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
Rise in Telehealth Expands Need for In-Home Phlebotomy Services
Mobile phlebotomist services have become a dynamic new segment of the medical labs market.
What Can You Do About Medical Lab Staffing Shortages?
Solutions you can implement right away to address current lab staffing concerns and prepare for the future.
Heart Attack Diagnostics Market to Be Worth More than $22B in a Decade
Increasing incidences of heart disease, as well as technological advances, will drive growth over the next eight to 10 years, reports say.
Digital Health Startup Fundraising Remains Robust Despite H1 2022 Declines
According to a recent report, digital health companies are on track to rake in $21 billion for 2022, below the 2021 total of $29.1 billion.
M&A Report: Fewer Deals, Higher Impact
Continuing recent patterns, M&A deal-making in the diagnostics space was low in volume but high in impact in October.
FDA Watch: Monkeypox, COVID-19, and MDD Tests
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
Getlabs Continues In-Home Phlebotomy Services Advance
The Miami-based startup has secured major in-home phlebotomy services contracts from some of the nation’s biggest lab companies.
Labs in Court: Could Elizabeth Holmes Get a New Trial?
In this month’s roundup of key lab-related cases, a bizarre twist in the Theranos saga leads to a slim chance of a mistrial.
November 2022 Enforcement Scorecard: UDTs and Genetic Tests
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
How to Use and Report ICD Codes
An overview and general briefing on some of the most common ICD codes concerns for labs.
