Digi-HTA, assessment framework for digital healthcare services: information security and data protection in health technology – initial experiences

It is well-known that security issues in medical devices, services and applications have potentially catastrophic consequences. To avoid compromising patient data or information systems, it is essential that healthcare services and products meet the relevant information security and data protection requirements. For these reasons, the Digi-HTA assessment includes information security and data protection assessment domains. The outcome of the Digi-HTA process is a recommendation that decision-makers can use during the procurement process. We present results and experiences from the first assessments made in the Digi-HTA process. We have assessed six products so far and multiple assessments are in progress. The results indicate that healthcare product manufacturers have found the process useful, and usually, the manufacturers have had to improve the security of their product during the Digi-HTA process to get a favourable recommendation for their product. The assessment processes have taken longer than expected due to shortcomings and ambiguities in the provided self-assessment forms, and due to feedback cycles and meetings prompted by assessment findings. Of the six assessed products, four received a green light in information security and data protection, whereas two have received a yellow light due to issues that were not fixed during the process. In addition to shortcomings in adhering to best practices, we have also found exploitable security issues.

Model-Based Security Testing

Security testing aims at validating software system requirements related to security properties like confidentiality, integrity, authentication, authorization, availability, and non-repudiation. Although security testing techniques are available for many years, there has been little approaches that allow for specification of test cases at a higher level of abstraction, for enabling guidance on test identification and specification as well as for automated test generation. Model-based security testing (MBST) is a relatively new field and especially dedicated to the systematic and efficient specification and documentation of security test objectives, security test cases and test suites, as well as to their automated or semi-automated generation. In particular, the combination of security modelling and test generation approaches is still a challenge in research and of high interest for industrial applications. MBST includes e.g. security functional testing, model-based fuzzing, risk- and threat-oriented testing, and the usage of security test patterns. This paper provides a survey on MBST techniques and the related models as well as samples of new methods and tools that are under development in the European ITEA2-project DIAMONDS.Comment: In Proceedings MBT 2012, arXiv:1202.582