{"id":3492,"date":"2024-07-30T08:58:41","date_gmt":"2024-07-30T06:58:41","guid":{"rendered":"https:\/\/www.bayoomed.com\/?post_type=news&p=3492"},"modified":"2024-07-29T18:19:21","modified_gmt":"2024-07-29T16:19:21","slug":"diga-six-facts-for-manufacturer","status":"publish","type":"news","link":"https:\/\/www.bayoomed.com\/en\/news\/diga-six-facts-for-manufacturer\/","title":{"rendered":"Digital health application (DiGA): Six facts for medical device manufacturer"},"content":{"rendered":"

Opportunities and challenges for DiGA manufacturers<\/h2><\/h2><\/div>

With the Digital Healthcare Act (DVG)<\/a>, the so-called Digital Health Application (DiGA) <\/a> has been included as a new service category in the catalog of standard care provided by statutory health insurance (SHI). Patients with statutory health insurance are entitled to the provision of digital health applications.<\/p>\n

Along with the various opportunities this presents for manufacturers, there are also a variety of challenges.<\/p>\n

What manufacturers should know about the legal framework of the law and the requirements for inclusion in the DiGA directory? We have summarized it.<\/p>\n<\/div>

<\/i><\/span><\/div>

Legal framework<\/h2><\/div>
<\/div>
\n

The legislator relied on three different types of standards when structuring the legal framework for DiGA. At the highest level is the parliamentary law, the Digital Supply Act (DVG), which defines the framework, the decisive cornerstones and criteria. A second form of the DVG framework is provided by a legal ordinance of the Federal Ministry of Health (BMG), the so-called Digital Health Applications Ordinance (DiGAV).<\/p>\n

Pursuant to \u00a7 139 e para. 9 SGB V, the BMG may regulate by statutory order relevant detailed questions regarding the requirements for DiGA, the inclusion procedure in the directory for digital health applications pursuant to Section 139 e SGB V (“DiGA directory”) and the arbitration procedure regarding the remuneration amount.<\/p>\n

In addition, the “DiGA guideline<\/u><\/a>” (The fast-track procedure for digital health applications (DiGA) in accordance with Section 139e SGB V, current version 3.5 dated 28.12.2023) is highly relevant. It contains a description of how the BfArM “will regularly interpret the normative requirements from the DVG and DiGAV [including the changes resulting from the Digital Supply and Care Modernization Act (DVPMG) and the 1st DiGAV Amendment Ordinance]”.<\/p>\n<\/div>

<\/div><\/div><\/div>
<\/i><\/span><\/div>

DiGA directory<\/h2><\/div>
<\/div>
The list of reimbursable DiGA can be viewed on the BfArM website. According to \u00a7 139 e para. 2 SGB V essentially take the following steps to achieve inclusion in the DiGA directory:<\/p>\n