Speaking to Congress recently, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, addressed some growing concerns in the Administration over the reliability of Healthcare Information Technology (HIT). He specifically noted an operating room electronic health record management system that tended to lock up during surgery. Among other things he said, “…we believe that a framework of federal oversight of HIT needs to assure patient safety.” He continued by outlining three possible approaches to regulating healthcare IT. To Summarize these, they include:
Requiring health IT developers to submit reports to the FDA on safety issues and fix problems that occur, setting minimum quality standards for products on the market, or treating HIT systems the way the FDA regulates new medical products.
Director Shuren is not voicing a uniquely American or governmental concern or issue. In related news, turn your attention for a moment to the UK’s NHS Connecting for Health (CfH). It supports the NHS in providing better, safer care, by delivering computer systems and services that improve how patient information is stored and accessed. The other day, this organization’s director of technical infrastructure joined the board of GS1 UK. Turns out, in fact, CfH and GS1 UK have been partners since 2007. GS1, it would be fair to think, associates healthcare product labeling with safety and links their mission with healthcare information technology infrastructure. By that I mean that while the FDA today has great authority over the production and use of product labels, in the future this may evolve to include the systems and software products that are used to generate product labels and medical device unique device identifications (UDIs).
Why is this important to think about? Because whether or not the FDA goes all the way or not, whether sooner rather than later, it is clear that the reliability of the whole healthcare infrastructure is under inspection with an eye to improvement. This being the case, in every facet of your healthcare products business you want the most reliable, proven, time-tested enterprise solutions. No, we at Loftware don’t make operating room patient electronic medical record solutions. We just make the world’s most reliable solutions for making sure the exact right label gets put on the exact right product, at the right time, on time, all the time. That, I would argue, is something to think about as you anticipate more scrutiny across the global continuum of the healthcare supply chain.