Germany: Referentenentwurf DVMPG

Draft for new German law to modernize health care
(Digitale Versorgung und Pflege – Modernisierungs-Gesetz – DVPMG)

This includes important changes to DIGAV!
(See “Artikel 8”, page 44ff)

  • From 1.Jan 2023 DIGA (digital health applications) would need to be able to export data into a the electronic patient file (elektronische Patientenakte)
  • Also new requirements on certified information security management (from no later than 1 Jan 2022) and a BSI certificate on data security (from 1 Jan 2023). This also applies to digital health applications which are already registered.
  • Also new requirements on integrating with the electronic patient card for authentication (elektronische Gesundheitskarte) – unless the DIGA is purely web-based. (31 Dec 2020)
  • Also the vendor needs to ensure that the provided health information is kept up-to-date.