Health information technology has been touted as crucial to better health care, but a new report says an entirely new agency is needed to investigate this largely unregulated sector, which can also injure or kill patients if it’s not operating properly. In pushing for a new entity, the respected Institute of Medicine, an independent research and advisory organisation, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job at this time — a recommendation that is bound to be controversial.
The eagerly anticipated report, titled “Health IT and Patient Safety: Building Safer Systems for Better Care,” will be publicly released Thursday. A copy was obtained by iWatch News. The study details nine other recommendations for how to ensure patient safety when doctors and other health care providers use health information technology, or health IT. The findings from the report were presented October 28 to the Department of Health and Human Services (HHS) and its agencies.
The question of who should regulate these devices comes at a time when the federal government is pushing the use of health IT through a $27 billion dollar portion of President Barack Obama’s 2009 economic stimulus. The initiative includes programs that award financial incentives for providers who use electronic health records and an additional $550 million in grants to states for creating exchanges that allow the sharing of clinical data.
But the push is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety.