Pharma SmartPhone/Tablet Apps Is There a Regulation for That?

FDA and iPhonePharmaceutical marketers have jumped on the mobile application bandwagon as more and more companies roll out health-related applications for smartphones and touchpads such as Apple’s iPhone and iPad.

“So many different health apps are popping up,” said Joseph Kim, MD, MPH, VP of Medical Affairs and Technology at Medical Communications Media, Inc. “How do you as a consumer, or as a physician, know which ones are reliable or which are accurate?”

Not only don’t users know which health apps are reliable and accurate, neither does the FDA. Some pharma smartphone apps that are intended to be used as diagnostic aids for physicians may be classified as medical devices. Indeed, FDA is planning to release guidance for mobile medical applications in 2011.

This article discusses the regulatory and other issues associated with pharma developed or sponsored health apps and summarizes a discussion of the topic with Dr. Kim.

Topics include:

  • Physician Smartphone Usage
  • Physicians Prefer Reps with iPads
  • Pharmacos Develop Apps for Docs
  • When is an App a Medical Device?
  • Recent FDA Letters
  • Third-Party Apps & Pharma
  • CASE STUDY: The Janssen Psoriasis iPhone App
  • Challenges of Regulating Mobile Medical Apps
  • Liability Versus Regulatory Issues
  • Apps Without Borders
  • Role of Physician Societies & Medical Schools
  • Can Medical Apps Improve Patient Care?

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Issue: Vol. 10, No. 9
Publication date: 15 May 2011
Word Count: 4181

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