Vol. 10, Issue No. 9: 18 MAY 2011 – EXECUTIVE SUMMARYPharma 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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Challenges of Regulating Mobile Medical Apps Legal and Regulatory Issues You Should Know About

Joseph KimA conversation with Joseph Kim, MD, MPH, VP of Medical Affairs and Technology at Medical Communications Media, Inc., about the rapid development of mobile medical applications and the legal and regulatory issues that physicians, patients, and pharma developers/sponsors should be aware of.

Read the article and listen to the podcast here:

Consequences of eDetailing Technology The Death of the Traditional Pharma Salesman and the Birth of the “Sales Cyborg.”

Death of a Salesman“You can’t eat the orange and throw the peel away – a man is not a piece of fruit,” says Willy Loman in Act 2 of Death of a Salesman. After reading an article in a recent issue of the Wall Street Journal, many pharma sales reps may be feeling like tossed peeled fruit.

“Big pharmaceutical companies have found replacements for the army of sales representatives they’ve laid off in recent years: digital sales tools that seek to sell doctors on drugs without the intrusion of an office visit,” says the WSJ.

Some sales reps may morph into what could be called “sales cyborgs” who engage in remote live human conversations with physicians aided by technology.

Read more about this here:
https://www.pharma-mkting.com/news/pmn109-article03/ Physicians Are Concerned About Pharma Support of CME But Are Unwilling to Pay Their Own Way!

Piggy CMETalk about having your cake and eating it too! Commercial funding of continuing medical education (CME) and the potential for bias appear to concern many physicians, yet only a TINY MINORITY (7%) are willing to pay registration fees to eliminate or offset commercial funding sources, according to a report in the May 9 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

The authors surveyed attendees at live CME courses delivered by the International AIDS Society-USA (IAS-USA), a nonprofit organization that pools the support it receives from industry so that no one company funds any particular program. In total, 770 attendees (a 57% response rate) completed the 22-item survey, which focused on beliefs about commercial funding and potential for bias, willingness to offset the cost of commercial support, knowledge about the costs of producing CME programs, and demographic information.

Find more results of the survey here: