At medXteam, the focus is on clinical data. In this context, as CRO we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection. This time the topic in this context is the DiGA. Data is also collected here. But this time the focus is on the question: Why are doctors holding back on prescribing DiGAs? In the following blog post, Dr. med. Gisela Knopf contributed. As a general practitioner, she has already had extensive experience in this area.

Since October 2023, the previous month's blog post has also been published as a podcast ( medXteam Kompakt ). This article appears as an interview with Dr. med. Gisela Knopf will then be available as a podcast in December 2023.


DiGA Digital Health Application

KV Association of Statutory Health Insurance Physicians

Underlying regulations

Digital Healthcare Act (DVG)
Digital Health Applications Ordinance (DiGAV)
DiGA Guide

1 Introduction

DiGAs (Digital Health Applications) have become increasingly important as digital applications in healthcare in recent years. They can help improve medical care and facilitate access to healthcare services. They provide patients with the ability to monitor their health and manage disease while providing doctors with valuable data to make better decisions.

Despite this, many physicians appear hesitant to prescribe DiGAs. This article examines this situation and the perspectives of doctors and health insurance companies. It also examines the reasons for this reluctance and suggests ways in which physicians can be encouraged to prescribe DiGAs.

2. Introduction to the DiGAs

DiGAs are medical applications that are reimbursed by health insurance companies and can be prescribed by doctors at the expense of the health insurance companies. They are intended to improve medical care, for example by helping to diagnose diseases or support the monitoring of patients. DiGAs can be used, for example, in the treatment of diabetes, mental illnesses or for smoking cessation. The applications are usually easy to use and can be downloaded to smartphones or tablets.

3. Case studies of successful implementation of DiGAs

DiGAs have become more important in recent years. They include a variety of applications, from fitness trackers to specialized health apps. Many of these applications were developed by medical professionals and provide evidence-based solutions to improve health. Nevertheless, DiGAs are often not formulated or used.

One reason for this problem is the lack of awareness and training among doctors. Many doctors are either not aware that DiGAs are approved as medical aids or they do not have sufficient knowledge of the benefits and possible uses. This means that they do not prescribe DiGAs or are hesitant to recommend them.

There are already some successful examples of the implementation of DiGAs in medical care. One example is the formulation of DiGAs for the treatment of diabetes. Applications can be used here to monitor blood sugar levels and support self-management of the disease. Another example is the use of DiGAs to treat anxiety disorders and depression. Appropriate applications can be used here to support psychotherapeutic treatment.

4. Prescription of DiGAs

Physicians have various concerns and challenges when it comes to prescribing DiGAs. On the one hand, they are concerned about the quality and effectiveness of the applications. You want to be sure that the DiGAs are evidence-based and actually help patients. On the other hand, doctors have limited time during patient consultations and do not want to have to recommend or prescribe too many different applications.

To address these challenges, better training and education for physicians is needed. They need to be informed about the latest developments in the field of DiGAs and learn how to effectively integrate them into their practice. In addition, criteria and guidelines should be developed to ensure the quality and effectiveness of DiGAs or, ideally, the DIGAs should be integrated into the existing guidelines.

4.1 The role of the doctor in prescribing DiGAs

Prescribing DiGAs is the responsibility of physicians. They must decide which applications are best for their patients, what benefits they can provide, and whether they are cost-effective. Doctors must also ensure that the applications are safe and effective and that they are funded by health insurance companies. This requires a certain level of expertise and experience in relation to DiGAs.

Doctors and psychotherapists can issue a prescription (sample 16) for a DiGA if the prescription is medically necessary. Economic efficiency must always be taken into account.

The cost-effectiveness principle also applies to apps: The DiGA regulation also applies to the cost-effectiveness requirement, according to which the service must be sufficient, appropriate and economical (Section 12 SGB V).

(Source: Apps on Recipe , accessed on November 3rd, 2023)

4.2. Factors contributing to physicians' reluctance to prescribe DiGAs

Despite the benefits of DiGAs, many doctors are hesitant to prescribe them. One reason for this is that they are not sure whether DiGAs are actually effective. There are also concerns about the security of DiGAs and data security. Another factor is the lack of time and resources to support patients in the use of DiGAs. Additionally, many physicians are concerned about the additional burden of prescribing and monitoring DiGAs. And last but not least, there is the concern as to whether the health insurance companies will really cover the costs or whether a corresponding prescription can lead to recourse.

Added to this is the already very complicated billing and prescription system used by statutory health insurance physicians. Especially with the constantly hovering sword of Damocles of the risk of recourse (see also the following section). Recourse means that a doctor who makes a “mistake” (according to the KV specifications) in prescribing a health insurance service can and often actually is asked to pay for this service. In the case of DIGAs, this means becoming the prescribing doctor The costs of € 300 - 500 may be billed personally. And in order to correctly carry out a DIGA prescription, a few points are required that are set by the Association of Statutory Health Insurance Physicians, which also differ from DIGA to DIGA if, for example, this is changed from “provisional” to “permanent” or from “provisional” to “no longer available on the list”. And how should the KV requirement of “economic efficiency” be met? Perhaps the DIGA will ultimately be compared with a medication that costs a few cents per day for therapy? What the KV understands by economic efficiency is unfortunately usually not defined in detail for the individual case and is the big black box when it comes to the risk of recourse. Unfortunately, it is well known that apples are often compared with oranges without the medical profession having any influence.

