On June 23, 2022, the German Federal Office for Information Security (“Office”) published technical guidelines on security requirements for healthcare apps, including mobile apps, web apps, and background systems.  Although the technical guidelines are aimed at healthcare app developers, they contain useful guidance for developers of any app that processes or stores sensitive data.

The guidelines set out a number of security levels and a security risk assessment.  The risk assessment takes into account the following aspects: (1) the apps’ purpose; (2) its architecture; (3) the source code; (4) third party software integrations; (5) cryptographic implementation; (6) authentication mechanisms; (7) data storage and protection; (8) auditing of paid resources; (9) network communication; (10) platform-specific interactions; and (11) resilience.  The guidelines also include specific security requirements for digital healthcare apps with biometric authentication mechanisms.

The guidelines are based on state-of-the-art security techniques used in the healthcare sector and the Office’s findings in several of its projects.  They also take into account feedback received from industry stakeholders, the German Federal Institute for Drugs and Medical Devices, and the German Federal Commissioner for Data Protection and Freedom of Information.

The Office offers a certification to healthcare apps that comply with the guidelines.

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Photo of Kristof Van Quathem Kristof Van Quathem

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty…

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty years and developed particular experience in the life science and information technology sectors. He counsels clients on government affairs strategies concerning EU lawmaking and their compliance with applicable regulatory frameworks, and has represented clients in non-contentious and contentious matters before data protection authorities, national courts and the Court of the Justice of the EU.

Kristof is admitted to practice in Belgium.

Photo of Anna Sophia Oberschelp de Meneses Anna Sophia Oberschelp de Meneses

I advise companies across the EU on technology laws, with a focus on data protection, cybersecurity, and current consumer protection laws. I help businesses navigate complex regulations like the GDPR, AI Act, Digital Services Act, Unfair Commercial Practices Directive, and the upcoming Digital…

I advise companies across the EU on technology laws, with a focus on data protection, cybersecurity, and current consumer protection laws. I help businesses navigate complex regulations like the GDPR, AI Act, Digital Services Act, Unfair Commercial Practices Directive, and the upcoming Digital Fairness Act, turning legal requirements into practical, business-friendly solutions.

In data protection, I support tailored GDPR compliance, international data transfers, and privacy-conscious marketing. On cybersecurity, I guide clients through risk assessments, incident response, and evolving laws such as NIS2 and the Cyber Resilience Act. Regarding consumer protection, I advise on existing laws to help businesses revise their terms and conditions for compliance and review online interfaces to ensure all mandatory consumer information is clearly provided, tackling issues like dark patterns and unfair contract clauses.

Fluent in multiple languages and experienced across borders, I’m passionate about helping clients embed compliance into their operations and thrive in the fast-changing digital landscape.