These Mobile Apps Are Subject to FDA's "Enforcement Discretion." Whaaa?

When I read Dominic Tyer's blog post ("FDA takes 'tailored' approach to mobile app regulation") about FDA's final guidance for regulation of mobile medical applications, the following segment gave me pause:"The FDA's guidance gives the following examples of apps that it intends to regulate [my emphasis]:Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environmentMobile apps that provide patients with simple tools to organise and track their health informationMobile apps that provide easy access to information related to patients' health conditions or treatments (beyond providing an electronic “copy” of a medical reference)Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditionsMobile apps that perform simple calculations routinely used in clinical practiceMobile apps that enable individuals to interact with personal health record or electronic health record systems."If true*, this would be BIG news and would have justified PhRMA's fear mongering regarding the stifling of innovation by FDA regulation (see "Mobile Regulatory Fears: PhRMA Raises an Alarm").If you download and  actually read the final guidance (find it here), the FDA says on page 16 of the document:"FDA intends to exercise enforcement discretion [my emphasis] for mobile apps that:Help patients (i.e., users) self-manage their ...
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: Drug Safety FDA Guidance mobile medical app Source Type: blogs