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Cyber Essentials
Certificate Number: ASME–CE-
The Cyber Essentials accreditation helps to guard our organisation against the most common cyber threats and demonstrate our commitment to cyber security.
It is a government backed scheme that protects our organisation and reassures our customers that we secure our IT against cyber attack to keep their data safe and secure.
CE Mark
Certificate Number:
LungHealth software is a certified Class 1 medical device. UKCA mark requirements for medical devices are based on the requirements of the relevant Annexes to the European Directive 93/42/EEC on medical devices (EU MDD) as modified by Part II of Schedule 2A of the UK Medical Device Regulations 2002 as they apply in Great Britain.
There is a variety of requirements including technical documentation, risk analysis, compliance with essential requirements and clinical evaluation to certify that our device works in accordance with the intended purpose and meets legislation relating to safety and performance.
NHS Data Security & Protection
Toolkit Number:
The Data Security and Protection Toolkit is an online self-assessment tool that allows organisations to measure their performance against the National Data Guardian’s 10 data security standards.
All organisations that have access to NHS patient data and systems must use this toolkit to provide assurance that they are practising good data security and that personal information is handled correctly.
Orcha
The ORCHA Review is a robust digital health assessment that underpins a large proportion of the world’s national and regional digital accreditation models.
The intelligent Review looks at a digital health technology’s nature and purpose and identifies which of the 350+ criteria points it meets across Clinical/Professional Assurance, Data & Privacy, and Usability & Accessibility.
The Review comprises nationally recognised digital health standards and regulations, and now includes an adapted version of the NICE Evidence Standards Framework. ORCHA’s algorithm looks at how appropriately the technology meets the relevant and compulsory standards, producing an objective and independent score.
