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...

Next-Generation Laboratory Information Management Systems Will Deliver Medical Laboratory Test Results and Patient Data to Point of Care, Improving Outcomes, Efficiency, and Revenue

Moving to market are the newest generation of LIMS products designed to serve clinical laboratories while supporting quality reporting initiatives and new sources of revenue It was Bob Dylan who made a big hit out of the song, “The Times, They Are A-Changin’.” The same could be said for the next generation of software products designed for use by medical laboratories. To be fully successful, these next-generation laboratory information management systems (LIMS) must be radically different than...