The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials. As discussed in our earlier posts on apps regulation (here and here),...
Read MoreIn preparing for my presentation on Stage 2 Meaningful Use (MU) requirements for the November, 2012 Fourth Annual Medical Connectivity Conference I had the opportunity to delve further into the question of what had to be...
Read MoreThose of us engaged in medical devices and their connectivity often (or perhaps not often enough) look to the FDA for regulation and guidance. In these pages there has been discussion of FDA regulation generally (here), as...
Read MoreI have previously discussed Meaningful Use (MU) criteria for EHRs (here and here) , and Clinical Decision Support (CDS) (here). These topics are closely linked since the MU requirements mandate the inclusion of CDS. On...
Read MoreA recent Class I recall (not pictured) of a medical monitor with a hospital network connected central station stimulates some generalities about software, "fixes", and connectivity. (Class I recalls are defined by the FDA as a...
Read MoreThe issue of the EHR relative to safety and effectiveness has again made the news with the November 7, 2011 pre-publication (and downloadable) release of an Institute of Medicine report on EHR safety, commissioned by the U.S....
Read MoreA recent NY Times article reported that hotel Wi-Fi capacity was again being challenged, this time by iPads and other tablets, or more specifically, tablet users. The Times notes that these users may have a smart phone and...
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The fact that connectivity, and perhaps wireless connectivity in particular, allows for hacking...
Read MoreAs medical applications for mobile devices have proliferated, regulatory questions have proliferated nearly as fast, at least in some quarters. The key questions are what kinds of apps are medical devices, and among those,...
Read MoreGiven the analogy between actual clouds and computer clouds, it now seems appropriate to extend the concept to storms that those clouds may bring. This was illustrated recently (April 21, 2011) when Amazon had a cloud outage (a...
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