14-day update

Für MedTech, Pharma und Forschung

Der mHealth Digest Monitor bietet einen zweiwöchentlichen Überblick über die News der Branche. Alles zu den Themen mHealth, DiGA und DTx mit relevanten Meldungen zu #Technologie, #Wirtschaft, #Politik, #Regulatorik und natürlich #DiGA und #Termine.

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#Politik, #Regulatorik, #Technologie 7. August 2024

+++ AI Act published +++

As of August 1, the new EU AI law Regulation 2024/1689 establishing harmonized rules for a... Weiterlesen

#DIGA, #Politik, #Regulatorik 7. August 2024

+++ Mapping reimbursement channels +++

In the fact sheets on the country-specific framework conditions for the reimbursemen... Weiterlesen

#Politik, #Regulatorik 11. July 2024

+++ Harmonization of standards in Europe +++

With a new harmonization proposal, the European Commission has postponed the due date for ... Weiterlesen

#DIGA, #Politik, #Regulatorik 23. November 2023

+++ Bundestag debate DigiG +++

The draft of the new Digital Act DigiG (Act to Accelerate the Digitization of the Healthca... Weiterlesen

#DIGA, #Regulatorik 3. November 2023

+++ DiGA app Pink! canceled +++

The BfArM has launched the breast cancer app PINK! Coach was removed from the DiGA directo... Weiterlesen

#Regulatorik, #Technologie 28. September 2023

+++ Prevention app certified +++

In addition to DiGAs, state-approved prevention apps are also reimbursed by statutory heal... Weiterlesen

#Regulatorik, #Termine 4. May 2023

+++ DiGA implementation guide for connection to TI +++

The Bundesverband Gesundheit-IT e. V. (bvitg) is offering DiGA manufacturers an online eve... Weiterlesen

#Regulatorik 21. March 2023

+++ TÜVIT certificate according to BSI TR-03161 +++

TÜV Informationstechnik (TÜVIT) can now offer manufacturers in the healthcare sector tests... Weiterlesen

#Regulatorik, #Wirtschaft 16. December 2022

+++ Medical devices with FDA approval in Switzerland +++

In addition to medical devices with CE certification under EU law, medical devices with ap... Weiterlesen