GDPR and Medical Devices
|What Is GDPR’s (General Data Protection Regulation) Effect On Medical Devices?
|Rights provided to data subjects reinforced via GDPR are:
These rights have many specific processing requirements built around them and the relevant Supervisory Authorities, those organizations that enforce GDPR, will have opinions on how these rights should be applied.
That said, GDPR is not much different, functionally, from HIPAA. If a medical device was created with a strong HIPAA understanding, making the device GDPR compliant may not be as burdensome as it initially seems. Still, GDPR imposes a software development burden on medical devices, from communications and storage to processing and data collection, as well as consent, and devices that have yet to be updated likely need revision in order to become GDPR compliant.
|Med Device Online, April 30, 2018
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