The Digital Healthcare Act (Digitale-Versorgung-Gesetz DVG) was published in the German Federal Law Gazette (Bundesgesetzblatt) on 18 December 2019 and entered into force on 19 December 2019, having been passed by the German Parliament (Bundestag) in November 2019. Among other regulations intended to expand the digitalisation of the healthcare system, the law will allow the prescription and reimbursement of digital health apps, which was called a “world first” by the German Health Minister, Jens Spahn.

Health applications, which are classified as low-risk medical devices (class I or IIa), will be reimbursed by the statutory health insurance under the following provisions according to new Sec. 33a Social Security Code V (Fünftes Buch Sozialgesetzbuch -SGB V):

• Prescription by a doctor or permission from the health insurance company

• Inclusion in the directory for digital health applications by the Federal Institute for Drugs and Medical Devices (Bundesamt für Arzneimittel und Medizinprodukte -BfArM)

The BfArM has to ensure the app’s security, functionality, quality, data security and data protection before including it in the directory. Furthermore, the manufacturer has to prove the positive effects of the health application on patients’ health within a trial period of one year. During this trial period, the manufacturer is allowed to freely set the price which would have to be reimbursed by the statutory health insurance. If proof of positive effects can be provided, the BfArM will include the app permanently in the directory, which leads to price negotiations between the manufacturer and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in order to determine the definitive reimbursement amount for the listed health application.

Further details, particularly on the procedure for the inclusion of health applications in the BfArM directory, have yet to be laid down by the Federal Ministry of Health in an ordinance.

The new law will have a far-reaching positive impact on the developers of such health applications as well as patients, as the vast majority (about 90%) of the German population is covered by statutory health insurance.