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Health informatics. Measures for ensuring patient safety of health software has-digital BS EN 16825 provides requirements1 Scope This Technical Report considers the control measures required to ensure patientsafety in respect to health software products. It does not apply to software which is: necessary for the proper application of a medical device or an accessory to a medical device or a medical device in its own right. This Technical Report is aimed at identifying what standards might best be used or created, and their nature, if health software products were to be