CDS Coalition requests FDA rescind final decision support guidance

CDS Coalition requests FDA rescind final decision support guidance

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight with the healthcare sector’s need for innovation, while comporting with the statutory language of the 21st Century Cures Act. ‘Flagrant’ disregard for Congressional law and intent
The coalition’s stakeholders – clinical decision support software developers, patient advocacy organizations, clinical societies, healthcare providers and healthcare payers – say the FDA’s guidance exceeds Congress’s statutory definitions of what is considered CDS and threatens to undermine lawmakers’ goals.
“The Office of the National Coordinator for…

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openEHR

openEHR is an open standard specification in health informatics that describes the management and storage, retrieval and exchange of health data in electronic health records (EHRs). In openEHR, all health data for a person is stored in a “one lifetime”, vendor-independent, person-centred EHR. The openEHR specifications include an EHR Extract specification but are otherwise not primarily concerned with the exchange of data between EHR-systems as this is the focus of other standards such as EN 13606 and HL7.

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