Hope For FOSS In Electronic Health Records 92
Fred Trotter writes "CCHIT is the dominant Electronic Health Record certification body in the US. It is also decidedly anti-FOSS and has been for years. Certification of one kind or another will be required for EHR systems to qualify for funding under the Stimulus Act. If CCHIT is chosen as the certification body, and the current certification strategies continue, it will not be possible to have a funded EHR that is both certified and truly FOSS. Now, however, CCHIT has agreed to meet the FOSS Health IT community at HIMSS 09 to address this issue." We discussed the shortcomings in the stimulus bill as it relates to FOSS a few days back.
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You mean someone mated with an anonymous coward? And they say promiscuity is going out of fashion!
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When it freezes over in hell and they allow FOSS, they can have frosty piss for medical analysis...
I'm ready and willing to provide a sample if my HMO covers the cost...
Speaking of cost... 25 to 35K one time fee and 5k a year? What kind of *scam* is that? One gurenteed to make it possible only for those with a huge finantial interest (and thus low OSS interest) to gain entry. Total bullshit. Who made these yahoos incharge?
Bigger Issue (Score:5, Insightful)
As I understand it, the stimulus bill allocates $17B to help hospitals across the country pay for medical record systems. Think about that number, $17 Billion.
There is absolutely no reason to distribute $17 Billion to a long list of organizations to individually license an EMRS. For far less than $17B the Federal government could buy any medical record system in the world to be deployed wherever and whenever they want at a fraction of the cost. Or, alternatively, for a lot less than $17B they could sponsor development of a standard, open source EMRS that could, again, be deployed by anyone who wants to at a fraction of what it would otherwise cost.
Obviously there are costs associated with deploying these systems, but the current "plan" amounts to a giveaway of $17B to Semens, GE and whatever other companies produce "certified" EMRS.
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That's right in theory, and would be the best, but there are issues:
- government-lead IT has a long track record of failures: look only at what in happening in the UK for their healthcare IT right now.
- the hardest part is the design and speccing. once that it done, actual coding should be trivial, but then deployment/training will be hard. FOSS only adresses the easy middle of the equation; the designing probably takes too much effort for a FOSS-type service company to do all the investment up front, and t
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- FOSS is by licence and definition not restricted to being government-lead.
- If $17 bn is available, I'm sure you could find an FOSS-type service company who would make the design effort for a tenth of that amount.
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Sure I make sure I keep my physical records too but that's just because the Navy used to be so bad at keeping med records that you would get the same shot 7 times when you needed it only once.
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The major software expense is the integration with all of the other crappy old proprietary systems that the typical hospital uses (billing, staffing, bed control/scheduling, inventory, labs, pharmacy, etc.) Billing is particularly a problem, which is something the Marines don't have to deal with since they are predominantly running a single-payer health care system.
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I finally refused the shots, the medic said he'd charge me for refusing a direct order, I countered by telling him I'd counter charge him with dereliction of duty for failing to properly record the shots he had given me last month in my health records properly; he solved the problem in two minuted.
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Get out of your mother's basement (Score:5, Insightful)
Speaking of cost... 25 to 35K one time fee and 5k a year? What kind of *scam* is that? One gurenteed to make it possible only for those with a huge finantial interest (and thus low OSS interest) to gain entry. Total bullshit. Who made these yahoos incharge?
I assume you have some basis for your outrage? Do you know how many hours of work goes into the one-time certification process? What sort of legal review is required? How much money in third party disbursements are involved?
Seriously, if you don't have $30K to pony up for the certification, what are the odds that you've spent the necessary money to ensure full compliance with all aspects of relevant legislation? Have you gone over your application with a team of lawyers to ensure full compliance? Have you hired UI designers to come up with a sane user interface and paid for a panel of doctors from various professions to perform UI testing and implement any suggested changes? Do you also have professional liability insurance to cover any errors and omissions that you might have made? How large is your support department, what's your SLA for support turnaround times, and what's the SLA for any bug fixes or feature improvements? What kind of physical and network-based authentication and permission policies do you employ in your office? If someone were to break into your office during the night and you've been examining data from my systems to track down a bug, can you guarantee that the data won't get compromised because proper information handling procedures have been followed? What's your two year roadmap for the product so that people comparing it against offerings can see where you're headed?
