Regulatory Approvals

Helicon Health operates in a highly regulated sector and as such is certificated by major regulatory and quality certifications including:

CE / CA Mark

The UK Government has made provision for a ‘UKCA’ mark. This is intended to be complimentary to the CE Mark and not replace it, and can be used where the Manufacturer is unable to apply a CE Mark; for instance, this may be if the Manufacturer has made use of a UK Approved Body (The UK equivalent of the EU Notified Body) and only wishes to place their products on the UK Market. Helicon Health and our partners work with UK and EU Notified Bodies.

ISO 9001

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS).

Helicon Health Limited have been assessed and approved by QMS International Ltd to the ISO 9001:2015 management systems, standards and guidelines under certificate number 336242020.

ISO 27001

ISO 27001 is the international standard that sets out the specification for an information security management system (ISMS). Its best-practice approach helps organisations manage their information security by addressing people and processes as well as technology.

Helicon Health Limited have been assessed and approved by QMS International Ltd to the ISO 27001:2013 management systems, standards and guidelines under certificate number 336262020.

ISO 14001

ISO 14001 is an internationally agreed standard that sets out the requirements for an environmental management system. It helps organisations improve their environmental performance through more efficient use of resources and reduction of waste.

Helicon Health Limited have been assessed and approved by QMS International Ltd to the ISO 14001:2015 management systems, standards and guidelines under certificate number 336252020.

Cyber Essentials

Cyber Essentials is a Government-backed, industry-supported scheme to help organisations protect themselves against common online threats.

Helicon Health Limited have been assessed and approved by Secured Business Computing Solutions to the Cyber Essentials scheme under certificate number IASME-CE-017424.

NHS DSPT

The Data Security and Protection Toolkit (DSPT) was developed in response to the 2016 NDG review of Data Security, Consent, and OptOuts (and the subsequent Government response).

The DSPT is an online self-assessment tool that allows organisations that process health and care data to measure their performance against the National Data Guardian’s 10 data security standards. The purpose of the system is to raise standards and provide confidence that health and care organisations are protecting the data they hold.

Helicon Health Limited are registered on the NHS Data Security and Protection Toolkit under Organisation code: 8K908.

Patient Management Tools

Our unique web based software offers secure access to a clinically useful electronic health record, alongside clinical guidance and an advisory system.

Clinical Governance

Our governance system gives anonymised access to INR and AF related results at practitioner, site, CCG and total service level.

Education and eLearning

Our courses for patients and healthcare professionals blend e-learning with face-to-face support.

Helicon Health started life delivering algorithmic precision medicine in stroke prevention with a strong clinical and socio technical research background. This led us naturally to hone our skills in the internet of medical things, remote vital sign monitoring and remote consultation. We describe what we do as “delivering healthcare virtually” which with quality, integrity and a sense of collaboration and fair-play is our mission.
Tony Bowden
Chief Executive Officer, Helicon Health
Share This