Medical Software and DiGA Development - Our Blog
DiPA Guide: Digital Applications for Care
On December 19, 2019, the Digital Supply Act (DVG) made it possible for doctors to be able to prescribe digital health applications (DiGA) to patients in a standardized way for the first time. Now a counterpart has also been created for nursing care: digital care...
AI Act: Guide for medical device manufacturers according to MDR (2024)
The EU is now also regulating the use of artificial intelligence (AI) with the EU AI Act. This also affects manufacturers of software medical devices that integrate AI into their MDR medical devices. The AI Act is intended to ensure that AI systems are designed in a...
Digital Health Applications in Belgium – Guide to Approval
In Belgium, a special approval process for digital health applications has been established alongside Germany and France. In Austria, too, efforts to integrate DiGA into regular health care have been growing stronger since 2020. With a view to the two pioneering...
Data security & data protection certificates for DiGA
Digital health applications (DiGA) will soon require certificates for data security and data protection. However, the original deadlines for this were set somewhat too optimistically, which is why they have now been postponed to the future by the Hospital Nursing...
Is your app a DiGA? Definition criteria of digital health applications
So-called DiGA (digital health applications) can be reimbursed by statutory health insurance companies. This became possible for the first time when the Digital Supply Act (DVG) came into force on December 19, 2019. However, not every health app or medical app meets...
12 tips for the approval of DiGA in 2024
The implementation of a digital health application (DiGA) involves effort and costs that should ultimately be worthwhile for your company. And indeed - many certified DiGAs that make it onto the market show extremely positive prescription and sales figures. Others, on...
Phrasing of the intended purpose for (software) medical devices
How do I actually decide whether my product is a medical device? Where do I start when I want to determine its risk class? And what statements can I use to promote my product in the end? The answers to these and many other questions can be answered on the basis of...
PECAN DMD – Guide to DiGA in France
What started in Germany at the end of 2019 is now also being adopted by neighboring France: The "app on prescription," the Digital Health Application (DiGA) is becoming an export hit - including a French equivalent to the Fast Track procedure. This provides a uniform...
Classification of software medical devices: MDR Guideline
"The use of my app is completely safe. It certainly falls into the lowest risk category."- MDR probably sees it differently. Anyone who wants to certify their software as a medical device in accordance with the Medical Device Regulation (MDR) must deal intensively...
Guide: Is your app a medical device?
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Mobile apps must also be classified as a regulated medical device if they are used for specific purposes such as the diagnosis or...
DiGA revenue & costs: Is a DiGA worthwhile?
As with any business idea, the financial potential of a DiGA project should be calculated at the outset. A central question arises: Is the development of your DiGA idea worthwhile for you? Potential investors for your DiGA project are also asking themselves this...
Current DiGA Reports 2024: Official reports at a glance
Where exactly can I find the latest figures and reports for approved digital health applications (DiGA)? For the strategic planning of new DiGA projects and market analyses, it is important to consider the prescription figures for listed DiGAs. However, when searching...
DiGA pricing & negotiations with the GKV-Spitzenverband
The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your...
DiGAV and DVG: important links
Here you will find the most important links to the Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV). This list is intended to help you access the relevant documents more quickly for regular reference. This page also provides an...
Interoperability for digital health applications (DiGA)
We would like to quickly introduce the topic of interoperability in DiGA development with a small example: “Μια DiGA πρέπει να πληροί ορισμένες απαιτήσεις διαλειτουργικότητας.” Do you understand this sentence? Unless you speak Greek, probably not. You therefore need...
DiGA in Austria: Approval of digital health applications (2024)
Since 2020, there have been increasing efforts in Austria to integrate digital health applications (DiGA) into regular healthcare. So is the "app on prescription" now coming to Austria? In this article we give you an overview of: the planned approval process in...