What it boils down to is that the $25K - $35K in fees is partly to cover the actual costs of the certification and partly a statement that "if you can't afford these costs, don't waste our time because odds are good you won't be in business in a year from now". Seriously, that's the salary and overhead cost of a half decent developer for a few months let alone all the other support staff you'll need to maintain a viable business.
Also from the article:
The "seal of approval" model is also problematic. Suppose I pay the fee to have MirrorMed (my project of choice) certified. There is no way for me to guarentee[sic] that only I benifit[sic] from the "seal". My competitors which have full access to the code that I would have certified would be able to correctly claim that the code had been certified, and would benifit[sic] with me. As with the original pricing there is no way to fairly spread these kinds of costs across a community.
Waah... cry him a river. He's complaining that because he's choosing to make his code available for everybody at no cost, that he's putting himself at a disadvantage because others can use his code at no cost? What the FUCK, dude? Choosing to use the GPL means that you've also chosen all the consequences of that particular license. If you don't like the consequences, then don't ask for special treatment because you think the GPL automatically gives you some kind of entitlement. Change your license!
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GPL Issue (Score:2)
The question here is about what it is reasonable for the certificating authority to do given a piece of code, rather than what it is reasonable for a programmer to do. Certainly, the argument for the fee may still hold, but the license requirement must be bias, since to oppose the GPL is to state that the GPL model intrisically yields poor code.
Of course the programmer can choose another license, but to require that of the programmer can only be a special interest. If this were made law, it would be a cle
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if you can't afford these costs, don't waste our time because odds are good you won't be in business in a year from now"
And that's what you're going to tell all the solo pediatricians and family practitioners who currently use paper charts and who are going to have to suck up that cost when they buy a certified EMR?
If you have five people in your minuscule company with salaries, benefits, office space, equipment, legal and accounting fees, insurance, and other overhead of $100,000 per year for each employee (and really, that's low for anybody decently skilled) then $30,000 represents 6% of the total cost. Over the course of ten years, the cost of acquiring and maintaining certification, assuming your expenses don't go up at all, represents an average of 1.5% of your total expenses.
So in answer to your question: no, i
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... $30,000 represents 6% of the total cost. Over the course of ten years, the cost of acquiring and maintaining certification, assuming your expenses don't go up at all, represents an average of 1.5% of your total expenses.
Interesting that you neglect to include the 5k yearly fee in your calculations, which changes the number from $30,000 to $80,000.
That's a signficant barrier to entry.
Also interesting that you assume that personal costs are $100,000/year.
When someone bends numbers to such an extent, on one hand to make one number look as small as possible and, to further their argument, to inflate another number as much as possible, you have to question the validity of their argument in the first place.
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5 employees @ $100,000/year (everything included) = $500,000/year
10 years @ $500,000/year = $5,000,000 over 10 years
$30K first year + 9 years @ $5K = $75,000
$75,000 / $5,000,000 = 1.5%
Have a nice day.
As to your assertion that $100,000 per year per employee is inflated, Oracle averaged $153,000 in operating expenses per employee over the last 12 years[1]. Red Hat was almost $250,000 in operating expenses per employee[2]. So $100,000 per year is low in the software industry and it's doubtful you'll find any
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If what you suggest were actually done, you might have a point, but all the EMR software I've seen has a nightmare interface, numerous features disabled (and done on paper instead) because they don't comply with the law, and a security model that is modeled after having physical access to a terminal because that is how the paper charts are secured!
Honestly the current software out there makes Diebold look like a secure and competent vendor.
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As with many new standards, there should be an open-source reference implementation, which has achieved certification. We do this with most other standards. I don't see why this is different.
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Medical applications cost a lot of money, if you are a facility that decides to try and save some money on the front end and go with the cheap option, don't be surprised when you find yourself in a hole because suddenly you don't meet some federal or state standard. When this happens the cost to change over to something that is compliant is going to cost you more than just spending a couple dollars more and getting one from a company that realizes the value of being certified in the first place. The cost of maintaining these systems to these standards is very expensive.
From what I've seen most of these vendors don't maintain to the standards with the rigor that I'd assume would be required from reading the standards, and I assume it's because of the expense. Furthermore a lot of these companies either tank from trying or get bought-out by a company that only does a half-assed job for a few months, then forces an "upgrade" to less capable system and you lose half your data in the conversion. At least with an open standard, your data wouldn't be held hostage to one company
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Seriously, if you don't have $30K to pony up for the certification, what are the odds that you've spent the necessary money to ensure full compliance with all aspects of relevant legislation?
