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
- 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
As Concern Over Monkeypox Grows, Testing Expands in US
Labcorp begins offering CDC’s PCR test for orthopoxviruses, including monkeypox, with plans to further expand testing capacity.
Blood-Based Tests Can Detect Early-Stage Lung Cancer
Team creates a mass spectrometry-based blood lipid test that, when combined with AI, identifies early signs of the disease.
National HCFAC Program Health Fraud Recoveries Top $5 Billion
According to a recently released report, in FY 2021, of 831 new criminal healthcare fraud investigations, 312 resulted in convictions.
Carolina Lab Owners Shell Out $6 Million to Settle FCA Charges
Owners of now defunct Physicians Choice Laboratory Services were accused of paying kickbacks to physicians to order tests from the lab.
AMA: How to Make Telehealth More Equitable
American Medical Association publishes its policy proposals to help ensure telehealth services are accessible and effective for everyone.
HIV Testing Saw Big Declines in Pandemic’s First Year, New Data Show
Recently released CDC data show that the largest drops occurred among groups who are most affected by HIV.
AACC to Host Discussion with Theranos Whistleblowers
Hosted by AACC president Dr. Stephen R. Master, the talk will cover the ethics of lab testing and the role of clinical lab professionals.
HHS Scrambles to Deal with Aftermath of Roe v. Wade Revocation
Now that the Supreme Court has revoked Roe v. Wade, HHS must rework policies, programs, and procedures related to reproductive rights.
Congressional Bill Offers Labs PAMA Pricing Relief
Legislation introduced last week would require the use of a more reliable representative sample to determine lab test reimbursement rates.
COVID-19 Test Profits Make Labs Potential Target for Public Backlash
Independent labs accrued a profit of at least $10 on each PCR COVID-19 test performed in the period from May to December 2020, study says.