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
Court Refuses to Dismiss EKRA Charges against Former Arrayit CEO
In this month’s Labs in Court roundup, Arrayit’s former president loses his bid to have EKRA charges dismissed, and more.
Take 14 Steps to Protect Lab Staff from Workplace Violence
While rules differ by state, the basic measures required to protect employees from workplace violence are pretty much the same everywhere.
Provide Lab Staff Training on Workplace Violence and Active Shooter Events
Part of the duty to protect workers is to ensure those at risk receive proper training on what to do if an active shooter incident occurs.
Theranos In Court: Balwani Lawyers Lose Bid to Exclude Damning Evidence
Legal team’s bid to dismiss part of CMS inspector’s testimony as hearsay is denied by the Northern District of California federal court.
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.
