Summary of DiGA: How Germany Channeled Digital Health Apps Into Its Healthcare System
Gov：
German Federal Institute for Drugs and Medical Devices (or BfArM in short), law-makers.
Gov established Digital healthcare Act. （App 變成醫材納入政府健保）
Insurance covers 90% of Germany population to use DiGA (digital health application) by statutory health insurance (a system of health insurance that insures a national population against the costs of health care. -> 像是美國拿medicare的私人保險機構)
Gov negotiate price with statutory health insurance companies prior to patient subscription (政府事先統一定價，所有私人保險機構採用 -> 醫材公司不用跟一堆保險機構打交道才能讓病患使用)，patient subscribe the app with code form insurance companies (40,000 codes released)
Open source guideline to subscribe APP （透明化/推廣：政府統一窗口公布使APP prescribe流程, 推薦資訊）and marketing with manufacturers.
App Developers
Becoming DiGA: CE certified -> fast track:
permanent pathway: excessive clinical study data before application, granted forever.
preliminary pathway: pre-clinical data, approval for 1year (build complete data for permanent pathway)
Trended: mental health e.g., anxiety, burnout APP, orthopedic rehab APP
problem: patients recruiting leads to approval failure.
