not just going to be dropping these devices into individuals without their consent. I mean, that would be a medical improbity. But the issue then becomes is the patient onboard with this. The caller raised a very interesting point as well and that's what about the patient who does not want to be compliant with treatment.

  • 11:43:49

    GIORDANOThis speaks to another issue, which is patient autonomy. Patients, if they do have capacity and they are, in fact, competent, can refuse care, if, indeed, they're not a minor and, as I said, they are capacious and they are competent. So what this then does is this puts an additional level of control and concern into the picture. Well, what do you do with the patient who then says, I don't want this anymore.

  • 11:44:10

    GIORDANOThis device has to then be removed, et cetera. Another question there is well, what do you do with children or with minors or with those who do not have capacity or cannot necessarily give consent? This, then creates external control. This just adds another layer onto the ethical complexity that has to be dealt with. Again, I'm not saying that is necessarily wrong, but this has to then be adjudicated on a case by case basis.

  • 11:44:31

    PAGEWell, Dr. Steinhubl, when you have patient have used some of these devices, I'm sure many very successfully and happily, but do you ever have patients who say I don't like this, take it away?

  • 11:44:43

    STEINHUBLNot yet, but it's certainly a possibility. We're still in the very hypothetical, even though people are working on that, of the implantable devices. We have that a lot already with pacemakers and defibrillators and the like that can measure. But these are in very sick patients and I've never had a patient say take this out or quantification. But certainly that potential is there for the scenarios that we've been discussing.

  • 11:45:08

    STEINHUBLBut back to, you know, Fred's point and what this technology, though, can enable is right now, the average time a cardiologist will spend talking to their patients is 10 minutes of face to face time. Of that time, 40 seconds of it is around talking about medications and the average cardiology patient is on 10 to 11 different medications. So it's woefully inadequate.

  • 11:45:31

    STEINHUBLAnd what a lot of this mobile health technology will allow is when you talk to a physician, instead of what he experienced with the here, take this medicine and come back, is that physicians will be more freed up to do really why they went to medical school for four years and did residencies for three years and maybe a couple more years for fellowship after that, is not to manage blood pressure, which, frankly, requires maybe a high school education at best for 98 percent of people.

  • 11:45:55

    STEINHUBLIt's very precisely measured. It's very algorithmically treated. But instead to be your diagnostician and your educator to be able to sit down and talk to the patient and saying, look, losing 45 pounds is going to be as effective, more effective, much better for you than starting on this medication. But that takes a lot more discussion and right now, our system is not designed to do that and that goes back to the whole issue of really changing our systems of care that's going to be better for providers, better for patients and this mobile technology will help a lot of that.

  • 11:46:26

    PAGELet's go to Louisville, Kentucky and talk to Linda. Linda, thank you for joining us on "The Diane Rehm Show."

  • 11:46:32

    LINDARight. My question is about the impact of these devices on the body. What about radiation put out by these wireless devices? Will it have an effect on the arm, if a person's wearing a necklace, cancer even? And what about these microchips as they're going through the intestines from the pills? Aren't they going to generate free radicals in the intestines, like minerals already do?

  • 11:46:59

    PAGEAll right, Linda, thanks for your call. Steve Posnack.

  • 11:47:02

    POSNACKSure. You know, this is just the basics around FDA. I think, you know, those would be concerns that the FDA would take into account looking for comparable types of devices that they've already approved relative to toxicity and other types of effects on the body that, especially something ingestible or implantable that would occur.

  • 11:47:21

    PAGEThanks for your call, Linda. Let's talk to Robert. He's calling us from North Carolina. Robert, thanks for joining us.

  • 11:47:27

    ROBERTThanks for having me. Good morning, a great show. Diane Rehm's a national treasure. My comment and/or question is having to do with pain management. I'm a 54-year-old male. I've had multiple surgeries on my spine and one of the things that you have when you deal with pain management is the stigma involved with people seeking drugs for all the wrong reason and therefore, they have urinalysis a few times a year and pill counts and that sort of thing to make sure that the patients doing it as directed.

  • 11:47:58

    ROBERTIf they use this technology for that application, it could reduce the cost of urinalysis and pill counts, the embarrassment, rule out the people who are doing it for all the wrong reasons so the point to have a person that's monitored and can tell they're taking the pills as directed, as needed for all the right reason and save some costs to the patients with no insurance when it has to do with pain for your urinalysis and that sort of thing.

