
| URL : | http://medicalconnectivity.com/ | |
|---|---|---|
| Filed Under: | Medical / Healthcare IT | |
| Posts on Regator: | 48 | |
| Posts / Week: | 0.3 | |
| Archived Since: | April 6, 2010 | |
On June 7th, 2013 the Texas Children’s Hospital and Smith Seckman Reid are producing an educational workshop on medical device connectivity. Nursing is the predominate perspective explored in this event. (One of my pet peeves is all the focus physicians get from vendor’s marketing departments. Yet, when it comes to systems in hospitals, the predominate [...]
Last month I spoke at the first CIS Qatar International Conference in Doha Qatar. My topic was the Importance of Enterprise Wide Medical Device Integration in CIS workflow. You can download a copy of my presentation here. This was the first such conference in Qatar with over 1,500 people attending. The ballroom only had capacity [...]
On April 8, 2013, the Joint Commission published a Sentinel Event Alert on medical device alarm safety in hospitals. Once again, alarm hazards tops the ECRI Institute’s 2013 Top 10 Health Technology Hazards. Alarm fatigue is unfortunately a topic that is evergreen because it has plagued hospitals for many years and shows little sign of abating. [...]
There are currently several private entities that seek to certify medical apps, connectivity solutions, EHR record exchange, and other products, services and people in our sphere of interest. Given the ongoing proliferation of private...Show More Summary
The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials. As discussed in our earlier posts on apps regulation (here and here), an app is a medical device if its meets the congressionally mandated and FDA enforced definition of a medical device as something whose [...]
In preparing for my presentation on Stage 2 Meaningful Use (MU) requirements for the November, 2012 Fourth Annual Medical Connectivity Conference I had the opportunity to delve further into the question of what had to be connected to what, and interoperable with what, in order for providers seeking EHR incentive payments to satisfy their MU [...]
Since my last blog post here at Medical Connectivity there have been some mHealth updates that may be of interest to the blog readers. USA and FCC Just this week the FCC released its task force findings on mHealth. The overarching goal given to the task force was: “By 2017 mHealth, wireless health and e-Care [...]
Those of us engaged in medical devices and their connectivity often (or perhaps not often enough) look to the FDA for regulation and guidance. In these pages there has been discussion of FDA regulation generally (here), as applied to Medical Device Data Systems (MDDS) (here), medical device mobile apps (here and here), and clinical decision support systems [...]
I commonly receive requests for information about connectivity and enabling technologies like indoor positioning systems. Here’s an example: …I am currently undertaking research into RFID technologies and WLAN to use within a hospital. In particular I am interested in implementing the use of patient/infant tracking tag, panic tag or status tag, asset tag and also [...]
Today, July 11, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act. Applauded by big pharma, the American Medical Association, the National Organization for Rare Disorders, and others, this new legislation reauthorizes various user fees, and revises regulations in an effort to address problems around drug shortages, the paucity [...]
I have previously discussed Meaningful Use (MU) criteria for EHRs (here and here), and Clinical Decision Support (CDS) (here). These topics are closely linked since the MU requirements mandate the inclusion of CDS. On February 22, 2012 the Centers for Medicare and Medicaid Services (CMS) released (in a mere 455 pages in manuscript form) a proposed rule for Stage 2 criteria [...]
Providing healthcare monitoring over that infrastructure changes the rules of the game.
A recent Class I recall (found here) of a medical monitor with a hospital network connected central station stimulates some generalities about software, “fixes”, and connectivity. (Class I recalls are defined by the FDA as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will [...]
The issue of the EHR relative to safety and effectiveness has again made the news with the November 7, 2011 pre-publication (and downloadable) release of an Institute of Medicine report on EHR safety, commissioned by the U.S. Department of Health and Human Services (HHS). This report expands the discussion beyond the EHR (used henceforth for both [...]
A recent NY Times article reported that hotel Wi-Fi capacity was again being challenged, this time by iPads and other tablets, or more specifically, tablet users. The Times notes that these users may have a smart phone and laptop going at the same time they are sucking up streaming video. The high bandwidth demand of [...]
Today I was contacted by a social media marketing firm working for a major MDDS vendor with an offer to contribute content that’s on topic for this site (that last part is important). I’m interested, and I imagine a lot of this blog’s readers will be too. As I will likely take them up on [...]
The fact that connectivity, and perhaps wireless connectivity in particular, allows for hacking for mischief, theft, politics, social protest and other forms and varying degrees of evil should surely come as no surprise. In turn, that a wireless medical device might be hackable should be somewhere on the mind of developers, users, and regulators. Thus [...]
This September 8-9, in Boston, will be the third Medical Device Connectivity conference. We’re returning to the Joseph B Martin Conference Center at Harvard Medical School – a really nice facility with great food. Of course, the ambiance and cuisine is secondary to what you’ll learn at this year’s conference – still the only event [...]
On LinkeIn this morning, I came across a couple of comments about the FDA’s recent draft guidance on mobile apps. Thoughtful comments by David Doherty and Nathan Billing in a LinkedIn discussion prompted the following. My imperfect interpretation of their comments was the impetus for this post. David suggests that FDA regulation will stifle mobile [...]
As medical applications for mobile devices have proliferated, regulatory questions have proliferated nearly as fast, at least in some quarters. The key questions are what kinds of apps are medical devices, and among those, which will the FDA focus on for regulatory action. To date these apps range from home use adviser’s, guides and “toys”, which may [...]