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
Who Needs to Follow the OSHA BBP Standard in the Lab?
Which staff members lab professionals should consider when developing their exposure control plans to ensure OSHA compliance.
Solving Lab Safety Challenges, Both New and Old
Dan J. Scungio, MLS (ASCP), SLS, CQA (ASQ), discusses recent developments in lab safety and how to address key challenges.
How ‘Voluntary’ Safety Standards Impact OSHA Compliance
Lab leaders need to be aware that in some cases, following additional standards such as ANSI may not be voluntary at all.
FDA’s LDT Proposal Raises Questions About Clinical Validity
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
A New Tool for Helping Labs Improve Diversity in Clinical Trials
Rachel Rangel, AuD, discusses a new toolkit to help laboratory professionals ensure diversity and inclusion is addressed in their research.
12 Steps to Manage BYOD Risks to Lab Data
How lab leaders can manage the data security risks of staff using personal devices for work-related purposes.
Compliance Tool: Model Bring Your Own Device (BYOD) Policy
This BYOD policy template illustrates the basic issues lab leaders may want to address to ensure cybersecurity in their facilities.
Expected Audit Targets for 2024 and How Laboratories Can Ensure Compliance
An overview of likely lab audit targets for the coming year, and how laboratories can ensure they’re prepared.
Expert Q&A: Key Developments in AI and Digital Pathology
Juan Antonio Retamero, MD, shares his thoughts on recent trends in AI and digital pathology, and how they may progress.
The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