  • 11:48:24

    ROBERTIt's just a great idea and would solve so many problems and weed out the drug seekers from the people who actually need this to have any kind of comfortable life.

  • 11:48:33

    PAGEWell, interesting point, Robert. Dr. Giordano, what do you think?

  • 11:48:36

    GIORDANOI think, Robert, you've hit the nail on the head, at least in part. And one of the viable uses for this type of technology is drug monitoring and this technology does that exceedingly well. And in those situations where it's problematic, particularly if it's litigious as you see in pain management where patients are almost called triplicate script, these are the opiod agents, that can be legally problematic not only for the patient, but also for physicians.

  • 11:48:59

    GIORDANOThis can be a real boon. But, you know, nothing is a panacea. The other question here is, well, what if, in fact, that patient then exhibits subjective increase in pain and has to take more drug? What if, just let's say, there is a problem with that patient's particular pharmical dynamics or pharmical kinetics as a consequence of activity? These things still have to be monitored.

  • 11:49:19

    GIORDANOAnd your point is right on. I think this is going to add some facility and some ease to the nature of some complicated medical systems, as you'd see in pain or in psychiatry or with patients with cognitive defect and cardiology patients, surely. But I think it also instills another level, another tier of monitoring that then needs to be built into the infrastructure and this creates some complications, certainly needs to be addressed before these things get into broad-base use.

  • 11:49:42

    PAGESteve Posnack.

  • 11:49:43

    POSNACKYeah, I was just going to add, I mean, you know, one of the reasons why we're talking about this today is because the possibilities really capture our imagination and we can come up with many different scenarios in which this is relevant, ethical challenges, safety challenges and the other thing I think Dr. Steinhubl mentioned as well is that, you know, the new sensors and devices give us a window into ourselves that we've never had before in understanding ourselves better and identifying patterns and outliers that you can't really do with paper.

  • 11:50:07

    POSNACKI mean, we just can't do that with paper today, nor can you compare yourself at a population level. So to the gentleman that called, I mean, he may be able to find certain trends in his behavior that would allow him to say, you know, and I've exercised this way and my blood pressure's at a certain level and then, the next day, I have more pain or, you know.

  • 11:50:25

    POSNACKAnd you can really play out these scenarios where, again, it kind of captures our imaginations in terms of the benefits of that technology as well as how it can potentially be, you know, used in other ways.

  • 11:50:33

    PAGEHere are two emailers with very different views. Laura writes us, "I had gastric bypass surgery on June 2. Prior to my surgery, my friend gave me a Fitbit. It made all the difference. I love the immediate feedback and the positive reinforcement when I meet my step goal. I've made great progress I know I would not have made without it. I also have an app where I log my blood glucose.

  • 11:50:55

    PAGEI was never able to keep up with it before, but I love being able to see my progress weekly, monthly, and so on." But here's another emailer, Martin, who writes, "I work for a large hospital corporation. A few years back, my employer started offering discounts in healthcare costs if I provide information that I don't smoke, my weight, my cholesterol levels. Now that's not enough. They want us to use Fitbit and monitor how many steps we take each day, how many fruit and vegetables I eat.

  • 11:51:21

    PAGEIt's all too much. It's none of my employer's business what I eat or how many steps I take, in order to get a lower cost on my monthly health insurance premiums." I wonder, Arthur Allen, do you find companies requiring patients or giving employees financial incentives to, say, wear a Fitbit?

  • 11:51:42

    ALLENYeah. To wear a Fitbit or to shop for the -- go to the doctor who offers a colonoscopy that costs three times less, even though maybe he's not your favorite doctor. There's all this data that's being amassed and provided to big employers and they're using it -- the employers are using that to see exactly who in their company is spending healthcare money and the employers are being offered it to incentivize.

  • 11:52:08

    ALLENI don't know of penalization, but on the other hand, the difference is it's sort of a gray area. If you're counting on 100 bucks a month and then you don't get it, then that's a penalty. And that's very widespread and, obviously, the goal is that what everyone's talking about is that, I mean, I think two-thirds of people are -- who have health insurance in this country, it's through employers. Employers are -- and the health costs keep going up and so they're looking for ways of using data to drive their prices down, and, you know.

  • 11:52:37

    PAGESteven Posnack.

