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
Federal Court Upholds $46.7 Million Medicare PHPs Fraud Conviction
Court rejects laundry list of defenses of a Texas hospital’s president who was convicted for his role in a $158 million PHP fraud scheme.
Recent FDA Clearance Allows Patients to Track PD Symptoms via Apple Watch
The FDA recently granted 510(k) clearance to StrivePD, a platform for collecting Parkinson’s patients’ symptom data via the Apple Watch.
Telemedicine Companies Owner Sentenced in $20M Healthcare Fraud Scheme
The owner, who also owned several telemarketing companies and committed tax evasion of just over $4 million, now faces 14 years in prison.
PacBio and RBI Collaborate on Lab Sequencing Robot
The companies are working together to explore LabDroid’s capacity to automate sample preparation workflows for long-read sequencing systems.
Theranos In Court: Balwani Lawyers Dealt Another Blow
Move to exclude testimony regarding potential patient impact of lab deficiencies as hearsay is dismissed by the court.
New Method Could Lead to an At-Home Test for COVID-19 Antibodies
In clinical training sets, the new test allowed SARS-CoV-2 antibodies to be detected using widely available glucometers.
Hospitals Brace for, Seek to Stave Off Medicare Sequestration Cuts
Combined with rising labor costs, COVID-19, and other challenges, stakeholders say the cuts will negatively impact patient care.
LumiraDx Gets CE Clearance for Five Different Products
The UK-based diagnostics firm received CE marks for a diabetes test, CHF test, as well as an analyzer, and two COVID-19 tests.
CMS Issues First Penalties to Hospitals for Price Transparency Violations
Georgia health system hospitals are the first to be penalized for failing to update their websites or reply to agency warning letters.
Guidance for Healthcare Workers Treating Suspected Cases of Monkeypox
Experts offer advice in a recent commentary article on treating patients who may have monkeypox during the current COVID-19 pandemic.
