Certification with CCHIT
Posted by Martin P in 
Living and working (as I occasionally do) outside the US, the workings of the FDA, and the CCHIT are of limited relevance. Limited, but by no means negligable. Many individuals as well as institutions outside the US consider FDA 510(k) an important indicator of fitfulness-for-use. Never mind the fact that the US – being the world’s largest market for Healthcare IT – is the primary driving force for the products that are subsequently shipped elsewhere. I suspect, should CCHIT follow the path that the US administration expects it to, then CCHIT will fulfill a similar role as the FDA does in PACS.
Indeeed, I’ve speculated before that CCHIT might take on some of the role the FDA has fulfilled to date in certifying the quality of potentially patient-threatening (as well, of course, as patient-benefiting) and I still believe that is a credible path forward. CCHIT has had critics in recent times over its positioning of the certification process at large corporate vendors, although progress seems to have been made – Fred Trotter being amongst the legions putting the pressure on.
But this is my problem: The certification requirements as far as I can see read like a functional specification. There is no consideration that the functionality as implemented might, quite simply, be crap.
The FDA process does include a loosely defined concept of software engineering best practice which at least ensures the vendor has put some thought into design, engineering and defect prevention. CCHIT seems to have none.
So as much as I turn green & roar a lot when I see Access databases (written by a couple of just-grads with little or no experience of real development) being wheeled into hospitals to manage departmental workflow or EVEN WORSE live clinical information, it seems if the current formulation from CCHIT is followed, I’ll have to put up with it.
The Firefox upgrade is impending
Way back last August I predicted we may see the upgrade from Firefox 3.0 to 3.1 appear potentially by late September 2008. So much for my skills of prediction. In the meantime, we’ve seem Firefox 3.1 being rebranded as 3.5 (justifiably, because the leap is substantially more than a 0.1 point release!) and go through an extended period of alpha- and beta – testing. Over the last week or so, we’ve seen the release of Release Candidate (RC) 1 and RC2 – possibly the final pre-release version.
The main benefits (from my perspective) are:
- Greater compatibility with HTML 5 – particularly <video> and <audio> tags which enable said formats to play without using pugins.
- A storming improvement in javascript performance.
- Massively reduced memory requirements.
- From a devs point of view, native JSON support is seriously cool.
More details in the release notes.
FF was beginning to remind me of the Debian Linux project’s problems in release strategy of years past but I’m glad they didn’t succumb to the temptation of competing with the Google Chromium release and IE 8 but instead took the time to make this a serious contender for (again) best browser.
Check it out. It’s good.
Complexity, Simplicity, Expectation
The key to a ‘good’ user interface (UI) is that the UI distills what is often a complex morass of information into a simple representation. Ben Galbraith likens the process to craftmanship. Quoting Joel, describing the fitting of trim around a door:
You can’t tell this from the picture, but the screws in the middle strips are almost but not exactly lined up. They are, maybe, 2 millimeters off. The carpenter working on this measured carefully, but he was installing the trim while the doors were on the ground, not mounted in place, and when the doors were mounted, “oops,” it became clear that the screws were not exactly lined up.
Avoiding that 2mm error before it becomes too costly to fix is where the craft is.
But more. Galbraith cites the popularity of the Nintendo Wii despite it being technically inferior in many respects to its competitors. The craft is knowing which expectations to exceed – to the folk that love the Wii (including myself), the expectations have nothing to do with the fastest, most realistic 3D rendering, but in the way I interact with the experience. The craft is knowing where those expectations lie. It has traditonally been called “requirements analysis” but in my mind, craftmanship beats requirements analysis every time.
Virtual Servers and PACS
I note from HealthTech Wire that Fuji are
the first PACS vendor to officially validate its virtualization solution at VMware corporate headquarters in Palo Alto, Calif.
… Which may be true, but I’m glad to say that the number of PACS vendors which are qualified on virtual infrastructure continues to build. For the last 3 or 4 years in particular, server virtualisation is the only way to deliver servers in any medium- to large- sized organisation.
the benefits of virtualisation are well proven at this point:
- Hardware consolidation means:
- Reduced power consumption. The typical non-virtual server room eats power (and the money it costs) at an obscene rate.
- Increased reliability. Each and every server can take advantage of the highly redundant hardware configuration traditionally reserved for only a handful of the most important servers.
- Hardware abstraction, or the control of the environment which each instance of operating system sees as its hardware base. This gives benefits:
- Performance management. Need extra processing power? Just move the virtual server over to a different corner of the environment which has lower overall utilisation. Simple as that.
- Business continuity. Especially when combined with good storage-level replication, the catastrophic loss of one of a pair of datacentres just means the servers need to be re-expressed in the other.
It is understandable perhaps that PACS vendors have been a little slow to qualify products in a virtual environment – there are two types of application in particular that perform less than optimally under virtualisation:
- Applications with dependence on parallel processing.
- Those with high IO demands – in terms of either volume or latency.
The latter of these clearly could be said to include PACS, but the evidence is now clear that PACS (at least good ones) does not have IO requirements that a virtual environment cannot deliver.
Which of the various flavours to invest in? There are three main threads:
- VMWare is free to download and use (even if they have some archaic licensing hooks) and is widely recognised as being the industry leader – although this is primarily down to the technologies to do the ‘enterprise’ stuff like move VMs across hardware without downtime which itself comes at a price).
- Microsoft’s Hyper-V is also free with Server 2008. I can’t speak too much to this but I suspect like VMWare, to do any heavy lifting with require additional product which costs.
