Digital Healthcare Arrives in Legislation
We are living in the midst of the digital age. This has consequences for the healthcare market: thanks to smartphones, smartwatches and apps, digital health applications (DiGA / dGA) are in high demand and the range of products on offer is ever growing. However, these applications must also be regulated in order to protect consumers and determine eligibility for reimbursement.
In Europe, legislators are beginning to adapt to this reality and are developing legislative frameworks to regulate digital medical devices.
In this article, we take a look at the German and Swiss models for digital healthcare. We explain the basics, outline the approval process and highlight differences between the two models – so that you, as a manufacturer, can gain an overview of the regulatory challenges and opportunities in digital medical device supply.
DiGA in Germany – Definition, Approval, Reimbursement
Disclaimer: Please note, that the legal texts referred to herein are only available in German language.
The basic entitlement of insured persons to medical aids is defined in Germany by SGB V, §33. Digital applications are specified in §33a as medical devices "[...] whose main function is based essentially on digital technologies and which are intended to assist insured persons or healthcare providers in the diagnosis, monitoring, treatment or alleviation of diseases or the diagnosis, treatment, alleviation or compensation of injuries or disabilities."
In addition, the DiGAV – the Digital Health Applications Regulation applies. This regulation defines how the reimbursement eligibility of digital medical devices can be applied for and determined. The DiGAV focuses on requirements for safety, quality and data protection, as well as proof of the positive care effect of the digital product. These products are approved as standard by the BfArM. Once approved, the product is added to the directory of digital health applications (DiGA directory).
Reimbursement via the National Association of Statutory Health Insurance Funds (GKV-SV) is possible as soon as a product has been included in the DiGA directory. The reimbursement price is renegotiated between the manufacturer and the GKV-SV 12 months after initial inclusion.
German speciality: Since 2020, the so-called fast-track procedure for digital medical devices has been in force. This requires the BfArM to decide on the provisional or final inclusion of the product in the DiGA directory no later than three months after receipt of the complete application documents. The DiGA directory is the German Medical Technical Aids Register (HMV) for digital medical devices and applications. Inclusion in the DiGA directory makes the product eligible for reimbursement.
Following the three-month review, the product enters the trial phase: During the following 12 months, the positive supply effect is quantified – if this is sufficiently evident, the product is permanently included in the DiGA directory. In addition, the National Association of Statutory Health Insurance Funds (GKV-SV) and the manufacturer renegotiate the reimbursement price of the product.
The fast-track procedure gives manufacturers greater planning security and faster market entry. However, it is important to note that the three-month rule only applies if the application documents are received in full! It is therefore all the more important for manufacturers and importers to maintain complete technical documentation and submit formally correct applications. If this is the case, approval can be granted (relatively) quickly.
dGA in Switzerland – Definition, Approval, Reimbursement
DiGA and dGA mean the same thing. And although the Swiss abbreviation has one less “i”, it defines the term “digital health applications” more broadly than the German one: in a fact sheet published by the Swiss Confederation, all products are defined as dGA, ‘[...] which are used for health promotion, patient support and information, or for medical purposes and use digital technologies.’.
This makes it clear that not only applications with an explicit medical purpose are considered dGAs, but also everything related to medical services that fulfils supportive, informative or even actual medical functions.
In Germany, the definition is based on the predefined term ‘medical device’. In Switzerland, the definition of dGAs covers everything that brings health and digital technology into a functional relationship.
Because this broad definition requires further restriction, Swiss law distinguishes between three categories of digital health applications:
- Health promotion: e.g. wellness apps – these are not eligible for reimbursement.
- Patient support: e.g. diary apps – eligibility for reimbursement must be checked on a case-by-case basis.
- Medical purpose: e.g. therapy apps – these are eligible for reimbursement if they have been classified as medical devices.
Health-promoting and patient-supporting or informative dGAs are therefore not reimbursable, or only through private supplementary insurance. In the event of damage to the consumer, the manufacturer is liable for the damage in accordance with the Product Liability Act (PrHG) if it was caused by defective products. A principle of ‘leniency in the event of damage’ applies here. DGAs that fall into these first two categories are therefore not required to meet the strict requirements of the German Medicinal Products Act and are generally not reimbursable.
dGAs with a medical purpose are more narrowly defined and more strictly regulated. Their approval is currently regulated in the same way as the approval of other medical devices in Switzerland: The conditions for reimbursement of medical devices are defined in the Health Insurance Act (KVG, Articles 32, 33). The manufacturer or importer must demonstrate that the product sufficiently meets the criteria of effectiveness, appropriateness and cost-effectiveness.
Due to the fact that the transferability of requirements for analogue medical devices to digital medical devices is not always straightforward, the individual case review for BMRs with medical benefits is slower and more complex in Switzerland than in Germany, where the fast-track procedure streamlines the bureaucratic processes.
It is therefore all the more important for manufacturers who wish to supply the Swiss digital healthcare market to have accurate and complete technical documentation and a well-structured QM system.
The Swiss Confederation provides various guidance documents for manufacturers of dGA for medical purposes, such as a guide for app developers, manufacturers and distributors including a detailed checklist for app development. These documents specify many of the requirements for reimbursable medical devices specifically for digital products. They thus help manufacturers to gain an overview of the requirements for reimbursable medical devices.
Conclusion: Differences, Outlook
The regulation of digital medical devices is still in its infancy. However, Germany has set an important example by implementing the fast-track procedure in 2020: The fast-track procedure is a model for the EU, and several countries are likely to follow suit in the coming years. However, German legislation is not yet the last word in DiGA regulation: meticulous documentation and careful preparation on the part of manufacturers are essential. There is also cautious criticism that the legally guaranteed faster approval process, even for higher-risk DiGA, could lead to reduced patient protection.
In Switzerland, the approval of dGA is less uniformly organised: legal standards must be transferred from the analogue to the digital space, and eligibility for reimbursement must be examined on a case-by-case basis. This can take a long time, particularly due to the mosaic of relevant legal bases and the lack of a fast-track regulation in Switzerland. Furthermore, it is often not easy for manufacturers to determine the scope of the documentation required, whether the product can be classified as reimbursable or non-reimbursable, and much more. However, it should be noted that the documents supporting manufacturers are relatively easy to understand and can provide manufacturers with good assistance. It is also interesting to note that a few weeks ago, Switzerland decided to cooperate with the US FDA on the approval of medical devices. Manufacturers could essentially outsource parts of the complex dGA approval process if approval for the US already exists or is in sight.
With BEO BERLIN, You are on the Safe Side.
For manufacturers, this means increased documentation requirements and longer waiting times for product approval – extra work and delayed market entry lead to lost profits. It is therefore advisable to have an expert on regulatory issues at your side to save time, money and bureaucratic headaches.
BEO BERLIN has been providing reliable support to manufacturers for over 25 years and has a team of experts who are also highly knowledgeable about digital compliance. In addition to professionals for technical documentation, we can connect our customers with experts in Swiss, German and US medical device law, thus guaranteeing comprehensive and targeted support on the path to reimbursement – pragmatically, cooperatively and professionally.
Please do not hesitate to consult our experts and work with us to achieve regulatory compliance and reimbursement eligibility.
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