FDA Use of EHR data in Clinical Investigations

The US FDA issued a draft guidance entitled: “Use of Electronic Health Record Data in Clinical Investigations”. This draft addresses a variety of issues including EHRs certified by ONC, data modifications, audit trials, informed consent, and Privacy and Security. The full draft guidance can be found at the following link:


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QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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