Both in healthcare provision and in healthcare policy management, data should help in enabling well-founded, informed decisions. The research community and the general public should benefit from the availability of health data. Also, Germany’s healthcare and long-term care system should be interfaced with the future European Health Data Space (EHDS) to enable quality healthcare provision and research across national borders.
The following should be achieved:
- i. Successively improve the quality of health and care data generated in healthcare provision and make it more easy to use.
- ii. Give insurance holders direct, secure access to their personal health and long-term care data and enable their low-threshold use to support and improve personalised treatment and care. This includes the right of insurance members to easily view their personal data, including with help from others.
- iii. Each and every individual has the opportunity to decide independently and without restrictions to accessibility on how their personal treatment, healthcare and long-term care data is used. This also enables an informed decision-making about non-use and its consequences, for example in connection with the electronic patient record (ePA).
- iv. Ensure the availability and possible linkage of data from various sources. This includes billing data, healthcare data from the ePA as well as study-related, genomic and/or registry data. It also fosters acquisition of knowledge on combating health risks such as pandemics, enables preventive and predictive action by means of personalised medical treatment and care, and takes the research data landscape to a new level. This increases patient safety, the quality of treatment and care, and also efficiency in the use of resources in healthcare, long-term care and the public health service. By facilitating
- v. secure access to data for research in both the public and private sector, Germany’s role as a leading science and industry hub will be further consolidated.
- vi. Promote the sharing of representative data for research and the development and use of data-driven technologies to secure more targeted support for provision and administration processes in healthcare and nursing, and place greater focus on people in research, development and application. For example, personalised treatment and care is facilitated by using AI to assist early detection of disease and, through early identification of complications in the course of healthcare and nursing.
To ensure these goals and objectives are met, the data used must be of high quality and available in structured form.
Measures
Short-term
- The research data landscape will be underpinned by the gradual introduction of a research pseudonym in healthcare-related registers as well as in routine and study-specific data to enable linkage between healthcare and long-term care data for use in research. In the medium-term, the research pseudonym should also enable linkage with electronic patient record (ePA) data.
- To improve public health and public health research, a Bundesinstitut für Öffentliche Gesundheit (Federal Institute of Public Health) will be established. The Institute will receive access to public health-related data from the various interconnected data sources, thereby making an important contribution to data-based decision-making on health policy concerns.
- Standardised and transparent division of responsibilities and roles in respect of interoperability issues in healthcare and long-term care. Moving away from system and sector-specific rules and regulations for interoperability and standardisation.
- A right to interoperability and data portability will be enshrined in law and gradually implemented into practice.
- Implementation of medical information objects (MIOs) which generate valuable healthcare benefits for a large section of the population (e.g. medication data) will be prioritised, thereby creating the foundation for harmonised availability and usability in practice. In both the short-term and medium-term, DMP datasets will be developed and established as MIOs (see the processes field of action).
- Initiate a paradigm shift towards enabling access to data via secure processing environments for specifically defined purposes, especially for medical science research, as data access authorisation criteria.
- Improve opportunities for health and long-term care insurance funds and other cost carriers, and also associations of SHI physicians to use – in the interests of insurance holders – available healthcare and long-term care data to identify regional care needs and deficits, design demand-based provision and conduct accompanying research.
- With further development of the leading data protection supervisory authority, a standardised data protection supervision practice in healthcare and long-term care will be promoted – with the goal of making use of data for care provision and research purposes safe and applicable.
- Working towards standardisation of digital documentation in long-term care (SGB XI). An assessment will also be made to see if the interoperability of long-term care documentation can be improved (syntactically and semantically interoperable data formats) and to identify the conditions that would need to be put in place (such as standardised care terminology and classification systems).
- For the benefit of patients, initially those with oncological and rare diseases, and as part of the model project on genome sequencing according to Article 64e SGB V, enable genomic medicine as a knowledge-generating form of healthcare and evaluate its use/benefits in practice. Monitor connectivity with relevant registers, the ePA, EU initiatives (1+ million genomes/Genomic Data Infrastructure) and the interface with the European Health Data Space (EHDS).
- The German Implant Register will initially go into operation to register breast implants.
Medium-term
- Establish a national access point for healthcare data as a touch point for stakeholders from research and the public health service to link healthcare and long-term care data from multiple sources (ePA, routine data, study-related data, etc.).
- By the end of 2026, no less than 300 research projects will be conducted or initiated using data from the Health Data Lab (HDL).
- Gradual development towards achieving the realm of the ideal in real-time availability of healthcare and long-term care data. Work towards ensuring that selected routine data from SHI healthcare provision is transferred to the ePA and to the Health Data Lab in a structured format and on a monthly basis at minimum. Service providers will be required to meet appropriate deadlines.
- Drive harmonisation and standardisation of IT infrastructures and an across-the-board increase of the digital maturity level of healthcare and long-term care institutions – especially among service providers not previously covered by digitalisation activities (such as physiotherapy/rehab).
- Create rules and regulations for secure use of healthcare and long-term care data in AI testing and training. The EU legal framework as well as prevailing national, EU and international initiatives will be taken into account.
- In a first phase, certain data from all Länder-specific cancer registers nationwide will be compiled by the German Centre for Cancer Registry Data (ZfKD) at the Robert Koch Institute. In a second phase, all cancer register data should be compiled as needed, linked with other data via a common platform and made accessible. Transparency regarding data storage sites will be ensured and duplicate structures dismantled.
- Following successful evaluation of the model project on genome sequencing according to Article 64e SGB V, its integration into standard healthcare provision will be enabled and an assessment made regarding its expansion to other indications and datasets for personalised medicine. This also ensures connectivity with other national and EU data infrastructures.
- Operation of the German Implant Register (IRD) will be expanded to cover endoprostheses and aortic valves.
Long-term
- Technical and organisational infrastructures will be expanded to ensure that access to healthcare and long-term care data is available for healthcare provision and research across EU borders.
- With the model project on genome sequencing according to Article 64e SGB°V, a sustainable structure for personalised medicine is created – among other things for use by various omics datasets in healthcare provision and research.
- Operation of the German Implant Register (IRD) will be expanded to cover additional implant types.