ePrescription and eDispensation of Authorised Medicinal Products – Guidelines on the electronic exchange of health data under Cross-Border Directive 2011/24/EU
On 10 June 2022, the eHealth Network published a guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU.
The eHealth Network was established under Directive 2011/14/EU and sets up a voluntary network of Member States’ authorities working with eHealth.
The guideline supports the ePrescription and eDispensation of authorised medicinal products for patients traveling inside of Europe and outlines the responsibilities of the Member States. This is for patients who have an ePerscription in one country and are retrieving the medication in another Member State.
The data that is being transferred is considered a special category of personal data defined by Art. 9 of the General Data Protection Regulation, and Member States will be responsible for ensuring that the processing of the data meets the data protection requirements.
The Member States’ authorities of where the ePrescription is granted will also provide an official health ID number, maintain electronic registers of health professionals, and agree on levels of authorization for certain healthcare roles. There will be access to ePrescription data through a value set catalogue and that will be accessible across Europe for both prescriber and retriever. The report also details that the information in an ePrescription document needs to be thorough to ensure secure dispensation. Member States should also consider establishing a function for cross-border ePrescription services and perform risk assessment activities to promote quality standards and validation. The Member States should also provide the appropriate information to train and educate all individuals, especially patients. Additionally, there should also be a controlled list of an agreed selection of concepts to facilitate the exchange of information.
These guidelines are not meant to be limited to cross-border use, they can also be used at a national and regional level.
