With the new DVG (“Digitale-Versorgung-Gesetz“), Germany’s BfArM (Federal Institute for Drugs and Medical Devices) is breaking new ground. Experts consider the topic to be both exciting and complex, as it will bring a great deal of dynamism to conventional processes and markets, and the regulatory movement will need to be correspondingly fast. According to Dr. Wiebke Löbker of BfArM, the first digital health applications (German acronym: “DiGA”) could be listed in the directory as early as the end of August 2020. Companies applying for a DiGA registration are likely to be met with a number of new and extensive requirements. In this post, we would like to zoom in on the background, advantages and requirements for digital health applications in the context of the new regulation.
What is a DiGA?
DiGA are medical devices of low risk class (I to IIa) which must be intended for these purposes:
- Detect, monitor, treat or alleviate diseases
- Recognise, treat, alleviate or compensate for injuries or disabilities.
As medical devices, they are thus also subject to the requirements of the EU MDR and must fulfil the corresponding conditions. Their main function is based on digital technologies. The patient’s entitlement to healthcare only covers digital health applications that have also been included in the register for digital health applications by the Federal Institute for Drugs and Medical Devices (BfArM) (SGB V § 139e). In addition, there must be either a prescription by a treating physician, by a psychotherapist or an approval by the health insurance company.
The Digital Health Applications Ordinance (DiGAV) is an ordinance on the procedure and requirements for testing the eligibility for reimbursement of digital health applications in the health insurance system. It regulates the procedure, requirements and examination of the eligibility for reimbursement of digital health applications for health insurance companies in Germany. A catalog of requirements defines which features your app must have, for example, it must be certified as a low-risk medical device. The medical purpose of the app must be determined by its main digital function. In addition, factors such as quality, security and data protection must be proven and the app should have at least one “positive care outcome”. This must be proven through a scientific evaluation.
Why do we need a DVG?
Our population is getting older and older, but there are fewer and fewer young doctors. As diseases increase, so do the fears of patients in Germany, and our healthcare system may not be able to cope with these developments in the future.
The DVG environment is supposed to make it easier for startups to develop and market their products. So far, it has been relatively difficult to bring Health Apps onto the German health market. For example, some lacked access to health experts and a medical network. Others did not have the resources for broader marketing or lacked experience in the approval of their app. In addition, there was no specific way for digital apps to enter the mainstream health care market, but different laws on prevention, remedies, aids, etc. For example, aids must be physical and a digital app is not. On the other hand, it is also not a remedy, because a remedy should be provided by a person. In all other areas, there were also exclusion criteria, which is why all of them could not quite fit for digital applications.
This is why the DVG was created. The law was created and passed within one year, extremely quick for a German healthcare law. According to experts, it is crucial to act quickly now, so that the system is not overtaken by new developments and we can no longer define by ourselves how we want to run the German healthcare system.
Once we have developed such strategies, we must be able to implement them even with structural restrictions. This means proving that there is an added value through the innovation. And this requires new methods of digitalization. Digitalization does not only mean apps and programs, but also decentralized technologies, such as in rural areas in Germany or in regions in Africa where there are too few doctors.
What is special about the DVG?
- For the first time, a very clear set of criteria is being used to define whether an innovation should be included in healthcare provision. The ensuing procedures then happen very quickly. The BfArM has three months to decide on DiGA applications and after 12 months an application could already be on offer in the care system.
- During these 12 months, manufacturers have freedoms that they would otherwise not have had in this form. For example, if necessary, they can start developing the evidence (with hypothesis and design) at this stage. In addition, manufacturers can set the price themselves, although there are also maximum prices.
- The patient’s wellbeing in his or her daily life is at the center of everything. Much medicine is geared towards the “point of care” in outpatient or inpatient care. But in the case of the DVG, the focus is really on the insured person. Innovations should help to simplify the patient’s life with the disease.
Which criteria must a DiGA meet?
First of all, the DiGA must be a Class I or IIa medical device certified under the MDD or MDR. This in itself presents an obstacle; a lot of preliminary testing must have taken place beforehand to check fundamental aspects such as data protection/security, quality or risk management. By pre-testing the CE mark, much of the testing effort is covered from the outset, thus ensuring that not just any product can be placed on the market.
In addition, the main function of the application must be essentially based on digital technologies. It should therefore be a consistent, digital product. According to the BfArM, DiGA is “not a digital application that serves only to read or control a device; the medical purpose must be achieved essentially by the main digital function”.
When it comes to medical purposes, it is important that the focus is on the insured person. This excludes everything that focuses purely on the doctor or service provider. The DiGA is intended to help the insured person to cope better with everyday restrictions in his health.
Finally, the functionalities are very broad. These should relate to the detection, monitoring, treatment, alleviation or compensation of illness, injury or disability.
How does the Fast Track in the DVG work?
In an initial step, a consultation with the BfArM can be taken up, which is subject to a fee, but optional. After that, the application is submitted to the BfArM for inclusion in the DiGA directory according to 139e SGB V and the following criteria are reviewed:
- General requirements: These include CE marking of risk classes I to IIa according to EU MDR, whereby the transitional periods of the ordinance are also applicable. Certain data protection, data security, functionality and interoperability conditions must be fulfilled. It should not be an “island solution”, but must work with all other applications. In addition, the application must be tested for robustness, user-friendliness and quality. Without these basic factors nothing works. For this purpose, a list of requirements was formulated in the draft of the legal regulation.
- Positive patient care effects and their proof: This area is still relatively new for all those involved and must be explored together. It is about the medical benefit as we understand it today and must give a clear indication of evidence-based medicine. For this, the diagnosis must be correct from the outset. The intervention must be superior to the non-application of DiGA.
