Asked by: Lord Clement-Jones (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether, and if so when, the minutes of the meetings of the NHSX Ethics Advisory Board will be published.
Answered by Lord Bethell
The Ethics Advisory Board has met seven times since Thursday 2 April and minutes from these meetings will shortly be made publicly available - subject to being agreed by the App Oversight Board.
Asked by: Lord Clement-Jones (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether the NHSX COVID-19 contact tracing application is considered to be a Grade 1 medical device in law, and if so, what rules must trials of such a product follow.
Answered by Lord Bethell
The NHSX COVID-19 contract tracing application is considered Class IIa under the Medical Devices Regulations (2002).
The legal requirements relating to clinical investigations are set out in the Medical Devices Regulations 2002 (section 16 and section 29) and the Medical Devices Directive (Annexes VIII and X).
A clinical investigation of a non-CE-marked device must be designed to establish that the performance claimed by the manufacturer can be adequately demonstrated, and that the device is judged to be safe to use on patients taking into account any risks associated with the use of the device when weighed against the expected benefits.
The Medicines and Healthcare products Regulatory Agency reviewed an application made by NHSX and authorised the supply of the non-CE-marked NHSX COVID-19 contact tracing app for a pilot on the Isle of Wight in the interests of the protection of public health under Regulation 12(5) of the Medical Devices Regulations 2002.
Asked by: Lord Clement-Jones (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government when the NHSX Ethics Advisory Board approved the Data Processing Impact Assessment, including its risk registers, for the NHSX COVID-19 contact tracing application.
Answered by Lord Bethell
The Ethics Advisory Board (EAB) is an advisory body and does not approve documentation. Notwithstanding, and in the interests of transparency, an early draft of the Data Protection Impact Assessment (DPIA) was shared with the EAB on 29 April and subsequently developed.
Further DPIAs will meet the best practice guidance set out by the Information Commissioner’s Office and will be iterated for every stage of the rollout.
Asked by: Lord Clement-Jones (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what advice they are giving to live music venues, retailers and recording studios on whether they should close due to COVID-19.
Answered by Lord Bethell
On 23 March the Government stepped up measures to prevent the spread of COVID-19 and save lives. To reduce social contact, the Government has ordered businesses and venues to close, except those with exemptions. With regard to music venue exemptions, small group performances for the purposes of live streaming could be permissible where Public Health England guidelines are observed, and no audience members attend the venue.
Further social distancing measures have also been enacted with the banning of all mass gatherings.