2.3 Legislation

How a country defines mandatory reporting, who creates the mandate, and whether or not it is enforced will vary by country. In the United States of America (USA), mandatory reporting for a surveillance programme means that hospital staff are required to keep a log and report all cases of congenital anomalies and fetal deaths to the surveillance programme within a determined time frame, and in a standardized format. Structured and reliable data provide a justification for countries to invest in sustainable programmes for prevention of congenital anomalies, and can help in the development of public policy for adequate distribution of resources for babies born with a congenital anomaly. Furthermore, regular reporting in a standardized format can greatly facilitate analyses of prevalence and trends for the congenital anomalies being monitored.

As countries vary in how they define mandatory reporting, so too they can vary in how they define voluntary reporting. Generally, in voluntary reporting, hospital/facility staff members are encouraged by the ministry of health of the country to keep a log and report all cases of congenital anomalies and fetal deaths to the surveillance programme; however, hospitals can choose whether or not to comply. The ministry of health can request that hospitals report cases in a uniform manner, but each hospital can decide whether, how and when they will report the information.