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
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
Breast Tissue Density Reporting Should Cover All Women
A recent study suggests that the US should standardize breast density reporting and require that all women receive notification.
How to Save Clinical Labs from Future Pandemic Challenges
A recent AMP report offers recommendations to policymakers to prevent problems in future public health emergencies.
MD Malpractice Premiums Rising at Rapid Rate: AMA Report
Malpractice premium costs are climbing at rates not seen since the turn of the century, according to a new AMA report.
Medicaid Fraud Enforcement Trends: Fewer Cases, Higher Penalties
MFCU enforcement activity has rebounded from recent declines but still hasn’t reached pre-pandemic levels, according to a recent OIG report.
2022 Laboratory and Pathology Coding, Billing, and Reimbursement Update
This free webinar addresses annual billing changes and critical developments currently facing laboratory medicine.
NIPS Tests Are under Fire Again—This Time from the FDA
With increasing media coverage about problems with genetic non-invasive prenatal screening, the agency warns of risks of false results.
The Sun Is Setting on the Controversial SUNSET Rule
While HHS hasn’t yet officially withdrawn SUNSET, recent indications are that it’s only a matter of time.
OCR Cracks Down on Right of Access Foot Dragging
Thanks to recent federal enforcement initiatives, prompt response to patient PHI requests should be a growing priority for HIPAA compliance.
