Confusion remains about ONC information blocking rules, even after start date
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Analysis of medical records shows physicians are more likely to doubt Black patients than white patients
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In follow-up to our colleagues recent post about the newly implemented Medical
Device Regulation ( MDR ) in the European Union, this
post will discuss some of the similarities between FDA s
Clinical Decision Support ( CDS ) Software Draft Guidance (together the CDS Draft
Guidance ) and the MDR.
While still in draft form, we note that FDA has signaled its intent to finalize the CDS
Draft Guidance in 2021.
STATUTORY FRAMEWORK
Under the current CDS Draft Guidance, FDA first bases its
approach to CDS on criteria set forth in the 21st Century Cures Act
Survey Shows Widespread Lack of Awareness and Readiness to Comply with Federal Mandate by April 5, 2021 Enforcement Date
As ONC starts enforcement, organizations must prioritize deepening their knowledge of these mandates and implementing changes to adapt to the evolving landscape, or run the risk of incurring significant penalties
April 7, 2021 Life Image, a medical evidence network for clinical and imaging data, released findings of its survey investigating the healthcare industry’s preparedness to comply with the Information Blocking and Improving Interoperability provisions of the Office of the National Coordinator for Health IT (ONC) Final Rule of the 2016 Cures Act, which will be enforced starting April 5, 2021. Findings from the survey, sent in March 2021 to nearly 4,000 clinical, technology and administrative leaders from provider, payer, IT, and other organizations, demonstrate a broad lack of awareness and readiness to comply with the federal information blocking r