Day

February 6, 2015
HIT Implementation, Usability and Safety Workgroup meeting on Friday, February 6, 2015 – SoftwareCPR® Partners Sherman Eagles and Alan Kusinitz gave a presentation at ONC’s request with recommendations on an approach to HealthIT provider quality systems regulation and standards. In addition to providing background on quality systems, SoftwareCPR® recommended that a standard or guidance be...
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The Federal Advisory Committee calendar of meetings is at the link provided. Attendance or downloading of material for most of these meetings is open to the public.
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FDA issued a final version of its guidance for “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The document is dated February 9, 2015, although it was issued several days prior. This guidance is very significant as it states FDA is exercising discretion and not requiring compliance to the recent...
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Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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