Efforts in the US to try to get healthcare IT regulated in the same way as medical devices are not being supported by large IT suppliers who prefer self-regulation.
I am grateful to a doctor who lets me know some of what’s happening in US healthcare. He writes:
“At present there are no standards for healthcare IT development or modification in the U.S. There are no good manufacturing process requirements for IT, and no regulatory body tasked to keep track of these systems.
“This was all well and good when the healthcare IT was all about billing this might have been reasonable but when it is used clinically, that’s another thing entirely.
“A few people have gotten really worried about this and are lobbying the Congress to get it to force the FDA to regulate HIT. FDA declined to get involved in this business – in part because it is such an unmanageable task – years ago.
“The powerful HIT companies are arguing that added regulation is unnecessary because their products are not like devices and the industry is essentially self-regulating through market mechanisms.
“Of course this is a little less convincing in the current economic climate but the big HIT companies are extremely powerful in Congress.
“Malpractice attorneys are torn here. On the one hand, the HIT companies have ‘deep pockets’ who can be sued in class action suits for billions. On the other hand, the new HIT records are a potential gold mine of malpractice and they don’t want to kill a goose apparently in the process of laying a golden egg.”
In the UK we have the National Patient Safety Agency but no real regulation of the safety of technology in hospitals. What if a hospital treats a patient using the wrong information or records, or loses track of a patient who needs urgent treatment because of inadequate practices and IT, and harm or death is the result? The technology may be regarded as a secondary or even peripheral consideration. In reality it’s becoming increasingly difficult to separate healthcare IT and the safety of patients.
And we can be fairly certain that if technology were an important factor in the death of a patients – or patients – the culture of secrecy in the NHS and Whitehall would prevail.
Clinical safety and the NPfIT – NHS Connecting for Health website
290 patient safety incidents under the NPfIT – IT Projects
Researchers warn NPfIT delays risking patient safety – E-Health Insider