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New Guide on Market Access and Reimbursement for Digital Health Care Products

New Guide on Market Access and Reimbursement for Digital Health Care Products

IGES has published a guide on market access and reimbursement for digital health care products.

When the Digital Healthcare Act (Digitales-Versorgung-Gesetz - DVG) came into force on 19 December 2019, “apps on prescription” for patients were introduced into the German health care system. This entitles approximately 73 million people insured under the statutory health insurance system to obtain access to apps called “DiGA” (Digitale Gesundheitsanwendung) with a prescription which can be given by doctors and psychotherapists and which is reimbursed by the health insurance scheme.

The prerequisite for a DiGA to be introduced is that it must have successfully undergone an assessment procedure at the Federal Institute for Drugs and Medical Devices (BfArM) and be listed in a directory of reimbursable digital health applications (DiGA directory). This directory summarizes essential information of all the DiGAs available to doctors, psychotherapists and users. In addition to the DVG, other laws exist which allow the costs of a digital health application to be covered by statutory health insurance funds (SHI funds). These laws apply if the digital health application is not listed in the DiGA directory or if reimbursement is covered under other regulations. In some cases, of course, reimbursement by the statutory health insurance funds is excluded.

IGES has published a guide which explains comprehensively this new law and the requirements for brining an innovative digital health care product to the German patients.

The authors are experts in the fields of medical technology, clinical and supply research, and reimbursement. In particular, the guide also describes reimbursement options for digital health care products that are not DiGAs and for combined products, such as a DiGA and a medical device. In addition, the guide provides general information on the German digital health market and the healthcare system.   

More information and ordering at: https://www.iges.com/presse/2021/guide-gesundheits-apps/index_ger.html