1. Describe two examples of mobile apps for health-care providers.
2. Is regulatory approval of medical mobile apps necessary? Will the FDA's requirement for approval constrain innovation? Explain.
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 health-care 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 (FDA), the agency responsible for regulating medical devices. So far, medical apps have been unregulated, but that is about to change. The FDA released guidelines requiring 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.