30k is alot of money. In our shop we have regulatory requirements with respect to watch lists, credit cards and so on. Fulfilling those duties cost significantly less than 30k.
25k + 5k/year is a barrier to entry to keep the big boys protected from competition, nothing else.
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So, I'm going to go out on a limb here and say that I'm one of the few here that has gone through the CCHIT certification.
I can say that it's an involved processes. The fee is justified. The EMR and HIE spaces aren't places where one-guy-in-a-basement can play, they're BIG deals involving BIG money and LOTS of CRITICAL (i.e. people die if you get it wrong) data.
I can also say that CCHIT are not anti-FOSS, from what I can see. The certification itself involved several FOSS tools (and some of them were mighty
As I am going to this... (Score:1, Redundant)
Anti-FOSS? (Score:5, Interesting)
So let me get this strait...CCHIT is considered anti-FOSS because they charge fees that for certification that the FOSS folks cannot afford?
Sounds like we need a welfare program for FOSS apps to be able to play in the big leagues. How do you think CCHIT gets their operating budget? Through fees I would expect.
Re:Anti-FOSS? (Score:5, Insightful)
Sounds to me like this organization should be getting funded a better way. It's pretty commonly accepted that certification groups that get their budget from fees have a pretty significant conflict of interest wrt. properly executing their duties.
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It's pretty commonly accepted that certification groups that get their budget from fees have a pretty significant conflict of interest wrt. properly executing their duties.
And a 25 to 35k entry fee with a 5k yearly fee is a prety BIG conflict of interest.
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FOSS is the ultimate conflict of interest. God forbid I need to make some money in order to get my FOSS software product in use in the medical industry. The community will think I sold out :((
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I must say sir, that your herring is a lovely shade of rouge.
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That's actually the point of such certification groups; they serve their paying clients by creating a competitive advantage for the existing big players that any new competitor has trouble meeting. That's even moreso, often, the point of such groups when certification through them is required by government regulation, as such regulations
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35k+5k is trivial compared to the other costs of developping and maintaining such a complex system.
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Sounds to me like this organization should be getting funded a better way. It's pretty commonly accepted that certification groups that get their budget from fees have a pretty significant conflict of interest wrt. properly executing their duties.
Well lets see
Well it seems to me that the authority of the CCHIT is self-assumed, they are a private organization, not a public one; being non-profit simply means they have to spend all their money each year, not that they are good or charitable or ev
Re:Anti-FOSS? (Score:4, Interesting)
Outside of the entire Fees for OSS idea, I think it is preposterous to think that once you certify a program or application to do a certain thing, you have to continue paying them based on annual sale of your program or application to keep that certification.
We don't need welfare for OSS, we need something different in place. A certification process shouldn't be dependent on future fees paid nor should it base any of the fees on the sales of the software. If you want to know why health care is so expensive, it's shit like this.
Think about it, 25K can go into 25 copies sold $1000 at a time. That isn't so much when considering what the software brings to the table. But an annual $5000 on top of that based on sales means the same program that was certified at $1000 a pop is now not certified if more money isn't paid. The question is, is that 5k a version sold?, up to 25 licenses sold? or is it 5 licenses sold? Now licenses could be a misnomer too, Take MS servers for instance, you need a license for the server, a license for the workstation's MS operating system, a license for the network connections to the server, and a license for all the MS applications running on those systems. Lets say MS Office is a given and for shits and giggles, lets say MS dynamics CRM is installed. Now, that means 1 server license, 1 workstation, 1 connection, 1 office and 1 CRM, that's 5 licenses just to be up and running. OF course more workstations will need less licenses but in the certification ordeal with CCHIT, how many of those licenses count as sales? I mean the ERM software could have modular features and easily require 5 licenses, so with the 5k based on sales, if that is for every 5 licenses, then you might need to recover 5k per workstation on top of your profit and expenses for creating the damn thing.
It's a racket that shouldn't be allowed. If we are going to require certification, then there should be some rules and guidelines and limits on costs instead of creating a get rich quick scheme that drives the cost of health care up so some damn politicians can fool the people when they claim to be fixing the problem. The opposite of that would be to open up the ability for other companies or organizations to become certifies and forbid lock ins to certain companies or organizations so competition can drive costs down to something more reasonable.
