Game Changer Health Data - A Call for Action for the 20th Legislative Period

We are at the most crucial point in setting the direction for digital transformation of healthcare in Germany.

One direction is that of denial, misgivings, overemphasis on data protection and informational self-determination, maximization of data security, blockade and stiffening of old-style data protection, which the apologists of this direction carry before them like a monstrance referring to the ruling of the German Federal Constitutional Court on the 1983 census.

And the other direction? The other direction is the use of data in the well-understood interest of diagnostics and treatment of the individual patient, for research into clinical correlations for the development of innovative drugs, medical devices, in vitro diagnostics, and digital health applications. This is a use of data that can take disease interception, prevention, and diagnostics, but also public health, workplace health promotion, pandemic management and much more to a whole new level. However, this requires adaptive legislation, quick and agile to new requirements.

With the editors of "Operation Healthcare" (OPG) we have opened a forum of 15 experts to shed light on the challenges surrounding this change from all perspectives. Provocative questions and well-founded answers offer a multi-faceted picture of this complex issue. The interviews contain more than a hundred individual suggestions, proposals and demands. And they all agree on one very important point: It is overdue to address Germany's shortcomings in the digital transformation of the healthcare system and make up for what has been neglected so far.

With astonishing clarity, the experts identify deficits, the need for action and solutions for a digital healthcare system. The topics can be clustered into three major fields of action: requirements for the development of the regulatory framework, interoperability, and data use. Based on the theses of the interviews the following aspects can be summarized as a call for action for the 20th legislative period:

1. The different legal requirements of the European Union, the Federal Government and the States must be aligned - the federal patchwork must come to an end. Concentration of responsibilities and harmonization of legal standards, also in the European context, are key tasks for the next legislative period. A code of conduct should ensure that undefined legal terms are interpreted uniformly and that uniformity in the application of the law is achieved.
2. The separation between health care data processing and research data processing must be abolished. Not only should the sectors in care (outpatient/inpatient/nursing/etc.) be linked, but a continuum between care and research and vice versa must also be established. Data from care must be accessible to research, and research results must be transferred to care in a timely manner to implement the state of knowledge directly on patient care. This data continuum is also necessary for monitoring therapy with drugs, medical devices, in vitro diagnostics and digital healthcare applications. Not only users, but also developers and manufacturers of new methods must be enabled to generate evidence-based findings from real world data for the further development of their products and services.
3. The minimal principle of data processing has had its day: to be able to really generate a benefit with the existing data and those still to be collected, the basic social and legal attitude for medical care and research should be that of comprehensive data collection. With such a default position, it can no longer be just a matter of opting in; it must be opting out. The electronic patient file should become part of this reorientation. Those who do not wish to be identified with it should be allowed to opt out. Other data processing will require standardized consent procedures. This data collection and processing is part of a generational contract with which we are laying the foundations for later knowledge, of which we cannot yet know what it will be.
4. To motivate citizens to provide their personal data, they must have appropriate measures of education (health literacy). Here, policymakers have a duty to provide reliable and easy-to-understand information.
5. Supervisory authorities with qualified staff and sufficient resources are an important factor in international competition. Qualification also includes the understanding that it is not the protection of data itself but the protection of research as an essential function, which also must secure the right to informational self-determination.
6. The quality of data is the crucial prerequisite for its use in improving care, especially for the training of intelligent algorithms. Therefore, it is important to create standards for structured data and to strengthen interoperability, without excluding German specifications from international competition. Germany must also play a stronger role in the formation of an EU Health Data Space. Companies from third countries outside the EEA can participate in these projects if they comply with the rules of the game laid down by the EU.
7. It is not enough to collect data and lock it away. It must also be used. Data use laws must therefore create the conditions for secure use, especially by private-sector companies. It is unacceptable that data use is omitted because of existing risks. The legal system has sufficient experience in enabling sensible but risky activities through a control framework in practical concordance of conflicting interests, just think of road traffic. The safeguards for this must include the criminal liability of attempts at identification. The target structure should include the use of pseudonymous data while maintaining the best possible security. Retrospective research in off-label use should also be simplified.
8. The use of artificial intelligence in health data research and individual diagnostics and therapy decisions holds great potential. Caution is advised when European and national legislators restrict these possibilities too severely, thereby minimizing not only the risks but also the chances.

The combined findings of the experts in this OPG Special are clear:

We need to balance data protection with the necessary access for scientific research, align the legal framework, establish interoperability and, above all, enable data use for the improvement of healthcare quality.

Only by doing so can we create the value that lies in the data.

Only by doing so will we be able to compete internationally and retain control over the data generated in our systems and how it is processed.

And only by doing so can we achieve the real goal of digital transformation - to improve the quality of care.

Now is the time to change the game and set the course – What are we waiting for?