Mobile Health News & Products

According to two reports, Mobile Health Devices and Applications—Global Market Briefing to 2018 (April 2012) and TeleHealth and Telemedicine—Global Opportunity Assessment, Competitive Landscape and Market Forecasts to 2018 (August 2012) from market analysts GlobalData, the healthcare industry will continue to grow exponentially from just over $1 billion in 2011 to $11.8 billion by 2018.

The rapid increase in use of smartphones and tablets is fueling an increase in demand for mobile health applications (apps) and devices that connect the patient to the healthcare provider and allow remote monitoring. mHealth is the fastest growing sector of the teleHealth market, with a 39% compound annual growth rate or CAGR.

According to GlobalData, software and services account for 80% of the total mHealth market, with hardware and connectivity accounting for 12% and 8%. Consumer apps and services dominate the software and services sector (70%), and the remaining share is occupied by apps for medical professionals.

The lion's share of the global market goes to the United States and Europe, spending $660 million and $420 million, respectively, on mHealth in 2011 followed by the Asia, with a $120 million investment.

GlobalData's report is consistent with the findings of a February 2012 report by ABI Research, Body Area Networks for Sports and Healthcare: Bluetooth Smart, ZigBee, 802.15.4, Wi-Fi, and Proprietary Communications, which estimates that the number of wearable wireless health and fitness devices and home monitoring devices will increase from 20.77 million in 2011 to 169.5 million in 2017, a CAGR of 41%.

Anyone who has ever visited a hospital can attest to the jumble of wires and cables that tether patients to their beds. These cables convey a steady stream of data to medical devices that monitor the patient's vital signs, but can also cause significant discomfort and increase risk of infection.

These wired devices may, however, soon go the way of rotary telephones. A new class of technologies known as Medical Body Area Networks, or MBANs—small, wearable, wireless sensors that collect real-time clinical data about the patient—promises to revolutionize and declutter patient care.

In May, the U.S. Federal Communications Commission (FCC) dedicated 40 MHz of radio spectrum at 2,360–2,400 MHz for MBAN use on a secondary basis, to be shared with the aerospace industry. The spectrum is free of interference from consumer device transmissions and Wi-Fi.

The move, applauded by industry giants GE Healthcare and Philips, means that users do not have to apply for individual station licenses, and enables “rapid and widespread development of innovative new MBAN applications” according to the FCC.

“MBANs represent the next evolution in monitoring a patient's health status,” says Richard Katz, director of cardiology at George Washington University Hospital.

This past spring, Happtique, a healthcare mobile app firm, launched mRx, a mobile app prescription program. According to the company's press release, this patent-pending technology works on multiple platforms, and will enable doctors across all specialties to prescribe apps to patients.

Depending on the mobile platform used, the prescriber can e-mail the app or a link to the app directly to the patient's phone or tablet. Enabling patients to monitor their own condition and treatment not only benefits the patient, but could also help save several billion dollars in global healthcare costs, says Happtique.

In August, The New York Times published an article noting that regulation of medical apps is still in its infancy, with fewer than 10 apps be cleared by the U.S. Food and Drug Administration (FDA). Privacy and security of medical app data, software compatibility, and patient use of medical apps are concerns.

Happtique, however, is banking on increased demand for the type of service that mRx provides, and has launched a trial of the program with “physician prescribers specializing in the treatment of heart disease, diabetes, and musculoskeletal conditions” according to its press release.

The U.S. Food and Drug Administration's regulation of mobile medical apps is moving forward with President Obama's signing this summer of a massive funding bill for the agency.

Before the Food and Drug Administration Safety and Innovation Act was signed into law in July, lawmakers wrangled over just what role the FDA ought to play in the regulation of these apps, with some members of Congress arguing that a more vigorous oversight role would stifle innovation. An earlier version of that legislation, according to several media reports, contained language that would have essentially slowed the FDA's ability to finalize its 2011 Draft Guidance for Industry and Food and Drug Administration Staff on the Regulation of Mobile Medical Applications.

