How do patients give consent to their data being shared?
Patient care and consent is incredibly important to EURO-NMD and using the CPMS will maximise security of patient data whilst discussing possible treatments, diagnosis and care. When a healthcare professional submits a patient case onto the CPMS, the minimum level of consent that must be provided by a patient is Consent for Care. Information about Consent for Care and what data is shared will be explained by a clinician before the case is submitted to CPMS and a form will be given for the patient to sign detailing whether they consent to their de-identified data being shared within ERN(s). The form will also ask if the patient consents to de-identified data being included in the ERN database or registry and if the patient would like to be contacted about research. This is a legal requirement in line with GDPR (General Data Protection Regulation) and patients have a right to access data held about them and to request correction to any errors they might find at any point.

The CPMS uses data which has been anonymised and so healthcare professionals other than the clinician directly involved with the patient will not be able to view any identifiable data including the full name of the patient; instead the CPMS uses nicknames.

Once a patient has consented to their data being provided onto the CPMS the clinician can commence the process of enrolling the patient and opening a panel. The patient may need to attend further consultations to gather more data to be uploaded onto the CPMS if this is requested. However, the patient will not need to provide any further information to the healthcare professional. Once the panel has concluded the patent will receive findings, recommendations and a treatment plan.

We hope that the CPMS process will be a lot less invasive and stressful for the patient as there is no need to travel to different Healthcare Providers and different countries. Furthermore, the process will hopefully be a lot quicker and so patients can be treated and diagnosed much faster than before.

Please see the attachments below for an example of a model consents form and "An overview of good practices for health data collection and processing in the
context of European Reference Networks for Rare Diseases"
Last Updated: 24 Jan 2019
Attachments
Good Practices Informed Consent Data Management ERNs.pdf(PDF, 942.96KB)
consent form - EURO-NMD.pdf(PDF, 437.11KB)
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