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When you choose to make your Product FOSS, you should realize you are automatically putting yourself at a disadvantage, by closing off the most direct and profitable revenue stream. So when the industry demands certification and standards if you want to keep going you need to pay for them. I am sorry that is the case.
If you want to be a Medical Doctor you need to pay for enough college for an MD. I am sure there are a lot of people without MD who could be great doctors and have the knowledge and skills to
To add some meat or beef or whatever... (Score:4, Informative)
Here are a few more links...
List of open source healthcare software:
http://en.wikipedia.org/wiki/List_of_open_source_healthcare_software [wikipedia.org]
Welcome to openEHR:
http://www.openehr.org/home.html [openehr.org]
"openEHR is about enabling ICT to effectively support healthcare, medical research and related areas. Today ICT is used ubiquitously elsewhere, but is far from effective in Healthcare. The main problem in health is the lack of shareable and computable information.
The principal challenge for health ICT is to represent the semantics of the sector, which are far more complex than in other industries. Doing this requires a knowledge-oriented computing framework that includes ontologies, terminology and a semantically enabled health computing platform in which complex meaning can be represented and shared. At the same time it must support the economically viable construction of maintainable and adaptable health computing systems and patient-centric electronic health records (EHRs).
The openEHR endeavour is about creating specifications, open source software and tools in the technical space for such a platform. In the clinical space, it is about creating high-quality, re-usable clinical models of content and process - known as archetypes - along with formal interfaces to terminology."
If the US has idiots in onbstructionist ways working in positions of power, then maybe, if other countries are technologically superior in such areas, offer help to them so they can grow and come back to haunt and compel the USA to "get with it, already!".
Re:To add some meat or beef or whatever... Alterna (Score:2, Insightful)
tively...
Screenshot of OpenEMR:
http://sourceforge.net/projects/openemr/#item3rd-2 [sourceforge.net]
The resources that already exist in the USA can be brought to bear by offering these to as MANY doctors as possible. It will first requiring conducting info gathering on providers, their electronic systems, having some insiders in the many types of medical offices to come in and user-test/kick the tires on these apps, and get THEIR opinions as to whether the software is worthy of being supported. It appears that some of the ope
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Thanks....Interesting, additional and refresher information!
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Also, consider that the US government has already paid to develop several healthcare systems itself. VistA and RPMS (they're related) serve the VA and Indian Health Services. They're free to download, and local sites often create, apply, distribute, and support various patches independently of any central control. It's free and open-source, at least in a sense. Installation and support (and hardware) aren't free, but a FOIA request will get your the code for free, at least. There's at least one other piece
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and that in all likely hood
Brain apparently shifted gears on me and I didn't notice before I hit submit.
Re:This article says a lot about FOSS... (Score:5, Insightful)
The problem is that the model breaks when the software environment breaks because of fees to make the software useful.
Requiring a certification isn't part of the normal software process or model. It's actually an add on that isn't necessarily needed but has advantages. If the model was changed and the vendor certified the software in house to pass a third party review and the customer had to cover the expense from a third party verification service, it would be the same model and nothing would be broke. But no where else in software, do you have to pay someone in order for your software to be used unless your licensing someone else' product. Of course if your licensing someone else' product and they don't want it open sourced, you can't open source your product that contains theirs.
And something you should note, it's only a problem currently because of the outrageous costs associated with certification. If the costs were lower and more reasonable, the problem disappears. It's disingenuous to associate the problems with the FOSS model or commercializing FOSS software without pointing to what broke it. It isn't like many other software packages ever require third party certifications that require large sums of money either. And of those that might, the sums generally aren't as outrageous and ongoing like this.
Something the poster didn't mention that could negate most all of his fears and black out the point you raised is that they could certify the software under a trademark name and do the releases with the normal name. This would lock the certification into something only he could use. For instance, he likes the program MirrorMed. Now he can create a company called Trotter inc. and certify MirrorMed as "Trotter's certified MirrorMed" software. He then distributes it under that name "Trotter's Certified MirrorMed" and distribute his code as MirrorMed. No one else could claim MirrorMed was certified under his certification because they couldn't use his trademark "Trotter's certified" in the name of the product even though he distributed the code and the certification is in his trademarked name.
