Speaking at a policy discussion panel Monday at the 2013 mHealth Summit in Washington, D.C., Jodi Daniel, director of the Office of the National Coordinator for Health IT's Office of Policy Planning, said the proposed report on health IT called for by the Food and Drug Administration Safety and Innovation Act (FDASIA) will be out and ready for public comment in early 2014.
Daniel (far right) said the report--which she stressed will not be "some new regulatory approach"--won't have all the answers with regard to health IT safety; to that end, she said the FDASIA workgroup looks forward to input to help mold what eventually will be a final guidance document.
"We're still putting forward something for folks to chew on and consider," Daniel said. "This is the beginning of the process."
Daniel added that beyond the process on this particular report, ONC wants to figure out even more ways to work collectively with the private sector.
Joseph Smith (second from right), chief medical officer for La Jolla, Calif.-based West Health, said the issue of health IT safety is not one that will be solved by any one person. Smith served on the FDASIA workgroup that helped ONC, FDA and the Federal Communications Commission to create the forthcoming report.
"Policy and regulation is essential to get right," Smith said. "Nothing really happens until the environment is conducive to acceptance of the innovations you would otherwise bring forward. ... I think we're now being confronted with obvious information that we need to innovate to get some safety."
In support of his point, Smith cited data recently published in the Journal of Patient Safety that said between 200,000 and 400,000 people each year are "hastened to their death" by preventable adverse events.
"To put that into some perspective, that's about 1,000 a day," Smith said. "The bloodiest war we've ever fought in this country is the American Civil War, and that's about 600 a day. In every real way, both economically, but also in terms of patient safety, we are practicing on a burning platform."