It was, according to a June 22 article in The Washington Post, “a classic showdown between Washington regulators charged with safeguarding the public's health and a free-wheeling tech industry that prizes agility and first-to-market bragging rights.”

The final version of the act was stripped of that language, but the agency is still under orders to work with other government agencies and come up with a report describing how it plans to regulate this fast-evolving market in a way that advances both safety interests and industry desires for innovative freedom.

mHealth products that have obtained FDA 510(k) clearance include the ViSi Mobile system (Sotera Wireless), Diabetes Manager (WellDoc), Remote Patient Monitoring or RPM solution (AirStrip Technologies), digital health feedback patch system (Proteus Biomedical), Centricity Radiology app (GE), and Mobile MIM 3.0 (MIM Software).

In addition to several 510(k) clearances for its AirStrip Remote Patient Monitoring system for the iPhone and iPad, AirStrip Technologies is enabling real-time mobile access to electronic health record (EHR) systems and usage tracking.

The company says that EHR data, such as a patient's X-ray, blood results, allergies, or medication history, can now be downloaded by clinicians onto their mobile devices, allowing the clinicians to access patient information whenever and wherever they need it.

Earlier mHealth apps such as AirStrip Ob and AirStrip Cardiology gave clinicians access to specific medical information, such as bedside data on their tablets and smartphones. The new system—an expanded platform and a new mobile app—was released this past June, and allows doctors to access patient electronic health records, bedside data, and consolidated patient summaries.

AirStrip says this increased access will improve workflow and mean that clinical decisions can be made faster, potentially improving patient outcomes. The system allows hospitals and other healthcare facilities to enable real-time access to EHR systems already in place, and potentially integrate patient care with other facilities.

The 1966 science fiction film Fantastic Voyage follows a miniaturized submarine and a team of medical experts as they travel through a human body in a mission to destroy a blood clot in the subject's brain and save his life. The team is able to see the inner workings of vessels and organs at first hand.

Proteus Digital Health has one-upped this science fiction premise by developing a pill containing a digital chip or sensor that transmits information from within the body to a medical team. In July, the FDA approved the ingestible one square millimeter chip for use with patients. The new digital health feedback system was previously known as the Raisin system.

The embedded chip monitors your body's chemistry (for example, whether you have taken your medication, or if the dosage is adequate) and transmits the data to a small wearable patch that resembles a Band-Aid, or to a mobile phone, doctor, or nurse if you choose. In the future, the system may be used to transmit other body measurements.

The company says the sensor has no battery or antenna, and obtains its power source from stomach fluids. The digital “heartbeat” generated with the sensor is transmitted to the patch, which “receives information from the ingestible sensor, detects heart rate, activity, and rest, and sends information to your mobile device.”

And the pill is temporary, passing “through your body like high-fiber food.”

The MedWatcher app for the iPhone was developed by the FDA's Center for Devices and Radiological Health (CDRH) together with the Children's Hospital Boston, Harvard Medical School, and the University of North Carolina.

MedWatcher allows users to bypass the current FDA's Adverse Event Reporting System (AERS) for devices, drugs, and vaccines, which relies on voluntary reports; and enables “rapid reporting of suspected adverse events” to the FDA.

The new app allows clinicians, the public, and manufacturers to quickly add information such as product name, date of adverse event, and outcome. Eventually the agency hopes users will be able to scan unique device identifiers (UDI). The app also allows users to access a wide range of information, such as thousands of medications, devices, and vaccines; product updates; recalls; and FDA warnings and announcements.

Developers believe that MedWatcher will lead to a real-time database created by an online medical community, which is in marked contrast to the FDA's MedWatch form and relatively slow traditional information transfer system from government to the general public.

The customizable, user-friendly, and free tool can be used by clinicians, patients, and the general public.

