Almost every element of the life sciences and health care world is in the midst of change, and it’s natural that the authorities charged with regulating those industries are working to keep up. As companies adjust to new market and statutory realities and attempt to master the “cost, access, quality” nexus, they are remodeling their business structures, alliances, innovation practices, and channels of communication. Regulators watching over all those changes are focusing on elements like the Affordable Care Act, excise taxes on high-cost employer plans, Medicare payment reform, and the 340B Drug Pricing Program. Meanwhile, the unique safety and ethics dimensions of the drug and device world bring regulatory challenges for life sciences.
Deloitte recently published a report that examines six key regulatory trends for the life sciences and health care industries in 2016. Here are some of the highlights:
For more information about these important regulatory trends, please visit Deloitte.com to download the full report.