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  • Lloyd Price

DiGA: should other European countries follow the German model promoting digital health?


Exec Summary:


there are a number of reasons why other European countries might consider adopting the German model. First, the German model has been successful in Germany. Since its launch in 2020, over 200 DiGAs have been approved, and over 50,000 patients have been prescribed DiGAs. This suggests that the German model has the potential to improve patient care and reduce costs in other European countries.


Second, the German model is relatively fast and efficient. DiGAs can be approved in as little as three months, which makes it easier for developers to bring their products to market. This could help to accelerate the adoption of digital health technologies in other European countries.


Third, the costs of DiGAs are covered by statutory health insurance in Germany. This makes DiGAs more affordable for patients, and it encourages doctors to prescribe them. This could also be a model for other European countries, as it could help to make digital health technologies more accessible to patients.


Of course, there are also some challenges that other European countries would need to consider if they were to adopt the German model. These challenges include:

  • The regulatory framework: The regulatory frameworks for digital health technologies vary from country to country. In order to adopt the German model, other European countries would need to ensure that their regulatory frameworks are compatible with the DiGA requirements.

  • The availability of digital health technologies: The availability of digital health technologies also varies from country to country. In order to adopt the German model, other European countries would need to ensure that there is a sufficient number of DiGAs available that are relevant to their healthcare systems.

Overall, there are both pros and cons to adopting the German model promoting digital health. Other European countries would need to carefully consider their own healthcare systems and regulatory frameworks before making a decision. However, the German model has the potential to improve patient care and reduce costs in other European countries, and it is a model that other countries could follow.


Here are some of the countries that are considering adopting the German model:

  • France

  • Belgium

  • Netherlands

  • Denmark

  • Sweden

These countries are all looking at how the German model could be adapted to their own healthcare systems. It is likely that we will see more countries adopting the German model in the future, as digital health technologies become more widespread.


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Background to DiGA


DiGA stands for "Digitale Gesundheitsanwendungen", which means "Digital Health Applications" in German. It is a new initiative in Germany that aims to promote the use of digital health technologies in the healthcare system.


DiGAs are digital health applications that can be prescribed by doctors for patient use for a variety of diagnoses. They can be used to support the recognition, monitoring, treatment or alleviation of diseases or the recognition, treatment, alleviation or compensation of injuries or disabilities.


DiGAs must meet a number of requirements in order to be approved for use in Germany. These requirements include:

  • They must be CE-marked as Class 1 or 2a low risk medical devices.

  • They must have been through a rigorous assessment process by the Federal Institute for Drugs and Medical Devices (BfArM).

  • They must have been shown to be effective in clinical trials.

  • They must be safe and secure.

Once a DiGA is approved, it is added to a list of approved DiGAs (the "DiGA Directory"). Doctors can then prescribe DiGAs from the DiGA Directory to their patients. The costs of DiGAs are covered by statutory health insurance in Germany.


The DiGA initiative is still in its early stages, but it has the potential to revolutionize the way healthcare is delivered in Germany. By making digital health technologies more accessible to patients and doctors, DiGAs can help to improve patient outcomes and reduce costs.


Here are some of the benefits of the DiGA initiative:

  • It can improve patient outcomes by providing patients with access to innovative digital health technologies that can help them to manage their conditions more effectively.

  • It can reduce costs by making it easier for patients to access care and by providing doctors with tools that can help them to diagnose and treat patients more efficiently.

  • It can improve the quality of care by making it easier for patients and doctors to communicate and collaborate.

The DiGA initiative is a bold step forward for the German healthcare system. It has the potential to make healthcare more accessible, efficient, and effective for patients and doctors alike.




Early success of DiGA

The early success of German DiGA has been impressive. Since the first DiGAs were approved in October 2020, there have been over 200 DiGAs approved, and over 50,000 patients have been prescribed DiGAs. The most popular DiGAs are for mental health, chronic diseases, and weight management.


There are a number of factors that have contributed to the early success of DiGAs. First, the DiGA initiative has been well-received by patients and doctors. Patients are eager to try new digital health technologies that can help them to manage their conditions more effectively.


Doctors are also supportive of DiGAs, as they see them as a way to improve patient care and reduce costs.


Second, the DiGA approval process is relatively fast and efficient. DiGAs can be approved in as little as three months, which makes it easier for developers to bring their products to market.


Third, the costs of DiGAs are covered by statutory health insurance in Germany. This makes DiGAs more affordable for patients, and it encourages doctors to prescribe them.


The early success of DiGA is a promising sign for the future of digital health in Germany. As more DiGAs are approved and more patients and doctors adopt them, DiGAs have the potential to revolutionize the way healthcare is delivered in Germany.


