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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
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.
Expert Q&A: Challenges in Pathology and Potential Solutions
Liron Pantanowitz, MD, PhD, discusses the key issues pathologists face today, and how technology could help.
Seeing Past the AI Hype
Artificial intelligence won’t take your job—but what are the real concerns around healthcare AI and its use?
AI: The Newest Member of the Lab Team?
AI is an increasingly useful tool in pathology—but its full value can only be realized in collaboration with human experts.
Lab Marketing & Staffing: 4 Common Kickback Pitfalls to Avoid
How laboratories can avoid compliance issues involving certain marketing and staffing practices.
Expert Q&A: How Technology is Improving Access to Lab Testing
Healthcare leader Steve Serota discusses a new partnership and how it is bringing high-quality lab testing to underserved areas.
Laboratory Relocation: 6 Common Pitfalls to Avoid
Missing small details or getting them wrong can be disastrous for a lab move—here’s how to avoid major issues.
Dx Deal Roundup: A Major Proteomics Merger, Ginkgo Makes Pharma Inroads, and More Legal Woes for Illumina
As is usual at this time of year, deals in the diagnostics industry were up, both in terms of volume and value.
