Now, all patients will automatically receive the digital medical record – anyone who wishes to forgo this will have to actively object to the ePA in the future via an opt-out procedure (for further information, see also ” Opt-out Models for the Electronic Patient Record from a Data Protection Perspective ” by the Bertelsmann Foundation). Gematik GmbH (National Agency for Digital Medicine) has been commissioned to develop a corresponding, detailed concept. However, there is still a long way to go before implementation – Federal Data Protection Commissioner Ulrich Kelber, in particular, is critical of the implementation of the ePA . Such an opt-out procedure is “fundamentally not intended” in the GDPR. Opening clauses exist only in exceptional cases, for example, in the context of research The e-patient record.
And what about data protection? The e-patient record
The information processed within the framework of the ePA predominantly constitutes health data within the meaning of Art. 4 No. 15 GDPR. This “highly personal” information has a particularly high potential for. Damage and discrimination, dubai business fax list with the result that the ePA data is therefore subject to. Extremely strict requirements – both with regard to the “whether” and the “how” of the processing modalities.
Data protection law basis for the “whether” given
When deciding whether to implement an opt-out model without prior patient consent. The legislator has the processing grounds of Article 9 (2) (h) in conjunction with Article 9 (3) GDPR (individual healthcare) and Article 9 (2) (i) GDPR (public health) at his or her disposal. The prerequisites for these grounds are also met in principle.
Data protection requirements for the modalities to consider the “how” in a differentiated manner
However, the “how” of the processing modalities, i.e. the creation and filling of the file, must be considered in a more differentiated manner – especially with regard to the data protection principles for the processing of personal data according to Art. 5 GDPR.
In compliance with the principle of purpose specification and limitation under Art. 5 (1) (b) GDPR, filling the ePA with existing data constitutes a change of purpose that requires justification – especially with regard to the the task of creating a long impermissible retention of health data. Filling the ePA with health data is primarily intended to facilitate future high-quality treatment and provide information.
Furthermore, the specific design option regarding the principle of data minimization pursuant to Art. 5 (c) GDPR and the storage limitation pursuant to Art. 5 (1) (e) GDPR must meet the requirements of suitability, necessity, and appropriateness. The criterion of appropriateness of data processing in particular argues for a differentiated data input into the EHR depending on the degree of data sensitivity. For example, through the use and assessment of specialist personnel, a differentiated data input can be carried out, thus limiting data processing to the extent necessary for the specific purpose.
And who then has access to the data?
Another important aspect is the question of how access to the EHR is structured. Who, besides patients, should be able to access the EHR data? Generally, botswana business directory it must be specified how personnel access authorizations should be granted—either through automatic authorization, through active patient activation, or a combination of both in the form of a differentiated authorization system.
However, the factual scope of the authorizations must also be defined – absolute or specifically restricted authorizations can be chosen.