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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Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies
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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
May 2024 Labs in Court
Recent enforcement actions and court cases include kickback schemes a-plenty and a reminder to focus on HIPAA compliance
Choosing and Using the Right Compliance Solution
Factors laboratories should consider when evaluating their compliance challenges, needs, and goals to select compliance solutions
Increasing Fees, Decreasing Access to Data in New CMS Proposal
New policies aim to better protect data against increasing cyberattacks, but academics say the changes will limit critical research
The Landscape of Laboratory Corruption
How widespread is corruption in the lab—and what can be done to combat it?
The Keys to a Successful Lab Partnership
This webinar will explore the benefits of strategic, deliberate partnerships in order to improve access to quality diagnostic laboratory services, support more timely answers to advance patient care, and serve as a defense mechanism against acquisition
Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Special Report: Will the COVID-19 Recovery Be Bumpier than Expected?
Though IVD and commercial lab Q3 2023 earnings reports held promising signs, Q4 2024 and FY2023 results tell a different story.
Dx Deals: Collaboration Takes Psoriasis Testing to New Level
Partnership between Mindera and PBM aims to optimize treatment matches for the disorder, as some drugs cost nearly six figures annually
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
