Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
RHCA Would Expand Medicare Coverage of Genetic Cancer Screening
Recently introduced bill would require coverage of genomic cancer testing and follow-up screening for certain at-risk individuals.
Ransomware Attacks Expose Labs to Costly Negligence Lawsuits
With cyberattacks in the health care industry on the rise, it’s more important than ever for labs to protect patient information.
Labs in Court Weekly Roundup
False and fraudulent claims, particularly those relating to COVID-19 and telemedicine, made up most of the key enforcement actions announced by the DOJ this past week
Congress Moves to Expand Medicare Coverage of Genetic Cancer Screening
Senators recently introduced a bill that would require coverage for individuals with a family history of hereditary cancer.
Global DTC Genetic Testing Market to Top $1.9B by 2026
Even when accounting for the impact of COVID-19, recent report suggests the future of direct-to-consumer genetic testing remains bright.
Research Shows Race May Affect Interpretation of Alzheimer’s Blood Tests
Study finds that three out of four blood tests produced different results depending on if they were used for White or Black people.
DOJ Nabs 21 Defendants for COVID-19 Fraud
The DOJ recently charged defendants in nine different US districts for allegedly carrying out COVID-19 scams worth just over $149 million.
Cardiovascular Genetic Testing Guidelines Get a Technology Makeover
Guidelines on use of genetic testing for inherited cardiovascular diseases have been revised in accordance with 2022 testing technology.
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
