Health IT Now Responds to FDA Software Comments

Today, Robert Horne, Executive Director of Health IT Now (HITN), issued the following statement in response to Dr. Jeff Shuren’s comments on the FDA regulatory pathway for software products:

“Health IT Now commends Dr. Shuren for his comments today outlining the potential of a system of pre-checked quality controls as a solution to the issue of software modifications. The speed of software updates makes calls for consideration important to ensure updates are timely and agency oversight remains effective. While we want to ensure that updates do not pose a risk to patient safety, requiring a full review means necessary software updates could be stalled for months. In the past year, FDA has made great strides to modernize its approach to software products overall, and this is another step in the right direction. This issue will continue to be a priority for HITN going into 2017. We look forward to partnering with the FDA and Congress on next steps to achieve the shared goal of clarifying the regulatory pathway for software products to ensure its effectiveness.”