The Health and Social Care Bill, expected to gain Royal Assent this year, will implement proposals in last year's white paper Trust, Assurance and Safety - the regulation of health professionals in the 21st century.
The main provisions of the bill are:
the creation of a new regulator, the Care Quality Commission;
changes to how health professions and the health and social care workforce are regulated, in response to the Shipman inquiry;
public health protection measures around infection control;
changes to the process and forum for regulatory disputes, including legislation to use the civil rather than criminal standard of proof for healthcare regulators and creating an independent adjudicator;
ensuring healthcare organisations appoint a "responsible officer" to work with the General Medical Council on cases of poor professional performance by doctors;
a health in pregnancy grant of£190.
The Care Quality Commission, a health and adult social care regulator created from the Healthcare Commission, Commission for Social Care Inspection and Mental Health Act Commission, should be operational by April 2010. Its remit and size - it will regulate the work of 2.8 million staff in the NHS, local authorities and the private sector - have been criticised.
The bill defines the commission's functions in the areas of safety and quality assurance, information and performance assessment, and safeguarding the rights of detained mental patients. However, performance may not be straightforward. Dame Denise Platt, chair of the Commission for Social Care Inspection, has said it is not clear how a single regulator could monitor a vast range of services.
Leaving aside start-up costs estimated at£140m, the government has said the commission will operate with a lower budget than the existing regulatory bodies. Operational savings may be achieved through economies of scale and a more flexible inspection regime.
The commission will have the power to carry out annual infection control inspections. If high rates of healthcare-associated infections are detected, it will have the power to step up inspections and close wards.
The commission will have statutory powers over foundation trusts, which Monitor says will overlap with its role. Monitor has called for the bill to be amended so that only it will have powers of intervention. Duplication could lead to failing trusts engaging Monitor and the new commission in three-way discussions, causing delay and potentially playing one regulator off against another.
Areas of concern relating to duplication and potential lack of accountability could be resolved via the proposed NHS constitution, which could set out which regulator was responsible for identifying shortcomings and which body was tasked with enforcement.
The bill aims to strengthen regulation following the Shipman inquiry. While most of the proposed changes have been endorsed by regulators, the British Medical Association has described the changes as an "assault on the profession".
Regulators have traditionally been responsible for hearing fitness to practise cases. Following the Human Rights Act 1998, concerns have been raised about whether this provides a fair hearing and about the closeness between prosecutors and adjudicators.
The Office of the Health Professions Adjudicator, separate from the regulators, will manage panels to hear fitness to practise cases, initially for the GMC and the General Optical Council. Other regulators will be able to opt in.
Some, for example the BMA, regard the creation of an independent adjudicator as the end of professionally led regulation. Others regard it as an important step in ensuring that criticism of the regulatory bodies about practitioners "looking after their own" is eliminated.
Perhaps the most controversial change proposed in the bill is to require healthcare regulators to use the civil standard of proof in fitness to practise proceedings. The GMC, Nursing and Midwifery Council and GOC still use the criminal standard. The subject has been a matter of debate, particularly in relation to the GMC, with practitioners insisting that, if a doctor stands to lose his livelihood, nothing less than the criminal standard of proof will do.
It remains to be seen what impact the proposed change will have in terms of numbers of cases and sanctions ordered, but anecdotal evidence suggests that the shift will be more symbolic than substantive.