In short, the certification would be locked to the "trotter's certified" which is the over package he provides instead of just the software MirrorMed. He could control this because MirrorMed itself as a name wouldn't have been certified. Now the code would have technically been certified so everyone else wanting to do the same could certify it themselves without fear of it failing, and most likely they would certify it under their own trademarked name too.
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In short, the certification would be locked to the "trotter's certified"...
That's strange. However, it jives with what I've learned from my experience w/ US governmental IT certification organizations. (The process is infuriatingly slow and inefficient, let me tell you what...)
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The medical records system has to get it right the first time. The cert is not going to be easy to get. It is not going to be cheap.
Now the code would have technically been certified so everyone else wanting to do the same could certify it themselves without fear of it failing
This sounds --- simplistic.
Is it the
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Certification requirements are a government-imposed market distortion that, if imposed in a way which attaches the cost to the developer systematically disadvantages FOSS software. Of course, since certif
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I guess I hit a nerve... all I did was point out that the author of the article, who wants to use FOSS, complained about the problem that once his software is certified, ANYONE can sell it, w/o sharing the cost of certification, and I instantly got modded into oblivion. Just to repeat, here's what the author of TFA article said:
"Suppose I pay the fee to have MirrorMed (my project of choice) certified. There is no way for me to guarentee that only I benifit from the "seal". My competitors which have full ac
one of FOSS's problems. (Score:5, Interesting)
If the law states that there should be a 'view but not save/copy/print' right (like here in the Netherlands), how could you enforce that *and* be truly open source? You have to certificate each and every release of the full software on a source code level (and provide authorization based on the (i.e.) md5 sum of the executable) to enforce such rights. One simple edit & recompile and you can save/print those x-ray pics, which is against the law.
At the very least, forking, maintaining your own version and fixing bugs for your (employer's) own use is either impossible or very expensive.
Let's not bring another made-up word into software (Score:2)
> You have to certificate each and every release
I have no idea why the aviation world decided that the perfectly good words "certify" and "certified", used to describe those concepts since the dawn of aviation regulation, should be replaced with abominations such as "certificate" and "certificated". But let's not bring yet another set of made-up words into the realm of software - we already have too many of them as it is.
sPh
Re:Let's not bring another made-up word into softw (Score:2)
Sorry, English is not my first language and I already thought that I didn't use the right word. I even used my dictionary, but to no avail.
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> Sorry, English is not my first language and I already
> thought that I didn't use the right word. I even used
> my dictionary, but to no avail.
My apologies - I did not mean to criticize the English skills of a non-native-speaker. In general United States English usage a person or object is granted (or possesses) a certificate, and is then said to be certified. As I noted the world of aviation recently (within the last 10 years) started using the word "certificated" (ser-tif-eh-cate-ed). English
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Re:one of FOSS's problems. (Score:4, Insightful)
The same way you would do that for commercial programs.
Being open source doesn't mean that there is an absence of government regulations that restrict your ability to distribute and/or use modified versions.
And...so, what? Its always possible for the user to modify either the software, the software environment in which the application software runs, or the hardware platform on which the software runs to avoid such restrictions. Certification of software only provides assurance for the software in the form it is sold, not anything that is done by the purchaser after they have received it. Other enforcement measures, like on-site audits, are necessary, whether or not the software is open source, to assure that the user uses the software in a manner which complies with the law.
It doesn't add any cost that isn't added to purchased software, even if the certification requirement is on software used and not software sold for a purpose, since you are going to be paying the cost of certification for any software you purchase, as well. OTOH, since the modification and use of software in house is part of the internal practices, it makes more sense to include those in whatever regulation and certification requirements exist for internal practices, rather than in the kind of certification requirements that are imposed on software sold for a regulated purpose.
Re:one of FOSS's problems. (Score:5, Insightful)
Opensource is about the code in question and the freedom to adapt it to your needs.
That being said, the ability to give the code away again is still there even with certification is the certification is assigned like a patent or copyright. In this case, the assignment of the certification would be a specific implementation by a specific company or person or person representing the company.