4.3 Impact of budget constraints on the prescription of DiGAs

Another important factor that can contribute to doctors' reluctance to prescribe DiGAs is the very special and sometimes difficult to understand billing systems of statutory health insurance physicians, including budget restrictions. The health insurance companies provide limited resources for financing DiGAs and so there are major concerns among the medical profession as to whether and under what conditions DIGAs will be reimbursed by statutory (and private) health insurance companies. Doctors are under constant pressure to work cost-effectively, combined with the ever-present time pressure in practice. Just dealing with the matter of when which DIGA can be prescribed and under what conditions requires a lot of time.

In addition, there is the Sword of Damocles already mentioned above, that if one of the specified conditions was (inadvertently) not met, the health insurance company or the Association of Statutory Health Insurance Physicians will generally refuse to cover the costs and the doctor will be billed for the costs of the DIGA in the form of recourse be provided. This risk is avoided if the doctor does not prescribe DIGA at all or recommends that the patient get a corresponding app themselves.

4.4 Addressing physician concerns regarding DiGAs

To encourage physicians to prescribe DiGAs, their concerns and concerns must be addressed. One way to do this is to provide training and education to improve physicians' knowledge and understanding of DiGAs. It may also be helpful to emphasize the benefits of DiGAs, such as improving patient care and reducing costs. Another option is to give doctors the opportunity to try DiGAs and test them themselves to assess their effectiveness and safety.

5. Health insurance companies’ perspective

Health insurance companies also play an important role in the prescription of DiGAs. They must ensure that the applications they reimburse actually provide patient benefit and are cost-effective. For this reason, they often conduct their own assessments and studies to verify the effectiveness of DiGAs.

Another problem that health insurance companies have is the large number of DiGAs available. They have to decide which applications they will reimburse and which they will not. This requires careful evaluation and selection to offer patients the best options.

6. Overcoming barriers to prescribing DiGAs

To promote the prescription of DiGAs, barriers to the adoption and use of DiGAs must be overcome. This includes providing sufficient resources and training for doctors and patients. With regard to doctors, the prescription modalities in particular must be trained or, better yet, significantly simplified, which then also fits with the topic of digitalization.

It may also be helpful to encourage collaboration between physicians and developers of DiGAs to ensure that the applications meet patients' needs. In addition, health insurance companies for DiGAs can create meaningful incentives for the prescription of DiGAs in order to promote acceptance and use. The health insurance companies already have these incentives, but obtaining them is so complicated and confusing that the ratio of profit to effort is not worth it for most doctors.

6.1 The future of DiGAs in healthcare

The future of DiGAs in healthcare is promising. They can help improve medical care and facilitate access to healthcare services. DiGAs can also help reduce healthcare costs by reducing the need for expensive follow-up medical costs. The demand for DiGAs is expected to continue to increase in the coming years as more and more people have access to digital technologies.

6.2 Resources for physicians to learn more about DiGAs

A number of resources are available for physicians interested in learning more about DiGAs. This includes training and education, specialist magazines and online resources. It can also be helpful to exchange ideas with colleagues who already have experience with the regulation of DiGAs. Although all of this is available, the effort required to obtain information must remain manageable; the prescription of DIGAs is ultimately only a very small part of the medical field of application.

7. Conclusion

DiGAs have the potential to improve medical care and make it easier for patients to access digital health applications.

There are a number of reasons for physician reluctance to prescribe, with concerns about the effectiveness and safety of DiGAs likely outweighed by the risk of recourse and lack of time.

In this respect, doctors simply hesitate to prescribe a form of therapy in the three-digit price range for the reasons mentioned above, which the manufacturers are probably not aware of. The fact that patients can sometimes receive the DIGAs directly from the health insurance company without a doctor's prescription seems to be a good approach here.

To promote the prescription of DiGAs, barriers must be overcome and physicians must be encouraged to become familiar with DiGAs. For example, better training and education for doctors as well as clear and, above all, uniform criteria and guidelines for DiGAs are required. In addition, health insurance companies may need to improve their evaluation processes to select the best DiGAs.

5. How we can help you

At medXteam we clarify whether and if so which clinical trial needs to be carried out under what conditions and according to what requirements during the pre-study phase: In 3 steps we determine the correct and cost-effective strategy in relation to the clinical trial required in your case Data collection.

If a clinical trial is to be carried out, basic safety and performance requirements must first be met. The data from the clinical trial then feed into the clinical evaluation, which in turn forms the basis for post-market clinical follow-up (PMCF) activities (including a PMCF study).

In addition, all medical device manufacturers require a quality management system (QMS), including when developing Class I products.

We support you throughout your entire project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation through to technical documentation - always with primary reference to the clinical data on the product: from the beginning to the end End.

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