Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications

Ulrike Elteste, Kristof Van Quathem and Anna Oberschelp de Meneses of Covington & Burling write:

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps.  Accordingly, on January 15, 2020, the German government published a draft regulation setting out the procedure for examining the eligibility of health apps to receive insurance reimbursements, as well as the requirements that such health apps must fulfill.

Notably, among its various obligations, the draft regulation and its Annex 1 include a number of data protection and data security requirements that health app developers must comply with if their health apps are to benefit from the reimbursement scheme.

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