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With a few exceptions, the biomedical industry, and the informatics field in particular, have not been affected by the standards litigation that has plagued the ICT sector. But with the increasing adoption of standards by informatics researchers and vendors, the issues faced by ICT standards groups will become increasingly relevant. This chapter summarizes general legal issues associated with standards development, then surveys standardization efforts in the informatics space and reviews the policies and procedures adopted by SDOs operating in the informatics area. It concludes with recommendations regarding prudent policy adoption by SDOs developing standards for informatics applications.