Activ8rlives⁴ Health+Wellbeing App by Aseptika achieves CE mark as a medical device
Posted on January 14, 2019
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 Health+Wellness 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.
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