(Addendum: the AHRQ hazards manager taxonomy report can see seen at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.)
In a July 2010 post "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and an Oct . 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?" I wrote about the postmodern "ready, fire, aim" approach to health IT:
In the first post, I wrote:
... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.
Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.
For crying out loud, talk about putting the cart before the horse...
Something's very wrong here...
However, this situation is anything but humorous.
How more "cart before the horse" can government get?
In the second post, I wrote:
... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?
Here we go yet again.
The problem with the AHRQ (Agency for Healthcare Research and Quality, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind.
If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (e.g., Health IT and Patient Safety: Building Safer Systems for Better Care, pg. S-2), then health IT is, it follows, an experimental technology.
If it is an experimental technology, AHRQ and others in HHS should probably be raising the issue of a slow down or moratorium on widespread rollout under HITECH until risk management and remediation is better understood. At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions. The principals should not just be announcing a webinar:
Sent: Tuesday, June 05, 2012 12:23 PM
To: OHITQUSERS@LIST.NIH.GOV
Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET
Agency for Healthcare Research and Quality
Purpose and Demonstration of the Health IT Hazard Manager and Next Steps
June 11, 2012 — 2:30-4 p.m., EST
The Agency for Healthcare Research and Quality (AHRQ) has identified a gap in a health care/public health practitioner’s competency within the health IT environment. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards.
The Webinar will explore the Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data to communicate potential and actual adverse effects. The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers.
... Webinar learning objectives include:
1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing.
2. Explain the process for identifying and categorizing health IT-related hazards.
3. Demonstrate how the Health IT Hazard Manager would be used [i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.] within and across care delivery organizations and health IT software vendors.
4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities).
In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck." This seems a form of negligence.
Have we thrown out all we know about medical research and human subjects protections in face of the magical powers and profits of computers in medicine?
-- SS
8 comments:
This hazard manger is a deaf to medical device and must be approved by the FDA, unless Secretary Sebelius blows off the Federal Food Drug and Cosmetic Act.
I like the part where they blame the doctors who are in need of better understanding of HIT. C'mon Man.
Get these damn devices scrutinized for basic safety, efficacy, and usability.
How many patients have to die as unconsented guinea pigs in these HIT experiments, exactly?
Anonymous June 5, 2012 5:16:00 PM EDT writes:
I like the part where they blame the doctors who are in need of better understanding of HIT. C'mon Man.
I do agree the statement "... identified a gap in a health care/public health practitioner’s competency within the health IT environment" is typically one-sided. "It's the users, not the producers."
This does fly in the face of recent reports from FDA, IOM, etc. that report the sellers have a lot to learn, too.
At least they do add "When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them."
-- SS
Are you kidding me? No hospital would ever voluntarily use a tool that exposes hazard information.
Kumbaya normally withers in the cross examinations. Backsides and elbows are all to
see as the well meaning policy wonks run for the courtroom door.
As Sgt Shuktz said, "I see nothing, I know nothing .."
It appears that Clatncy too is conflicted, avoiding the real issues of the life threatening dangers of these devices.
Hospitals and vendors already know the hazards. This program is a grand cover up by AHRQ. Do they really think that doctors have not told the hospitals of the deaths, injuries and hazards?
This hazard gig sounds like it comes from the IT maven at hospital system in central Pennsylvania
Please note that AHRQ does not make policy. It only does and funds research and education.
I do not see how developing a tool to identify hazards of health care IT could be construed as trying to cover these hazards up, quite the opposite, in fact.
Furthermore, the development and teaching about a tool to identify health care IT hazards certainly is evidence that such hazards exist. It is not, however, evidence that those developing the tool somehow condone these hazards.
As InformaticsMD and I have said repeatedly, health care IT should be regarded as a set of medical devices, and should be subject to rigorous testing, that is, by well-designed randomized controlled trials, before widespread clinical use. However, given that this has not been how things have gone, it makes sense to try to identify the harms and hazards of health care IT post hoc, while we advocate for better policies that might prevent such harms in the future.
Afraid said...
No hospital would ever voluntarily use a tool that exposes hazard information.
Indeed, I can imagine pushback on bringing a tool like this into use in a hospital. The information would likely be discoverable (as it should be).
health care IT should be regarded as a set of medical devices, and should be subject to rigorous testing ... However, given that this has not been how things have gone, it makes sense to try to identify the harms and hazards of health care IT post hoc, while we advocate for better policies that might prevent such harms in the future.
I have no issues with development of such a tool, only that it should have occurred many years ago. The ethical implications I have pointed out in my post are another matter; there's still time to slow the train to a more sane speed.
Id rather that happen than a major train wreck.
-- SS
SS Says: "I can imagine pushback on bringing a tool like this into use in a hospital."
Afriad says - No that is naive. They will bring it into use with much fanfare then let everyone know that they will know the names of the people reporting problems into the tool.
So the tool will then show no problems and a really high quality because people know that if they report, they will be punished in insidious and legal ways.
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