If the application fulfils the general requirements and shows positive effects on care, such as medical benefits and patient-relevant procedural and structural improvements in care, it will be reviewed by the BfArM and, following a positive decision, included in the DiGA directory.
The BfArM has three months for the review and the decision. However, if the general requirements are not met, inclusion in the DiGA directory will not be possible. If the criteria are met but no positive effects on the provision of care have (yet) been proven, a provisional admission and a trial in the standard care system will take place for 12 months. During this period, the manufacturer sets the price for DiGA and the remuneration of medical services is determined. If no agreement is reached within the 12 months, an arbitration board determines the remuneration amounts. The prices of the manufacturers of DiGA apply until the remuneration amounts have been agreed, after which the BfArM decides on the final inclusion in the DiGA directory.
For DiGA which are included in the DiGA directory on a trial basis or permanently, services can be prescribed and reimbursed by the statutory health insurance. Reimbursement amounts, which apply to all health insurance companies, are agreed upon between the umbrella organisation of the German Health Insurance Association and the DiGA manufacturers. The amounts are valid after the first year after inclusion in the DiGA directory.
Demonstrating positive care effects with Climedo
To provide evidence for the positive effect of a DiGA, clinical data must be collected. For example, it can be proven that the application is superior to non-use or to another analog or even digital solution. A comparative study must be submitted to the BfArM for this purpose. According to the guideline, “comparative studies […] are retrospective comparative studies including retrospective studies with intra-individual comparison”. Retrospective means that the collection of clinical data has already taken place before the start of the study. A prospective comparative study can also be submitted in exceptional cases. In this case, the data collection takes place after the study has started and specifically for this study. An intra-individual comparison can, among other things, be the difference between two measurements taken at two different times in the same person.
To collect data for these studies or to monitor the performance and safety of a DiGA already on the market, digital solutions such as Climedo can be used. Climedo helps you collect data quickly, easily and safely, both for clinical studies and for Post-Market Surveillance (PMS) of medical devices. In this way, you also meet the requirements of EU MDR. For example, patients can provide feedback on a DiGA at any time and anywhere via links to online questionnaires sent by SMS or e-mail.
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Requirements from the patient’s perspective
From the patient’s perspective, the following criteria must be met:
- Patient-friendly, i.e. no “app for app” or unnecessary intermediate steps
- Minimum effort in terms of input or data and automation where possible
- Timely, barrier-free DiGA deployment with a redemption process that runs without interruption and guided
- Can be integrated into existing applications and is therefore flexible / open
- The patient should not go to prepayment. Use based on the benefits-in-kind principle
Requirements from a doctor’s perspective
Another huge stakeholder group are doctors. From their perspective, the key requirements are:
- No additional costs for the use or prescription of DiGA
- The DiGA should not cause any additional expenditure in the daily work and the refund should be possible without support
- It should be possible to use existing media
- It must be possible to integrate the DiGA into existing systems
Finally, there are further requirements from the point of view of health insurance companies, manufacturers, the judiciary and store operators:
- According to the Federal Ministry of Health (BMG), anonymous use should ideally be made possible
- The DiGA must be operational for insured persons of all insurance companies at the start of the 1st DiGA
- Social law requirements must be fulfilled
- The DiGA must be economically viable
- For manufacturers, a settlement security must be guaranteed
- An uninterruptible DiGA supply must be made possible
- The standard must be uniform for all cash registers and flexible (web versus native app)
- A differentiated accounting basis must be guaranteed
- The store conditions must be fulfilled.
EU MDR matters
As far as the EU MDRs are concerned, manufacturers are recommended to initiate their DiGA application, if possible, before the new regulation comes into force on 26 May 2021. Until then, DiGA can still be marketed according to MDD. Since some of the requirements of the MDR and the DVG or DiGAV overlap, DiGA applicants are confronted with the risk of multiple evidence (e.g. for clinical evaluation according to MDR). Many regulations and recommendations regarding the EU MDR are currently subject to an adjustment process, especially with regard to IT security. Regulatory expenses may become too high in some cases and cannot be refinanced on the market even with reimbursement by the SHI. In addition to the Notified Bodies as MDR “gatekeepers”, the BfArM has now been added as a further gatekeeper at the regulatory level. Thus, manufacturers expect a number of publication obligations, especially with regard to study results and reimbursement rates. With regard to risk classes I and IIa there are still some uncertainties. This is because, under Rule 11 of the new Medical Devices Ordinance, software can in some cases fall into higher risk classes, depending on the device with which it is used. Unfortunately, this does not fit in with the DVG’s objective of promoting digitalisation in the German health care market.
The DVG creates new possibilities to introduce DiGA into standard medical care. Since the law has not yet existed in this form worldwide, it will certainly receive a lot of attention initially.
The BfArM now has just over a year until the federal elections in September 2021, after which coalition will need a few months to establish itself and see whether the new law fulfils its promised purpose. Due to the large advance in trust, all players must now work together in the first year to ensure that everything works as planned. For example, manufacturers must not be negatively affected by data protection problems and must also be aware that the law will not be particularly lucrative for them. If doctors lose confidence in the regulation, they will not prescribe DiGA. Negative reports could also appear in the press. DiGA manufacturers have a great responsibility towards their co-actors and the end users – the patients. It is particularly important that DiGA has been proven to be rightly prescribed.
Now, especially start-ups and smaller companies are being asked to take a long breath in order to create the path to DiGA supply. We remain curious to see how things will continue and hope to see positive results in a few months.