Advice

Regulatory information

Regulatory information

Table 4 shows the regulatory status of the remote electrocardiogram (ECG) interpretation consultancy services included in this briefing. Telehealth services operating in England must be registered with the Care Quality Commission (CQC). The CQC inspects these services and reports on the quality of care provided.

Some of the services included in this briefing supply or lease medical devices from third parties. These devices are regulated under the Medicines and Healthcare products Regulatory Agency's (MHRA) medical devices directive and must carry a CE mark.

Table 4 Regulatory information

Company

CQC registration

Medical device and CE mark

Broomwell Healthwatch

Registered 19 May 2011. Last inspection report 28 March 2013.

  • HeartView 12L and HeartView 12i (Aerotel Medical systems Ltd). Class IIa.

  • LifeCard (Spacelabs Healthcare Ltd). Class IIa.

MEOMED

Will register with the CQC when work begins (registration not needed before starting contract).

Intend to register with the CQC when work begins.

Primary Diagnostics

Will register with the CQC when work begins (registration not needed before starting contract).

Intend to register with the CQC when work begins.

ECG On‑Demand

Registered 28 October 2015. No inspection reports to date.

  • eMotion Faros 90, 180 and 360 (Mega Electronics Ltd). Class IIa.

  • Cardioline TouchECG with HD+, ECG100+, ECG200+ (Cardioline SpA). Class IIa.

Express Diagnostics

Registered 30 December 2010. Last inspection report 5 September 2013.

  • LifeCard (Spacelabs Healthcare Ltd). Class IIa.

  • eMotion Faros 90, 180 and 360 (Mega Electronics Ltd). Class IIa.

Smart Telecardiology

Not registered.

No information available.