To walk through this just so we are clear, if I create an open source product called "Little Dog" and I get it certified, if the certification is assigned to me for version 1.0, then version 1.2 or 1.45 or whatever would need a new certification. And because the certification is assigned to me, if you decided to take the code and offer your own product or even improve it, you wouldn't be able to claim it was certified because only the person assigned the certification could do that. Technically, the code would have been certified so you could get a certification in your name without fear of failing but you couldn't lay claim to my certification.
Now, I believe this follows along with the open source model and principle because you can get the code, you can distribute the code, you can modify it, you can still do anything you want with it. The only thing you couldn't do is make claims or representations over a certification for use that was assigned to me. Think of it like this, if Time magazine said you were the hero of the month because of some open source program you created, I couldn't accurately take the code, distribute it, and claim Time Magazine called me the hero of the month even though I would be using the same code you created that caused them to notice you.
I hope I didn't just write in circles and confuse my point.
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It might be cost effective to have a third party certify patches (but probably not).
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I think the more likely scenario is that certain versions or releases of any FOSS software would be certified. A health care organization is only going to be running binaries. If there's a concern about a bad actor within the health-care organization re-compiling FOSS code to run renegade binaries, I'll bet that person ha
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This is where the laws and audits come in. It is just like keeping records in a filing cabinet. There is nothing inherent in the file cabinet that prevents users from copying information, taking the records home, etc. It is simply policy that is enforce
CCHIT? (Score:5, Informative)
Disclaimer: I work in this industry.
To be blunt, CCHIT is among the least significant and cheapest of the regulatory considerations in healthcare software, particularly when you're talking hospital-caliber systems. Far more onerous are the FDA regulations and oversight (at this level, healthcare software is regulated as a medical device), and similar bodies in other countries. Software bugs can also create enormous legal risks; malpractice or wrongful death claims are never cheap, and bad code or human error does not get you off the hook. All of this means enormous testing and documentation costs, shared by both the software companies and the hospitals. (The VA, as an arm of the federal government, enjoys some legal advantages over other hospitals in this regard.)
Combine this with the enormous complexity and the domain expertise required to model what can occur in a hospital, and you have a market with a very high cost to enter - not the best opportunity for open source. Indeed, there's been several highly-capitalized and failed attempts to enter the market by tech giants ...
That said, most modern healthcare software contains and uses healthy quantities of open-source code, but generally not of the GPL variety. We regularly contribute to the projects we use, inasmuch as our employment contracts permit. However, generally speaking, these projects are not specifically healthcare oriented (though there are exceptions - hapi [sourceforge.net] is a personal favorite.)
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What, you mean I can't make every shmuck that comes in my hospital click on an EULA that says that they can't sue me even if I kill them?
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What, you mean I can't make every shmuck that comes in my hospital click on an EULA that says that they can't sue me even if I kill them?
Sure you can! But the courts will ignore it I bet; some types of clause are generally reckoned to be unconscionable and "can't sue me if I kill you" would be a prime candidate for that sort of thing.
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That hasn't stopped Microsoft or most of the rest of the software industry from doing exactly that. Their EULAs basically all say that if defects in their software cause harm, they are only liable for the cost of refunding the purchase price. If their software defects kill someone, they are trying to be not liable. To my knowledge that type of clause has
Getting a second opinion (Score:1, Interesting)
There is a HUGE problem with this issue of electronic records and it relates to the philosophy of who should be responsible for what. IMHO each person should be responsible for his own records. When you use medical services, you always receive the records produced during those services, and the provider will keep a record as they always have. But these records should not be shared with anyone nor go into any kind of national database. These records can be in a standardized electronic format if that makes li
Just another example of why (Score:3, Insightful)
CCHIT is SH*T (Score:3, Interesting)
Its really disheartening when you write software all year to provide useful tools for doctors that improve the standard of care, and then have a bunch of useless and counterproductive features slapped on because of an upcoming CCHIT certification.
IS the FOSS system that the VA system certified ? (Score:2)
IIRC the VA uses a pretty robust system, and it is FOSS (public domain).
Is there some paricular reason it cannot (or isn't) certified, and or become the reference system?
It's simple (Score:1)
Original Author replies (Score:1)
First, one of the assumptions is that an EHR is -one- kind of thing and it needs to be certified. This is much more a category buster, like a car. If a required car certification mandated that all cars should have beds like a truck, be able to off-road and break 150 mph, then you would have a tremendous change in how the auto-industry works. Even if you have seemingly reasonable requirements like "auto-door locks" or "automatic transmi