The legal framework for DTx is complex. Companies wishing to successfully place a DTx on a given market, promote it there and get paid for it need to take into account several legal requirements. And once a company has launched a DTx in one market, similar questions occur when planning the expansion to further markets.
The CMS DTx Legal Navigator assists companies to address and answer these questions efficiently. It is the first of its kind international guide covering the key legal aspects any company active in this field faces.
Our experts provide practical guidance for 18 jurisdictions on how to comply with the legal boundaries in relation to placing a DTx on the respective market, promoting the DTx and getting paid for it.
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Placing a DTx on the market | Promotion of a DTx on the market | Payment for a DTx on the market |
| This part provides an overview of the key legal requirements a company offering a software in this field needs to consider and, depending on the actual legal qualification of the software, comply with. This covers the product qualification – medical device or not –, the interaction between product and service component, data protection requirements and other key legal points to consider to get market access. | This part provides an overview of the key legal aspects that need to be observed when starting to promote the DTx on the respective market. For companies wanting to enter a market it is often crucial to understand whether direct to consumer promotion is possible and whether benefits or rebates may be offered. Also, it is important to understand which distribution channels exist and how to best partner with third parties already active on the target market. | This part provides an overview of the key legal aspects that apply in relation to the creation of revenues for a DTx. Without the prospect of creating revenues it is unlikely that a company would enter the respective market or at least remain there. Different options of creating revenues exist, each depending on the respective legal and reimbursement framework. Points covered here are the identification of potential payors, payment options in the private sector and the public sector as well as – if already in existence – reimbursement mechanisms for DTx, such as the German DiGA process. |
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