DiGA 2.0 is here – and brings far-reaching changes for manufacturers of digital health applications. The new Digital Act has been in force since March 26, 2024, redefining the framework conditions for DiGA: from higher regulatory requirements to innovative care models. This article shows what is important now.

What is a DiGA?

A DiGA is a digital health application that can be used by patients to monitor, improve or stabilize their health. These applications are classified as medical devices and offer, among other things, personalized feedback based on the data they receive from patients or indication-specific exercises and tips. The main function of the DiGA is based on digital technologies and the medical purpose of the underlying medical device must be essentially achieved through the main digital function.

DiGA 2.0: The most important changes due to the Digital Act 2024

The new law has introduced some key changes aimed at further improving the quality and effectiveness of DiGA:

Integration into the supply

DiGAs should be better embedded in existing care processes and thus also enable more complex treatment processes. This requires DiGAs to be seamlessly integrated into the workflows of doctors and patients.

Extension to risk class IIb (MDR)

One of the key innovations is the extension of the DiGA to medical devices in risk class IIb, which are classified in accordance with the Medical Device Regulation (MDR). This concerns more complex medical applications, such as the control and monitoring of vital physiological parameters. In this context, the requirement for proof of efficacy has also been tightened. A positive effect on care must already be proven by a prospective comparative study when the application is submitted. This means that the results of an evaluation study that prove the medical benefit of DiGA must be submitted. The role of contract physicians, psychotherapists and other medical professionals must be part of the study. Simply increasing the number of contacts between doctors and patients is not sufficient to prove the positive effect of a DiGA on care. Provisional approval is not possible for DiGA of risk class IIb.

Diagnostic DiGA

DiGAs that include a diagnostic component are becoming increasingly important. However, these must demonstrate extensive studies that prove their diagnostic quality (sensitivity and specificity), for example in the early detection of complications of chronic diseases.

Performance measurement and remuneration

Another important innovation concerns performance measurement: from January 1, 2026, DiGA manufacturers will be obliged to record parameters such as the duration and frequency of use as well as patient satisfaction. This data will serve as the basis for determining a performance-based remuneration model. A minimum of 20% of the remuneration will then be performance-based, which could provide a strong incentive for manufacturers to maximize the benefits of their applications.

No legal transactions with pharmaceutical manufacturers

An important regulation intended to protect competition and freedom of therapy is the ban on exclusive contracts between DiGA manufacturers and pharmaceutical manufacturers. These contracts could restrict patients’ freedom of choice. and restrict doctors’ freedom of therapy. DiGA manufacturers are therefore not allowed to enter into agreements that favor the prescription of certain drugs. Exceptions only apply if there is only one provider for a particular treatment.

Rules for hardware components and loaning

Some DiGAs require special hardware components to fulfill their medical purpose – for example, to record vital parameters. According to the Digital Act, DiGA manufacturers must generally provide this necessary hardware on loan if it cannot be used without it. Only the hardware components that are inseparable components of the DiGA and whose use is absolutely necessary to fulfill the medical purpose are reimbursed by the statutory health insurance companies. The manufacturers and the statutory health insurance funds (or the GKV-Spitzenverband) still have to agree on the details, such as the duration of the transfer and the reimbursement regulations.

Fast provision of the activation code by health insurance companies:

An important step in being able to use DiGA quickly and effectively is the provision of the activation code that enables the use of DiGA. According to the new regulations, the statutory health insurance funds are obliged to issue this code to the patient within two working days of the application being submitted. This measure is intended to ensure that access to the DiGA is provided promptly and without unnecessary delays.

With regard to DiGA development and indication-related use, two further changes lead to new approaches:

DiGA 2.0 in pregnancy: use in high-risk cases

A particularly interesting area of application for DiGA concerns the care of pregnant women. A normal pregnancy is a condition and by definition does not constitute a disease.

A digital health application that aims to treat medical problems or complaints during an irregular pregnancy can be approved as a DiGA under certain conditions. This applies, for example, to high-risk pregnancies or pregnancy-related illnesses. The focus here is on the therapeutic benefit – applications that specialize in the control of pregnancy-associated complications can therefore significantly improve the care of affected individuals.

The use of such DiGAs could, for example, help to manage gestational diabetes or reduce the risk of premature births. It is important that these applications are based on sound medical studies that prove their diagnostic and therapeutic benefits.

DiGA and telemonitoring

The combination of DiGA and telemonitoring is a step into the future of networked healthcare. The extension of DiGA to higher risk classes (IIb according to MDR) creates new opportunities to use telemedicine procedures to better manage diseases across geographical distances.

DiGA can now also include more complex telemedical monitoring functions. This means that in future the focus can be placed on evaluating the positive effect of care, including the services of contract doctors, contract psychotherapists or other service providers.

Especially in combination with telemonitoring, both sides – patients and service providers – benefit from the data collected and its analysis. This promotes holistic care in which medical professionals and digital tools work hand in hand.

Challenges and future prospects

The requirements for DiGA are constantly increasing, especially in terms of interoperability. This means that DiGA must be able to transmit and receive data in standardized formats in order to ensure a higher quality of treatment and better data protection. The binding nature of standards and profiles will ensure that DiGAs are integrated even more closely into existing healthcare processes in the future.

Conclusion: DiGA 2.0 as a driver of digital patient care

Digital health applications are a central component of modern patient care. The changes brought about by the Digital Act will not only pave the way for innovative, effective applications, but also prioritize the safety and effectiveness of DiGA.

New opportunities for more individualized and efficient healthcare are opening up, particularly in the care of pregnant women. The ban on exclusive contracts with pharmaceutical manufacturers ensures that patients’ freedom of choice and medical freedom of therapy are not impaired. The loan of hardware components and the rapid provision of the activation code also ensure that all patients have prompt and uncomplicated access to the necessary devices and applications.

The combination of DiGA with telemonitoring is a milestone in the development of digital health applications. These new arrangements make it possible to efficiently manage chronic and complex diseases over long distances, while the active role of contract physicians and other professionals remains integrated into the treatment process. Strict requirements for proof of medical benefit ensure that the quality and effectiveness of these technologies is assured. Digital networking through DiGA and telemonitoring thus offers considerable benefits not only to patients, but also to doctors and the healthcare system as a whole, and will play a central role in patient care in the future.

The future of healthcare lies in digitalization – and DiGAs are the key to this.

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