Regulating digital health and care Sir David Behan CBE, Chief Executive The International Enabled Care Conference 2017 16 October 2017 1

Does everyone have a smartphone? Use of technology is diversifying Why? Lifestyles are changing.. Limited time, faster, busier lives Usage of smartphones have increased to 81% of UK population 55% of people look at their phone within 15mins of waking Source: There’s no place like phone - Deliotte

A collective effort The public – people who use services, families and carers Staff – capable, confident and supported Providers – culture, organisation, expectations Commissioners and funders – expectations of quality Regulators – monitor, inspect, rate, take action, celebrate The public, staff, providers, commissioners and funders, as well as the regulator all have a responsibility Not just the regulators responsibility

Digital and inspect First round of PMS inspections are complete 40 providers registered 28 first-round inspections have been published Enforcement action in 15 Requirement notices alone in 9 No action required in 4 in addition, we have made referrals to other regulators where concerns have been raised about individual clinicians We have developed close working relationships with partner regulators throughout the UK and established a cross-regulatory forum which meets regularly to share intelligence and align our approaches. We are working with this cross-regulatory forum to clarify the regulatory landscape for online primary care services, and to consider where regulatory reform may be needed to ensure patients receive good care We have agreed a new MoU with the MHRA to underpin our strategic relationship (29 September 2017) Challenges for our regulations (especially our scope) include – increasing utilisation of artificial intelligence/machine learning, geographic distribution of services and UK professional registration of clinicians We are engaging with national stakeholders to identify and develop best practice guidance for this modality of consultation coordinated through the National Quality Board We have identified the importance of access to NHS medical records by independent sector services as an important component of safe care and treatment During this first round of inspection, we have identified five key themes: ascertaining patient identity consent capacity communication with registered GP safeguarding in the online environment We summarised this in a joint letter with regulatory partners to providers We have published advice to service users and their families about things to look out for when choosing an online healthcare service We have a number of ongoing registration applications, and are investigating cases where providers may be operating unregistered We are establishing a forum with providers on 26 October 2017 and will be publishing our final guidance on our approach to this sector in autumn We will publish an end-of-programme report before Christmas to take a cross-cutting view of what we have found, identify notable practice and to encourage improvement

Technology innovation work programme Our approach Encourage improvement, innovation and sustainability in care Technological innovation is changing the nature and delivery of care This work will encompass; Horizon scanning The development our approach, capacity and capability Review CQC’s role in the wider quality landscape for health and care services In line with our strategic objective to encourage improvement, innovation and sustainability in care, we have are developing a work programme to look at our approach to regulating technological innovation in health and care services To date, we have concentrated on the online primary care provider sector due to its growth, size and intelligence concerning risk to service users. However, it is clear that technological innovation is changing the nature and delivery of health and care services throughout our scope of registration: in social care, independent healthcare providers and the NHS Technological innovation is changing the nature and practice of health and care service delivery. Whether through increasing personalisation of medicine through genomics, the role of telemedicine and e-health services, advanced artificial intelligence or machine learning underpinning clinical decision-making or care robots into care homes: the way providers will deliver care and service users access or experience care, is changing We have established a cross-CQC work programme to develop our organisational capacity, capability and expertise to facilitate effective regulation of technologically innovative services across our scope of registration This work will encompass three main aspects – a horizon scanning exercise to understand the innovation landscape, implications and meaning for CQC, the development of our approach, capacity and capability to regulate technological innovation in health and care services, and reviewing CQC’s role in the wider quality landscape for health and care services. We are looking to engage with stakeholders and innovators across the healthcare landscape to develop this work. Engaging with stakeholders and innovators to develop this work

Increasing visibility of QSF CQC and TSA Working together to develop ‘what good looks like’ in technology enabled care Increasing visibility of QSF Revising public information on surveillance We are working with the TSA to develop “what good looks like” in technology enabled care, making the link between TSA’s Quality Standards Framework (QSF) and CQC’s assessment frameworks. We are attending TSAs annual conference in October, meeting with Alyson and others to take this forward. We have put TSA in contact with provider engagement in CQC to help increase visibility of QSF. We are revising our public information leaflet in the use of surveillance, expanding it cover a wider range of technologies and will ensure TSA’s perspective and the role of TEC is covered. We have shared the current version of this leaflet with Alyson.

Thank you www.cqc.org.uk enquiries@cqc.org.uk @CareQualityComm Sir David Behan CBE Chief Executive 7