Remove new-blog category Regulatory News
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Bonus Features – November 20, 2022 – 90% of healthcare buyers prioritize virtual care but want a clear roadmap, wearable data helped predict COVID-19 infections 12 days before the CDC, and more

Healthcare IT Today

This article will be a weekly roundup of interesting stories, product announcements, new hires, partnerships, research studies, awards, sales, and more. News and Studies. ONC published a blog post highlighting how to meet the 2015 Edition Cures Update requirements for ONC certification.

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Compliance is Everybody’s Business: Clinical, Revenue Cycle, IT, Sales and Marketing

YouCompli

Sharon Parsley, JD, MBA, CHC, CHRC contributes a monthly post on compliance officer effectiveness for the YouCompli blog. But we also identify opportunities to improve processes based on regulatory guidance and we can help protect revenue and income. Build relationships with key clinical and operational areas. Sales and Marketing.

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A Whole New World for Laboratory Developed Tests – FDA Proposes End to Its Longstanding Policy of Enforcement Discretion

Hall Render

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Specifically, the definition of IVD in 21 C.F.R.

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TAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year

Health Law Advisor

15] An Overview of the Proposed TCET Pathway An FDA-designated breakthrough device that has been determined to be within a Medicare benefit category, is not already the subject of an existing Medicare NCD, and is not otherwise excluded from coverage through law or regulation may be eligible for the proposed TCET pathway.

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