Smartphone Medicine

Talk about disruptive innovation.
The cellphone – now smartphone – has changed the way people access information and communicate with each other. And it’s not all small talk.

In November 2011, Pew Internet, a project of the Pew Research Center, reported 29 percent of surveyed adults who have downloaded an app to a cellphone or tablet computer reported downloading a health app. Pew estimates that this translates to about 11 percent of all adult cellphone users.

True, many of those apps are designed to help people track calories consumed, calories burned, miles run, etc. But increasingly, devices and accompanying apps are helping people – particularly those with chronic conditions – monitor their health and communicate with their caregivers. The implication for physicians and physician office traffic could be huge.

Some examples:

  • A blood pressure monitor from Withings, a French firm, calls for the user to wrap the cuff around his or her arm, plug it directly into their iPad, iPhone or iPod, and, with the Withings app in place, begin measurement. Results are stored on the mobile device or the user’s computer (on their personal Withings webpage), and can be e-mailed to a doctor or anyone else using an automatic sharing feature. Cost $129.
  • The iBGStar™ Blood Glucose Monitoring System from Salem, N.H.-based AgaMatrix (and distributed by Sanofi U.S.) was the first blood glucose meter to be FDA-cleared (in December 2011) for use with the iPhone and iPod Touch. The device measures the amount of glucose in the blood and transfers the data to the mobile device, for storage or transmission. Estimated cost: $80.
  • Bethesda, Md.-based Telcare received FDA clearance to market its Telcare Blood Glucose Meter in August 2011. The meter has a built-in cellular chip that automatically sends all test results to MyTelcare.com’s secure server, which can be viewed by the patient or anyone else, with the patient’s permission. MyTelcare.com can be accessed with an iPhone app. The cellular connection can be used to send the patient messages about the readings, if necessary.
  • Though not yet cleared by the FDA for sale in the United States, a credit-card-sized wireless device from Oklahoma City, Okla.-based AliveCor can reportedly turn an iPhone, iPad or Android device into a ECG recorder. The device sells for about $100 in Europe.
  • San Diego, Calif.-based HealthInterlink says its software platform can incorporate any FDA-approved, Bluetooth-enabled device. One platform can fulfill a variety of remote health management needs, according to the company, including oxygen saturation, blood pressure, blood glucose, weight, temperature, peak flow, etc. The main HealthInterlink gateway device collects data from devices and routes it through the company’s platform to the appropriate care provider. Examples of existing tablets and mobile gateway devices are Samsung Galaxy Tab tablet, Motorola Xoom tablet and most Android-enabled smart phones.
  • AirStrip Technologies, San Antonio, Texas, says its AppPoint software platform can securely send critical patient information, including waveform patterns, bedside alarms and other patient data, to clinicians anywhere. The platform is said to be available with virtually any cell carrier and mobile device, including smartphones, iPhones, BlackBerrys, Android-based tablets, Windows Mobile devices and iPads. In February 2012, hospital company HCA announced a collaboration with AirStrip that includes expanded use of AirStrip’s mobile patient monitoring software and a financial investment in the company.
  • Although not intended for consumers, Redmond, Wash.-based Mobisante’s MobiUS™ SP1 is a smartphone-based ultrasound imaging system. Cleared for marketing by the FDA in February 2011, the system allows the practitioner to archive or share images using a cellular network, WiFi or direct connectivity to a personal computer. Cost is about $8,000.

Well-established trends
“The trends are already being established,” says David C. Kibbe, MD, MBA, senior advisor, American Academy of Family Physicians, and consultant to the AAFP’s Center for Health Information Technology. Smartphones are compatible with testing and monitoring equipment. “They are also ‘ever present,’ and are showing promise for automated alerts and reminders, helping patients remember when to take medications, or interactively querying and replying to patients who need to monitor the side effects of medicines very closely.” Smartphones are capable of linking people in social networks and making healthy behavior a part of online games and competitions, he adds. “And cameras on smartphones extend a person’s ability to visualize their bodies and to communicate images to healthcare providers remotely.”
To fully exploit the potential of smartphones, however, physicians and care teams need to work actively with patients to help them collect and interpret data, and then act on it accordingly, says Kibbe. And that education process has already begun. “There are home monitoring programs in some larger institutions already, and it’s often the nurses or case managers who handle this education, working in concert with primary care doctors,” he says. “Nurses in small practices all over the country have instructed new diabetic patients in home monitoring for decades. So we do have models.”

Welch Allyn is exploring the use of smartphones and tablets in healthcare, including so-called Health applications, says Scott Gucciardi, executive vice president, chief marketing officer. “It is clear these mainly consumer-oriented devices are here to stay, and their usage in professional settings, including healthcare, continues to grow. We already see iPads, iPhones and Android devices being used to do a number of things to support workflow in both the hospital and physician office settings, including integration with various health information systems and EHRs. Whether, or to what extent, they will be used to acquire and process diagnostic data will depend on the workflow fit and preference of providers.

