According to this report, the cost of healthcare data breach rises 10% to an average of 7mill in 2020. Just a single breach could bring loss of reputation and trust in an institution brand. A certification would give one’s brand a competitive edge over the competitors, providing credibility and reducing time dedicated to audits.

• There will be challenges for the manufacturer that would like to have their DiGA reimbursed by health insurance companies since they will have to demonstrate compliance with requirements for data protection, interoperability, through generally recognized standards.
• The obligation to carry out studies with their own DiGA and the obligation to be better than alternative devices or procedures implies higher costs for the manufacturers. 
• The requirements of the DiGAV framework, the first of this kind to become operational in Europe, are stricter than the requirements of the MDR when it comes to the clinical evaluation and this might increase the manufacturers costs.
• Certificates usually do not provide a sufficient proof that a product is secure, as they exhibit a perspective on an application’s security posture at a given time for a given scope by a single auditor or tester. A validity of up to twelve months, combined with comparatively short release cycles, is not appropriate for making precise statements about the product.
• Reporting and remediation of the vulnerabilities and the monitoring of this process by national security authorities.