But the planned new regulations for DiGA make it clear why Germany is still struggling so hard with sustainable digitization: Many of the requirements slow down innovations in the DiGA sector instead of promoting them. At the same time, there is a lack of urgently needed impetus for DiGA to fulfill the intention of the law of “acceleration.” Better information from patients and doctors and simplified access for users to their DiGA is essential for this. That is why we are proposing the following improvements:

Introduction of a simplified regulation and approval process

The current process for prescribing and using DiGA is unnecessarily time-consuming, complicated and therefore not focused on users and patients, both for patients and for prescribing care providers. There is therefore a need for a new, simple access channel where insured persons can redeem their regulations or permits directly with manufacturers and use DiGA immediately.

Investing in independent education

DiGA is still a new form of care and requires clarification in everyday life. Here, doctors and psychotherapists make an important contribution to informing patients. This additional cost of patient education as part of the ordinance must be rewarded (e.g. through the reintroduction of GOP 01470). Health insurance companies should also be required to provide vendor-neutral information about digital care innovations and the underlying evidence when addressing their insured persons.

Introduction of a regulation for blended care models

So far, the combination of DiGA with human services has regularly been rejected by the BfArM. The approval of such blended care models is clearly provided for in BMG's digitization strategy and should be introduced in order to improve care in the future. Currently, such approaches are only included in the explanatory memorandum to the Digital Act, but not in the actual legal text. It is therefore necessary to include a new provision to approve the combination of DiGA with other medical services in the current legislative process (blended care).

No 14-day “trial period”

According to the draft law, a free “trial period” is to be introduced, during which the remuneration of a DiGA for the manufacturer is completely waived, provided that the insured person decides against permanent use within 14 days of initial registration. Although the manufacturer has therefore already provided a service for over two weeks, this will not be reimbursed retrospectively. This is based on the assumption that an interruption of use is directly attributable to the quality of a DiGA. However, there can be many reasons for this: The patient's personal circumstances, random factors or even a sudden contraindication can lead to an end to use. In addition, depending on the concept and area of application of a DiGA, an effect can also occur within the first 14 days. There is no such mandatory “trial period” in which benefits are provided but not remunerated in any other healthcare sector. For example, the compensation claim of an aid provider (e.g. hearing aid acoustician) remains unaffected if insured persons decide not to use the aid (e.g. hearing aid) after all. The regulation is a significant disadvantage for DIGA manufacturers and violates their fundamental rights in an unlawful and constitutional way.

Develop a framework for application-related performance measurement by consortium

The effectiveness of DiGA has already been proven by manufacturers with the help of comprehensive scientific studies. DIGA manufacturers are also open to performance-based compensation models, which are already possible under current legal bases. However, the new approach of mandatory performance measurement during the application, e.g. based on frequency of use, is critical in many ways. Just because a user was not logged into the application doesn't mean that he/she did not follow the program, because exercises are also carried out offline. As a result of an increase in knowledge, e.g. in the case of exercise or diet adjustments, an effect can also persist significantly beyond the actual period of use of DiGA. The proposed regulation is not only insufficiently differentiated for the wide range of DiGA and disease patterns, it also supports addiction-promoting mechanisms, as known from the social media sector. In order to justify the influence of an application-related performance measurement on remuneration amounts, a clear conceptual and methodological framework is needed. This should be developed by a consortium of involved stakeholders, define the value concept of successful treatment and provide guidelines for the concrete implementation of the performance measurement accompanying the application.

No obligation to loan hardware

The draft law provides that DIGA manufacturers should be required to provide patients with hardware and devices, in part on loan. This proposal is unspecific: DIGA providers are not required to provide patients with technical devices, such as smartphones — they should and cannot do so regularly. If a DiGA also includes additional devices, such as sensors, additional hygienic aspects must be considered. Loans result in significant administrative costs as well as quality management and processing obligations for DIGA manufacturers, which result in further costs. Loan of technical equipment should therefore only be considered if there are no hygiene concerns.

Same DIGA approval conditions for medical devices risk class IIb

The draft DigiG provides that risk class IIb medical devices can also be approved as DiGA in the future. However, the approval requirements differ from the previous ones for risk class I and IIa products. The approval of risk class IIb medical devices as DiGA should follow the same mechanisms as those of medical devices class I and IIa. Since a benefit-risk assessment is already carried out as part of medical device certification, this must not again play a role in DIGA approval. For medical devices class IIb, there should also be the option of provisional DIGA approval and recording positive structural and process improvements.

No blocking period for manufacturers if the DIGA application is withdrawn independently

DigiG now provides for an additional blocking period of 12 months, provided that a company withdraws its already submitted application itself. Such a sanctioning of an application withdrawal is critical. There can be many reasons for the company to withdraw the application, which are in no way related to the quality of the product. The corresponding addition to Section 139e (4) SGB V, which provides for an additional blocking period, must therefore be deleted.

Germany is at risk of losing its pioneering role

DiGA has enormous potential to overcome future challenges in the German healthcare sector: They can bring about real inclusion of people who have largely been excluded from care so far. They offer the opportunity to use data responsibly and thus improve supply. And they create completely new treatment options for doctors and therapists, in which patients are closely involved and their sovereignty is strengthened.

It is therefore time for us to shape this digital transformation together from Germany. Instead of imposing new hurdles once again on the young DiGA supply concept — whose share of statutory health insurance expenditure is only in the per thousand range — measures are needed that now bring the concept into the area. So that we can expand our initial pioneering role instead of squandering it as in other industries.

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