“A major consideration is whether smartphones and tablets are really capable of displacing ‘purpose built’ devices, such as vital signs monitors, that are designed to meet the needs of healthcare delivery environments,” he continues. “Those needs include reliability, durability, and human factors including the ergonomics of repetitive motion and ensuring safeguards in the user interface to meet regulatory standards.”

Just-in-time messaging
“The beauty of mobile devices – and what they are doing to revolutionize healthcare delivery – is that they are always in [your pocket], and that allows for just-in-time messaging,” says Joseph Kvedar, MD, founder and director of the Center for Connected Health. “Wherever you are with your phone, I can reach you.” The Center for Connected Health was founded in 1995 by Harvard Medical School teaching hospitals. Its mission is to develop strategies to move healthcare from the hospital and doctor’s office into the day-to-day lives of patients, leveraging information technology.

“When we decided to use mobile phones for part of our program development a couple of years ago, the adoption of [smartphones] among our population was about 10 percent, so we decided not to build apps,” says Kvedar. “So we used text messaging as an important tool to encourage behaviors that are health-improving.” Patient populations include OB patients, individuals battling addiction, and those in need of assistance with medication adherence.
Today, the Center uses a home hub-type mobile device from a firm called MedApps, which accepts short-wave wireless signals from sensors, then sends that to the cloud, where caregivers at the Center pick them up to make medical decisions or educate patients on next steps. But Kvedar is confident that smartphones will play a larger and larger role in medical delivery in the future.
That’s true for several reasons, he says. First, smartphones allow caregivers to send messages to the patient with confidence that the patient will receive the message quickly. Second, they can accept data from medical devices, such as sphygmomanometers and glucometers, and feed them to the cloud. “Third, and perhaps most interesting, is that mobile phones as display devices enable mobility for doctors,” says Kvedar. In other words, doctors can view a patient’s EKG or X-ray on their cell phones, or they can videoconference with patients when necessary. In fact, doctors are using smartphones as much or more than other professionals, he says.

Lower cost?
Better patient care aside, proponents believe smartphone technology can lead to reduced healthcare costs. “Under the right payment incentives, there’s no question that home monitoring can help reduce healthcare costs,” says Kibbe. “Every time I can help keep a patient in a low-cost setting instead of a higher-cost one, there will be cost savings.” In Hawaii, Kaiser Permanente used e-mail with patients to reduce the number of face-to-face primary care visits by 20 percent. That meant lower costs for Kaiser and for patients, who were spared the cost of taking time off to drive to the doctor’s office. “There’s no question about it: Better communications informed by better information saves healthcare dollars.”

But reimbursement – or the lack thereof – does pose some problems. “As long as doctors are paid per visit in a piecemeal fashion, and patients don’t have accountability for the cost of their care, there isn’t any gain from device monitoring,” says Kibbe. “However, change the nature of the payment system to create a win-win-win for doctors, patients and the organizations used for care delivery, through shared savings arrangements, bundled payments and gainsharing – and then it becomes obvious that device monitoring can save time, energy and avoid duplication of services.

“So, I’d say, as I always do, that payment reform has to happen first, or at least parallel to the best and most meaningful uses of these new technologies.” The American Academy of Family Physicians has been very active in prompting payment reform, he adds.
Avoiding information overload

There’s no doubt that the rising incidence of home monitoring, work monitoring and smartphone-anywhere monitoring will generate lots of new data from patients, says Kibbe. That’s the good news. But that data collection must be well-managed in order for the care team to avoid information overload, or even information chaos, he says.

“Physicians and care teams need to work actively with patients to help them collect and interpret these data, and then act on them accordingly, if we’re going to make body monitoring via these devices efficient as well as a means of improving quality of care. In other words, I’m advocating for a participatory approach to this kind of device monitoring, in which patients and their providers – including physicians, nurse practitioners, nurses and pharmacists – are all on the same page with respect to the reasons for monitoring, the value to be achieved, and the improvements in care that are expected.”

Of course, not all the data collected by smartphones is meant to be reviewed by a doctor, nurse or other healthcare professional. Rather, devices can be programmed to sound alarms or otherwise signal caregivers when readings stray outside agreed-on parameters.
The question becomes, “Where should these new streams of data go, and how can you optimize their collection and interpretation so as to achieve the desired improvement in care?” says Kibbe. Caregivers have a generation of experience with home monitoring of blood pressure, blood sugar and, to a lesser extent, weight, he points out. “The systems that help us interpret these data need to identify trends and signal when the data show something worrisome. I’m a big proponent of dashboards and filtering systems that use dynamic presentation layers, like green-yellow-red coloring, to indicate safe and non-safe levels.”

