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Healthcare IT | Medical Connectivity

Last Build Date: Tue, 13 Feb 2018 00:38:41 +0000


Health Care Messaging and Orchestration — Systems of Action

Mon, 12 Feb 2018 15:35:53 +0000

In this post we will delve into a growing enterprise software category, consider the underlying technology, and explore the ways this technology is being developed and applied in health care. System of Action A system of action provides the right information, at the right time, in the right format, to the right user(s). As a near […]

FHIR in Action – How Well Does It Work?

Wed, 22 Jun 2016 16:50:04 +0000

 Two years ago, I was at eHealth week in Athens, Greece, and stumbled upon several other Americans who represented the Office of the National Coordinator (ONC) touting Fast Healthcare Interoperability Resources (FHIR) as a standard that would help move healthcare interoperability forward more quickly than what we have seen over the last few decades. FHIR […]

Connectivity and Hackability

Fri, 28 Aug 2015 23:48:49 +0000

It is somewhat ironic that Hospira and Cerner announced a new collaboration on Hospira’s infusion pumps and Cerner’s EHR given that Hospira has recently had more than its share of attention with respect to asserted LifeCare and Symbiq pump cybersecurity vulnerabilities. This attention included a notice from the Department of Homeland Security as well as from the FDA […]

DHHS OIG Work Plan Targets Networked Devices

Mon, 10 Nov 2014 21:53:47 +0000

The Office of the Inspector General (OIG) of the U.S Department of Health and Human Services has released a report (pdf) outlining its 2015 work plan. Among a host of subjects is "Information Technology Security, Protected Health Information, and Data Accuracy" with the subsection "Controls over networked medical devices at hospitals". The focus here is […]

FDA Takes Step Backwards with New MDDS Guidance

Tue, 09 Sep 2014 22:06:03 +0000

This summer, FDA proposed lifting regulations from certain currently regulated medical devices. This unprecedented policy shift targets devices known as Medical Device Data Systems (MDDS) and is intended to benefit the mobile app industry and companies like Google, Apple and others. The current regulatory burden for MDDS devices is Class I, 510(k) exempt. This means […]

Health Care Messaging Market Segmentation & Adoption

Thu, 10 Jul 2014 02:59:21 +0000

The previous post in this series suggested a set of characteristics to define the messaging middleware market and described the typical product architecture for these systems. In this post, we'll look at ways the market may be segmented and how the market is adopting these systems. Market Segmentation Market segmentation is the dividing of a […]

A Medical Device Recall of an EHR-like Product

Wed, 19 Mar 2014 15:26:09 +0000

The recent recall (links below) for McKesson’s Anesthesia Care system raises interesting questions about potential information system failure modes as well as what system/software functions cross the imaginary line between unregulated EHRs and regulated medical devices. First the facts. The FDA announced McKesson’s voluntary recall of its Anesthesia Care system in several on-line (here, here […]

Guidelines for Using Wi-Fi for Medical Devices

Mon, 13 Jan 2014 16:00:16 +0000

On a recent LinkedIn group discussion, the following question was posed by Taimoore (Tim) Rajah of the NIH: We are encountering many hospital which are still based on wired LAN technology for medical device connectivity. Many have mentioned their gripes and major concerns about using Wi-Fi technology for patient monitoring and drug delivery monitoring in […]

Have You Read a Disclaimer Lately?

Tue, 07 Jan 2014 23:05:21 +0000

Some time ago Tim Gee pointed out that a major vendor for an in hospital communication system included the following statement in its documentation: "This product is not intended for use with patient monitoring devices or other patient care devices. Do not use this product as the primary communications tool in health care environments, as […]

FDASIA Report on Regulating HIT

Mon, 30 Sep 2013 16:00:16 +0000

On September 4, 2013, the FDASIA mandated workgroup presented their recommendations to the Health IT Policy Committee in Washington, D.C. Some reporting on the meeting cast the draft report as downplaying potential FDA regulation of healthcare IT applications (HIT), while others emphasized the uncertainty (subscription required) of the process and ultimate outcome. Such news stories […]