There is no question that the number of medical apps available either free or on the market is skyrocketing: Health IT analysts Chilmark Research estimate that the current app market of $8.3 million will top $1 billion by 2017. This is great news for those among us searching for an app that can diagnose hypochondria.

However, browsers of apps may be daunted when faced with thousands of different choices for, say, a weight tracking app. You can sort through online stores using criteria such as date released, key words, or app popularity. Without doing a bit of research, though, it is hard to tell whether an app will work, or whether it can be integrated into your healthcare organization.

A myriad of organizations, firms, websites, and blogs offer healthcare providers guides to choosing mobile apps, based on criteria such as clinical efficacy, ease of use, or interoperability. Apple, for example, has created a section called “Featured Apps for Healthcare Professionals” with six categories: reference apps, educational apps, EMR and patient monitoring apps, imaging apps, point of care apps, and personal care apps.

In short, finding an app that works best for a patient's or clinician's specific needs may not be as easy as it may seem, but with the explosion in app development, new products that offer to sort through the market cannot be far behind.

Diabetes is a chronic condition that affects 26 million people in the United States alone, and incidence is expected to increase drastically in the future as a result of an aging population, unhealthy diet, and sedentary lifestyle. Diabetics are at increased risk of heart disease, stroke, and kidney failure.

In August 2012, Alere Health and AT&T announced that they would jointly deliver WellDoc's diabetes mHealth system, DiabetesManager—which received 510(k) clearance by the FDA in 2010—to help adult patients with type 2 diabetes manage their conditions with their healthcare providers.

According to WellDoc, “members enter blood glucose readings and medication data into DiabetesManager on their compatible mobile device or the web and receive real-time feedback regarding their blood glucose control and immediate, recommended next step actions.”

The system is based on behavioral algorithms and medical coaching, and relies on real-time collection of the patient's blood glucose levels. This allows caregivers to identify trends and coach patients on how to better manage their type 2 diabetes.

Philips has developed IntelliVue cableless, wearable patient monitors, which allow patients to move freely, while measuring vital signs. These devices transmit data wherever the patient is, reducing the number of connecting wires that hamper patient mobility, and reducing the possibility of accidental disconnections, according to the company.

Patients can gain freedom of movement, as the devices are battery powered, and transmit information via short-range radio. For example, Philips IntelliVue CL SpO2 and NPB pods (SpO2 and blood pressure/pulse rate measurement respectively) which received 510(k) FDA clearance in 2010, have been shown to produce reliable results in motion.

Sanofi says its iBGStar is the first approved blood glucose meter to interface with the iPhone and iPod, and together with an app, features a range of views and options to analyze glucose data. Patients can record blood glucose levels, track fluctuations, measure carbohydrate intake and monitor insulin levels.

The meter features a dock connector for the iPhone, as well as a glucose test strip reader. Patient information can be read directly from the meter, forwarded to caregivers, or accessed via a smart device. Settings allow personalization, and patients and clinicians can analyze patterns to better manage the patient's condition.

VGo robots, produced by the company VGo, will soon be accompanying nurses on their rounds as part of a pilot program at the Visiting Nurse & Hospice of Vermont and New Hampshire. Other VGo bots are finding their way to hospitals, clinics, patient homes, and even classrooms.

The telepresent device, which became available in 2011, allows two-way audiovisual communication, and enables a person at one location to ‘replicate’ themselves at another, according to the company: “They can see, be seen, hear, be heard and move around in any remote facility – just as if they were there.” The applications for VGo are myriad, including real-time medical consultations and patient monitoring.

Mobisante's MobiUS is a mobile phone ultrasound device, cleared by the FDA in 2011. The handheld, wireless, cloud-based device can be used for abdominal, cardiac, and thyroid imaging, to name a few, and can be used to confirm pregnancy, fetal presentation, and fetal viability.

The Toshiba TG01 handset runs Windows Mobile 6.5 (newer devices are iPhone or Android-based), reflecting the fact that the mobile device took two years to come to market.