iPads, iPhones, Androids, Windows Mobile Phones, Life Sciences and Compliance

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 For customers in the US, one key document to be considered as input, to answer some of the questions, is FDA’s DRAFT Guidance for Mobile Medical Applications.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.

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About Venu Mallarapu

I am currently working as Director & Global Client Partner at Cognizant Technology Services in their Life Sciences division. I have over 19 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for over 13 years. I have worked with small to large pharma customers to address their business needs across R&D, Sales and Marketing and Manufacturing & Supply Chain areas. My passion is Pharma R&D. I blog and write about varied topics in Pharma Industry as well as latest Technology trends that impact Clinical Research and have also presented at various conferences and workshops on wide variety of related topics.

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