An extract from The Healthcare Law Review, 4th Edition
The licensing of healthcare providers and professionalsi Regulators
There are a range of healthcare regulators, including separate regulators for healthcare operators and professionals.Institutional healthcare providers
The key regulator for institutional health providers in England is the Care Quality Commission (CQC). Whether a provider requires CQC regulation is dependent on the activities they provide; carrying out a 'regulated activity' without being CQC registered is a criminal offence subject to a potentially unlimited fine or up to 12 months' imprisonment, as well as lesser regulatory sanctions. The regulated activities are set out in the Regulated Activities Regulations and include:
- the provision of personal care at home;
- residential accommodation with nursing or personal care;
- treatment for a disease, disorder or injury by or under the supervision of a healthcare professional;
- surgical procedures carried out by a healthcare professional;
- diagnostic and screening procedures; and
- medical advice or triage, over the telephone or by email.
To be registered, a new provider must register with CQC, which will assess the suitability of the applicant. All registered providers must have a registered manager responsible for the overall management of the service, who also must be fit for the role. Among others, the following documents may be required:
- safeguarding policy and procedures document;
- buildings regulations document;
- registered manager's supporting evidence; and
- governance document.
CQC anticipates that it will provide a decision within 10 weeks of an application. Registration can be either unconditional or with conditions. Appeals against a decision on registration are made to the First Tier Tribunal. When assessing an application, CQC will focus on:
- compliance with the fundamental standards, including person-centred care, dignity and respect, consent, and safe care and treatment;
- management and safeguarding; and
- whether the provider's directors are of good character and have the necessary competence and qualifications.
Once registered, providers are required to share information with CQC and notify it of changes in registered details or certain adverse incidents. CQC also operates a regime of both announced and unannounced inspections of providers. CQC has wide-ranging enforcement powers to place conditions on registration or to suspend or even cancel registration where there have been breaches of its requirements.
Following the failure in 2011 of Southern Cross, one of the largest care providers in England at the time, CQC also has limited market oversight powers in relation to the largest care providers.Healthcare professionals
Healthcare professionals in England are usually required to be registered with one of the eight different regulators, including the General Medical Council and the General Dental Council. Some regulators operate on a UK-wide basis, while others only operate in certain nations. A new profession of nursing associates has been regulated in England only since early 2019. These regulators are overseen by the Professional Standards Authority for Health and Social Care (PSA). The PSA also accredits voluntary registers for health and care professionals (such as psychotherapists or complementary healthcare practitioners) where there is no legal requirement for registration. Not all individuals involved in front-line care are regulated, including 'healthcare assistants', who may provide a wide range of services to patients under the direction of a registered healthcare professional.
Where a profession is regulated by a statutory regulator, registration is compulsory under the applicable legislation. Each regulator details its requirements for initial registration (i.e., qualifications, experience and good character), continued registration (i.e., standards and continuing professional development) and disciplinary procedures to address serious concerns about a registrant. The requirements for registration typically vary according to whether an applicant is coming from the UK, the EU or overseas. The long-standing mutual recognition of EU qualified healthcare professionals may be lost in the absence of a comprehensive trade agreement after Brexit. As regulators are typically involved in setting the requirements of UK qualifications leading to registration, an overseas applicant will normally need to demonstrate how their qualifications and training meet the requirements of a UK qualification. This may be done either by their overseas registration, qualification or further training being recognised by the UK regulator, by the applicant undergoing testing, or by a period of supervised practice in the UK. Following a Law Commission review and subsequent consultation about reform of professional regulation in the UK, the government responded on 9 July 2019 proposing some amendments. The government announced on 18 July 2019 that the General Medical Council will become the regulator for physician associates and anaesthesia associates.
Negligence liabilityi Overview
As a result of the UK's domestic implementation of Directive 2011/24/EC on the application of patients' rights in cross-border healthcare, all the professional regulators require registrants to have indemnity or insurance arrangements providing appropriate cover for their practice. This will usually be provided by their employer. In medical negligence claims the primary defendant will be the NHS trust or the private corporate provider, rather than the individual practitioner. The practitioner's employer (or hospital with whom they have a relationship) would usually be deemed to have vicarious liability for any negligence, subject to the nature of the relationship between the practitioner and the institution and the connection between the wrongdoing and the relationship.
The cornerstone of medical negligence case law in the UK is the concept of consent – patients are required to be fully informed of the risks of treatment before continuing. As a result, patients are normally required to sign consent forms setting out the risks of treatment before any but the most common procedures are carried out.ii Notable cases
The most significant recent case is the Supreme Court decision in Montgomery v. Lanarkshire Health Board, which revisited a patient's right to information about the risks of a procedure in light of societal changes in the doctor–patient relationship. The judgment noted that patients are 'now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession' (paragraph 75) as the duty of doctors is 'to take reasonable care to ensure that a patient is aware of material risks of injury that are inherent in treatment . . . a duty of care to avoid exposing a person to a risk of injury which she would otherwise have avoided'.
Much controversy was generated by the case of Dr Hadiza Bawa-Garba, a trainee paediatrician who was found guilty of gross negligence manslaughter in November 2015, following the death of a child after delays in diagnosing septic shock. Dr Bawa-Garba had recently returned to practice following an extended period of maternity leave and the incident occurred towards the end of a 12-hour shift. The case led to a review into gross negligence manslaughter and culpable homicide.