The Care Quality Commission (CQC) is the independent regulator of health and adult social care in England. Their role is to register, monitor and rate healthcare services.
Under the Health and Social Care Act 2008, Healthcare providers in scope are required by Law to register with the CQC and submit themselves for inspection.
For the avoidance of doubt, Diagnostic and Screening providers supplying ambulatory ECG (Holter) analysis and reporting services are required, by Law, to register with the CQC. Whilst an exemption exists for 12-lead ECG interpretation, it does not extend to Holter analysis. Companies who provide in-scope services in England, without CQC registration, put themselves and their customers at risk.
This requirement seems to be poorly understood particularly in the wearable ECG-Patch market where even big brand names flout the regulations.
ECG On-Demand is the first of the wearable Holter monitoring services to be inspected by the CQC using the UK Government mandated rating system introduced in 2018.
An inspection was carried out by 2 senior CQC inspectors on 9th July 2019 with a detailed assessment published on 16th September 2019 https://www.cqc.org.uk/sites/default/files/new_reports/AAAJ5815.pdf. The report identifies 4 areas of outstanding practice in addition to awarding an outstanding rating for leadership.