The US elections are behind us, the EU still stands and China and India continue to increase their production of global products for the healthcare industry. On an international and national level, healthcare is in transition. No industry, right now, in fact, is being more affected by advances in technology. But with each advance—in medical devices, medications, methods of care, and healthcare administration—new standards emerge that affect how the entities in the industry need to communicate.
With healthcare costs soaring, administrative costs comprising a whopping 7% of healthcare expenses, and increased concerns about medical errors and counterfeiting, to name a few challenges, various government agencies in the US are taking legislative action. This report addresses the most recent changes impacting those who trade in the US market—across the whole value chain—and the impact the Affordable Care Act and other recent legislation will have on the deployment of standard electronic
Global and national mandates, standards, and legislation that impact the life sciences/healthcare industry are now expected to be implemented. And that includes the whole value chain from discovery through manufacturing of medical devices, supplies and pharmaceuticals; to the distributor, retailer, and the point of care—clinics, hospitals, physicians, and home healthcare services. These mandates have an underlying philosophy that specifically calls for integrating the chain of care. And this will have long-term implications for the way we transact and communicate. Therefore, they will form the foundation for now and for the digital future of the industry.
Several pieces of legislation—updates to HIPAA implemented in 2012; the Food and Drug Administration Safety and Innovation Act of 2010, which mandates specific product codes on medical devices (the UDI or unique device identifier) which can support product traceability; the California SB 1307, the so-called epedigree mandate, which requires digitally sharing information about pharmaceutical products across the supply chain; and of course the Patient Protection and Affordable Care Act of 2008, more easily called ACA—all play a role in our digital future.