The Danish Act of Patient Safety entered into force in 2004. This paper studies the consequences of the Act for the health care system and its users by a literature evaluation and an interview study with key persons. Despite the substantial resources spent on the reporting system, no evidence is found that the Act has an improved effect on patient safety. One of the biggest barriers for reporting adverse events is a lack of follow-up and feedback. Research into the patient's role on preventing adverse events is limited. The possibilities created by the Act should be utilized to their full potential.