Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Government Oversight Committee Report May Change FTC Case Outcome
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Unencrypted Laptops Increase the Impact of a Burglary
By Christopher P. Young, Editor, G2 Compliance Advisor A mental health organization, Aspire of Indiana, is sending breach notification letters to 45,030 clients and employees after several of its laptops were stolen from administrative offices during a Nov. 7, 2014...
ONC Announces Over $35 Million in Funding Opportunities for IT
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence To help spur further development of safe and secure methods for sharing health information, the Office of the National Coordinator for Health Information Technology (ONC) announced three funding programs...
ViveBio Strikes Licensing Deal For Renal Health Biomarkers
By Ron Shinkman, Editor, Laboratory Industry Report ViveBio, a Georgia-based company that is attempting to transition from the dry storage and transportation of laboratory specimens, has struck a deal that would place it into the realm of lab diagnostics. The...
Joint Statement Calls for Education Regarding Expanded Carrier Screening
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies A new joint statement has been issued by five medical societies regarding use of expanded carrier screening in reproductive medicine. The paper, published in Obstetrics & Gynecology, does...
Genomic Profiling Shows Promise for Personalized Approach to Cancer of Unknown Primary Site
By Stephanie Murg, Managing Director of Conferences, G2 Intelligence Last Thursday marked the debut of JAMA Oncology, which will be published online each week before premiering as a monthly formal print/online issue beginning in April, and among the first published...
Laboratory Fees Reduced in 2015
By Christopher P. Young, Editor, G2 Compliance Advisor While a quarter of a percent reduction in laboratory fees in 2015 doesn’t sound like much, when spread over thousands of tests it can have a meaningful impact on a laboratory’s bottom line. Centers for Medicare...
Biotech Industry 'Shatters' Records in 2014
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The biotechnology industry closed 2014 breaking records in many key financing categories, including private venture capital investment and initial public offerings (IPOs). While exact...
California Pathology Practice Admits To Balance-Billing Patients
By Ron Shinkman, Editor, Laboratory Industry Report A San Diego-area pathology practice was recently cited by California regulators for years of billing hospital emergency room patients for sums they were not legally obligated to pay. North Coast Pathology Medical...
Quest CEO Outlines Growth Strategies for a Changing Market
By Stephanie Murg, Managing Director, G2 Intelligence The nation’s largest provider of laboratory services is not waiting to react to the changing dynamics of healthcare but is balancing aggressive cost-cutting with a decisive focus on diagnostic information...