Bradley Merrill Thompson has answered the above two questions in his article at mobilehealthnews . The article in 3rd in series where in first article, he outlined what factors FDA considers while deciding which products need to be regulated. In second article, he outlined basic steps for getting medical device cleared by FDA.

The article is must read for any mobile health application developers considering selling their applications in US.

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The market for medical automation technology is forecast to grow from $13.1 billion this year to $23.2 billion in 2014, according to BCC Research. The report, Medical Automation Technologies, Products and Markets, pegs the compound annual growth rate (CAGR) at 12.2 percent.

Among the technologies examined in the report are:

* Automated health assessment and monitoring technologies;
* Automated medical imaging and image analysis;
* Automated prescription fulfillment devices;
* Automated therapeutic (non-surgical) devices;
* Robotic and computer-assisted surgical equipment;
* Automated laboratory testing and analysis;
* Automated healthcare logistics, resource and patient tracking;
* Automated medical training.

Major end-user segments for automated medical technologies include hospitals, stand-alone outpatient surgical centers, physician practices, pharmacies and other retail establishments, home-care recipients, the military, medical research institutes and clinical laboratories and medical schools and other training programs.

Another reason for Android developers start developing  automated health assessment and monitoring technologies or automated healthcare logistics, resource and patient tracking applications or any of the above technologies , if they haven’t already.

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The Zii EGG is an energy efficient handheld StemCell Computer based on the powerful ZiiLABS ZMS-05 media-rich applications processor. Besides its multi-touch 3.5-inch LCD screen, it can also output HD video at up to 1080p. The ZMS-05 has 24 floating-point processors that deliver up to 8 GFLOPS of raw processing power and its flexible StemCell computing architecture allows stunning 3D graphics on a small handheld battery-powered device.

Zii Optimized Android gives developers the chance to use the familiar Android OS, but with a difference. Harnessing StemCell Computing Technology found on the ZMS-05 Media Rich Processor, Android is now super-charged with seamless 3D graphics and High Definition video playback performance.

The Plaszma SDK Starter Kit is available for immediate purchase at US$399 on www.zii.com. This Starter Kit comes bundled comes with Plaszma OS, Plaszma SDK and the Zii Optimised Android OS.

As an introductory offer, ZiiLABS is offering a 32GB Zii EGG for FREE with the purchase of the Plaszma SDK Starter Kit, limited to one per customer while stocks last.

For customers who want to run the Android OS, an after-sales installer upgrade will be made available soon allowing them to change their operating system selection.

Another device for Android developers to be excited about.

Looks like Apple has really good competition for its Ipod Touch and Zii Egg Plasma will give Apple run for its money, if the marketing and launch of the device is done properly.

Is investing 399 USD in a non phone device worthwhile? The question remains to be answered

For product information, please visit www.zii.com.

For more technical information, please visit www.ziilabs.com

For press release visit http://www.ziilabs.com/news/releases/pr20090728A.aspx

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North America, with its aging population and tech-oriented medical industry, is central to the telehealth market and is expected to remain so over the report’s forecast period which extends through 2014.

The report focuses on embedded cellular connectivity for remote patient monitoring and ambient assisted living, the monitoring of the well-being of elderly or at-risk people.

“Wireless telehealth systems can reduce healthcare costs in a couple of ways,” ABI research practice director Sam Lucero, said in a statement. “First, for patients with chronic conditions, wireless telehealth’s ability to monitor and track their status allows many problems to be nipped in the bud before they require expensive hospitalization and treatment.  “Second, the traditional approach to home health care requires regular visits by nurses to check on patients’ condition. By providing that same information automatically, wireless telehealth systems can reduce those labor and travel costs.”

In addition, Lucero notes, a secondary benefit is that more people will be able to remain in the safety and comfort of their own homes as they age, at the same time reducing the burden on medical and residential institutions.

ABI believes availability of coverage for telehealth systems by private insurers and Medicare/Medicaid could be  barrier to widespread adaption of telehealth devices.

“The industry believes reimbursement for telehealth systems should be more comprehensive and straightforward. Proposed legislation is generating optimism,” said Lucero.

For more details on the report, visit eWeek.

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In his article, he outlines the factors that FDA considers when deciding whether to regulate such equipment.

The Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either]
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or]
intended to affect the structure or any function of the body of man or other animals.”

For more details, visit mobihealthnews

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According to the report by Infiniti Research Limited, the above mentioned new diagnostic and treatment modalities have also increased the need for flexibility and leveraged usage of staff driving the healthcare industry to adopt Bluetooth technology. As most mobile devices today are already equipped with the technology, healthcare organizations and patients are leveraging the technology to perform various tasks including medication management, measuring, transferring, and accessing patient records etc., in a wide range of healthcare environments.

