The Health Insurance Portability and Accountability Act (HIPAA) is a US law that establishes requirements for processing protected health data. Institutions that collect or process these data in the USA and their subcontractors must comply with HIPAA if they want to avoid sanctions. For European companies in particular, HIPAA is a regulation that is difficult to understand…
DetailsWe have known how vulnerable IT security is in the healthcare sector since February 2016, when the IT infrastructures of many clinics were brought to a standstill by a simple virus attack. As a result, the authorities are paying closer attention to ensuring that not only clinics but also manufacturers guarantee the IT security of…
DetailsThe regulations relevant to usability engineering require formative evaluations. 1. Formative evaluation: Definition and differentiation a) Definitions In its guidance document, the FDA has published its own definition of the term: Thus, it replaces the old definition in the guideline Applying Human Factors and Usability Engineering to Medical Devices: „Process of assessing, at one or…
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