To understand regulatory approvals for medical devices to be placed on the UK and EU markets, see the government guidance and find more information on the Medicines & Healthcare Regulatory Agency MHRA website.

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You may need to register with Care Quality Commission (CQC) if you provide, or intend to provide, health or adult social care activities in England, even if the activity is delivered remotely or online. This is a legal requirement under the Health and Social Care Act 2008.

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For artificial intelligence technologies, this guidance issued by the Department for Science, Innovation & Technology in February 2024 for regulators is useful to understand the current position.

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NHS England have developed a self-assessment tool, the Digital Technology Assessment Centre (DTAC) which demonstrates to NHS stakeholders that digital and technology solutions meet clinical safety, data protection, technical security, interoperability and usability and accessibility standards.