The report forecasts the size of Bluetooth Market in the Healthcare Industry over the period 2008-2012. It segments the Bluetooth Market by applications and into various geographic regions. Further, it discusses the key market drivers and challenges of this market in the Healthcare Industry, and profiles some of the key market players of this Industry.

Last month, the non-profit, open-industry coalition for technology healthcare, Continua Health Alliance, announced that Bluetooth technology will be adopted as a healthcare device standard in version two of its guidelines for low-energy wireless communication.

“Continua’s choice of Bluetooth low-energy technology – a specification in development at this time and expected to be adopted by the end of the year – underscores the excitement and need for this Bluetooth wireless standard in the telehealth arena,” said Michael Foley, executive director of the Bluetooth SIG (Special Interest Group).

The Bluetooth SIG brings not only a superb wireless technology to our design guidelines, but a state-of-the-art testing and qualification program to our members,” said Rick Cnossen, Continua president and chairman of the board of directors.

“The continued choice to work with Bluetooth wireless technology and the Bluetooth SIG is a natural extension for Continua.”

Continua certifies many telehealth devices, ranging from health-monitoring (pulse oximeter, blood-pressure cuff, thermometer, weight scale, glucose meter) to cardiovascular fitness devices to independent living monitors for the elderly or frail.

For more details, refer to the article in SiliconRepublic.

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“It’s a pretty big business,” notes ABI Research vice president Stan Schatt in a classic understatement. “The strong uptake of Wi-Fi in the health industry is underpinned by its need for improved asset management, staff mobility, transfer of digitized records, and standardized administration of medications. In addition, government security requirements including HIPAA often mean replacing older wireless equipment with modern versions.”

Among the benefits of increased Wi-Fi penetration are reductions in operating costs, which is also a theme stressed by the Obama administration in its drive for healthcare reform.

However, healthcare Wi-Fi is no one-stop-shop. “No one vendor has all the necessary pieces to make a complete system for a major medical institution,” says Schatt. “It is truly a Tower of Babel.” So there is a premium on partnerships and systems integration. Generally it’s the wireless LAN equipment channel partner that integrates all these things and makes them work together. The manufacturers have to develop technology partnerships too, and share information so that devices can be optimized for their systems.

For more details , refer to press release by ABI research.

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One of the challenges usually doctors/physicians face , is that  whether patients have  taken their medications or not. This is even more challenging in case if the patient has to taken medicine for longer periods( e.g. couple of months).

Mobile applications could come in handy to ensure if the patients have taken their medicines or not. The application could be a simple reminder service which could be installed on patient’s phone (with patient’s consent) with reminders set for medication dosage and times. Another option could be a reminder sms sent to the patient’s phone(  In most of countries except US, incoming Sms is free).

In developing countries, where doctor/physician to population ratio is very low, these applications could be more helpful. Incentives could also be added for patients to take their medicines with the help of sponsor(e.g.  local mobile company or local grocer ).

I found an interesting article in The Economist titled  ” Taken your medicine? “, where patients were given incentives to take medicine and report back. The trial done in Nicaragua involving 30 people with tuberculosis was a success and a second is about to be carried out in Pakistan, where a batch of 400 XoutTB patches is arriving this month.  The details regarding the project in Pakistan from the article are below:-
” Conditions in Karachi, the Pakistani city in which the trial is being conducted, could politely be described as “challenging”. According to Rachel Glennerster, a member of the XoutTB team who has worked as an economist at the IMF and the British Treasury, the local medical clinics are closed about 60% of the time and doctors or nurses are often absent during the 40% when the doors are nominally open. Such absences—and the associated lack of compliance-monitoring—are some of the problems for which XoutTB is designed to compensate.

Pakistan, though, presents a second difficulty. Aamir Khan, the director of XoutTB’s operations in the country, quickly discovered that one of the neediest groups of people there are 15- to 25-year-old women. Unfortunately, they are often under the thumbs of their parents or husbands and are not allowed mobile phones of their own. Dr Khan is therefore considering the idea of a different reward—high-energy food supplements to combat malnutrition. The system would not supply food directly, but would instead top up credit at the patient’s grocer using an automatic link.

If XoutTB does work, the team has ambitions to extend it. Other drugs can also be a nuisance to remember. The anti-retrovirals used to combat AIDS, for example, have to be taken for the rest of a patient’s life. And taking medicines for non-infectious conditions such as diabetes and high blood pressure is also a chore. Find the right “litmus test”, though, and what is now being done with TB drugs could succeed with any of these as well. Taking your medicine could, at last, become a truly rewarding experience. “

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The document “Ten Principles for Fostering Development of an “iPhone-like” Platform for Healthcare Information Technology“, details the Ten core principles.

