Connected health involving health technology, digital media and mobile devices opens up new opportunities to improve the quality and outcomes of both health and social care. Such transformational innovation, however, may also bring about significant regulatory compliance risks.
On 3 March 2017, four UK healthcare regulators, including the Care Quality Commission (“CQC”), made a joint statement reminding providers of online clinical and pharmaceutical services, and associated healthcare professionals, that they should follow professional guidelines to ensure such services are provided safely and effectively.
As indicated in the joint statement, CQC inspections found that certain online services were found to be too ready to sell prescription-only medicines without undertaking proper checks or verifying the patient’s individual circumstance, raising significant concerns about patient safety. The view taken by the regulators is that the same safeguards should be put in place for patients whether they attend a physical consultation with their GP (primary care physician) or seek medical advice and treatment online.
UK domestic law already provides that online providers must assess the risks to people’s health and safety during any care or treatment and make sure that staff have the qualifications, competence, skills and experience to keep people safe. The CQC has the power to bring a criminal prosecution if a failure to meet this responsibility results in avoidable harm to a person using the service or if a person using the service is exposed to significant risk of harm. Unlike other enforcement regimes, the CQC does not have to serve a warning notice before prosecution. The CQC can also pursue criminal sanctions where there have been fundamental breaches of standards of quality and safety and can enforce the standards using civil powers to impose conditions, suspend or cancel a registration to provide the online services.
In March 2017, the CQC published guidance clarifying its existing primary care guidance by setting out how it proposes to regulate digital healthcare providers in primary care. The guidance provides that the CQC will evaluate the following key lines of inquiry (“KLOEs”): whether services are safe, effective, caring, responsive to people’s needs and well-led. Each KLOE is accompanied by a number of questions that inspectors will consider as part of the assessment, which are characterised by the CQC as ‘prompts’.