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Germany: Bundestag adopts Patient Data Protection Act

With the "Patient Data Protection Act", digital offers such as the e-prescription or the electronic patient file can be used - and sensitive health data can be protected in the best possible way. The Bundestag passed the law today. With a new, secure app, insured persons can now redeem e-prescriptions in a pharmacy of their choice. Specialist transfers can be transmitted digitally. And patients have the right to have the doctor fill their electronic patient record (ePA). From 2022, the vaccination card, the mother's passport, the yellow U-booklet for children and the tooth bonus booklet can also be saved there.


Federal Minister of Health Jens Spahn explains: "The pandemic shows how important digital offers are for the care of patients. That is why we ensure with the patient data protection law that digitization arrives in everyday life. Insured persons can have their data stored in the electronic patient file You will have the opportunity to use the e-prescription with a new app. And specialist referrals will also be available digitally in the future. Patients can always be sure that their data is safe. "


The regulations in detail:

From 2021, patients will be entitled to have doctors fill the ePA with data that the health insurers must then offer them. Doctors and hospitals who make entries in an ePA for the first time receive EUR 10 for this. Doctors, dentists and pharmacists also receive remuneration for supporting insured persons in the further management of their ePA. The amount is determined by the self-government in the healthcare system.


The use of the ePA is voluntary. The insured person decides which data is stored in the ePA or deleted. He also decides in each individual case who can access the ePA.


For the e-recipe, there should be an app with which the e-recipe can be displayed directly on the smartphone. The patient can then redeem it in a pharmacy of their choice. The app becomes part of the secure telematics infrastructure and also offers interfaces for other apps. Alternatively, the insured person can show a 2D barcode on paper. In this case, too, the prescription will be sent digitally to the pharmacy.


From 2022, insured persons will also have the option of using their smartphone or tablet to individually determine who can access each document saved in the ePA. For example, you can specify that a doctor may access the ePA, but that certain findings are not displayed.


From 2023, insured persons will have the option of making the data stored in the ePA voluntarily and in accordance with data protection regulations available to medical research.


For the e-recipe, there should be an app with which the e-recipe can be displayed directly on the smartphone. The patient can then redeem it in a pharmacy of their choice. The app becomes part of the secure telematics infrastructure and also offers interfaces for other apps. Alternatively, the insured person can show a 2D barcode on paper. In this case too, the prescription will be sent digitally to the pharmacy.


Referrals to specialists should be able to be sent electronically.


Everyone - whether doctors, hospitals or pharmacies - is responsible for protecting the patient data they process in the telematics infrastructure. The details are regulated in the draft law without gaps.


Operators of services and components within the telematics infrastructure must report malfunctions and security deficiencies to gematik immediately. If they do not do so properly, they face a fine of up to 300,000 euros.


The law is expected to enter into force in autumn. It does not require approval in the Federal Council.


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