Protecting and using health data: Access to independent research in Research Data Centres (RDC)
The German Data Forum (RatSWD) welcomes the planned amendment of §§ 303.a ff. SGB V on the establishment of a research data centre. The current discussion highlights the need for clarification regarding data protection, which has already been established in comparable Research Data Centres (RDC). Health care data offer an enormous analytical potential for scientific research; at the same time, scientific use ensures the quality of data and promises socially relevant innovations and improvements in care.
The German Data Forum (RatSWD) considers it important to establish a Research Data Centre (RDC) for research practice, focused on health data (GKV care data), and accompanied by a data protection-compliant, user-friendly design of data access, and improved user care. The RDC should be provided with adequate resources to handle tasks prescribed in the amendment, and the present bill of the Federal government (printed matter 19/13438) outlines an important course to accomplish this.
According to the § 303e SGB V- new, the planned RDCs will be assigned the task of making the anonymous and aggregated data available to beneficial owners (in justified individual and pseudonymised cases, as outlined in para. 3-4). The German Data Forum (RatSWD) considers the following points to be indispensable for a RDC that enables scientific re-use of data and thus promotes research in a variety of disciplines. These assertions are based on the experiences of 34 German Data Forum (RatSWD) accredited RDCs.
Timely Data Delivery
The German Data Forum (RatSWD) considers the direct data transmission by the Central Association of Health Insurance Funds (GKV Spitzenverband) to the trust office (according to § 303b SGB V-new) to be an important first step in developing faster data availability. The more direct provisions of the data should also be reflected in a short-term possible use in the RDC, which requires sufficient data preparation and provision, as well as adequate staffing. The outlined compliance effort for the RDC provides a good basis by which dynamic and necessary development in the use of research data can be supported; scheduled use of supply data should also be supported.
Data Access Routes
The appropriate- and privacy compliant- way of providing data varies with the sensitivity of the data. The German Data Forum (RatSWD) accredited RDC usually have varying data access routes (RatSWD Activity Report 2018, p. 24), which increases the usability of the data and thus the frequency of actual re-use. The German Data Forum (RatSWD) therefore welcomes the possibility to provide authorised users with pseudonymous individual details (as outlined in § 303e para. 4, SGB V-new).
Background: The provision of weak, anonymised microdata is performed by the German Data Forum (RatSWD) accredited RDCs, via guest science workstations (GWAP), controlled remote data processing (KDFV), or remote access. The provision of stronger anonymised research data, often induced by aggregation, is provided through the standardised provision of Scientific Use Files (SUF). More aggregated data sets can be provided in accordance with data protection law, as public or campus files (PUF and CF) have lower access hurdles
In addition to the provision of data, the RDC should have a service concept for the support of data users and plan to incorporate corresponding resources. Above all, the service concept will provide work aids, as well as qualified and informed additional offers to the data in the form of training courses, workshops, and webinars.
The German Data Forum (RatSWD) therefore welcomes the § 303e (para. 4, sentence 2 SGB V-new) and the possibility to provide authorised users with pseudonymised individual and detailed information.
Background: In 2018, German Data Forum (RatSWD) accredited RDCs offered almost 100 qualification measures, including training courses, workshops, and conferences (RatSWD, Activities Report 2018, p. 29). In addition to privacy-compliant handling of data, analysis potential was also communicated in during these events. The commitment of these RDCs to active user-involvement represents important developments to these services, and the envisaged working group of authorised users (§303d para. 2 SGB V-new) is an additional important building block for the development and quality assurance of RDC services.
Promotion of Data Usage
The German Data Forum (RatSWD) accredited RDCs use more than nine different communication channels to publicise the data; the amendment to the law §303d (para. 1 lit. 10, SGB V) also promotes the scientific development of the data by the RDCs (RatSWD Activity Report 2017, p. 25). The data provided are frequently communicated through their website, lectures, conferences, metadata portals, publications, flyers, posters, and their newsletter. Future RDCs should use the aforementioned means to publicise its data and service offerings.
Only a small portion of the German Data Forum (RatSWD) accredited RDCs charge data usage fees (RatSWD, Activity Report 2018, p. 20). In order to make data as accessible as possible, the German Data Forum (RatSWD) recommends the most cost-effective and free of charge access to the research data.