- The Xen family of vendors, including Oracle and Citrix leverage the Open Source (i.e. truly free) Xen Project.
Which is best for you is dependent on a number of factors – including your own appetite for risk. The biggest consideration though is the same as with selecting a PACS – be sure to chose a vendor (or in most cases, a reseller) that you can work with.
EDIT: Of course the 3 flavours mentioned above are the main ‘heavyweight’ options with big enterprise features. There are many others more designed more for smaller shops or desktop environments. Parallels is popular on the Mac, VirtualBox is popular on all platforms and KVM popular in a Linux environment. For even more options (and there are many) check out the comparison page.
Multi-User Collaboration
Google has recently announced a new project: Wave. In the words of the project leaders – it is what email would be like if it were invented today. Effectively, it is a platform for multi-user collaboration which is loosely based on some of the social networking paradigms but takes the ideas to an entirely new level, and has real potential for improving collaboration within PACS.
Collaborating across different locations and specialties has been a challenge that few PACS products address terribly effectively. Problems that can only be described as human-specific mean that relatively simple issues like critical results become more intractable. Google Wave, even with no PACS-specific consideration, gives a good stab at working through the technical and UI challenges. That’s a good start.
Lead by the originators of the Google Maps (hey, there’s a cv) product, it was made public at the Google I/O conference on 28th May but has no published software yet (available later this year, apparently, although even then it’ll probably be in beta). The demo video on the site (1h 20m) is worth the time but potted highlights are:
- Although it runs in the browser, it is a real-time IM and collaboration tool with asynchronous (and simultaneous) editing. (Postnote: Damn that’s clever !)
- Conversation playback for late-coming participants.
- Can incorporate publically published (e.g. blogs) with native collaboration functionality.
- Mobile device integration.
- Server-driven, therefore can better address issues like non-repudiation
- Seamlessly supports right-to-left alongside left-to-right languages on the same screen.
- Designed from the ground up to be easily extensible via plug-in architecture. Indeed the demo includes a real-time sync of zooming into Google Maps (screenshot below).
-
- Google Wave – Maps plugin
- Google is committed to Wave being Open Source.
This last point elevates my interest to an even higher plane. This means that Wave can be incorporated into anybody’s system – both the software source and the protocol are fully open. As cool as Wave is even in this really, really, really early stage, how cool would it be if a user on a PACS from, say McKesson, can collaborate with a user on a PACS from, say, AGFA?
Actually, I chose those two vendors not quite at random. McKesson is known to be comfortable with Open Source – especially Linux and MySQL (at least to some extent). Also, what I understand of the development methodologies at McKesson show a high degree of synergy with Open Source. Agfa, of course, has a high visibility in Open Source circles.
Food for thought. I for one will be keeping a very open eye on how Google Wave progresses. My one concern is that Google has in the past been a little confused on its position with Open Source licenses. The digging I’ve been able to do has not revealed what kind of licensing (other than a somewhat unusual open patent license) is going to be involved.
A Future With Or Without MySQL?
Oracle’s recent acquisition of Sun has exercised many over the future of two of Sun’s important Open Source IP holdings – Java and MySQL (another – OpenOffice – is under question also but not terribly relevant here). Ownership of Java in its current state would seem to complement the positioning of Oracle as an all-things-middleware outfit so is unlikely to change significantly and very likely, is safe in its current form. The biggest questions hover over MySQL.
As a database, clearly it has been a significant competitor to Oracle’s own flagship product, and as such, it is difficult to see where Oracle is likely to go with it. Indeed, many of MySQL’s core developers have already defected to one or other forks of the project, including the founding developer, Monty Widenius.
The main criticism from Widenius is that MySQL (under Sun) has lost focus on quality, and has addressed that himself by forking to an alternative project – MariaDB.
Other criticisms include one that MySQL has fallen into the trap of feature-bloat (ironic, then, that it ends up in the hands of Oracle 
. In reality, 90%+ of database-driven applications (including, to a large extent, PACS and RIS) do not need much more than a SQL-compliant engine, which is what MySQL was when it grew to power the planet’s Interweb infrastructure. There is a MySQL fork to address this also – Drizzle.
But does it matter? The option to fork is often cited as one of the benefits of open source software. If the core developers, including Widenius, have forked the project and are returning to original values, then why not simply use MariaDB or Drizzle instead of MySQL? There are two reasons why such a situation could be unhelpful to the free database ecosystem:
- The community becomes fragmented. MySQL boast(ed) a healthy community as well as the corporate sponsorship of MySQL AB and that was always part of its strength. Even one fork (let alone multiple) will dilute that community.
- MySQL for many years has had one particular distinct advantage over the other free databases – and that is the class of it’s support. Yes, the likes of PostgresSQL has support offerings from ‘partners’ but nothing close to the corporate heft of MySQL AB. When persuading ultra-conservative C-level folk that Open Source and ‘Free’ can be as ‘safe’ as anything proprietary, that credibility is a major help.
The world awaits the word of the Oracle.
eFilm adds archiving?
As AuntMinnie reports, Merge eFilm has added archiving and routing to its PACS product. You mean they didn’t have it before? WOW.
Actually I have a small chip on my shoulder about eFilm from the days when it was free (and not very good). When I say free, specifically as freeware rather than free software. I continue to come across people who tried to build the freeware eFilm workstation into a workflow but gave up because, well, it wasn’t very good. But disentangling that bad ‘freeware’ experience from potentially good ‘free software’ experiences (DC4CHEE, Osirix, Mirth, ClearCanvas to name but a few) is not always an easy task and certainly erects extra hurdles for good free software.
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