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
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
After delays in sentencing and attempts by her legal team to win a mistrial, Holmes was sentenced last week for her role in defrauding investors of millions.
Where your remote employees actually work may have significant legal consequences for your lab.
While again light on lab-related cases, this week’s healthcare-related enforcement actions featured improper billing, kickbacks, and telemedicine.
POC tests offer speed and simplicity, but are less reliable than tests performed in labs.
FDA confirms the new rule, which will update the Mammography Quality Standards Act, will publish before the end of 2022, or early 2023.
Medical device makers will have to show that their products will be accessible to disadvantaged populations.
In case you don’t feel like reading all 3,300+ pages of the Final Rule, here’s a quick briefing on the main changes you should be aware of.
Though light on lab-related cases, last week’s enforcement actions cracked down on COVID-19-related violations.
However, the increase still isn’t enough to keep pace with inflation, providers contend.
While likely not a surprise to medical labs, a new report may add more urgency to solving recruitment and retention issues.