External Resources on Medical Device Interoperability
AAMI white paper on Medical Device Interoperability, published March 2012
July 2011 IOM report on 510(k) regulatory framework, "Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years"
White paper of the California Healthcare Institute, "Upcoming Changes to the 510(k) Process: New Approval Pathways and the Impact on Medical Device Development and Innovation"The Open Group's Semantic Interoperability Work Group
WHO publication, Medical Device Regulations: Global Overview and Guiding Principles
Device Advice: Comprehensive Regulatory Assistance from the FDA
mHealth Regulatory Coalition's Proposed Guidance on Regulation of mHealth Technologies, submitted to the FDA in September 2011
Friends of the MD PnP Program