New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories

Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools...

Medicare Clinical Laboratory Price Cuts and Cost-cutting Predicted to be 2018’s Two Biggest Trends for Medical Laboratories in the United States

To offset the loss of revenue from the price cuts to Medicare Part B clinical laboratory tests, labs will need to aggressively—but wisely—slash costs to balance their budgets Any day now, Medicare officials will announce the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) for 2018. Both the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) have issued reports indicating that these fee cuts will total $400...

Genetic Testing Company Invitae Now Contacting Physicians about Possible False Negative Test Results That It Reported in Recent Months

In recent weeks, company representatives began informing physicians at cancer centers and hospitals about a problem with a specific variant in the MSH2 gene Invitae Corporation (NYSE:NVTA), a genetic testing company in San Francisco, has told some physicians and clinicians in recent weeks that it has reported false-negative results. Clinical laboratory professionals with knowledge of the facts in this case believe the cause of the false negative results may have gone undetected for months and...

Agreement on Use of Genetic Information from 61-Year-Old Cervical Cancer Cells Sets New Ethical Privacy Standards for Clinical Pathology Laboratories

Family of Henrietta Lacks, who died in 1951, will have a say in the research use of the  HeLA cancer cells Patient privacy rights involving genetic information has gone to a new level. Pathologists and clinical laboratory managers will want to understand the legal precedents and new standards established in an unprecedented agreement between the family of a woman who died in 1951 and the growing research establishment studying her cervical cancer cells following her death. It is a human...

Shopping for HealthCare Services Not Easy Due to Lack of Publicly Available Information on Quality and Value

Study Finds Most State Websites Aimed at Transparency in Healthcare Pricing Inaccurate and Basically Useless in Helping Consumers Shop for Services With growth in high-deductible health plans, healthcare is becoming increasingly consumer-driven. But shopping for healthcare services isn’t easy due to lack of available resources that enable consumers to compare price and quality, according to a recent study published in the Journal of the American Medical Association (JAMA). Recently, the U.S....