Digital health Sharing data from electronic patient records

Medical data is generated during almost all medical examinations, for example when measuring the blood pressure or taking blood and having it analyzed in a laboratory. This and other data can be stored in the electronic patient record (ePA). The data recorded is primarily used for the specific patient’s medical treatment. The ePA makes it easier to share important data and information, especially if several medical practices and hospitals are involved in a patient’s treatment. In future, however, it will be possible for people with statutory health insurance to voluntarily provide this data for the purpose of research for the common good.

Medical data is needed to research illnesses and their emergence as well as healthcare. Data from the ePA should now be included in this. Research using data from the ePA can deliver new findings about illnesses and treatments and help to improve healthcare. 

Medical data such as the following can be stored in the electronic patient record (ePA):

• details of medication
• doctors’ letters
• results of laboratory tests
• Results of imaging diagnostics
• hospital discharge letters
• reports on operations
• results of genetic testing, provided that the patient has provided consent in written or electronic form

Users have the right to determine which health data is stored in the ePA.

Structured data

Hospitals and medical practices can use medical data more easily if it is stored in a uniform, standardized format in the ePA. A uniform structure makes it simpler to use the data irrespective of the computer program used by the clinic. One example of this kind of structured data is that of diagnosis codes, which health insurance funds use for billing purposes. Structured data is also the best kind of data for research.

X-rays or customized discharge letters are classed as unstructured data. It is hard to evaluate this kind of unstructured data for research purposes.

Sharing medical data from the electronic patient record (ePA) makes it possible to use large volumes of data for the common good. “For the common good” means that the data usage ultimately benefits as many people in society as possible. 

Medical data from the ePA is particularly useful for research into healthcare, rare diseases and personalized medicine although it can also be useful for many other areas of research.

Further information can be found in the article Medical data in research.  

Data sharing makes it possible to analyze many people’s data

Scientists frequently strive to use the largest possible volumes of data for their studies. This is because, depending on the question, incorporating data from as many people as possible into a study can increase the probability of obtaining accurate scientific findings. However, obtaining data from high numbers of people is often time-consuming and expensive. 

In addition, the group of study participants is often not representative of the entire population. In other words, it is made up differently to the population as a whole. This can be because not everyone is willing to participate in studies, for example. Also, many of the methods used to attract participants do not reach everyone in equal measures. This can distort study results. 

The electronic patient record (ePA) is now available for everyone in Germany with statutory health insurance. Sharing data from the ePA therefore makes it possible to take the data from extremely high numbers of people and use it for scientific studies without any great effort. It also makes it possible to use data from people who would otherwise not have participated in scientific studies, for example due to being unaware of them or not having time to do so.

Versatile data usage

If existing data from the ePA is used for research, it is sometimes not necessary to collect any additional data. This can potentially save time and money.

Despite the above, not all scientific questions can be answered using data from the ePA. For many medical studies, it will therefore still be necessary to collect targeted data.

The sharing of data from an electronic patient record (ePA) is voluntary. Data from the ePA is automatically approved for research purposes unless a patient has previously indicated that it should not be used. This means that people who do not wish to provide their data must actively opt out from data sharing. They can do this at any time in the ePA app or by contacting their health insurance fund. 

Data from the ePA is managed by the Health Data Lab (HDL). The HDL bundles data as required and enables researchers to access it.

The data shared from the electronic patient record (ePA) is extremely well protected. Data sharing from the ePA is based on the Medical Data Use Act (GDNG) and is in accordance with the EU General Data Protection Regulation (GDPR). Accordingly, research using medical data is in principle only permitted following pseudonymization or anonymization. The procedures for protecting data from the ePA have been agreed by the Federal Office for Information Security (BSI) and the Federal Commissioner for Data Protection and Freedom of Information (BfDI).

The Health Data Lab (HDL) only ever approves the usage of the data for a specific institution or group of people for a particular purpose. The use of the data for other purposes and its forwarding without permission are prohibited. Attempts to identify individuals based on the data are liable to prosecution. 

Further information about the Medical Data Use Act can be found on the Federal Ministry of Health website.

Further information about pseudonymization can be found in the article Medical data in research.