OF EHRs, Beta Testing and Informed Consent

Mar 6th, 2009 Posted in Health Care IT | No Comments »

There has been some discussion as to whether or not Electronic Health Records (EHRs) are “medical devices” and as such should be regulated. Recently there was an excellent posting at LINUXMEDNEWS tackling the issue of informed consent for patients subjected to being beta testers for proprietary EHRs and clinical HIT devices.

The article does provoke some thought on why healthcare IT is a somewhat different animal from Management Information Systems for business. Should you have the right to know what the bug ratings look like for an EHR the same way you expect a list of potential side effects for medications and clinical procedures? The phenomenon of  “E-Iatrogenesis” has been coined at JAMIA to indicate unintended consequences of using an EHR. If paper is also used for clinical decision making, should the patient also be made aware of potential drawbacks of using that medium as well?