Every once in a while a revolutionary product comes along that changes everything. It’s very fortunate if you can work on just one of these in your career. Apple’s been very fortunate in that it’s introduced a few of these. Steve Jobs
These were the words of Apple CEO, Steve Jobs in January 2007 before the release of iPhone. You must be wondering why are we talking about iPhone in this health blog? Well, smart phones such as iPhone have ventured into the medical realm to the extent that it is predicted that iPhone can become a medical device.
Apple introduced new version of iPhone Operating System (OS) 3.0 this year along with Software Development Kit (SDK). This will aid iPhone to be more user friendly to application related to health care industry. You can watch video from Apple, wherein, it shows it’s appetite for medical applications. First let’s look at main features of OS 3.0 and then we will delve into medical applications of iPhone. I think you can expect some technical details in my health-o-meter section.
How OS 3.0 and SDK make iPhone in medical applications?
SDK is an integration tool for innovative people out there, who are working meticulously to design accessories and software for the iPhone. The third party developers can use application programming interfaces (APIs) that have thousands of software features. Let’s look at some of the key features:
External Accessories: Your iPhone can communicate to external accessories by either dock connector or wireless Bluetooth. Key element is that this connectivity will support standard protocol of iPhone along with proprietary protocol of accessory developers. So, it eases burden on poeple who are developing applications for your iPhone.
Game kit: Game kit is a new frame work that has capability of a voice chat service or a wireless VoIP. So, Bluetooth or WiFi can be used by developers to establish a chat service. As per my understanding, it reduces complexity on developers end, as they don’t have to write a separate software code to integrate their iPhone application to health care vendors, such as Cisco, Ascom, Vocera, etc.
Voice Recording: Apple has tons of audio recording application that does acquiring, storing and managing data for you. Third party application developers can leverage the iPhone’s audio appl. and add it to their appl. Looks like even I can start working on developing applications for iPhone.
What kind of medical applications are we looking at?
Now we come to the medical application part of the iPhone. Can you imagine your iPhone directly hooked to a blood pressure monitor? The picture below will give you sense of this application. This is possible through “virtualized medical device” technology.
This device has three main elements, a sensor that gathers data, software that analyzes data and interfaces with computer and a computer to store the data. Instead of computer you can use your iPhone.
Most of the applications are based on storing and managing data gathered by different type of sensors or external health meters. Let us look at some examples:
Glucometer: A company called LifeScan developed a prototype that allows diabetic patients to interface their glucometer with the iPhone. The data from glucometer is transferred to iPhone through dock reader or Bluetooth. You can ask how it is different from virtualized medical device. Well, whole data is processed and ready to use before it enters into the device; whereas, in the previous case data measured by the sensor gauge is to be processed to have any meaning to the user.
This glucose reader application is capable of tracking insulin schedule by classifying reading as pre- or post-meals. Your iPhone can actually estimate how much insulin you need, which is based on the diet you consume. You want to your know insulin level history? The application can compare your current insulin level to the past user friendly format like charts and other graphical tools.
Drug and formulary reference: Epocrated Rx introduced a software for iPhone in 2008. This software is good data source about the medicines like serious and adverse reactions, drug interactions, pill pictures with drug monograph, pricing and manufacturer of pills and so on. You can read some more details from the article medgadget/epocratesRx. The software requires minimum of 8 GB memory with OS 2.0 or greater on your iPhone and wireless connection to get updates.
You can think of patient care management applications day in and day out and I am sure you will not run out of ideas. Ultimately, you will have to decide which application is useful and which not. I found a list top 100 applications from a blog connecting iPhone with health and fitness applications.
Are there other phones exploring medical application apart from iPhone?
Almost every smart phone company is tapping into opportunities to interface their devices with medical applications. Picture on the left shows electrocardiogram (ECG) and tumor imaging data that can be transmitted through cell phones to a computer where it can be analyzed and reviewed by a doctor.
Microsoft has funded around 30 health-care-related projects at various universities that are investigating such medical applications. This Business Week article gives a broad outlook of the research in this area.
What are regulatory issues of iPhone being a medical device?
Center for Devices and Radiological Health (CDRH) is a branch of the FDA that is “responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products.”
There are regulatory hurdles that could arise with smart phone acting as a medical device. iPhones are currently intended to be used as consumer devices and their blood pressure prototype device started as an unregulated device. If you collect and use the data for your healthcare and fitness, it will not be termed as medical device. But, if you decide to share the blood pressure or glucose results with a physician, then the system become a medical device as data is being used for diagnosis.
One more application, where iPhone used for alarm notification for various health issues meets the definition of a medical device. The FDA has recently published a rule subjecting alarm notification systems to regulatory enforcement.
iPhone and the competing smart phones are looking at industry that is worth Billions of dollar. Now it depends on Apple to be succesful in this health care market as to how effectively it can support itself to ever growing market and how well are the smart developers and entrepreneurs, attracted and integrated to the iPhone. It is estimated that hospitals alone could add several million additional iPhones to Apple’s sales that could potentailly make their revenue shoot up much more than any other product. One thing is sure, Apple has given many technological breakthrough to the consumer market and presents lot more potential to the health care sector.