Recommendation 4

HM Government Accepted in Part

Partially accept The government partially accepts this recommendation. We are committed to ensuring high quality, safe–to–use STI testing and as such, self–test online diagnostic STI tests that meet the definition of a medical device or In Vitro Diagnostic (IVD) must comply to the UK Medical Devices Regulations. They are therefore regulated by the relevant bodies who carefully monitor safeguarding risks for all users and ensure quality standards are met. Whether sold online or in physical premises, licences for treatments for STIs are only granted by the Medicines and Healthcare products Regulatory Agency (MHRA) once applicable standards of safety, quality and efficacy (effectiveness) are met. As with any medicine, the MHRA keep the safety and effectiveness of medicines to treat STIs under close review. Although patient safeguarding is an absolute priority for MHRA, there is no separate process for child safeguarding. The market surveillance process through which MHRA regulates treatments, ensures that any safety concerns raised (whether by children or adults) will be picked up if they do arise. The Care Quality Commission (CQC) is the regulator for health and social care services in England (there are different regulators for the other home nations). If an STI service (whether wholly online or with a face–to–face element) is based in England and is delivering one or more regulated activity to people in England, then the provider will need to register with CQC. For all services that they regulate, CQC can challenge poor care and drive improvement, including in the important area of safeguarding. Providers of online STI services required to register with CQC must assure themselves and CQC that they have systems, processes, and adequate training to support staff in identifying and responding to child safeguarding risks and concerns. This must include a clear understanding of the legal framework pertaining to children of different ages and competence. Safeguarding assessments, including the risks of sexual exploitation and abuse, must be completed before providers issue self–test kits to under–18s. Any risks identified should have a timely and appropriate safeguarding response, in line with internal policies, as well as those of the Local Safeguarding Children Partnership. The CQC’s single assessment framework has a specific quality statement around safeguarding, which describes what they can ask providers to demonstrate during regular assessments, for example: • There is a strong understanding of safeguarding and how to take appropriate action. • There are effective systems, processes and practices to make sure people are protected from abuse and neglect. • There is a commitment to taking immediate action to keep people safe from abuse and neglect. This includes working with partners in a collaborative way. For online services CQC pay particular attention to the way people who use services are identified online and to how issues of consent (for example, sharing information with other healthcare providers) are managed. Some online only providers of STI tests and treatments, however, may be out of scope of CQC regulation due to the way in which they are set up. For example, if they are not based in England and/or if they do not employ healthcare professionals currently listed as being in scope of TDDI. The National Institute for Health Care and Excellence’s (NICE) guidance on Child Maltreatment will be included as a link in the new internal CQC Safeguarding Guidance for CQC staff that is due to be published in February, alongside the updated Safeguarding Policy. However, the NICE guidance is not specifically referred to when evaluating safeguarding on inspection. A European Conformity (CE) marking or UK Conformity Assessed (UKCA) marking is required to demonstrate conformity to current regulations. There are essential and regulatory requirements that must be met before self-test diagnostic tests are made available in the UK and a conformity assessment be undertaken by UK Approved Bodies or EU Notified Bodies.