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
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- 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
Enforcement Trends: Six Ways Your Lab Can Avoid HIPAA Right of Access Issues
An analysis of recent OCR enforcement actions and settlements identifies the common pitfalls labs should watch out for.
Expert Q&A: Developments in Noninvasive Prenatal Testing
Diana W. Bianchi, MD, discusses how NIPT has evolved, key challenges, as well as her team’s research on using these tests to detect cancer.
Which Test? Choosing the Best Approach to Diagnosing Rare Disease
Genomic sequencing is almost twice as likely to yield a diagnostic result, but lags behind panel testing in speed, cost, and concordance.
Streamlining Lab Operations with Software Automation
Using LIMS and no-code solutions can unlock opportunities for efficiency.
Pursuing the PFAS Problem
Tackling the challenges of “forever chemicals” in the diagnostics industry.
Dx Deal Roundup: Key Acquisitions for Danaher & Exact, and a Big AI Partnership
Here are what G2 Intelligence considers the three most significant deals announced in the period from late August to early September.
Compliance Perspectives: How to Ensure HIPAA Compliance among Marketing Staff
Lab leaders are at the greatest risk of HIPAA violations when they get complacent about privacy training.
Compliance Tool: Model Policy on Use of HIPAA-Protected Health Information for Marketing Purposes
This template helps lab leaders implement a written policy limiting and establishing procedures governing use of PHI for marketing.
Compliance Tool: HIPAA Compliance Fact Sheet for Lab Marketing Staff
This template helps labs create a fact sheet that highlights the key HIPAA-related do’s and don’ts for marketing staff.
Inside the Lab Industry: Q2 Earnings Decline Despite Rebound in Core Business
Though COVID-19 testing declines continue to negatively affect lab industry profits, the latest figures suggest the worst may be over.
