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
Year in Review: The 8 Most Important Lab Compliance Stories of 2023
Though things appeared status quo in 2023, last year may prove to be a turning point for the laboratory industry.
Dx Deal Roundup: Top 10 Clinical Lab M&A Deals of 2023
An overview of the key 2023 mergers and acquisitions in the diagnostics industry and the trends they reveal.
FDA Watch: Key Lab Test Clearances of 2023
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
Inside the Lab Industry: Q3 Earnings Signal Beginning of the End of ‘COVID-19 Hangover’
What 2023 Q3 earnings from 30 key US lab companies indicate about the current state of the industry and outlook for 2024.
A Modern Healthcare Collaboration
Labs, patients, and technology must all work together to deliver forward-thinking patient-centered care.
January 2024 Labs in Court
Recent cases involve Medicare’s 14-Day Rule, improper PHI disclosure to a media outlet, kickbacks, and COVID-19 fraud.
Expert Q&A: 2023 Lab Industry Highs and Lows, and 2024 Outlook
Robin Divine, MBA, president and CEO of TriCore Reference Laboratories, discusses key recent developments in the lab industry and predictions for 2024.
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
AI in Healthcare: What Do Recent Developments Mean for Labs?
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.
Diagnostics Pipeline: FDA Opens Path for Blood Tests Assessing Genetic Cancer Risk
First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
