Fundamental questions are being asked about the watchdog set up four years ago to ensure that patients are safely treated by the NHS in England.
A committee of MPs says the public does not have confidence in the Care Quality Commission (CQC) - in part because people still do not understand what it is for.
The Commission says it has been gathering people's views and intends to work more effectively in future.
The Chair of the Health Select Committee, Stephen Dorrell, said it is "odd" that the CQC is not responsible for co-ordinating patient safety information, and that it should be.
"What the Committee is recommending is that there should be a very clear focus within the CQC on patient safety and essential standards, in order that the public can have a growing confidence in the CQC as a regulator which is focused specifically on those things that are a real concern to patients.
"It's a very basic principle of medicine - first do no harm," he added.
David Behan, chief executive of the CQC, outlined that the commission are focusing on "six changes", to be made over the next year to ensure "we can deliver the challenge that Stephen and committee members have issued to us today".
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