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
Already a Subscriber? Log in Here
Lab Industry Advisor Subscription
Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
![Essential](https://www.g2intelligence.com/wp-content/uploads/2023/11/Essential.png)
![62934_G2_Subscription Website Images_JL V1](https://www.g2intelligence.com/wp-content/uploads/2023/11/62934_G2_Subscription-Website-Images_JL-V1.png)
![Special-Report](https://www.g2intelligence.com/wp-content/uploads/2023/11/Special-Report.png)
![62934_G2_Subscription Website Images_JL V12](https://www.g2intelligence.com/wp-content/uploads/2023/11/62934_G2_Subscription-Website-Images_JL-V12.png)
![Special-Analysis](https://www.g2intelligence.com/wp-content/uploads/2023/11/Special-Analysis.png)
![Elite](https://www.g2intelligence.com/wp-content/uploads/2023/11/Elite.png)
Additional Business Intelligence Offerings
Lab Industry Advisor Subscriptions Include
![paper_magnifing_glass_512](https://www.g2intelligence.com/wp-content/uploads/2023/11/paper_magnifing_glass_512.png)
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
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
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
FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.