FDA Recognition of Medical Device Standards for Interoperability

This is a follow-up to Interoperability: Arrested Progress.

The FDA has recognized voluntary interoperability standards for medical devices: Improving Patient Care by Making Sure Devices Work Well Together.

The FDA and HHS has (my highlight):

published a list of recognized standards for interoperability intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The standards are searchable here: Recognized Consensus Standards. The Software/Informatics area currently lists 54 items.

Some consider this a “landmark announcement” (see here) but “voluntary” and “elect to declare” just seem like more of #1 (same old, same old) to me.

UPDATE (9/4/2013): More here: FDA Updates List of Recognized Standards, Confusion Ensues

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