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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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
‘Full Speed Ahead’ with Test Results? Not So Fast
Lab scientists using testing equipment too quickly brings up training concerns in discussions at recent ADLM conference
Using AI to Improve Reimbursement and Decrease Claim Denials
Though payers’ adoption of AI has made reimbursement more challenging for labs, providers can also use AI to address these issues
FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible
Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening
The First Steps to Implementing Digital Pathology and AI
A guide to understanding, implementing, and benefiting from digital pathology and artificial intelligence in the clinical lab
Removing Restrictions to Germline Testing
With the global cancer burden growing, is a universal germline genomic testing approach the key to more effectively combating the disease?
PGx Testing: First, Do No Harm
Recent advances in pharmacogenomic testing—and their role in ensuring safe, effective treatment selection for precision oncology
Key Lessons for Clinical Labs from the CrowdStrike Outage
A few months on from the historic CrowdStrike outage, what lessons can clinical labs take away from the incident?
In (Digital) Defense of HIPAA
How clinical laboratories and pathology groups can ensure that their digital pathology and AI workflows are HIPAA-compliant
Preserving Patient Privacy in a Digital Era
What labs need to know about keeping patients’ data safe when using digital pathology and artificial intelligence-based solutions