  • 11:52:37

    POSNACKYeah. I mean, I saw an article in Forbes the other day about insurers, you know, also looking at using Fitbit and tools of the like. You know, we know that with our vehicles, right, Allstate gives you a discount if you, you know, report your data. So I mean, you can, again, captures the imagination, come up with scenarios where this can be relevant.

  • 11:52:53

    PAGEI'm Susan Page and you're listening to "The Diane Rehm Show." Well, Dr. Giordano, is it ethical to require or to give financial incentives to employees to wear a Fitbit so that you can gather this information and monitor some of their health and their habits?

  • 11:53:09

    GIORDANOWow. On many grounds, certainly you could say it's ethical. The question then becomes is that legal to do as well. And this is where ethics and law have an interface. I think one of the things that would certainly drive this type of technology is a very strong what we call market pull. I mean, there's going to be a market for this. Data can be interpreted and when its interpreted, that, then, becomes information and information can either be viable information or misinformation.

  • 11:53:32

    GIORDANOAnd this is the point that both of my colleagues here in studio have brought up, as has Dr. Steinhubl. How we use the information, who will use this information, who has access becomes not only a pragmatic issue, a practical issue, but certainly one that brings forth the ethical issues and the legal issues of how this technology will actually be employed on a day to day basis.

  • 11:53:50

    PAGELauren is calling us from Muskogee, Oklahoma. Hi, Lauren.

  • 11:53:54

    LAURENHi. Good morning, Diane. Thanks for taking my call. My question goes along with the legal aspect of it. Who's going to have monitoring rights? Is it going to be the doctor solely or is it going to be insurance? And what about the HIPAA laws? As a patient, that's what I'm concerned about.

  • 11:54:08

    PAGEAll right. Thanks for your call, Lauren. Steve Posnack, what's the answer?

  • 11:54:12

    POSNACKWell, I'll give you the legal answer, right? It's really going to depend. It could depend on the Federal Trade Commission depending on whether or not it's strictly marketed to consumers. If it goes into the healthcare sector, then the HIPAA privacy and security rules could be applicable. And there's some gray zones in between.

  • 11:54:27

    PAGEJim has been really patient, holding on from Baltimore, Maryland. Jim, you're finally on the air.

  • 11:54:32

    JIMThank you, thank you. Every summer, I go to a small island called Samos in Greece. I spent a couple of months there and I observed the people, how they live. And I see there's a hospital 32 kilometers away from the town that I live in. There's only two major towns on the island. And they had a health clinic, but they had to close it down due to financial difficulties. I asked the ambulance driver what would happen if somebody had a heart attack and he pointed up to the sky.

  • 11:55:03

    JIMAnd I think to myself, they still have -- I check the obits once a week in the newspaper. They still have a life expectancy which is beyond ours. Next door, there's an island called Icaria, which is one of those blue areas where people live forever. And I think the trick is that we're forgetting how to live sensibly and gracefully here. Our environment is quite toxic compared to what I see there.

  • 11:55:38

    JIMI buy fresh vegetables. Despite the lack of care, they live longer than us. Tobacco is their main sin and there it is.

  • 11:55:52

    PAGEJim, thanks so much for your call. Dr. Steinhubl, I'm going to give you the last word. We're almost out of time. But what would you say to the points that Jim was making.

  • 11:56:00

    STEINHUBLFirst, I want to join Jim for two months every summer. But I think he's absolutely right. But if you look at the way our healthcare system is arranged, we don't -- the time it takes to discuss with our patients, about healthy living to really reinforce that, is just not built into -- it's not what our healthcare system is rewarded for right now. And it's a very perversely incentivized system that has to change.

  • 11:56:26

    STEINHUBLCertainly in the Mediterranean areas, there's diet, there's activity is hugely underemphasized and it goes back to even what some of the employer questions. And, you know, the workplace is invested in our health, being more active is important for our health. Eating the right things is more important, but the employers have to go beyond making a person responsible. They should also have to make the workplaces responsible to make it easier for employees to be more active, to eat better and eat easier.

  • 11:56:58

    STEINHUBLSo those are things that are critically important in all aspects of healthcare that, right now, are just not adequately addressed.

  • 11:57:02

    PAGEDr. Steven Steinhubl, Steve Posnack, Arthur Allen, Dr. James Giordano, thanks for joining us this hour.

  • 11:57:08

    GIORDANOThank you, Susan.

  • 11:57:08

    ALLENThanks for having us.

  • 11:57:09

    PAGEI'm Susan Page of USA Today sitting in for Diane Rehm. Thanks for listening.

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