How DigiG influences DiGA?
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For the past few months, we have been carefully observing the development of the new German law regarding healthcare digitalisation – DigiG. What is it? How does it influence DiGA?
Germany’s plan for healthcare digitalisation
Germany is one of the European pioneers in incorporating medical softwares into the reimbursement plan and making it more accessible to patients.
The most important elements of their system are DiGAs. DiGA (Digitale Gesundheitsanwendungen) is a digital app on prescription which is considered a medical device. The aim of DiGA is to “support the recognition, monitoring, treatment, or alleviation of diseases or support the recognition, monitoring, treatment, or alleviation of compensation for injuries or disabilities”.
In Germany, DiGAs can be prescribed by doctors and reimbursed by the state scheme systems according to the regulation named DiGAV. Thanks to this, patients can easily use the newest digital therapeutics to treat and alleviate diseases or disorders such as Irritable Bowel Syndrome and many more.
You can find more information about DiGA (such as technical and regulatory requirements) in our article “What is a DiGA and why is it worth creating?”. Yet, today, we will focus on the new German law – DigiG.
What is DigiG (Digital-Gesetz)?
DigiG stands for Digitalisierung des Gesundheitswesens, which means “Digitalisation of the healthcare system”. This law, sometimes referred to as Digital-Gesetz, came into force in Germany on 26th of March 2024 and aims to simplify everyday treatment for doctors and patients through digital solutions.
If you are a medical software manufacturer, you should be interested in changes introduced by DigiG as it influences DiGA.
What DigiG changes about DiGA?
Introduction of ePA
The first change isn’t connected to DiGA but is essential to the German healthcare system. DigiG introduces the electronic patient record (ePA), which aims to create a digital medication overview of all the patients' medicines. This way, it will be easier for doctors to prescribe medication to their patients and make sure that medicines do not interact undesirably. ePA will become available at the beginning of 2025.
What’s more, e-prescription will become a standard way of prescribing medication.
Class IIb medical devices can now be DiGA
The crucial change for software manufacturers is that MDR class IIb medical devices can now become DiGA. Is there anything special you have to do to include your class IIb medical software in the DiGA directory? No. You should maintain compliance with MDR, prove the medical benefit of your software, and meet the requirements provided by DiGAV.
Good to know
It is worth noting that manufacturers of class IIb medical devices can’t apply for the Fast-Track Process and they have to prove positive healthcare effect (pVE) prior to application for inclusion in the DiGA repository.
Telemedicine inclusion in DiGA
There have also been changes regarding DiGA and telemedicine. It is possible to include telemedicine services in DiGA; however, there are some rules to oblige.
Second, bear in mind that telemedicine services must be conducted by healthcare professionals, not by the manufacturer’s employees. What’s more,
a positive care effect for patients needs to be proven as DiGA aims to support patients, not healthcare professionals.
DiGA and aids or therapeutics
If your medical software works with aids or therapeutics developed by other manufacturers, you should remember that DiGA must allow patients to choose their type of care. What does it mean?
Imagine that your medical device can only work with medicine provided by one manufacturer. Such a situation isn’t permitted unless it’s the only medication of this type on the market and the manufacturer has provided “detailed justification” for its usage.
In general, the patient should be able to choose which manufacturer’s therapeutic they will use in combination with DiGA if there are many alternatives existing on the market.
To sum up, your medical software should work with medicine provided by different companies (maintain interoperability standards) to be considered a DiGA.
Interested in learning more about DigiG? You can find the full text of the law here.
Make your medical software a DiGA
Do you want to prepare your medical software for DiGA requirements? At Revolve Healthcare we can help you to build medical software in compliance with MDR requirements. Our Regulatory Affair Team will guide you through the process to provide you with the highest quality services.
Schedule a free regulatory consultation, and let’s discuss your idea!
