What Is GDPR’s (General Data Protection Regulation) Effect On Medical Devices?

If the patient is interacting with the medical device, a consent form must be provided to patients, allowing them to acknowledge their rights and consent to processing of their information (either on the device itself, or on the device’s back end). John Kenneth Barchie, Arrakis Consulting
Basically, there is a long list of what cannot be processed without explicit consent….
The basic concept with GDPR is that your patient’s data is no longer yours to process at will. Instead, the device now needs to be configured to protect patients’ data, as is THEIR right.  Violation of this concept can be grounds for penalties….
If the device is used by practitioners, each practitioner will need a way to signify that the patient understands and gives consent to the processing  of their data that will take place on the medical device (or on the back end)….
Other things to keep in mind include: if actual processing takes place on the medical device, it will need to be captured as a place of processing on reports that may go back to the patient….
MED DEVICE ONLINE, Guest Column, April 30, 2018
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