As per the FDA press release "the diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety. Innovative health IT products present tremendous potential benefits, including: greater prevention of medical errors; reductions in unnecessary tests; increased patient engagement; and faster identifications of and response to public health threats and emergencies. However, if health IT products are not designed, implemented or maintained properly, they can pose varying degrees of risk to the patients who use them. The safety of health IT relies not only on how a product is designed and developed, but on how it is customized, implemented, integrated and used"
There are interesting debates all around the globe about whether there is the need for a next gen EA framework. James Lapalme recently published an excellent article: Three Schools of Thought on Enterprise Architecture explaining the reasons of such debates.
In this article James identifies three schools of thoughts for EA, each with their own scope and purpose:
"Enterprise IT architecting" which addresses enterprisewide IT, and the alignment of IT with business.
"Enterprise integrating" which addresses the coherency of the enterprise as a system with IT is only one component of the enterprise.
"Enterprise Ecological Adaptation" which addresses the enterprise in its larger environment