Astrid Schulze

7 steps to the DiGA directory

By Astrid Schulze April 24, 2023 Leave a comment

Since 2020, the German legislature has allowed the reimbursement of digital health applications (DiGA). DiGA manufacturers must fulfill several requirements for this. This article describes the steps required to do so. Step 1: Define the business case a) Determine the intended purpose of the DiGA The intended purpose is the basis for all further steps.…

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EU General Data Protection Regulation GDPR

By Astrid Schulze June 4, 2018 Leave a comment

The EU General Data Protection Regulation must be complied with starting at 25 May 2018, at the latest. Many companies, amongst them also medical device manufacturer and operators such as hospitals, are not adequately prepared. This article gives you a review of the main concepts and requirements of the General Data Protection Regulation and examines…

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