The Zanadio app, which helps in treating obesity, has been proved effective in reducing weight in over 30,000 patients, and the manufacturer, Aidhere GmbH, had permanently included the app in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM). However, Aidhere filed for bankruptcy due to lower reimbursement amounts. The company was granted less than half of the original price per prescription, which had caused severe financial difficulties. The new reimbursement amounts are effective from October 2021, and the company did not disclose the amount of repayments.
Other health applications have also had similar issues. The manufacturer of the migraine application M-sense stopped operating in 2021 because it did not fulfill the requirements for permanent listing. Similarly, the makers of the cancer psychological distress app Mika also ceased operations.
Security breaches have also been a consistent issue with various DiGA apps. Zerforschung, a hacker organization, found security gaps in the depression app Edupression, and the digital diary for cancer patients Cankado, which resulted in it being removed from the DiGA directory. Therefore, the BfArM released new test criteria for DiGA and digital care applications in September 2022.
Despite Aidhere GmbH filing for bankruptcy, the Zanadio app will remain available and prescribable, with the company planning to continue operations with new investors and retain its 150 employees. Overall, the “apps on prescription” initiative has not seen a significant breakthrough, with the health insurance companies complaining about their high costs.
