Tuesday, July 29, 2008

Does PACS Need to Be Regulated?

Ms. PACS: So you think PACS needs to be regulated?
There are already HIPAA requirements in place – why should we add another regulatory layer to PACS? Oh right, to keep people employed.

I mean, look at what happened with DICOM – it’s taken 20 plus years for DICOM to come fruition, and it is still difficult to interface disparate systems. And now there are the EMRs aspiring to achieve, and paying for, the CCHIT certification (The Certification Commission for Healthcare Information Technology). But nothing is for free, and everyone tries to pass the buck. So, to pay for it, will those EMRs that get the shiny gold seal get to charge more than those systems without it? Sounds like an anti-competitive tactic that threatens to force small vendors out of the market.

If you regulate PACS too heavily, opening the floodgates for the FDA, more associations and more vendors to get involved, the only thing you get is more red tape, putting small PACS providers in the red — this, my friend, is a red flag.

The more regulation, the more frivolous stamps of approval, the more cost you generate. These costs are then passed from the vendor on to the end-user — the outpatient centers, hospitals and radiologists. I thought the government wanted to cut healthcare costs?

Why not let the market choose the PACS it wants. There is sufficient competition in the PACS market to allow the end-user to be selective. Look, PACSman, the last thing PACS needs now is more bureaucratic hot air.

- MP


PACSman: I like rules about as much as Howard Stern likes rules and agree - we don’t need no stinkin’ new rules - but what we do need is rule enforcement. Everyone is getting in the PACS game these days- the feds have given us HIPAA, the ACR has given us their PACS and teleradiology standards, and groups like DICOM, HL7 and IHE all contribute their $.02 worth wanting to make the PACS world a better place (someone cue Michael Jackson, please). That would be great if the rules we had were rules, but they aren’t - they are all “guidelines” with no requirement to adhere to them and no penalties if you don’t. That’s like me telling my kids “Clean your room, or else!!” “Or else what, Dad?” “Or else…something…”

We have the 10 suggestions, not the Ten Commandments - this industry is going down the tube because of it. Look at DICOM - 20 years later and you can’t find two vendors who support this “standard” the exact same way, requiring a ^*^# ! conformance statement to explain just how they adhere to it. We let the wolf guard the hen house when creating DICOM decades ago. After all, vendors were part of the DICOM committee just as they are in IHE today, and we wonder why there are no steadfast rules? My mom always used to say “My house, my rules,” yet the vendors seem to own the PACS house…

After 20 years, the PACS market is still like a two year-old expecting that the environment it plays in will be kept safe. It’s anything but. Unfortunately the end users also don’t know it’s not safe out there either - they are like my dog trying to play with the poisonous snake - he just puts his head down, butt in the air, wags his tail and says “Hey, wanna play?” - oblivious to the potential damage that can occur. Of course if I’m not there, the snake might bite him right in the …which is what is going to happen to this industry unless someone steps in soon with some enforceable rules….

So save the hot air for balloons MP- the time for talk is over… The feds may not be the answer, but someone needs to say “Vendors - this is the way it is… if you don’t follow the rules to the letter, you don’t sell.” Write ‘em on a tablet, bring them to the top of the Mount for all to see and let’s make and keep the PACS industry safe…

- PACSman

4 comments:

  1. I've seen too many dog-awful clinical apps in live use (not just in Radiology) to think that full deregulation is appropriate, but I do think that a significant refactoring is overdue. Three thoughts I'd like to see included:
    1. A review of the concept of 'fit for use' in the context of today's understanding of software engineering, clinical processes and the intersection thereof.
    2. The FDA divesting of the software element of the equation (not the hardware, obviously), and that role going to someone like CCHIT (although maybe not in current form).
    3. ALL clinical systems required to go through the same process.
    4. I'd add a desire for more global scope but that would probably mean something like ISO & makes even my skin creep.

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  2. This comment has been removed by the author.

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  3. Great Blog! Dalai's blog is also another great one on PACS. Would you like to link exchange w/ radRounds? Let me know! radrounds@gmail.com

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  4. A PACS is neither a food nor a drug.

    Ask GE whether PACS should be regulated! :)

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