Medical Devices

The new group consists of tech vendors and device manufacturers working to create sets of security best practices for both providers and manufacturers.

Theranos, the embattled blood testing startup, is now under investigation by the U.S. Securities and Exchange Commission, as well as the U.S. Attorney's Office for the Northern District of California, according to Bloomberg. The investigation is the latest in a series of hardships for the once-vaunted company, coming on the heels of a recommendation by the Centers for Medicare and Medicaid Services that founder Elizabeth Holmes be banned from the blood testing business for a two-year period. In March, a study in the Journal of Clinical Investigation found that cholesterol test results obtained through Theranos – which are drawn from small finger pricks – were much different than those from large laboratory companies, implying that doctors' medical decisions could be thrown off by results acquired through Theranos technology. [Also: Theranos results differed from Quest, LabCorp enough to impact care decisions, study finds] In all, Theranos' results for total cholesterol were found to be an average 9.3 percent lower than those obtained through clinical laboratories Quest and LabCorp, according to the March study. This has lead researchers to surmise that in some instances, doctors may inappropriately begin, or fail to begin, statin therapy, a drug-based regimen that aims to prevent heart disease. The investigation by the SEC, which ensures companies give accurate information to investors, was one of several described in a memo from Theranos (once valued at $9 billion) obtained by Bloomberg. The memo was originally furnished to Theranos' partners including Walgreen's, which has reportedly been looking to cut ties with the startup. "The company continues to work closely with regulators and is cooperating fully with all investigations," Theranos officials said. Before the federal investigations were announced Monday, Holmes appeared on NBC's Today show to say she was "devastated" that her lab did not discover its deficiencies. Holmes also said Theranos would rebuild its lab from scratch to avoid future problems. In addition to suggesting that Holmes be temporarily banned from the industry, CMS has proposed a number of other sanctions, including revocation of Theranos' Clinical Laboratory Improvement Amendments of 1988 certificate – or, alternatively, a civil monetary penalty of $10,000 per day for each day of non-compliance. Theranos could delay the effective date of the sanctions by filing an appeal. Twitter: @JELagasse Like Healthcare IT News on Facebook and LinkedIn

The Centers for Medicare and Medicaid Services has warned Theranos founder Elizabeth Holmes that the company could face serious sanctions after the startup failed to address numerous problems with its technology and practices.

Pfizer and IBM are teaming up to combat Parkinson's Disease with analytics and the IoT, the companies announced Thursday.

The popularity of health and wellness apps and devices is being fueled more by fitness or activity trackers than clinically-focused tools to help manage chronic conditions.

The Venture Fund challenge will award winners money, mentorship and the opportunity to pilot emerging technologies.   

New research found variations in cholesterol levels that drew concern because they could potentially determine whether a physician at point of care would prescribe medication to a patient.

A new report determined that a dozen key executives have left in the past year and half of those since January 1, 2016. And some people are pointing the finger at CEO Andrew Conrad.

"We believe that mobile devices such as iPhones will become the predominant means by which patients interact with BIDMC," says Beth Israel Deaconess Medical Center CIO John Halamka, MD. "Your phone will be the repository of your medical record."

LAS VEGAS – Infection control technology vendor Seal Shield LLC has introduced at HIMSS16 its new ElectroClave UV-C Sanitizer and Mobile Device Management System. The vendor is demonstrating the technology in the HIMSS exhibit hall in booth #368. The ElectroClave is an enterprise mobile device management system that uses low-power UVC LED technology to disinfect hard-to-clean devices such as tablet computers and smartphones while charging, syncing and managing the devices via a custom RFID backbone. Each sanitizer can manage up to 12 devices at a time. [Also: See photos from Day 3 of HIMSS16] Tablet computers and smartphones can harbor harmful bacteria and viruses. A study published in the Journal of Applied Microbiology warns that 20 percent to 30 percent of viruses can be readily transferred from a fingertip to a glass surface, like that on a mobile device touchscreen. Today, hospitals use autoclaves to sterilize a wide variety of instruments. But numerous devices such as tablets, smartphones and other electronics cannot withstand the high heat of these sterilization systems, Seal Shield explained. The ElectroClave bridges the gap for IT professionals and infection control practitioners, using high-efficacy UV-C LED technology that has the advantages of low power and low heat, Seal Shield said. The vendor's Smart Clean technology enables what the company describes as "failsafe disinfection," adjusting UV exposure to bulb life and environmental conditions. These features allow electronic devices to be charged and synced while they disinfect, the vendor explained. The ElectroClave combines HEPA filtration and positive pressure with UVC LED technology to provide the most efficient means of combating cross-contamination bacteria, viruses and fungi on hard-to-clean devices, Seal Shield added. Built-in spectroscopic analyzers measure the change on the mobile device surface in order to ensure a clean and safe device for every user, the vendor said. Twitter: @SiwickiHealthIT This story is part of our ongoing coverage of the HIMSS16 conference. Follow our live blog for real-time updates, and visit Destination HIMSS16 for a full rundown of our reporting from the show. For a selection of some of the best social media posts of the show, visit our Trending at #HIMSS16 hub.