With the explosion of mobile devices and apps, it's not surprising that medical apps are taking off.

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With the explosion of mobile devices and apps, it's not surprising that medical apps are taking off. There are apps to identify pills, track pregnancy, check for melanoma skin cancer, and even teach medical professionals how to read electrocardiograms. Some apps are replacing devices used by healthcare professionals in hospitals and doctors' offices. There are more than 40,000 medical applications available and the market is still in its infancy. The market's growth has caught the attention of the Food and Drug Administration, the agency regulating medical devices. So far, medical apps have been unregulated, but that is about to change. The FDA released guidelines requiring app developers to apply for FDA approval, which could take years. According to the Government Accountability Office, it takes the FDA six months to approve a device that is similar to an existing one and up to 20 months for new devices. According to another report, approval costs $24 million to $75 million. Not all apps would require FDA approval-only ones making medical claims. Although many developers think regulation is necessary to protect the public, most believe that the current process is too slow and a new regulatory framework is necessary.

1. Describe two examples of mobile apps for healthcare providers. Are these only for U.S. providers, or would Canadian providers be able to use them as well?

2. Do you think regulatory approval of medical mobile apps is necessary in the United States? What about Canada?

3. Will the FDA's requirement for approval constrain innovation? Explain.

4. Find out whether the market for these apps exists in Canada, and, if so, which government body, if any, is regulating it. (AACSB: Written and oral communication; Information technology)

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Marketing An Introduction

ISBN: 978-0134470528

6th Canadian edition

Authors: Gary Armstrong, Philip T. Kotler, Valerie Trifts, Lilly Anne Buchwitz

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