Transferring medical data from a device (Sec 201(h)): regulatory implications

PacoRabanez

Starting to get Involved
#1
Hi forum fellows,
I am investigating the possible regulatory implications, if any, regarding the export (complete transferring) of the database from an previously cleared and currently distributed medical device to another, in particular, from a corneal topographer to a biometer, or from one of these to a web-based software platform for managing data from multiple devices.
The database includes patient records and all the tests performed by the device.
I'd like to know if regulations, standards, reference guidelines related to this topic are available and, therefore, if specific applicable requirements and responsibilities (if any) of the manufacturer exists?

Hope you can help me.
Greetings to you

PS: can anyone help me for the same problem but for Europe regulation?
 
Elsmar Forum Sponsor

Junn1992

Quite Involved in Discussions
#4
I do not see any immediate MDR implications from this. However, you should take note of the following:

EU GDPR:
- data export. did patient consent?
- data storage. does it fulfill requirements under the GDPR?
- where is data going to be stored? GDPR is very strict regarding cross border data flows
- should also consider cybersecurity of the system where data is being stored

So immediately I can see that your issues would be with patient consent, storage of the data, and using the data in a compliant manner with reference to the GDPR.
 
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