Which apps are referred to in the DVG?
Apps that support a healthy lifestyle are very popular. The range extends from wellness and lifestyle apps to health and medical apps.
The latter are characterised by their specific purpose: they fulfil therapeutic or diagnostic purposes. For this reason, they are classified as medical devices or, where applicable, in vitro diagnostic medical devices within the meaning of medical device law and must therefore also comply with the legal requirements for medical devices (Medical Device Regulation (MDR) and/or In Vitro Diagnostic Regulation (IVDR)). When we talk about ‘apps on prescription’, we are generally referring only to medical apps, i.e. medical devices that are MDR or ICDR compliant and CE marked.
How are they included in the ‘reimbursement list’?
In future, such health apps are to be prescribed by doctors and their costs reimbursed by statutory health insurance funds. The proposal for ‘health apps on prescription’ is part of the draft bill for the Digital Care Act (DVG) (PDF) of the Federal Ministry of Health.
The draft DVG stipulates that the BfArM shall maintain a list of digital health applications (health apps) that meet the requirements specified in the law and are therefore eligible for reimbursement. The directory is to be published in the Federal Gazette and on the Internet. Manufacturers of health apps can apply for inclusion in the directory, and a decision will be made within three months of receipt of the complete documentation. The BfArM is to advise manufacturers of health apps on the application and notification procedures and on the requirements for inclusion, and publish guidelines on this on the internet. The detailed procedure and the determination of the evidence and criteria required for inclusion in the directory will only be regulated in detail in a supplementary statutory instrument to the DVG, for which no draft is currently available. If the manufacturer is unable to demonstrate positive healthcare effects at the time of application, they may apply for provisional inclusion in the register for up to 12 months, so that the app can still be prescribed by doctors during this period. To do so, the manufacturer must provide plausible reasons why its app can contribute to improving healthcare. To this end, it must submit a scientific evaluation concept prepared by an independent institution to prove positive healthcare effects.
After the 12-month period has expired, a final decision will be made on permanent inclusion in the directory. If positive effects on healthcare are not sufficiently proven, but the test results submitted indicate a high probability of subsequent verification, the BfArM may extend the period of provisional inclusion in the directory by up to twelve months. If positive effects on healthcare cannot be demonstrated during the trial phase, the app will be removed from the directory. Repeated provisional inclusion in the register for testing is not permitted.
Which risk classes of health apps are covered?
The draft law, and thus future prescribability, only covers health apps that are classified as medical devices in risk classes I and IIa according to the MDR and are already on the market. However, the draft does not cover ‘wellness’ and ‘lifestyle apps’ that are not medical devices.
The MDR and IVDR impose stricter requirements on clinical evaluations and clinical trials of medical devices, including health apps, than was the case under the European directives. They include higher requirements for quality and risk management, technical documentation and post-market surveillance. In addition, the redesign of the classification rules with MDR/IVDR may result in health apps being assigned to a higher risk class than was previously possible under the directives. The higher risk classification and the associated conformity assessment procedure, which must be accompanied by notified bodies from risk class IIa onwards, can significantly complicate the manufacturing process and considerably extend the time-to-market phase. Manufacturers should already take this into account in their scheduling.
What needs to be improved?
The risk classification of digital health applications is regularly based on the risk class of the ‘main product’. As a result, many of the digital health applications on offer are classified as higher-class medical devices. This applies in particular to software or apps that process information from another medical device and communicate it to the doctor or patient. Such apps may also be classified in the higher risk classes I and IIa. According to the draft DVG, they cannot be prescribed – even though they offer the possibility of detecting complications in care. With regard to planning security and the development of future innovations, it would be desirable for manufacturers if a binding timeframe for the opening up of higher-risk digital medical devices were to be established now.
Conclusion
With its proposal for ‘apps on prescription’, the DVG is taking a further step towards improving patient care through digitalisation. For manufacturers of health apps, the DVG offers the opportunity to distinguish their own product from the multitude of offerings and to achieve a significant competitive advantage over rival products by being included in the list of apps that can be prescribed. Inclusion in the directory also means that the app must have successfully undergone the conformity assessment procedure in accordance with the regulations and complies with the stricter regulatory framework for analogue and digital medical devices associated with the MDR/IVDR. For manufacturers and developers of health apps, it is therefore advisable, especially with the DVG, to make their products MDR/IVDR-compliant in order to take advantage of the opportunities offered by the inclusion of their app in the directory of prescribable apps and to benefit from the new possibility of ‘prescribability’ when the law is passed.
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