Digital Health Applications (DiGAs) in Germany

In our dig­i­tal age, more and more apps are being devel­oped that improve patient care. Called Dig­i­tal Health Appli­ca­tions or “DiGAs” in Ger­many, these are evi­dence-based cer­ti­fied med­ical devices that sup­port patients in their treat­ment and whose med­ical pur­pose is achieved through a dig­i­tal tech­nolo­gies-based main function.

Man­u­fac­tur­ers of DiGAs will be reim­bursed by statu­to­ry health insur­ance com­pa­nies in Ger­many if the dig­i­tal health appli­ca­tions meet the require­ments of laws and reg­u­la­tions such as the Dig­i­tal Health­care Act (DVG), the asso­ci­at­ed ordi­nance (Dig­i­tal Health Appli­ca­tions Ordi­nance — DiGAV) and the Dig­i­tal Act (DigiG), the lat­ter of which only came into force on March 26, 2024.

All DiGAs that are pro­vi­sion­al­ly or per­ma­nent­ly list­ed in the DiGA direc­to­ry main­tained by the Ger­man drug and med­ical devices reg­u­la­tor BfArM become eli­gi­ble for pre­scrip­tion and thus reim­burse­ment. But to be list­ed a DiGA must first under­go a review pro­ce­dure at the BfArM, the so-called “fast-track procedure”.

In addi­tion to the tech­ni­cal and data pro­tec­tion require­ments, § 10 of the DiGAV stip­u­lates that clin­i­cal inves­ti­ga­tions must be con­duct­ed to demon­strate a so-called “pos­i­tive care effect” of the DiGA. Pos­i­tive care effects are either a med­ical ben­e­fit (e.g., improve­ment in qual­i­ty of life, pro­lon­ga­tion of sur­vival, or short­en­ing of the dura­tion of ill­ness) or patient-rel­e­vant struc­tur­al and pro­ce­dur­al improve­ments in care. In the case of struc­tur­al and pro­ce­dur­al improve­ments, DiGA aims to sup­port the actions of patients or to inte­grate process­es between patients and ser­vice providers. For exam­ple, Dig­i­tal Health Appli­ca­tions can be used to sup­port patients in cop­ing with ill­ness-relat­ed dif­fi­cul­ties in every­day life or in the coor­di­na­tion of treat­ment process­es. Treat­ment adher­ence, patient safe­ty, patient sov­er­eign­ty, and health lit­er­a­cy are oth­er areas that can be achieved or sup­port­ed with the help of dig­i­tal health applications.

Accord­ing to the Ger­man Social Code (SGB) — Fifth Book (V) § 139e clause 4, the sci­en­tif­ic eval­u­a­tion con­cept to be sub­mit­ted as part of the fast-track pro­ce­dure has to be pre­pared by a man­u­fac­tur­er-inde­pen­dent insti­tute to demon­strate the pos­i­tive care effect. As a con­tract research orga­ni­za­tion and con­sul­tan­cy with many years of expe­ri­ence, we are hap­py to do this for you.

Our range of services and consulting includes:

  • Cre­ation of the eval­u­a­tion concept
  • Sys­tem­at­ic lit­er­a­ture research
  • Prepa­ra­tion of the sys­tem­at­ic data analysis
  • Clin­i­cal Inves­ti­ga­tion Plan (CIP) creation
  • Sta­tis­ti­cal Analy­sis Plan (SAP) creation
  • Sup­port dur­ing the con­sul­ta­tion pro­ce­dure with the BfArM
  • Con­duct of the clin­i­cal trial
  • Clin­i­cal Inves­ti­ga­tion Report (CIR) preparation

Con­tact us and get an impres­sion of our dynam­ic team and way of thinking.