Position paper of BIO Deutschland concerning big data applications in healthcare

Big data – the analysis of large quantities of data – has become a top issue in the healthcare sector. The sector association of the biotechnology industry, the Biotechnologie-Industrie-Organisation Deutschland (BIO Deutschland), therefore welcomes the fact that German lawmakers, through the Law for Secure Digital Communication and Applications in Healthcare (e-Health Law), aim to seize the opportunities that the digital age offers the healthcare sector. Recognising the genetic diversity of humans is the basis for developing effective and advanced personalised medicine. This provides tailored treatment for individual people, but is also significantly more complex and necessarily based on highly differentiated knowledge that can be obtained only through the analysis of a vast amount of data. We therefore urgently need to develop new approaches to healthcare delivery, which can be achieved only through new discoveries in the digital healthcare sector.   

Big data not only improves the quality of healthcare delivery, enhances healthcare efficiency and strengthens the patient’s right to self-determination, it also creates added social value on a broad scale, particularly if big data solutions can help advance innovative research.

In 2016, studies on the potential of the digital healthcare sector – commissioned by the Federal Ministry of Health (BMG)[1] and the Federal Ministry of Economic Affairs and Energy (BMWi)[2] respectively – were published. These studies found that big data offers significant potential for improving research. In order to fully realise this potential, it is of critical importance that data protection laws be revised. Germany must be careful that its strict regulations and myriad restrictions do not lead to it squandering its position as an innovation location.

BIO Deutschland therefore calls for:

• the creation of statutory exemptions allowing for the processing of data for research and development (R&D) purposes,
• the recognition of a more flexible purpose limitation principle and
• the harmonisation of data protection laws.

The aforementioned studies also discovered that a connected healthcare infrastructure (interoperability) has increasingly become a central prerequisite for the digitisation of actors involved in healthcare delivery. The current version of the e-Health Law leaves unanswered the crucial question of how to integrate medical data from the various information systems.

BIO Deutschland therefore advocates making healthcare actors more connected through standardised cross-sectoral guidelines and the incorporation of bioinformatics experts into the development of interoperability structures.

The isolated solutions that still prevail today create an environment where, for example, physicians in other fields or other clinics often cannot access important patient information, which they would need to make comprehensive decisions regarding appropriate treatment options. Here the electronic health card applications, the telematics infrastructure and the Big Data for Better Outcomes programme, which has received several hundreds of million euros of EU funding to promote distributed data networks, offer a path to more interoperability in healthcare. These applications have the ability to create an improved data basis – not only for service providers in terms of their delivery of healthcare to patients, but also for biotech companies in terms of their development of innovative and highly effective diagnostic and therapeutic methods.

BIO Deutschland therefore calls for a swift introduction of all applications that go along with the electronic health card, including the involvement of biotech companies in the associated decision-making processes, and for the development of a strategy for gaining a better understanding of big data in healthcare.

[1] “Weiterentwicklung der E-Health-Strategie” (Further Development of the e-Health Strategy), published in November 2016.

[2] “Ökonomische Bestandsaufnahme und Potenzialanalyse der digitalen Gesundheitswirtschaft” (Economic Stock-Taking and Potential Analysis of the Digital Healthcare Sector), published in May 2016.