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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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
Mitigating Biotin Interference in Lab Tests
Biotin interference can lead to erroneous lab results in certain IVDs, including some troponin tests.
Guidance on HIPAA Abortion Privacy Rights Post-Roe-v-Wade
Loss of constitutional abortion rights undermines privacy protection of patients seeking reproductive care.
When & How to Use Changed Clinical Laboratory Consult Codes
Use of these codes has frequently raised concerns for compliance due to a lack of clarity regarding when they’re appropriate.
How the Roe v. Wade Ruling Will Impact Prenatal Testing
Without abortion rights, basic lab testing applications for those who are or want to become pregnant have new and ominous legal implications.
ML Model Predicts Cancer Patient Response to Immunotherapy
New tool helps determine whether immunotherapy is a better option for patients than chemotherapy or radiotherapy.
GAO: FDA Needs Policy to Avoid Repeating EUA COVID-19 Test Mistakes
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.
AI and Wearable Devices Offer Promise as an Early COVID-19 ID Method
While still in its infancy, recent research shows the combination of AI and wearables can accurately detect early SARS-CoV-2 infection.
Diagnostic Lab to Pay Nearly $10 Million to Settle FCA Allegations
BioReference Health LLC and its parent company have agreed to pay $9.85 million to resolve alleged violations of the False Claims Act.
NCCN Recommends Molecular Testing for Pediatric Cancer Treatment
The new guidelines will likely prove highly influential with oncologists and payors.
CDC, Major Laboratory Companies Launch New Tests for Monkeypox
As the outbreak continues to grow in countries that have not historically seen monkeypox cases, testing companies are stepping up.
