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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Virtual events & webinars offer a variety of solutions and strategies for dealing with key issues labs face.
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
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.
FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
November 2023 Labs in Court
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
Compliance Perspectives: When Do Cybersecurity Donations Violate Kickback Laws?
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
Compliance Tool: Model Policy on Donating Cybersecurity Technology to Physicians
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.
Digital Pathology: Regulatory and Business Considerations for Laboratories and Pathology Groups
This session will explain the digitization of the practice of pathology and the resulting business and compliance considerations of evolving digital pathology models
