Entry in the force of ordinance on the European Health Data Sector (EHDS) is seen as a milestone for healthcare in Europe. Now the European Union member states have two years to implement regulation requirements by 26 March 2027.
From the point of view of politics, the corona crisis portrayed the urgency of a uniform European approach to health data-especially in time of crisis, data should be more easily available.
Data source for EHD
(Image: BMG)
Along with EHDS, pseudo-designated health data is to be provided legally insured, from electronic patient files of clinical studies, 400 medical registers in healthcare systems, billing data from health insurance companies, genetic data for AI training.
EHD targets
One of the main goals of EHDS is to improve cross -boycover health care. By introducing a digital patient file which is accessible in the European Union, citizens should be able to see their health data, including prescriptions, image data and laboratory tests, beyond borders. It aims to improve the treatment of patients in other European Union countries.
EHD is particularly focused. It is also for supporting evidence in health policy -based decisions. It plans to keep public interests, inform political decisions and use data for statistical analysis.
The objective of EHDs is to promote the difference between the health systems of the European Union member states. To end this, the European Union Commission wants to define technical specifications for the following categories through the implementation law files “by 26 March, 2027” and thus a difference for electronic health records (honors), also European exchange format, which can be a big challenge:
- Patient small files
- Electronic remedies
- Electronic tax of medicinal products
- Imaging medical imaging and related conclusions
- Results of medical studies including laboratory and other clinical results and related reports
- Discharge report.
For example, dishes should come in a normal format – an interoperability for this may be for HL7.
Member states are obliged to connect the service provider to the Central Data Exchange platform Myhealth@EU to enable access to information like prescription, allergies, vaccination and current medicine.
On the other hand healthdata@eU project, needs Regulation “Secondary use accelerates and increases legal certainty at the same time, the privacy of natural individuals is correct and internal. Due to the sensitivity of health data, ” data security ‘through technology design,’ data protection ‘,’ data protection through preservation ‘and concept follow questions about data about data.”
The function of federal states is to connect the name of national contact points and Healthdata@European Union for secondary data use. The Federal Institute for Medicines and Medical Devices (BFARM) in Germany has data access and coordination office. The legal foundation for this was created with health data use law. “European Health Data Joint Action Towards Space 2” (Tehdas 2) develops guidelines and technical specifications for cross -board secondary use of health data.
Provision of data on request
Access to health data is to be strictly regulated. Data should only be available for approved purposes at request. However, there were always considerable data security concerns, especially when secondary data is used due to the risk of commercialization of health data. Along with large technology, drugs and medical technology companies show great interest in health data. Originally, no right to the object was provided, but the adjustment was done after violent criticism.
This is not clear even when the first research projects begin with data from Germany. It was recently announced that the data of the electronic patient file will not be sent to the Research Data Center Health located in the Federal Institute for Medicine and Medical devices, as planned from the middle of the year, as it is delayed. Overall, a large part of the infrastructure for EHD is still under construction. It is not clear when scientific knowledge can be generated from the data that will have to be cured in the future. In addition, the legal question about what is possible should still be clarified.
Butcom is happy
Bitcom general manager Dr. Bernhard Rowlder says, “Whether for the development of new remedies or for training in artificial intelligence in medicine: with pseudo -nominated health data from Europe, new clinicals and methods of treatment in Europe will be possible in future.”
This is important “Implementation of EHD in all member states is no other special paths in the same limit and speed. In particular, the degree of digitization in individual countries can obstruct smooth implementation”.
(Mac)
