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MPs have criticised the Department of Health for failing to properly assess the potential impact of a new compensation scheme for patients injured during NHS treatment.
A report from the Commons constitutional affairs committee warned that the new scheme should be properly piloted before being rolled out across the country.
Under the NHS Redress Bill, any patients who sustain injuries while undergoing NHS treatment could make claims for up to £25,000, with the government paying the bill for legal costs and medical reports.
The scheme is designed to reduce legal costs by taking cases out of the court system.
But the MPs said there would be questions over how NHS-funded experts will be demonstrably independent.
They also warned of a "level of uncertainty as to the number of additional claimants who could come forward under the scheme".
The Department of Health has accepted that there could be as many as 19,500 additional claims every year but is unsure of what to expect.
"We are particularly concerned that the Department of Health is seeking to introduce this redress scheme without any idea of the potential increase in the number of claimants," said committee chairman Alan Beith.
"It is worrying that the department has displayed a lack of focus in working out the detail of the proposals and that it does not appear to have given detailed consideration to the potential cost.
"As we indicated in our previous report 'Compensation culture', we believe this scheme should be piloted, so that the cost implications can be properly judged.
"These weaknesses threaten the viability of the scheme, and we are alarmed that the NHS appears relaxed about these problems and about the potential costs."
Dods Parliamentary Communications Ltd