Below are those core principles along with Android platform features that support those principles:-

1. Technology platforms that support substitutable applications should be promoted.
   Android Platform source  is open source and open to modifications. The core components of the platform are substitutable and custom platform image can be created to suit one’s needs and promote the creation of, and enable the incremental adoption of, useful task-specific applications with low switching costs.
2. Messages and protocols for data exchange should be allowed to emerge on demand in a market-driven approach, and specified transparently at every level.
   Android Platform source being open source it is easy to add unique protocols for creation of a suite of wellness applications linked to everyday activities. Currently (as of Android 1.5- Cupcake edition) , bluetooth is not fully supported, but one can enhance the bluetooth source code to communicate with medical devices with bluetooth support (ex. glucose monitors with bluetooth support). Google has also released NDK(Native Development Kit) which provides tools that allow Android application developers to embed components that make use of native code in their Android applications. The NDK allows developers to implement parts of their applications using native-code languages such as C and C++. This can provide benefits to certain classes of applications, in the form of reuse of existing code and in some cases increased speed.
3. Protocols and application programming interfaces should allow the possibility of multiple platforms co-existing.
   The Android platform is open platform with open source. It is part of OHA(Open Handset Alliance), so it enjoys support of various mobile operators, handset manufacturers,semi-conductor companies, software companies and many more …. For more details on Open Handset Alliance, please visit http://www.openhandsetalliance.com.
4. Application programming interfaces should be open.
   Android Platform allows the development of plug-and-play applications and developers can reuse their knowledge of Java( most commonly used open source development language)
5. Substitutable application or platform vendors should not have control over what is installed on the platform.
   Even though Android platform is available from Google, it does not control what gets installed on the platform. It has removed its Google Maps API from Android platform and is available as separate API.
6. Application installation should be turnkey.
   Installation of Android Applications is easy and can be done without any knowledge of software programming. Currently, the applications can be installed using Android Market. The mobile phones with root access can install applications without Android Market.
7. The intellectual property of platforms and applications should be kept separate.
   Even though Android Platform source is open source, the applications developed by third party does not need to be open source and is not governed by open source agreement.
8. All applications should be removable and none should be required to run a platform.
   Android Platform is not vendor locked,  the core components can be substituted easily.
9. The platform should have a highly efficient delivery mechanism for applications.
   Android platform is not limited to mobile phones. The various netbook manufacturers are planning to release Android based netbooks by end of year and early next year.
10. Certification requirements for platforms and applications should be kept minimal to maximize substitutability.
    

Though the document’s title includes Iphone and the authors mention Iphone within their document,  Android platform is better suited for being the platform for Healthcare Information Technology.

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What should the applications do to ease the daily work of Nurse practitioners along with efficient and error-free results. What kind of devices would they prefer?

A study titled “ Human Factors Evaluation of PDAs and Smartphones in Nursing Practice” was performed by Healthcare Human Factors Group based in Ontario, Canada . The objective was to determine which design features of popular mobile devices are supportive of various nursing tasks. Device usability was determined through metrics such as performance and user perceptions using various mobile devices.

The following observations were made by the study:-

• Nurses expect lightweight devices with physical keyboards, advanced rendering capabilities, intuitive menu structure and data access speeds that are comparable to desktop applications
• Devices need to be portable and compact; ideally weigh less than 180g
• Larger screen sizes are preferred, so long as page rendering is advanced
• System speed perception was also an important indicator of device acceptance; in addition, Wi-Fi compatible devices are recommended
• Be mindful of the types of applications and tasks the nurses will be using most; if text entry is required for the majority of tasks, a device with a physical keyboard is recommended
• From an infection prevention and control standpoint, devices that can easily be used with a protective cover that can be easily wiped with a disinfectant are recommended. Those devices with the fewest buttons, connectors, and crevices that could trap microbes are considered best.

The key points to take-away from the study are:

• Nursing application should support large screen
• Nursing application should have advanced rendering capabilities
• Nursing application should make text entry easy and intuitive
• Nursing application should have intuitive navigation
• Nursing application should be responsive and quick

The above study results, suggests that netbook would be preferred instead of mobile phones where majority of daily nursing tasks include typing. This could be good news for Android developers , as seen lately, almost all netbook manufacturers are planning to have Android based netbook within a year’s time. With Android capability to allow developers to create device independent code, the same application could potentially run on mobile phone as well as netbook. This provides an advantage compared to other mobile platforms available.

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