On 14 December 2023, the German Federal Parliament (Bundestag) passed the Act to Accelerate the Digitalization of the Healthcare System (Gesetz zur Beschleunigung der Digitalisierung des Gesundheitswesens," DigiG").
This Act is meant to boost the further development of digital health in Germany. It has inter alia consequences for DTx in Germany.
Key elements of the Act include, inter alia, new provisions on digital health applications (DiGA) and telemedicine. DiGA should be more strongly integrated. In this context, various new aspects are being determined. Digital medical devices in risk class IIb are now also allowed to be used as DiGA and can be reimbursed by statutory health insurance funds. Previously, reimbursement only applied to digital medical devices in the lower risk classes I and IIa. Digital medical devices in risk class IIb are software that can also be used for serious illnesses or for decision-making in situations that are critical for the person's state of health. Regarding the Guidance of the Medical Devices Coordination Group (MDCG 2021-24) this can be for example "a mobile app intended to analyze a user’s heartbeat, detect abnormalities and inform a physician accordingly […], if the information provided by the software is intended to guide the physician in the diagnosis".
The Act also contains new provisions regarding the pricing of DiGA: The decisive factor shall be success-based remuneration – up to 20 percent of the price is to be calculated based on success. According to the current version, this shall apply from 26 January 2026.
At first, the draft of the DigiG stipulated a trial period of 14 days for DiGA. This meant that if the insured person declared to the manufacturer within 14 days of using a DiGA for the first time that he/she would not use it permanently, the manufacturer would not receive any remuneration for the DiGA. This trial period is no longer included in the current version of the DigiG. It is explained that the deletion of the provision continues to consider the balance sought by the Act between openness to innovation in the interest of better healthcare and the interest in an economical use of funds.
Moreover, measures were introduced to expand telemedicine. The limit on telemedicine has been canceled. Previously, there was an overall limit of 30 percent of all treatments that could be provided as telemedical consultations.
Under the DigiG, the provision of telemedical services by institutions such as university ambulances or psychiatric institute ambulances as well as psychotherapeutic consultations are now also possible. Furthermore, new regulations on "assisted telemedicine in pharmacies" are being introduced. Assisted telemedicine measures mean, for example, advice from the pharmacy on telemedicine or instructions on how to use it.
Other key elements of the Act are the electronic patient file and the e-prescription. An opt-out system applies regarding the electronic patient file. Those who do not wish to use the electronic patient file can object. The e-prescription is to be developed further and shall become a binding standard in the future. In addition, a digital advisory board is to be set up at the National Digital Health Agency (Gematik) to advise the Agency on an ongoing basis on all its findings with balanced recommendations on issues of data protection, data security, data usage and user-friendliness.
Following the second and third readings in the German Federal Parliament, the Act is now expected to be finally presented to the German Federal Council (Bundesrat) in February 2024.
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