Here are some of the challenges that DiGAs still face:

  • Some doctors are still not familiar with DiGAs, and they may be hesitant to prescribe them.

  • Some patients may be reluctant to use DiGAs, as they may be unfamiliar with them or they may not trust them.

  • The DiGA market is still in its early stages, and it is not yet clear which DiGAs will be the most successful.

Despite these challenges, the early success of DiGA suggests that it has the potential to make a significant impact on the German healthcare system. As the DiGA market matures, it is likely that DiGAs will become more widely adopted by patients and doctors.


Challenges of DiGA


The German DiGA initiative has been met with some challenges, including:

  • Lack of awareness: Some doctors and patients are still not aware of the DiGA initiative, or they may not understand how it works. This can make it difficult to get DiGAs prescribed and used.

  • Cost: The costs of DiGAs are covered by statutory health insurance in Germany, but there are still some out-of-pocket costs for patients. This can be a barrier for some patients, especially those with low incomes.

  • Data privacy: There are concerns about the privacy of patient data that is collected by DiGAs. These concerns need to be addressed in order to ensure that patients are comfortable using DiGAs.

  • Quality: The quality of DiGAs can vary. Some DiGAs have been shown to be effective in clinical trials, while others have not. It is important for patients and doctors to be aware of the quality of the DiGAs that they are using.

Despite these challenges, the DiGA initiative has the potential to make a significant impact on the German healthcare system. As the DiGA market matures, it is likely that these challenges will be addressed, and DiGAs will become more widely adopted by patients and doctors.


Here are some of the ways to address the challenges of German DiGA:

  • Increase awareness: The DiGA initiative needs to be more widely promoted to doctors and patients. This can be done through educational campaigns, webinars, and other outreach efforts.

  • Reduce costs: The costs of DiGAs need to be reduced to make them more affordable for patients. This could be done by negotiating lower prices with DiGA developers, or by providing subsidies to patients who use DiGAs.

  • Protect data privacy: The privacy of patient data needs to be protected. This could be done by using encryption and other security measures to protect patient data.

  • Ensure quality: The quality of DiGAs needs to be ensured. This could be done by requiring DiGAs to undergo rigorous clinical trials before they are approved.

By addressing these challenges, the DiGA initiative has the potential to make a significant impact on the German healthcare system.




Should other European countries adopt Germany's DiGA initiative?


There are a number of factors to consider, including the specific healthcare systems of each country, the regulatory frameworks in place, and the availability of digital health technologies.


However, there are a number of reasons why other European countries might consider adopting the DiGA initiative. First, the DiGA initiative has been successful in Germany. Since its launch in 2020, over 200 DiGAs have been approved, and over 50,000 patients have been prescribed DiGAs. This suggests that the DiGA initiative has the potential to improve patient care and reduce costs in other European countries.


Second, the DiGA initiative is relatively fast and efficient. DiGAs can be approved in as little as three months, which makes it easier for developers to bring their products to market. This could help to accelerate the adoption of digital health technologies in other European countries.


Third, the costs of DiGAs are covered by statutory health insurance in Germany. This makes DiGAs more affordable for patients, and it encourages doctors to prescribe them. This could also be a model for other European countries, as it could help to make digital health technologies more accessible to patients.


Of course, there are also some challenges that other European countries would need to consider if they were to adopt the DiGA initiative. These challenges include:

  • The regulatory framework: The regulatory frameworks for digital health technologies vary from country to country. In order to adopt the DiGA initiative, other European countries would need to ensure that their regulatory frameworks are compatible with the DiGA requirements.

  • The availability of digital health technologies: The availability of digital health technologies also varies from country to country. In order to adopt the DiGA initiative, other European countries would need to ensure that there is a sufficient number of DiGAs available that are relevant to their healthcare systems.

Overall, there are both pros and cons to adopting Germany's DiGA initiative. Other European countries would need to carefully consider their own healthcare systems and regulatory frameworks before making a decision. However, the DiGA initiative has the potential to improve patient care and reduce costs in other European countries, and it is a model that other countries could follow.


Engage with the HealthTech Community


HealthTech M&A Newsletter from Nelson Advisors - Market Insights & Analysis for Founders & Investors. Subscribe today! https://lnkd.in/e5hTp_xb

HealthTech M&A Advisory by Founders for Founders, Owners & Investors. Buy Side, Sell Side, Growth and Strategy mandates - Email lloyd@nelsonadvisors.co.uk


HealthTech Thought Leadership from Nelson Advisors - Industry Insights & Analysis for Founders, Owners & Investors. Visit https://www.healthcare.digital



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