Analysis och regulatory and legal requirements for commercial version of Asthmatuner
|Funding from Vinnova||SEK 67 500|
|Project duration||September 2016 - November 2016|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
Asthmatuner is unique because it makes the meeting between doctors and patient more efficient and also improves communication. One of the functions is that the patient receives a direct concrete treatment advice in their mobile phone, the innovative step in this makes legislation and regulatory control of the area still a little unclear. The aim has been to strengthen expertise in the form of regulatory and legal expertise to ensure the quality of the commercial version. We believe that the project objectives have been met.
Expected results and effects
The judicial analysis clarifies questions including queries about personal data management for various caregivers, data storage, and managing health professionals using the system. It also clarifies the login and requirements for consent, and what the data protection requirements entails. The regulatory assessment has reviewed the regulatory strategy and a risk analysis before release. We have also developed templates and documents for Medituner, and clarified methods and work processes.
Planned approach and implementation
It is primarily the function that allows the patient to receive a concrete treatment advice directly into their mobile phone from their healthcare provider that is new and so innovative that the legislative and regulatory control around the area is still not clear. We have identified two leading experts who have previously worked with investigations at a national level. The regulatory and legal assessment from them with specific questions has been invaluable for the development of a complete commercial version of Asthmatuner.