Table 1 Description of regulatory context per country

England

The supervision authority in England is the Care Quality Commission (CQC) [19]. CQC was established in 2009 as an independent non-departmental body, which is at arm’s length from government ministers. The CQC is held accountable to Parliament through the Health and Social Care Select Committee and to the Department of Health and Social Care through quarterly accountability review meetings. The CQC has a unitary board with a majority of non-executive members, which holds public and private meetings. The purpose of the CQC is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and to encourage care to improve. The CQC regulates the activities of health and social care organizations at almost 50,000 locations, serving the 55 million people in England. The main functions of the CQC are:

 • Register: Maintain a register of who is legally able to deliver regulated activities. Organizations are required to show they can meet standards of care set out in regulations in order to join the register. Subsequently they must notify the CQC of deaths and other incidents affecting service users, such as deaths not attributable to their illness, injuries, abuse, insufficient staff, and interruption of basic services such as gas and electricity.

 • Monitor, inspect and rate: Monitor the quality of care by gathering and analyzing data, including from people who use services, providers and other stakeholders. Monitoring informs the inspection of services to make sure they are providing care that is safe, effective, caring, responsive and well-led. Inspection findings are published, including for many services a rating of the quality of care. The CQC protects people by taking enforcement action to address poor care.

 • Independent voice: Publish reports on major national and regional quality topics, while also highlighting good practice.

The CQC does not routinely have a role in investigating adverse incidents or complaints. Healthwatch England, the national consumer champion for users of health and social care services, is a statutory committee of the CQC’s Board. The CQC has a duty in law to take account of the views and experiences of local Healthwatch.

(Source: [19])

The Netherlands

The regulatory authority in the Netherlands is the Health and Youth Care Inspectorate (HYCI) (Inspectie voor de Gezondheidszorg en Jeugd, IGJ) [20], which is part of the Ministry of Health, Welfare and Sport. This inspectorate regulates and promotes good and safe care. It’s regulatory activities are partly risk-based, thematic and incident based. The work of the inspectorate is based on different national acts focusing on, amongst others, quality of care in different sectors and the governance thereof, individual professionals, complaint procedures, and medication safety.

One of the current focus points of the HYCI is person-centred care as it is considered an important condition for providing good and safe care. The HYCI distinguishes between the perspective of the public and the patient. Including both perspectives in its work is high on the regulatory agenda and mentioned specifically in multi-annual policy plans of ‘16-‘19 and ‘20-‘23. A vision document ‘Public and patient’s perspective in regulation’ was also written. The HYCI installed a Coordination Group Public and Patient Perspective in Regulation in May 2018 to collect information, advice and coordinate activities aimed at stimulating the inclusion of the public and patients perspective in regulation.

The National Healthcare Report Centre, where citizens can ask questions and report complaints about the quality of care, is part of HYCI.

In the Netherlands, healthcare organizations mostly conduct their own investigations in response to incidents. The HYCI requires that they involve patients or family members in these investigations. In addition, the HYCI has conducted many experiments to involve citizens in its inspections (more on this below). The HYCI works together with a number of universities in an academic collaborative where research is conducted into all kinds of aspects of regulatory work. This includes the subject of public/patient participation.

(Source: [20])

Australia

Regulation of the Australian healthcare system is complex and fragmentary. Responsibilities are shared among a network of national, six state and two territory departments of health, in addition to other government bodies [21].

Accreditation against standards is one of the major strategies for assuring the quality and safety of healthcare organizations. Before the federal government became involved, Australian hospitals were early-adopters of this approach, dating from the 1970s via the Australian Council on Healthcare Standards [22]. Accreditation was initially a voluntary activity. Due to growing scrutiny of hospital adverse events in the 1990s, Australian states passed laws mandating their hospitals take part in accreditation [23]. From 2000, the Council of Australian Governments passed reforms that subsequently established the Australian Commission on Safety and Quality in Health Care (ACSQHC) [24] and made accreditation against the national standards mandatory for all public and private hospitals [23]. However, the accreditation of general practices is still voluntary [25], and national accreditation standards have only recently been made mandatory for government subsidized residential aged care facilities [26].

Unlike other health systems discussed in this paper, in Australia, there is no national regulatory body conducting inspections to ensure health services are delivered safely and according to the law. Rather, the National Safety and Quality Health Service Standards, developed by the ACSQHC, are used by independent organizations who are contracted by healthcare organizations to conduct their accreditation surveys, usually on a 3–4 yearly basis [24]. If any of the standards are ‘not met’, hospitals have up to 3 months to resolve the issue, depending on the risks associated with the issue. At state and territory levels, there are also departments of health, and a range of commissions and divisions that play a role in monitoring and improving the quality and safety of healthcare organizations, such as the Clinical Excellence Commission in New South Wales (Australia’s most populous state). When a standard is not met during an accreditation survey, state and territory health departments are notified and may take other regulatory action or provide support to health services as they address the issue [24].

(Source: [24,25,26])

Norway

The supervision authorities are the Norwegian Board of Health Supervision (NBHS) (the central office), and the Offices of the County Governors (regional offices). The NBHS [27] is a national public institution organized under the Ministry of Health and Care Services. The overall aim of public supervision is to ensure that health and social services are provided according to national acts and regulations. In Norway, there is comprehensive legislation regarding child welfare, health and social services that:

 • constitute requirements about the services that shall be offered to the population;

 • constitute requirements about the quality of services;

 • regulate the work of health care personnel who have authorization;

 • give users of the services rights, for example, according to the Patients’ Rights Act.

Supervision applies to all statutory services, irrespective of whether they are provided by municipalities, private businesses, publicly owned hospitals or health care personnel who run their own practice.

Regulatory activities vary from area surveillance, proactive and planned supervision, and reactive event based after adverse events or deficiencies in services.

At the level of the counties, supervision is carried out by the Offices of the County Governors. The NBHS has a special Department that can conduct onsite inspections in cases of the most severe adverse events. Most inspection activities are conducted by the Offices of County Governors.

(Source: [27])