While information regarding its potential is abundant, the risks associated with the use of information (including mobile) and communication technology in health care have scarcely been addressed. In order to implement e-Health technology successfully and safely, the evaluation of their benefits should be integrated into and complemented with systematic risk assessment. This is the main recommendation resulting from an exploratory literature study that was performed at the request of the Dutch Health Care Inspectorate.

A review of scientific literature identified no systematic studies (randomized controlled trials) that directly investigated the risks of e-Health technology. However, many unintended, 'secondary', outcomes have been reported that indicate risks for patient safety or quality of care at the level of the technology, the end-user (patient, professional) or the organization. They vary from high time consumption, adverse effects, usability problems, limited server access and malfunctioning devices due to improper use or financial issues. Similar outcomes were found through searching 'grey' sources accessed through the internet. From the combined scientific and grey sources, we found anecdotal evidence for a wide variety of risks in e-Health, of which the magnitude is largely unknown. Confirmation of these findings was obtained from several other recent, authoritative reports.

E-Health interventions are being increasingly used in Dutch health care. It is important that tools currently used for risk management are applied to e-Health as well. A reliable system to report, identify, document and monitor risks would help to increase transparency in this field.