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...

Smartwatch-based Fitness Apps Gaining Popularity Over Other Fitness Wearables such as Fitbit. Will This Affect the Data Clinical Laboratories See Streaming Their Way?

Consumer demand for health trackers combined with other smartwatch capabilities is driving a trend away from simple health trackers and toward more complex devices, such as the Apple Watch, for their more powerful capabilities It is still an open question as to whether clinical laboratories will experience an onrush of patient test data streaming at them from healthcare consumer portals and mobile devices. The popularity of wearable fitness/medical technology has been widely touted in the...

Apple’s Update of Its Mobile Health App Consolidates Data from Multiple EHRs and Makes It Easier to Push Clinical Laboratory Data to Patients

January’s press release confirmed the tech company is working to integrate critical medical data into its mobile devices, while further promoting interoperability and patient access While interoperability has improved since the earliest electronic health record (EHR) systems, today’s active patients often need to sort through multiple healthcare portals—including those of clinical laboratories and anatomic pathology groups—to get a comprehensive view of their medical history. Not only can this...

Australia Moves Closer to Nationwide Electronic Health Record as Nation’s Leading Pathology Laboratories Join Initiative

Doctors’ advocacy organization praises potential of ‘My Health Record’ but voices concerns about functionality, interoperability, and added burden placed on providers Australia’s goal of implementing a nationwide electronic health record (EHR) system received a major boost when the country’s largest pathology laboratories signed agreements with the Australian Digital Health Agency (ADHA) to join the project. But the My Health Record system has yet to fully win over providers as the Australian...

Innovative Pathologists and Clinical Laboratory Scientists Use Diagnostic Management Teams to Support Physicians with More Accurate, Faster Diagnoses

At institutions such as University of Texas Medical Branch, Galveston, and Vanderbilt University Medical Center, pathologists are using diagnostic management teams to improve patient outcomes while lowering the medical costs Diagnostic Management Teams are a hot concept within the medical laboratory profession. In fact, a new annual DMT conference in Galveston, Texas, is the fastest-growing event in the clinical laboratory industry. This year’s Diagnostic Management Team Conference will take...