Leyr - secure and scalable sharing of health data

Purpose and goal:

Leyr offers a platform for scalable and secure sharing of health data between health apps and medical record systems. The project aims

to combine eligibility requirements according to medical technology regulations with eligibility requirements on information security and implement the working methods and

processes required to, as a small and fast-growing company, ensure compliance with the high eligibility requirements set for products

within healthcare. Collaborating with regulatory consultants in both medical technology and information security has gone very well. Expected results and effects:

The goal of the project is well met, we have implemented a quality management system that covers both quality and information security and prepared for a certification according to ISO 27001. Approach and implementation:

Together with regulatory experts, we have analyzed the regulations and eligibility requirements from important partners that exist in the area of information sharing in healthcare. We have then mapped the requirements against the eligibility requirements set for quality in medical technology with a focus on medical technology software. We have set up a framework for quality management and information security and written policies and instructions based on how we work.