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 data protection, data security and cybercrime matters in various sectors, and in particular in the pharmaceutical and information technology sector. Kristof has been specializing in this area for over fifteen years and covers the entire spectrum of…

Kristof Van Quathem advises clients on data protection, data security and cybercrime matters in various sectors, and in particular in the pharmaceutical and information technology sector. Kristof has been specializing in this area for over fifteen years and covers the entire spectrum of advising clients on government affairs strategies concerning the lawmaking, to compliance advice on the adopted laws regulations and guidelines, and the representation of clients in non-contentious and contentious matters before data protection authorities.

Photo of Anna Oberschelp de Meneses Anna Oberschelp de Meneses

Anna Sophia Oberschelp de Meneses is an associate in the Data Privacy and Cybersecurity Practice Group.  Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker.  Anna advises companies on European data protection law and helps clients coordinate…

Anna Sophia Oberschelp de Meneses is an associate in the Data Privacy and Cybersecurity Practice Group.  Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker.  Anna advises companies on European data protection law and helps clients coordinate international data protection law projects.  She has obtained a certificate for “corporate data protection officer” by the German Association for Data Protection and Data Security (“Gesellschaft für Datenschutz und Datensicherheit e.V.”). She is also Certified Information Privacy Professional Europe (CIPPE/EU) by the International Association of Privacy Professionals (IAPP).  Anna also advises companies in the field of EU consumer law and has been closely tracking the developments in this area.  Her extensive language skills allow her to monitor developments and help clients tackle EU Data Privacy, Cybersecurity and Consumer Law issues in various EU and ROW jurisdictions.