The broader backdrop
If we are to realise individualised, data-driven diagnosis and treatment options for today’s and tomorrow’s patients, there is no way past what are called omics technologies. The term stems from sub-disciplines of biology whose names carry the -omics suffix, including genomics, proteomics, metabolomics, metagenomics and transcriptomics. Omics approaches seek to collectively characterise and quantify pools of biological molecules which have an effect on the structure, functioning and dynamics of an organism or organisms.
We expect the future to raise needs for data integration methods and algorithms for further data contexts, which will mean the use of existing levels of biodata via innovative data integration methods and their handling in line with data protection regulations. The benefit will be innovative data analysis of consistent quality for patients, their doctors, and scientific research.
General representation of an integrated multi-omics strategy (modules currently mapped by DaMeSA are dark blue).
Omics technologies are growing exponentially in significance, across national borders, with 1,010 PubMed records featuring the term in 2020 alone; and yet we remain without standardised methods for integrating the various data levels involved.
We find exemplary cases of omics data application in Israel and the UK. In 2018, Benjamin Netanyahu, Israel’s prime minister, announced the investment of almost 287 million dollars in a big data project whose aim was to make citizens’ health information available to researchers and data protection organisations. The infrastructure thus created enabled the extremely rapid realisation of the world’s first study on the effects of Covid-19 vaccination at population level. In the UK, the Topol Review, carried out by the world-leading cardiologist and geneticist Eric Topol, outlines steps necessary for preparing the UK’s National Health Service (NHS) for a digital future. One of its core statements is as follows: “The successful implementation of technology-enabled care requires the system to deliver targeted support across health and social care sectors and to deploy it to where and when the patient may need it. Monitoring access, usage and outcomes and mapping it to key characteristics, which are markers for inequalities, are essential”. Further issues raised in the Topol Review, including data ethics, patient engagement and multimodal data communication, are key components of our proposed endeavour.
The status quo in Germany
The German Federal Ministry of Education and Research (BMBF) is currently funding a ‘Medical Informatics Initiative’ with the aim of ‘clos[ing] the gap between research and healthcare’, It requires university hospitals to work closely with research institutions, commercial businesses, health insurers and patient advocacy groups. A number of local consortia have created examples of the initiative in action in the fields of oncology, intensive care, neurology, infectious disease, and knowledge generation. Unlike our proposal, these funding structures largely refrain from the creation of new infrastructure, instead seeking to derive value from an evolutionary process of collaboration. Our consortium will aim to engage in scientific collaboration within the Initiative through organisations which are members of both.
Saxony’s growing life sciences sector is receiving support from initiatives under the auspices of federal legislation intended to help coal-producing regions of Germany transition to a post-fossil fuel future (Strukturstärkungsgesetz Kohleregionen, StStG) and has bright prospects of becoming one of Germany’s premier biomedical research hubs. Further, Saxony is already an engineering innovation heartland, and this sector is increasingly beginning to interact with the state’s emergent medical cluster. Closing the data integration gap will provide a vital springboard for upcoming innovation in the region, establishing it as internationally competitive.
IT today and tomorrow
The IT industry is currently experiencing a second revolution, with cloud computing shifting digital processing away from local end devices. The tech giants Amazon, Google and Microsoft, the ‘hyperscalers’ which between them cover around 75 per cent of public cloud services, are driving this development, and are effectively unbeatable in market penetration terms.
One key feature of our proposed project is that the data processing methods on whose basis it will proceed do not belong to a particular business, therefore existing in isolation from others, but instead ensure free data exchange – and the accessibility of big data to analysis - by using open standards. The rise of cloud computing will lead to harmonisation among data formats, just as the emergence of international rail networks in the nineteenth century forced polities to agree on a standard gauge.
The cloud technologies that are the keys to these future advances will be available to everyone. Google’s Cloud Native Computing Foundation, for example, has made the Kubernetes standard for managing containerised applications freely available to the IT community, enabling it to read and process large data sets via microservices. One of Kubernetes’ users is Germany’s statutory health insurance system (GKV), whose data centres use it to link up health system stakeholders; an example is the software implementing electronic patient records in the GKV system, which runs Kubernetes via open-source cloud technology. We therefore have access to the skills and expertise we need in the German statutory health system’s data centres.
Things are looking even brighter on the infrastructure side, thanks to Germany’s long track record of special protection for health-related data, which dates back to the pre-GDPR era. Digitalisation efforts in the German health system gave rise to a distinct health-related data network, kept separate via technical means. What is referred to as the telematics infrastructure (TI) is already in place, under the supervision of gematik, a company founded for the express purpose of running this telematics infrastructure, whose shareholders are the German Federal Ministry of Health, the German National Association of Statutory Health Insurance Funds, and other health system stakeholder organisations. Dedicated data centres, limited to this data only, handle the health records of people insured in the German system. Overall, the institutional and organisational conditions available in Germany put us at a distinct advantage in international terms.
The political and regulatory framework
EU laws make it difficult for the major US-based cloud providers to comply with European data protection standards. Judgments issued by the ECJ on the transfer of personal data to the US bear witness to these difficulties and to the lack of legal clarity they engender. Just one example is the current (as of March 2021) de facto illegal status of European businesses’ Facebook accounts.
These issues notwithstanding, GDPR, which came into force across Europe in 2018, is a crucial milestone on the road to standardisation and legal certainty in this field. One of its major achievements is its enshrinement in law of the data subject’s consent and the need for a ‘specific purpose’ as requirements for the lawful collection and processing of personal data. Contrary to frequently aired suspicions, GDPR does not block the collection of data per se. Indeed, the opposite is true; the legislator’s explicit intent was to make possible, on a lawful basis, the exchange of personal data within the world’s largest economic area by creating a standardised, consistent regulatory framework.
GDPR is a beacon of state actorhood in the data revolution, with an impact reaching far beyond its area of application, one example being the adoption into Californian state law of standards drawn from GDPR. Germany itself, meanwhile, had strict laws in place prior to the advent of GDPR, via its Federal Data Protection Act and its multi-volume Social Codes.
The implications for our proposed project primarily relate to our ability to draw on the advantage of a well-established legal and regulatory framework with state supervisory authorities to match. We know what is required of us and will work from the outset to design our data handling processes in line with data subjects’ rights, in the knowledge of working within laws that will last.
All this said, the strict boundaries currently in place between the various sectors of Germany’s health system, and the associated rigid funding rules, complicate the endeavour of incorporating research findings into routine medical care. We believe that our proposed multi-omics consortium could act as a role model for reform in this arena across the German health system.