(Including references to German legislation in particular, but not exclusively)

German State Minister for Digitisation Dorothee Bär gave an interview to the German newspaper Welt am Sonntag on 23 December 2018, in which she explained that digitisation in the healthcare sector could be achieved, among other things, by easing data protection regulations.

“In Germany we have the strictest data protection laws worldwide and the highest privacy requirements. This blocks many developments in the health sector, so we have to disarm at one point or another, delete some rules and loosen others”(see interview). In particular, she took aspects into account concerning the introduction of the electronic health record until 2021.

Regardless of whether there actually is a causal connection between data protection and slowed digitisation, the question is, if the constraints of the data protection regulations in Germany can simply be “eased” or even have to be “eased”!

The General Data Protection Regulation regulates the processing of health data in various places and should therefore be taken into account in all matters of digitisation in the health sector. This article is intended to provide an overview of the data protection requirements of the GDPR in the health sector and show some possible fields for Member States’ own national regulations.

Background: Regulations on health care within the GDPR

The GDPR does not explicitly regulate the health system. Originally, there was the intention for an Article 81 “Processing of personal data for health purposes”, but it was dropped after the discussions on the latest version. Nevertheless, the GDPR contains provisions that specifically relate to health data and thus have a significant impact on digitisation within the healthcare sector.

Data processing, i.e. the processing of personal data, is generally prohibited under the GDPR, but allowed in accordance with Article 6 (1) lit. a), for example, if the person affected consents to the processing. Furthermore, in addition to other permission reasons, data processing is even permissible if a balancing of interests turns out to be in favour of data processing (such as a company’s interests). For health data, however, Article 9 GDPR provides for special regulations. Health data is considered particularly worthy of protection under Article 9 because it is particularly sensitive. Due to the sensitivity of the data, their processing is therefore only permissible in accordance with the strict requirements of Article 9 (2) GDPR in conjunction with Article 6 GDPR.

The scope of application of Article 9 (2) GDPR

Businesses are urgently advised to monitor closely the legislation of the EU and the Member States, as Article 9 (2) lit. (a) gives the respective legislators the possibility to make certain areas of the processing of health data consent consistent. If legislators make use of this option, the processing of certain health data would be unlawful, despite the consent, since Article 9 GDPR does not provide for a contractual basis for processing.

However, up to a national rule, it remains the case that if consent meets the requirements of Article 9 GDPR, it can serve as the legal basis for the processing of health data. Especially in connection with the use of health apps, such consent becomes relevant.

Health Apps

An important use case in the processing of health data in the field of digitisation are health apps, such as heart rate monitors or sports trackers. Firstly, Article 9 (2) lit. (a) GDPR enables the processing of personal data via consent of the data subject. It is important to pay attention to the extensive information and transparency obligations of the GDPR. The affected person must know at all times what happens to his data. Without his permission, health data may not be disclosed to third parties (such as insurance companies).

Article 9 (2) GDPR contains a large number of other permissive rules that health apps can be taken hold of. An example is the protection of vital interests if the person affected is no longer able to give consent (for example, if the person affected is located having a heart attack reported by an app). However, for this permissive rule to apply, there must be an actual and specific case concerning a vital interest. That means, that the permanent tracking of data that (eventually) can also affect a vital interest is therefore not allowed. Likewise, the prior obvious publication of data by the data subject (such as posting a lower resting pulse as a result of regular training) constitutes a permissive rule.

In addition, the protection of individual and public health is considered as a legal basis. Where the individual health requires to treat certain illnesses and symptoms of the person affected professionally, this may also require falling back on the data needed from the app. Public health mainly covers cases of spreading health threats, such as epidemics, of which the spreading can be tracked by an app. The justification standards of individual and public health for the operation of health apps lead to the related question of the admissibility of the electronic medical record under the GDPR. In any case, there is sufficient legitimacy for the apps on the basis of the GDPR, so that the loosening of German national data protection regulations does not seem necessary in this respect.

The Electronic Medical Record

Both Article 9 (2) lit. (h) (individual health) and Article 9 (2) lit. (i) (public health) enable Member States to determine when the processing of health data for these two purposes is necessary. Thus, there are so-called opening clauses giving Member States great flexibility to adopt their own national regulations without violating the GDPR. In this context, corresponding provisions in the German Social Security Code V (SGB V) could be introduced, which not only allow an electronic patient record having the format of a health card, but also of an app on the smartphone. Although the opening clauses of the GDPR and SGB V thus make it possible to introduce the electronic patient file, their respective use in individual cases must always be dependent on the respectively given consent of the patient (or the other permission norms of Article 9 (2) GDPR). If German State Minister for Digitisation Bär in this regard has spoken of a relaxation of standards for data protection to introduce and use the electronic medical record, there are considerable doubts whether the use of the patient record would be compatible with the GDPR without the consent of the patient and outside the provisions of Article 9 (2) GDPR.

The current proposal for reform on Article 305 (1) SGB V expressly stipulates such a need for consent to use the electronic patient record. However, it remains uncertain whether under the proposed version of Article 305 (1) SGB V “providers of electronic medical records” would not be able to undermine the consent requirement, since the current wording of the reform proposal enables such an exemption by allowing easier access for such providers. This probably represents a violation of the consent requirement of the GDPR.

Big Data

Big Data analyses of health data happen in different applications. For example, such analyses can also prevent the spreading of diseases and optimise the need-based supply of medicines and medical devices. For both reasons, therefore, they may be founded upon Article 9 (2) lit. (i) GDPR (protection of public health and ensuring the quality of medicinal products and medical devices). However, the data subject rights, such as the right of revocation – which is mostly difficult to implement in respect of big data analyses – must always be considered. In order to meet these challenges, the principles of pseudonymisation and anonymisation must be taken into account. This also applies in the event, that the Member States decide to use the opening clauses – which are also available in this context.

Conclusion and Recommendation for Action

Upon evaluation to the GDPR, health data represent data, which is particularly sensitive and therefore particularly worthy of protection. Regardless of whether these data are processed on the basis of national law or based on the GDPR, one must always ensure a legal basis for their processing. If the legal requirements are met in each individual case and their conformity with GDPR has also been checked, the processing of health data in new digital applications will be admissible.