Tim provides a good starting point for understanding this in EMR Integration for Medical Devices: The Basics.
What this highlights of course is that getting data from a medical device into an EMR is a lot harder than it should be. "It’s not pretty" is an understatement. In the ideal world nobody should have to be connectologist to get medical data where it needs to be. Unfortunately, we have a long way to go before that becomes a reality.
As Shahid points out in Consider MySQL ‘Archive’ storage engine to store large amounts of med device structured or waveform data, saving physiologic waveform data from a medical device in a MySQL database for archive purposes is a reasonable alternative to using flat files.
In SQL Server 2008 you can have it both ways. In addition to saving binary data directly in the database you have the option to have a varbinary column stored as a file stream. From the article How to store and fetch binary data into a file stream column:
File stream data can be used from the .NET Framework using the traditional
SqlParameter, but there is also a specialized class calledSqlFileStreamwhich can be used with .NET Framework 3.5 SP1 or later. This class provides mechanisms, for example, for seeking a specific position from the data.
There are pros and cons to this approach. The backup and transactional issues, along with the performance considerations, all have to be evaluated against your specific system requirements. Having the SQL Server engine manage the database relationship to the binary files seems like a big advantage over maintaining flat files yourself.
Read the MSDN article FILESTREAM Storage in SQL Server 2008 for all the gory details.
UPDATE (3/25/11): Who's Got Access to your FileStream Directories?
Jeff Atwood is a great writer. All of his blog posts are informative and interesting.
How to Write Without Writing is a case in point. It starts off with a clever hook ("trick my fellow programmers"), expounds the benefits of writing, particularly answering questions ("fun sized") as a way to improve your communication skills. All of this is true.
The worm in the apple of course is the blatant promotion for the Writers Stack Exchange site. You really can't fault Jeff for doing this though. If you were running a venture funded business that depended on driving traffic, you'd make use of your celebrity in exactly the same way.
This will hopefully not diminish the message that writing can be used as an effective vehicle to gain technical knowledge as well as being a critical professional skill.
That wasn't as insurmountable and impenetrable as I thought it was going to be.
I'm jealous of companies that get to produce diagnostic medical devices without having to go through the FDA 510(k) process. For example, the iHealth BP3 blood pressure monitor is a high-tech looking device with a free Apple application:
Hopefully they're using an approved non-invasive blood pressure (NIBP) device like the SunTech module.
The built-in ability to e-mail results to family or a physician seems useful, but posting your blood pressure on Facebook or Twitter? I don't know...
Hat Tip: medGadget
The article Is Cloud the tomorrow of Medical Devices Industry? includes some of the challenges -- regulatory, privacy, security etc. -- faced by manufacturers trying to manage medical device data in the cloud. You can't disagree with this statement:
The success of the vision of Smart Connected Health Grid is dependent on wide scale adoption of cloud computing in all areas of healthcare.
There's no doubt that adoption of cloud-based technologies are starting to provide concrete market opportunities in the Healthcare space.
There are also two major market barriers that will have to addressed in order for the cloud's full potential to be realized:
The potential is there, but IMO creating a value proposition that will result in a sustainable market based on a technology alone will probably not work. It's the old "hammer looking for a nail" problem.
Medical device data combined with cloud-based technology will be part of many effective healthcare solutions. Some of these may actually make money, someday.
Today's New York Times Magazine The Year in Ideas: 10th Anniversary Special features the MIT Cardiocam:
Cardiocam is a low-cost, non-contact technology for measurement of physiological signals using a basic digital imaging device such as a Webcam. The ability to perform remote measurements of vital signs is promising for enhancing the delivery of primary health care.
Medgadget covered this in October: MIT Student Uses Webcam to Measure Heart Rate From a Distance includes a video that shows how the Cardiocam is used to create a “medical mirror” for home health monitoring.
A link to a PDF (here) has a full description of the research, including their Cardiac pulse recovery methodology:
The method uses Blind Source (Signal) Separation (BSS) by Independent Component Analysis (ICA) of the changes in the video signal:
Volumetric changes in the facial blood vessels during the cardiac cycle modify the path length of the incident ambient light such that the subsequent changes in amount of reflected light indicate the timing of cardiovascular events.
Very cool.
The MassDevice article Doctors to patients: Track your own health data has an interesting take on the personally controlled healthcare record (PCHR).
Keely Wray advocates that PCHR data should be "Hackable" (my highlight):
I mean "hackable" in the sense of the word that is quickly growing in popularity: allow owners of a product to manipulate, re-purpose or add to the functionality of a product to serve their own personal needs.
Ms. Wray asks:
Doesn't it make sense to allow patients to put the technologies together in a way that meets their needs?
Their own needs? Maybe yes, but probably not.
The biggest incentive for innovation will be where someone sees an opportunity to meet a lot of other people's needs. This may well be for group that shares a common problem or aliment with the technologist(s). The initial intent may be altruistic, but real growth will only take place when a market emerges. This is the reality that could lead to significant new health data management solutions.
For example, PatientsLikeMe started off this way (from the About Us page):
Our personal experiences with ALS (Lou Gehrig's disease) inspired us to create a community of patients, doctors, and organizations that inspires, informs, and empowers individuals.
There's nothing wrong with that.
Today's New York Times article Making Ads That Whisper to the Brain gives a pretty balanced view of using EEG monitoring for doing market research -- "Neuromarketing."
This is not a mind reader,... We can only measure whether you are paying attention.
I write frequently on EEG related technologies, and often sceptically about some of its applications. The term "pop neurology" seems to apply here, especially when it comes to the ability for this technology to correlate to purchasing behavior. The establishment of NeuroStandards will only ensure that everyone is fooling themselves the same way.
Also, "brain-whispering" makes no sense. Most ads I see are loud and intellectually insulting (TV) or are visually annoying (Web) -- it's more like brain-shouting.
Here's a Today show segment on this: Inside the brain of a shopper.
As part of a series on High Assurance Agile Development in Regulated Environments is the article
Agile Software Development in Regulated Environments Example: Medical Devices. The purpose of this article and future posts is to introduce the FDA regulatory landscape and then
... see what we can do to “agilify” our practices under these standards as we move forward.
It's been three years since I wrote Agile development in a FDA regulated setting. I'll be interested to see if the application of "agile, high assurance activities" in this environment -- and the associated issues -- have changed since then.
UPDATE (10/23/10): Can and should agile be used for medical device development? Absolutely!
UPDATE (11/27/10): More discussion here: Can Agile Software Methods be used in medical device software development?
UPDATE (11/28/10): Agile Medical Device Software Development?
UPDATE (12/17/10): GE Healthcare Goes Agile
UPDATE (1/5/11): Missed this one: Four Reasons Medical Device Companies Need Agile Development
There have been some interesting EEG related stories lately:
I've followed BCI: Brain Computer Interface and EEG work for a long time. There is still a long way to go on the "mind reading" front, but these types of developments are all encouraging.