Patients directly benefit from the trending data that home monitoring provides, says Derek Kosiorek, senior consultant, Medical Group Management Association. For example, someone monitoring LDL cholesterol can see where they are today vs., say, three months ago. They can see that even if LDL is still high, perhaps it’s trending downward. “If the data [demonstrates the need for medical] attention, the doctor will proactively schedule an appointment with the patient. But if it’s normal, [the doctor] won’t take any action. If we’re scheduling a visit or test, it’s because we have documented proof that the patient needs assistance. So I’m not concerned about information overload.”
And when the patient does come to the office, the physician will have much more information to draw on prior to seeing him or her, he continues. “They’ll have accurate and timely information, and they’ll be able to make more effective decisions because of it.”
“Healthcare is prejudiced toward doing things to people,” says Kvedar. “It’s something patients and providers gravitate to. There’s something a little creepy about Watson [the IBM computer which, famously, competed successfully on the game show Jeopardy] being your doctor, even if Watson could do a better job.”

But the fact is, “the science and implementation of analytics is way, way, way ahead of healthcare,” he says. Retailers like Target and Amazon analyze millions of data points about consumers in order to create better advertising profiles. “We can do that with healthcare data, though we haven’t done it more than the first level.” Medical software can easily filter out normal from abnormal readings. “We won’t overwhelm doctors with meaningless data,” he says. “It will get better and better, and more automated. Fifteen years from now, people will get comfortable with that.”

Tradition
Doctors who fail to embrace technology – including smartphone medicine – may lose relevance in the near future. The Pew study, for example, showed that 30-to-49-year-olds were just as likely as 18-to-29-year-olds to have download a health app. But adults age 50 and older lag behind.

“If you walk into a bank and they pull out a paper ledger, my guess is you’ll find another place to keep your money,” says Kosiorek. Similarly, physician practices that lack electronic patient portals or that fail to offer remote monitoring may find themselves squeezed aside by more aggressive competitors.

“Many of the doctors I have worked with are concerned they will have to spend time on activities usually performed by their support staff,” says Kosiorek. In addition, physicians may find they have more direct contact with their patients outside the office. Messaging is, after all, a key component of portals. “In their mind, they’re doing more work.

“But it’s hard to argue that this innovation isn’t going to make a difference in the patient/doctor relationship – a positive difference when it comes to communication,” he adds. Well-managed, it can lead to a more efficient workflow. Support staff can triage patient requests, handing to the doctor only those requests that truly demand his or her attention.

“And doctors shouldn’t forget that responding to e-mails is much more than providing great customer service,” says Kosiorek. “Via this method of communication, doctors and their patients will be able to form stronger relationships. When you get an e-mail from your doctor, it’s like getting e-mail from a celebrity,” he says, only half-joking. “Interaction with patients improves their healthcare. And doctors have to understand that the communication they have with their patients provides more than comfort. This type of communication helps to strengthen the doctor/patient relationship and could ensure that the patient remains a life-long client.”

The FDA’s role
Where medical devices go, even into the home, expect the Food and Drug Administration to follow, and perhaps lead, say experts. “There’s no question the FDA is constantly looking for the appropriate way to interact with this technology and its clinical components,” says Kibbe. “I wouldn’t be surprised at all if we find a somewhat stronger position from the FDA as smartphones begin to do things that make them more like medical devices.”

The FDA may get more involved with regulating the software used to transfer, store, convert and display medical data than with the hardware, says Kvedar. “What if the software on your mobile phone has a bug and doesn’t expose high blood-pressure readings, so you’re going along thinking you’re fine, and your blood pressure is [abnormally high] 10 days in a row?” The agency wants to ensure that remote systems are sound, does what they say they will do, and protect patients’ privacy.

“It is clear the FDA is moving to regulate mHealth applications, and this will only raise the bar for players planning to enter and make this new market,” says Gucciardi. But the challenges of making smartphone medicine part of the healthcare landscape are broader than that.
“Smartphones and tablets are already utilized in the home for consumer healthcare applications,” says Gucciardi. “The question is, again, whether and to what extent these devices will be used to record and transmit diagnostic data, not only for the personal consumption of the patient but also as a part of the provider’s management of the patient’s care. While there are hurdles to overcome for both the patient, including simplicity and cost (consider the demographic and their tech-friendliness), and for the provider, including workflow and reimbursement, very gradually these hurdles are being overcome. The final solution may or may not include consumer devices, because other technology solutions may better lend themselves to meeting the complex needs of this new care paradigm.

“The hurdles indeed include regulatory and payer/reimbursement issues, and the technology needs to be mindlessly simple to realistically enable deployment on any significant scale in the target home demographic.”

What’s next?
“One thing is clear,” says Gucciardi. “Smartphones and tablets will continue to get smarter, smaller, lighter, faster and cheaper, and will continue to proliferate so that nearly every individual will have one, much the same way the cellphone market evolved. What will be exciting is that the technological innovation will continue to amaze us.

“A recent example is Apple’s Siri on the iPhone 4S. While subject to some criticism in its beta version, just imagine the possibilities as this technology gets smarter and eventually perfected. Some day your smartphone/tablet may anticipate your every need, including healthcare needs, such as managing your conditions, meds, vital signs, diet, exercise, provider interactions, etc. And perhaps this will all be done without you lifting a finger.”

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