With the new legislation for national reimbursement of digital solutions, Germany has become the single largest market opportunity for reimbursed digital solutions. With one national decision, it will be possible to establish national reimbursement for your digital solution! The key criteria for the scope of reimbursable products are: - Medical device class I or IIa under the new MDR (with transitional rules) - Main function relies on digital technologies - Untended use is centered around the patient, possible to include the doctor Agenda Description of formal the pathway for the DIGA From what is known about the legislation today, there is limited methodological framework in place to support the decision-maker on how to assess and reimburse the most relevant solutions. The new pathway creates valuable opportunity, however, the development of an appropriate methodological framework is crucial for society as well as for those companies who have solutions with a relevant value in the healthcare system, to prevent solutions with little or no value from entering the system. It is intriguing that until the final decision about reimbursement is made (Coverage with Evidence Development), there is an initial period where evidence can be generated while being reimbursed in the statutory healthcare system. Generally, the use of digital solutions involves multiple evaluation approaches, since they have different modes of actions.