Digi­tal Act: New regu­la­ti­ons on digi­tal health applications

The Ger­man Act to Acce­le­ra­te the Digi­ta­li­sa­ti­on of the Health­ca­re Sys­tem (Digi­tal Act, DigiG) has been in force sin­ce 26 March 2024. It is the basis for a num­ber of chan­ges in the area of digi­tal health appli­ca­ti­ons (DiGAs).

Inclu­si­on of risk class IIb products

Pri­or to the Digi­tal Act, DiGAs had been limi­t­ed to the lower risk clas­ses (I and IIa). This has now also been exten­ded to the hig­her risk class IIb within the mea­ning of Art. 51 in con­junc­tion with Annex VIII of Regu­la­ti­on (EU) 2017/745, so that the pos­si­bi­li­ty of inclu­si­on into the cata­lo­gue of reim­b­ursable DiGAs now appli­es to a signi­fi­cant­ly wider ran­ge of pro­ducts. Howe­ver, for DiGAs in risk class IIb stric­ter requi­re­ments app­ly for inclu­si­on into the list of reim­b­ursable pro­ducts main­tai­ned by the BfArM (Fede­ral Insti­tu­te for Drugs and Medi­cal Devices). Digi­tal health appli­ca­ti­ons in risk class IIb must pro­vi­de evi­dence of a medi­cal bene­fit in addi­ti­on to the rele­vant evi­dence of a posi­ti­ve health­ca­re effect (Sec­tion 139e (2) sen­tence 4 SGB V). This requi­res the sub­mis­si­on of a pro­s­pec­ti­ve com­pa­ra­ti­ve stu­dy (Sec­tion 11a (1)  DiGAV). A mere impro­ve­ment of a patient-relevant struc­tu­re or pro­ce­du­re is not suf­fi­ci­ent for the inclu­si­on of risk class llb DiGAs into the cata­lo­gue of reim­b­ursable products.

New § 33 (5a) SGB V: No agree­ments bet­ween manufacturers

The new­ly inser­ted sub­sec­tion (5a) in Sec­tion 33 SGB V pro­hi­bits manu­fac­tu­r­ers of digi­tal health appli­ca­ti­ons from ente­ring into legal tran­sac­tions or agree­ments with manu­fac­tu­r­ers of medi­cinal pro­ducts or medi­cal aids that are likely to rest­rict the insu­red per­son’s free­dom of choice or the free­dom of doc­tors to sel­ect medi­cinal pro­ducts or medi­cal aids. It is inad­mis­si­ble to design a DiGA in such a way that it only works with a spe­ci­fic sui­ta­ble medi­cinal pro­duct or medi­cal aid and does not take other sui­ta­ble pro­ducts into account. This is inten­ded to pre­vent so-called lock-in effects. Howe­ver, the ext­ent to which coope­ra­ti­on bet­ween manu­fac­tu­r­ers is per­mit­ted in con­nec­tion with DiGAs is not cle­ar­ly described.

It also remains to be seen what con­se­quen­ces this will have for the manu­fac­tu­rer’s design pro­cess for a DiGA. The­re is still con­tro­ver­sy among legal experts as to whe­ther it is suf­fi­ci­ent to con­sider a respec­ta­ble num­ber of medi­cinal or auxi­lia­ry pro­ducts or whe­ther an inter­pre­ta­ti­on of the facts based on the cor­re­spon­ding ele­ments of the GWB (Com­pe­ti­ti­on Act) and the UWG (Act against Unfair Com­pe­ti­ti­on) is more appro­pria­te. This is not yet fore­seeable or even bin­din­gly deci­ded. Manu­fac­tu­r­ers are the­r­e­fo­re well advi­sed to check on a case-by-case basis whe­ther the pro­hi­bi­ti­on in Sec­tion 33 (5a) SGB V is or has been observed.

Per­for­mance mea­su­re­ment and adjus­t­ment of remuneration

The DigiG intro­du­ces an application-accompanying per­for­mance mea­su­re­ment. Manu­fac­tu­r­ers are obli­ged to pro­vi­de the BfArM with data, such as the dura­ti­on and fre­quen­cy of use of the DiGA, in anony­mi­sed and aggre­ga­ted form. The new­ly intro­du­ced Sec­tion 139e (13) SGB V spe­ci­fies the data rele­vant for mea­su­ring the suc­cess of a DiGA:

  • the dura­ti­on and fre­quen­cy of use of the digi­tal health application,
  • pati­ent satis­fac­tion with regard to the qua­li­ty of the digi­tal health appli­ca­ti­on and
  • the patient-reported health sta­tus during the use of the digi­tal health application.

Accor­ding to the DigiG, the performance-based pri­ce com­pon­ents based on this data will be included in the remu­ne­ra­ti­on amounts by at least 20% as of 1 Janu­ary 2026. Manu­fac­tu­r­ers of DiGAs must take this increase in the pro­por­ti­on of performance-based com­pon­ents within the remu­ne­ra­ti­on into account in their calculations.

Con­clu­si­on

Manu­fac­tu­r­ers of digi­tal health appli­ca­ti­ons should check whe­ther they can bene­fit from the exten­ded scope of use for medi­cal devices in risk class IIb. The reusch­law quick check offers the pos­si­bi­li­ty of a free and non-binding check as to whe­ther a DiGA is sui­ta­ble for the fast-track pro­ce­du­re and can the­r­e­fo­re be included in the SHI reim­bur­se­ment catalogue.

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