Very high protection requirement
Whether a DiGA has a very high protection requirement must be determined with a protection requirement assessment. For this purpose, the DiGAV refers to BSI Standard 200-2. This standard describes a detailed assessment of the need for protection as well as sample criteria for orientation. One of these example criteria is, quote:
“The protection of personal data must be guaranteed at all costs. Otherwise, there may be a danger to life and limb or to the personal freedom of the person concerned” Source: BSI-Standard 200-2