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The Fda Guidance Document For Medical Mobile Apps And Its Impact On Innovation: Bringing The Promise Of A New Way To Look At Medicine Closer, Or Pushing It Further?, Ioana Ciopraga
Journal of Law, Technology, & the Internet
"This Note critiques the guidance document released by the Food and Drug Administration (“FDA”) in connection with the medical mobile apps it intends to regulate and the regulations that govern medical mobile apps. Specifically, the main argument of this Note is that, while the document is clearly a step in the right direction, significantly more guidance, focused on the characteristics of this new field, such as the rapid change of mobile technology, and on the transformational impact on healthcare of health IT in general and mHealth in particular, should follow soon. Part I provides an overview of the guidance document, …