An innovative app that enables people with long-term conditions to manage their own health has been approved as a Class 1 medical device.
Aseptika has announced that its Activ8rlives4 Health+Wellness App has been awarded the coveted CE mark by the UK’s Medicines and Healthcare products Regulatory Agency.
The certification is an important part of establishing quality standards during future development and gives confidence that the data created is of a medical standard.
The app synchronises to a UK-based Cloud database which means that data is never lost, is protected under UK law and can be coordinated across many Smart devices. The data system complies with GDPR and is Cyber Essentials certified. The Activ8rlives informatics system also adheres to the NHS Information Governance Toolkit Level 2 so that it can be used to provide services to NHS patients.
The technology is central to the Eastern AHSN-supported Active+ programme which enables people with long-term conditions to monitor a range of markers, including symptoms, weight and physical activity, as part of their self-care routine.
It has been used by Active+ participants to support their cardiac rehabilitation at Huntingdonshire District Council. Eastern AHSN provided funding for this initial project and has been supporting the set-up of the programme in other parts of the region.