E-Health law boosts digitization in healthcare sector

Digitalization is not only changing the way we work, it has also reached government agencies and the healthcare system. Attitudes have gradually changed, and more and more people can now imagine reducing paper-based workflows in the healthcare sector.
For many years, Germany has been working on the telematics infrastructure and the implementation of the electronic health card. Since the E-Health Law came into force in 2016, however, the pace has clearly increased. At the same time, health apps, online health insurers and online pharmacies have become much more common. As in online banking, growing familiarity with digital services also increases acceptance of digital processes at the family doctor's office or with health insurance providers.
In 2017 and 2018, several smaller but important developments in Germany further accelerated digitization in the healthcare sector. These include the E-Health Law as well as changes related to telemedicine and ordering medication via online pharmacies.
What is the E-Health Law?
The German E-Health Law creates a framework for digital applications in healthcare. This includes telemedicine services such as video consultations, provided certain requirements are met. This benefits, for example, people with limited mobility or patients in regions with poor medical coverage. Acceptance of online health insurers and online pharmacies has also increased. Medication can now be ordered online, including prescription drugs in permitted scenarios.
What is E-health?
The term e-health combines medicine, IT and healthcare management. In the healthcare sector, information and communication technology is used to digitize processes related to treatment, care, documentation and communication. The E-Health Law defines a timetable for the required infrastructure and for the introduction of medical applications. Its goal is to move digitization in healthcare forward in a structured way.
What does e-health involve in Germany?
- electronic health card
- electronic health record / electronic patient file
- electronically supported disease and knowledge management
- telemedicine services
- health portals, including senior care, assisted living, data monitoring with apps and activity trackers
- online pharmacies
Current status 2018/2019
The ePA, or electronic patient file, is used to document a patient's medical history. Under the E-Health framework, health insurers were expected to make an ePA available to insured persons by 2021. One central principle is that use remains voluntary and that patients decide which information is stored. In addition to the ePA, there is also the eGA, the electronic health record (German: elektronische Gesundheitsakte). With the patient's consent, doctors, pharmacies and care facilities can access relevant data more quickly. Additional information such as diet plans or physiotherapy can also be stored there. Some health insurers, including Techniker Krankenkasse and AOK, had already presented their own concepts for an electronic health record.
Digitization in the health sector: advantages and disadvantages
The advantages of electronic patient files and digital workflows in doctors' offices, hospitals, pharmacies and pharmaceutical companies are obvious. At the same time, digitalization in healthcare brings both opportunities and risks.
| Advantages | Disadvantages |
|---|---|
| Data can be made available and shared more quickly, making communication more efficient. | Many doctors remain skeptical of electronic records and fear additional workload. |
| In emergencies, hospital staff can access important information faster. | If patients decide which data is stored, records may be incomplete for medical assessment. |
| Patients can store and manage documents themselves and receive more transparency. | Data entry and storage errors can lead to incorrect medical conclusions. |
| Health insurers can reduce costs if processes are handled electronically. | Strict data protection requirements must be met. |
| Statistics from health data can support prevention and early intervention. | Sensitive data could be misused if systems are not adequately protected. |
| Digital technologies can reduce costs across the healthcare sector. | Data protection and medical confidentiality may be at risk. |
| Double prescriptions, supply gaps and harmful drug interactions can be reduced. | Critics fear data loss or cyberattacks. |
| Telemedicine and online services can improve healthcare delivery. | A digital workflow only works with secure, standardized access and a sustainable storage strategy. |
To sum up: The greatest advantage lies in the cost savings on the one hand and the improvement of preventive health care for patients on the other. According to a McKinsey study in 2018, millions can be saved through consistent digitalization in the healthcare sector. Digital technologies can save a great deal of time and money with electronic patient files, electronic prescriptions and telemedicine. Most of this can be saved by making paperless and fast data processing possible. Ultimately, patients as well as doctors and clinics can benefit from the smooth, fast process.
Even so, digitization is not purely beneficial. It also brings risks and practical hurdles that still complicate consistent implementation in the healthcare sector.
Why has digitization not been implemented uniformly so far?
Similar to the implementation of a paperless office, introducing new digital technologies is often difficult because of outdated systems, staff training needs and adherence to established structures. In healthcare in particular, digitization also faces data protection hurdles. Many people still hesitate to move to digital workflows because they prefer working with paper. Some critics also doubt that digitalization will actually reduce workload in practice.
Compared with other European countries, Germany still has ground to make up. Digital technologies can only be implemented successfully if both patients and healthcare institutions have access to the necessary equipment, software and know-how. One of the biggest hurdles is the need for a uniform system across Germany and across all healthcare facilities. Until now, different systems and specifications have still been used for data storage by health insurers, doctors and hospitals.
What formats are available for data storage in the e-health sector?
The focus should always remain on the data and on better patient care. Digitalization should speed up processes and create tangible benefits for both doctors and patients. That requires a consistent timetable and a secure, standardized storage strategy. The format PDF/A-3, or PDF/H, can play an important role here because it is well suited for secure and legally compliant long-term archiving. Ideally, the data should be stored in a searchable electronic archive in a compact and standardized form.
PDF/H = Portable Document for Healthcare
The PDF/H format has been available since 2008 and was designed as a data format for the healthcare sector. It is intended to support the input, display and exchange of medical data. PDF/H is suitable for exchanging medical information between patients and doctors and can contain a wide variety of findings from imaging diagnostics, including laboratory reports, X-ray and CT images, forms, ECG data and EEG information. PDF/H is not an ISO standard, but rather a recommendation.
In general, PDF/H makes it easier to store patient data in a consistent form and, depending on the security settings, protects it against subsequent changes. Another advantage is that digital signatures, barcodes and OCR technology can also be used with appropriate software such as webPDF. This improves both security and the fast retrieval of documents, two key requirements for long-term archiving.