The Risks of Products in Health Informatics

Electronic devices do the impossible in that they introduce new measures and monitors, achieve the automation of manual tasks, and potentially enable the relocation of care and patient monitoring to less intensive settings. But at the same time they circumvent established processes of external peer review and calibration, professional responsibility, and consumer understanding. Most innovations seek to reduce risk, but any innovation introduces new Risk. Health has proven systems to assess Risk, but devices circumvent these. Examples will be given of various risks, and the argument put for greater investment in shared knowledge development. More investment in reporting and evaluation are needed, based on an philosophy of Social Responsibility in Science.