The health and social care information watchdog has raised concerns that the smallprint in the draft NHS constitution could undermine patient confidentiality.
The technical document published alongside the draft constitution this summer explained that patients could expect health professionals or researchers to look through their care records in order to identify potential participants in clinical trials.
Harry Cayton, chair of the new National Information Governance Board, told HSJ: "This seems to arise from the enthusiasm to increase the numbers of people who take part in clinical trials. But we don't think undermining patient confidentiality is the way to do it. It is contrary to all good practice and to the care record guarantee."
The board is discussing its concerns with the Department of Health.
The board becomes a formal statutory body this month after working in shadow form for a year. It is charged with ruling on information governance standards and processes in the NHS and the social care sector.