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The article focuses on the approval of the used of whole-slide imaging system for primary diagnosis in Europe and Canada. Topics discussed include challenges on the development of digital pathology such as workflow and technical issues and standardization, the awaiting of approval of U.S. Food and Drug Administration on the use of whole-slide imaging system in the U.S., and the issue of licensure in physicians. Also mentioned are federal medical licensure, federalism, and mutual recognition.

The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (US) and European Union (EU). In the US, breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in dinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the US than in the EU, a decision US government health agencies can point to with pride. Nevertheless, the IDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. [ABSTRACT FROM AUTHOR]