Activ8rlives4 Health+Wellness App by Aseptika achieves CE mark as a Class 1 medical device.
Aseptika Ltd (Cambridgeshire, UK) is pleased to announce that its Activ8rlives4 Health+Wellness App has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a Class 1 medical device.
Users of the App are empowered to monitor their physiological signs, symptoms, weight, physical activity, food diary and medication adherence as part of their self-care routine. Any number of custom “trackers” can be created. Many Users of the App comment on how Activ8rlives4 brings all of their data together in one place.
Activ8rlives4 App synchronises to a UK-based Cloud database which means that data is never lost, is protected under UK law and can be co-ordinated 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. CE marking as a medical device is an important part of establishing quality standards during future development and gives confidence that the data created is of a medical standard.
In early January 2019, the NHS announced its Long Term 10-Year plan. Self-management, patient education and empowerment are themes highlighted throughout. Enabling patients to monitor their health conditions at home and exchange data with their medical records is becoming a powerful way to decrease the load on front-line clinical services. Ensuring that patient-generated data is being imported from a trusted source is vital if clinical staff are to have confidence to use it to make clinical decisions. CE marking as a Class 1 medical device is an important qualification in establishing this confidence.
The Activ8rlives4 Health+Wellness App is available for patients to use free of charge and is available for the Apple, Android and Kindle Fire platforms.