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What specific regulations are you referring to, that apply to EHR software and the like? I know things sold as medical devices/appliances require FDA approval,
by jsperx 3y ago
What specific regulations are you referring to, that apply to EHR software and the like? I know things sold as medical devices/appliances require FDA approval, but for general electronic healthcare record systems (e.g. Epic), what applies other than of course the security/privacy provisions of HIPAA?
- ochoseis 3y agoIt permeates the systems. For example, any time you want to update the complement that sends e-prescriptions the network will want you to recertify the system for conformance to requirements.
- dtx1 3y agoSeems like a better solution would be making the recertification an easy fast automatic process, not skipping it entirely
- ochoseis 3y agoI doubt very many people skip recertification, because of the risk of losing it.
- DangitBobby 3y agoThey are saying, in other words, the answer is not to remove regulations but to fix broken implementations of them.
- sjducb 3y agoI’ve worked with 62304 and 13485
- DontchaKnowit 3y agoTheir very existance is a regulation that gets in the way of care. Doctors are in many cases required to keep databases of patient records and they have to be digital. Well that shoehorns them into using old bloated ehr software that takes forever to use when they could just use paper