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Developing Safety Critical Healthcare Software

Posted on June 21, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The Healthcare IT Guy, Shahid Shah, has a great post up on his blog about writing safety critical software using an agile, risk-based approach. Here’s a portion of the blog post where Shahid really hits the nail on the head:

Much of that [every software being custom] changed in the 90’s and then upended even further in the early part of the 21st century; we should no longer weighed down by the baggage of the past.These days even our hardware is agile and extensible, real-time operating systems are plentiful, software platforms are malleable, mHealth is well established, and programming languages are sophisticated so we need to be open to reconsidering our development approaches, especially risk-based agile.

Why should we use “risk-based” agile? Because not every single line of code in software can or should be treated equally – some parts of our medical device software can kill people, many parts merely annoy people, but most other parts simply aren’t worth the same attention as the safety-critical components. When you treat every line of code the same (as is often true in a plan-driven approach) and you have a finite amount of resources and time you end up with lower quality software and less reliable medical devices. It’s not fair to blame the FDA for our own bad practices.

I’m always amazed by Shahid’s knowledge and ability to describe something in simple terms. I should know since I’m often on calls with Shahid since he’s my partner in Influential Networks and Physia.

The irony is that in the EHR and mHealth world you could argue that many have taken too much of a lean approach to building their applications while the medical device world treats every part of the software as a patient safety issue. Now if we could just bring the two together into a more reasonable balance of what’s important from the safety side and what’s not.

As far as I can tell, the FDA is planning to mostly stay out of regulating the general mHealth and EHR side of healthcare IT and will stick to the medical devices and mHealth devices that fit under the medical device term. I think this is generally a good thing for a number of reasons. Not the least of which is that the FDA doesn’t have the expertise needed to regulate EHR software. However, I wouldn’t mind a touch more patient safety concern from EHR vendors. Maybe the EHR Code of Conduct will help add a little more to this concern.

Of course, as Shahid points out, you don’t have to sacrifice agile software development to develop safety critical software. This is true in medical device development, EHR development, and even mHealth development.

My Top 3 Health IT Bloggers

Posted on May 18, 2011 I Written By

Katherine Rourke is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Folks, today I thought I’d take things in a different direction in share links to my favorite health IT bloggers.  Each brings insight, straight talk and deep experience in the healthcare business to the table.

By the way, just to avoid bragging too much, I haven’t included the other blogs in the Healthcare Scene network, but I recommend them highly!

Now, without any further ado, here’s the list:

* The Candid CIO:  This blog offers a rare view into the mind of the IT leader of a large health system.  It’s written by Will Weider, CIO of Ministry Health Care and Affinity Health System. As he notes, the system includes 14.5 hospitals and 400 employed physicians across northern and central Wisconsin. Weider delivers as promised: he’s candid, conversational and quite willing to share his frustrations when things don’t go well.  Definitely a worthwhile read.

*  The Healthcare IT Guy
:  This blog, which is written by health IT consultant Shahid Shah, is always an interesting read. His goals are ambitious — he calls the blog a “healthcare IT, EMR, EHR, PHR, medical content, and document management advisory service” — but believe it or not, he manages to cover pretty much all of this territory. Shah is an entertaining writer with a very long health IT resume, and he knows his stuff.  I learn something new whenever I visit.

* HISTalk:  Something’s always bubbling away at HISTalk, an influential site where insider industry folks come to hang out. Mr. HISTalk, an anoymous health IT administrator, not only provides interesting content, but also draws out juicy gossip from readers. For example, check this item out:  “Re: Cerner. Word on the street is that Cerner is getting ready to announce some big organizational changes and these are not good kind of changes for the employees (may be good for Wall Street, however). This is supposed to hit the CareAware division pretty hard.”  I don’t know if any blog is a “can’t miss” but it’s a good idea to visit now and then.

So, I hope you enjoy these sites — I have for years. Meanwhile, I’m open to hearing about other great health IT blogs as well. Please feel free to let me know if there’s others you admire.