Artificial intelligence (AI) in medical devices – MDR guide (2024)
With ChatGPT at the latest, artificial intelligence (AI) has become the topic of our time - also in the field of software medical devices. Many manufacturers are unsure about the extent to which AI can be used in medical devices at all. For this reason, in this...
The Digital Act (DigiG): Guide for DiGA manufacturers
The new Digital Act of the Federal Ministry of Health was passed on February 2, 2024. It touches on a wide range of topics relating to modern healthcare, such as the electronic patient file (ePA) and regulations on the telematics infrastructure. With regard to DiGA,...
Guide for DiGA marketing and sales
Having fulfilled all regulatory parameters and been entered in the central DiGA directory, have all hurdles been cleared and a successful market entry guaranteed? Unfortunately not quite. Contrary to some wishful thinking, entry in the central DiGA directory itself...
Medical devices in Switzerland: MedDO vs. MDR
Although Switzerland is geographically located in the heart of the EU, it is not part of it. This also affects manufacturers of (software) medical devices. Is it possible for MDR medical devices to enter the Swiss market without further ado? How do Swiss manufacturers...
Validation of medical device software according to MDR
If you are developing software that qualifies as a medical device under the Medical Device Regulation (MDR), validation is one of the most critical issues. Successful validation of your software is an absolute prerequisite for bringing your medical device to market....
Requirements of the ISO 13485 – A comprehensive guide
Anyone involved in the development of software medical devices is certainly no stranger to the term "Quality management system" (QMS). You may also have heard of ISO 13485 in this context. ISO 13485 is a standard that defines the requirements for a quality management...
Guide to §374a SGB V – Interoperability for DiGA, aids & implants
Attention manufacturers of electronic aids, implants and DiGA! From mid-2024, a new legal requirement will apply to improve interoperability between medical devices and digital health applications (DiGA) approved by the BfArM: §374a SGB V Specifically, this involves...
Approval & certification of software medical devices (MDR)
How does medical device approval for software work? How long does this process take? And what are the costs involved in certification? The path to medical device approval is also complex for software products. It is therefore advisable to deal with the...
MDR Guide: Clinical evaluation of software medical devices
"Clinical evaluation? No problem!" "A doctor was recently interviewed in the Süddeutsche Zeitung! She clearly stated that mindfulness apps help with depression. We can refer to that, can't we?" Unfortunately, it's not that simple. Of course, our exaggerated example...
DiGA: Guidelines for demonstrating positive supply effects
What is the point of a DiGA if it does not improve patients' lives? There is none! This is why DiGAs are only justified when their positive supply effect has been proven. Only then do you have a chance of being permanently included in the BfArM register. Ultimately,...
IEC 62304: Software life cycle processes for medical devices
IEC 62304 specifies processes and activities that you must observe when developing software as a medical device. It places specific requirements on how you must develop and maintain your software. This applies both to stand-alone software (e.g. medical apps) and to...
Interoperability in medicine: Explained using simple examples
A large number of electronic devices are used in medicine, and medical apps are now also increasingly being used. However, a major problem to date is that many of these devices cannot “talk” to each other: Exchanging data is often difficult or impossible. In this...
Guide to the DiGAV: Digital Health Applications Ordinance
The Digital Supply Act came into force on December 19, 2019. One of the biggest changes: Digital health applications (DiGA) can now be reimbursed by statutory health insurance companies if they meet certain requirements. To do this, the manufacturer of the healthcare...
Digital Supply Act (DVG): Implications for App Manufacturers
The Digital Care Act for “better care through digitalization and innovation” came into force on December 19, 2019. The aim of the so-called “Digital Care Act” (DVG): Patients will be allowed to have healthcare applications prescribed by their doctor, telemedicine will...
Guideline for the development of medical apps: What manufacturers need to look out for
Medical apps are now being used more and more frequently, e.g. in disease prevention, disease diagnostics, disease treatment or for the monitoring of vital parameters. However, it is not that easy to launch a medical app on the market that is secure and compliant with...