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.

iPhone Medical“So many different health apps pop up,” says Kim, a specialist in the use of technology in medicine. “How do you as a consumer, or as a physician, know which ones are reliable or which are accurate?”

“Unfortunately, the technology is moving faster than any regulatory body can keep up. Releasing an app is very easy,” he said, but if it is developed abroad, the standards may be different than they are in the United States.

“There are a lot of questions of liability that have yet to be answered. If a patient uses an app on the iPhone, who, at the end of day, is liable? If someone buys a WebMD Symptom Checker and there’s a problem, is the Apple store liable? Is WebMD liable?”

“The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play,” according to iMedicalApps. Dr. Jeffrey Shuren, Center for Devices and Radiological Health director, said that the FDA is planning to release guidance for mobile medical applications in sometime in 2011.

  • What are pharmaceutical companies doing to reach physicians and other health care professionals via mobile devices?
  • What are some of the potential concerns associated with mobile apps for health care professionals and/or patients/consumers?
  • What are some of the privacy and security issues and concerns that surround mobile health apps?
  • What role will the FDA play in regulating mobile health apps?

Listen to this podcast to get the answers:

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Issue: Vol. 10, No. 9
Publication date: 15 May 2011
Word Count: n/a

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