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...

Up to 50% of Aetna, UnitedHealth Group, and Anthem Reimbursements Go to Value-Based Contracts; Clinical Laboratories Must Implement Value-Based Strategies to Remain Competitive

Aetna expects 75% to 80% of its medical spending will be value-based by 2020 Many pathologists and medical laboratory executives may be surprised to learn how quickly private health insurers are moving away from fee-for-service payment arrangements. According to Forbes, the nation’s largest health insurance companies now associate nearly 50% of reimbursements they make to value-based insurance initiatives. This is a sign that value-based managed care contracting continues to gain momentum. And...

Community Hospital Creates Mobile App to Deliver Clinical Laboratory Test Results to Its Physicians

Smartphone mobile app is dubbed “MicroHIS” by Holy Name Medical Center At one community hospital in New Jersey, physicians love getting clinical laboratory test results over their smartphones or similar wireless devices. Radiology and cardiology results can also be accessed or viewed using this unique mobile app developed for use at Holy Name Medical Center in Tea Neck, New Jersey. The story about mobile applications at Holy Name Medical Center demonstrates to pathologists and clinical...

Threat to Clinical Pathology Laboratories is Payer Pre-Authorization of Genetic Tests

Health insurers want to control the rapid growth in expensive genetic and molecular assays For many clinical laboratories and pathology groups, genetic tests and molecular diagnostic assays are the fastest-growing part of the test menu. This is true both in the increased volume of specimens for genetic tests and the growing number of such medical laboratory tests that are accepted for clinical use. This is a bright spot for the nation’s clinical pathology laboratories. That’s because many...