The chief executive of a troubled NHS trust recently remarked to me: “The problem was, we thought we worked for the regulators, not for our patients.”

It’s a shocking indictment; not of the NHS but of regulators. When regulation comes between providers and patients it has confused process with purpose. When regulation becomes an end in itself we’ve definitely lost the plot.

I think we are now in a curious stand-off between regulation and the NHS. Much has been heaped on regulators in recent years and they have in turn heaped much on the people, organisations and processes which make up healthcare. This has undoubtedly held failings up to scrutiny but continuing failures have also exposed the weakness of regulation as a means of improvement.

Regulation has been oversold as a solution to poor quality and safety. If it is becoming a scapegoat for failures in safety and performance it may only have itself to blame. Overstated claims combined with public enthusiasm for regulation as an easy response to risk means regulation has been set up to fail. Much of the time it’s in the wrong place doing the wrong thing with the wrong result.

Health secretary Andrew Lansley has described the NHS reforms as creating “more autonomous independent providers and more independent autonomous regulators”. If regulation in health and social care is scarcely fit for purpose now, how far must it change to meet the needs of the new regulated healthcare market?

Yes, market. The health system in the UK is already a market; regulation restricts entry of people, goods and services, controls supply and pushes up price with the worthy intention of maintaining or improving quality. UK healthcare regulation has ignored its impact on this market. In the “liberated” NHS it will no longer be able to do this. Monitor will have an explicit role but the white paper Enabling Excellence: autonomy and accountability for health and social care staff says professional regulation will have to demonstrate cost effectiveness and value for money.

Regulation as command and control will be inadequate to oversee “any willing provider” and too rigid to respond with agility to rapid system and professional change.

The Council for Healthcare Regulatory Excellence paper Right-Touch Regulation argues that statutory healthcare regulation is ineffective if it applies pressure at the wrong point in the system. High-quality healthcare must depend on the competence and care of the practitioner, the self-respect and caution of the service user and on organisational commitment to safety and quality. The regulator is never in the room.

The first Francis report on Mid Staffordshire NHS Foundation Trust identified regulation among a chain of failures to act. It is ironic, then, that a call for more regulation might emerge from the second inquiry. If regulation has failed, more regulation is surely not the answer.

Calls for the regulation of managers is an example; it fails the right-touch regulation tests. The problem really lies with the selection, training, supervision and accountability of managers. Responsibility must lie with employers and the boards of trusts. Putting poor managers on a list and spending years paying them as they go through fitness-to-practise investigations would be wasteful and pointless. A list is not a solution.

Regulation has a place, of course. It should set frameworks to support and encourage professionalism and to help organisations to be excellent. It should care about outcomes, not processes, it should be based on an assessment of actual harm, not possible risk, and it should be proportionate to the problem it is trying to solve.

There is no such thing as safe, only safe enough. We need to place responsibility for deciding what is safe enough in the right place, where decisions are made, we need to hold individuals and organisations to account and we need to use regulation only for those things where its effect is demonstrably good.

First we need to stop pretending that regulation can remove all risk. Next to understand that those who offer us a service, be they electricians, doctors or managers, have an interest in banding together to assure us that we can trust their members to be competent and honest. Last and only last, the state should intervene to ensure consistency, manage markets and limit risks that cannot be controlled by other means for the benefit of consumers, not providers.