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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Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.
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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
Congress Moves One Step Closer to Passing “Surprise Billing” Legislation
Bipartisan bill would mandate that patients receive an upfront estimate of treatment services costs, along with notification about the provider’s network status.
HIPAA: OCR Clarifies Rules for Sharing Coronavirus Patient Medical Information During Current Health Emergency
The usual HIPAA Privacy restrictions on collecting, using and disclosing personal health information (PHI) are relaxed during public health emergencies. With this in mind, the Office for Civil Rights (OCR), the HHS agency charged with enforcing the HIPAA rules,...
Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests
The 2019 novel Wuhan coronavirus outbreak caught regulators and diagnostic test makers off guard. As the death toll mounts, the scramble is on to develop tests capable of detecting the virus. Here’s a rundown of what the FDA is doing to achieve that objective. The...