Focuarea Datadrivven Health and Health Care

Purpose and goal:

To increase knowledge about secondary use and evidence generation based on health data from a medical technology perspective. Concrete progress should be achieved regarding legal, regulatory and organizational issues surrounding the secondary use of health data for the development of data-driven products, such as digital information systems and decision support.

Knowledge is increased through exchange between the work packages as well as further dissemination. Through a larger case study within healthcare data, opportunities and obstacles will be mapped. Expected results and effects:

Activities around data storage and sharing for secondary use, classification of health technology products, as well as follow-up and evidence, will promote a coherent and effective support system for the development and implementation of MT solutions in Sweden. This by enabling MT product development based on health data,

supporting the regulatory and legal strategy in product development, as well as facilitating follow-up and evidence generation for implemented medical technology. Approach and implementation: The project is divided into three work packages. AP1: development of processes and functions for data storage and sharing

AP2: development of a tool to identify legal and regulatory eligibility requirements for medical devices based on health data; AP3: development of a data model to link health data regarding safety, efficacy and use of implemented medical technology in HSV.

The project is also given additional support functions through project management (AP0), as well as legal support from involved actors in the regions and healthcare.