Building native applications for mobile devices is like building a ‘Client-Server’ application which was popularized in the 90’s and 00’s with the explosion of personal computers. While this trend leveraged the fact that an application can use the computing power of the client device and provide better user experience and performance. However, from a maintenance perspective this was a nightmare. I still remember the “DLL Compatibility” issues driving me and my team crazy when we were deploying these applications in an enterprise environment and having to update/upgrade the application frequently. It generated a lot of call volume to the support teams. Combine that with the lack of good collaboration tools and you have a perfect storm whenever there is a new release.
The reason I bring this up is that the web has changed this whole ‘Client-Server’ paradigm and drove the application development model to adopt web-based architectures. With respect to Mobile Application Development we are looking at another such paradigm shift where there should be more and more applications built using ‘HTML5’ based app development for mobile devices. Just as in the case of Client-Server apps, ‘Native Apps’ for mobile devices provide a lot of power for developers to build apps that provide better user experience and performance, but it is a maintenance nightmare and also tend to increase the deployment cycles. A ‘HTML5’ application that follows the “80-20” rule and uses 20% native code will provide greater flexibility by delivering almost all the advantages that a ‘Native App’ would. Plus, it also fits into the “Build Once Deploy Anywhere” model where the app can be deployed to multiple mobile devices (iOS, Andriod, Blackberry, Windows Mobile etc.) with minimal changes (to the 20%) of the native code (all the HTML5 code doesn’t need any platform specific changes).
This approach is being recommended by many analysts, thought leaders and vendors. It would be interesting to see how many developers adopt this approach and accelerate the shift in Mobile Application Development paradigm.
Apple has sold millions of iPads in the past 18 months. The adoption of the device in the market is phenomenal. This trend is reflected in Life Sciences & Healthcare industry as well. A mobile Health News article (2012: About 62 percent of physicians use tablets) puts the adoption of tablets by the physicians at 62%. Another report by IDC puts the Smart Devices sales exceeding the combined sales of laptops and desktops. All these trends are indicative of the rate of adoption of mobile and smart devices by the population in general. The healthcare and life sciences industries are no exception to this.
While the adoption is growing in general, the challenges and bottlenecks are numerous for adoption of the devices in an Enterprise/Business setting. To make this even more complex, consider using the tablets and smart phones in a validated environment to capture and manage personal health information of patients.
Some key questions to be asked while considering adoption of Mobile devices in a validated environment are:
- Will the device and application be considered a Mobile Medical Device?
- If so, what should we do to validate the application?
- What are the regulatory requirements and guidance from the agencies?
- Should we consider a native application vs. a web based application?
- If so, how does the validation activities and artifacts differ?
- Would the data be stored on the device or would it be transferred to the server as soon as it is captured?
- Should we make it available offline to enable usage without internet connectivity?
- What are the synchronization challenges?
- How do we handle identity management?
- How do we ensure data security?
While some of these questions are applicable to any enterprise mobile application, they are even more important to consider if the Mobile device is slated to be used in a regulated environment. For customers in the US, one key document to be considered as input, to answer some of the questions, is FDA’s DRAFT Guidance for Mobile Medical Applications.
mHIMSS Policy & Regulatory Implications Workgroup has provided a very good summary of how the guidance should be interpreted with respect to Mobile Medical Applications. You can read the summary here (needs registration).
FDA also provides more useful information on Mobile Medical Applications here.
I look forward to comments and insights into any specific experiences that you might have had with respect to developing Enterprise Mobile Applications in a regulated environment. These applications may or may not be companion applications to devices, but may fall under the MMA purview as defined in the guidance.