Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Dx Deals: Walmart Teams with Simple HealthKit to Provide Accessible At-Home Testing
The national retailer recently signed a deal with Simple HealthKit to provide Walmart customers online access to at-home diagnostic test kits.
July 2023 Enforcement Roundup
Though UDT-related enforcement actions predominate, an uncommon vendor-related case was in the mix this month.
July 2023 Labs in Court
Recent cases involve COVID-19 fraud, UDTs, and the latest HIPAA Right of Access settlement.
Compliance Perspectives: The Risks of Using ChatGPT & How to Manage Them
While ChatGPT has its place, allowing lab staff to use it exposes you to liabilities—here are some ways to manage the risks involved.
Compliance Tool: Model ChatGPT Acceptable Use Policy
As generative AI chatbot use increases, labs may want to implement a written acceptable use policy for staff.
Genetic and Multiorgan Imaging Approach Reveals Heart–Brain Connections
Multiorgan analysis of biobank data elucidates heart–brain links that could enhance disease prevention and detection.
The Diagnostics Pipeline: First FDA Approval of CRISPR Therapy Possible This Year
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
Making Complete Genome Sequencing Affordable, Accessible
Automation software uses advanced computational tools to generate gapless genome sequences in just a couple of days.
Emerging Polygenic Risk Score Tests Demonstrate Potential for Improving Cancer Screening
Although PRS technology and adoption still have a way to go, it is progressing quickly, especially in the cancer and oncology space.
4 Open-Source Diagnostic Software Projects to Explore
Free open-source software can be leveraged across diagnostic processes—how can your organization benefit from it?
