The American Medical Informatics Association has advised the FDA on how it should approach oversight of clinical decision support systems, according to an AMIA news release.
The AMIA advised the FDA at the Sept. 12-13 public workshop on its Draft Guidance on mobile medical applications. The AMIA said the determining factor in risk classification is whether the CDS is mediated by a human or not. Applications that provide automatic CDS should receive the most attention, according to the AMIA.
The AMIA's presentation focused on the following areas:
- The need for the FDA to articulate how it characterizes and defines CDS.
- The need to coordinate efforts among federal agencies and public- and private-sector research and practice communities.
- The potential limitations if FDA focuses too narrowly on CDS and considers CDS on mobile devices as somehow separate from CDS based on other delivery methods or contexts.
- The importance of addressing rapidly emerging and converging technologies and devices along with new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods.
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The AMIA advised the FDA at the Sept. 12-13 public workshop on its Draft Guidance on mobile medical applications. The AMIA said the determining factor in risk classification is whether the CDS is mediated by a human or not. Applications that provide automatic CDS should receive the most attention, according to the AMIA.
The AMIA's presentation focused on the following areas:
- The need for the FDA to articulate how it characterizes and defines CDS.
- The need to coordinate efforts among federal agencies and public- and private-sector research and practice communities.
- The potential limitations if FDA focuses too narrowly on CDS and considers CDS on mobile devices as somehow separate from CDS based on other delivery methods or contexts.
- The importance of addressing rapidly emerging and converging technologies and devices along with new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods.
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