Monday, November 15, 2010 Web Site to Collect EHR Safety Reports

At "Cart before the horse, again" I observed the irrationality of creating "meaningful use" rules for health IT before usability issues (i.e., poor usability) had been robustly addressed, and the further irrationality of the IOM studying HIT safety after HIT became slated for national rollout in the next few years.

The horse seems to be starting to catch up to the cart (or is it the other way around?):

HDM Breaking News, November 15, 2010

The iHealth Alliance, a coalition of industry stakeholders, has launched an electronic health record safety reporting Web site, called

The site is designed to be a national system where providers can report safety issues related to the use of EHRs. Reported events will be confidential but used as the basis to generate other reports that medical societies, malpractice insurers and government agencies can use "to help educate providers on the potential challenges that EHR systems may bring," according to the alliance. The Food and Drug Administration will use data collected on the site to assist in evaluating safety issues that may arise during the forthcoming widespread implementation of EHRs.

Initial supporters of include the American Medical Association and some state medical societies, American Cancer Society, National Patient Safety Foundation, American Pharmacists Association, CentrEast Regional Extension Center in Texas, and EHR vendor eMDs Inc.The PDR Network, which distributes drug labeling information, FDA-issued product safety alerts and other services such as the Physicians' Desk Reference, will operate the network. Participating insurers, medical societies, EHR vendors and other entities will have links to on their own Web sites. A similar site to report adverse medication events,, will launch in 30 to 60 days. [Is the FDA outsourcing MedWatch? - ed.]

Federal agency supporters include the Agency for Healthcare Research and Quality, and the Food and Drug Administration. Malpractice carrier supporters include COPIC Insurance Company and The Doctors Company.

From the homepage at

The EHR Safety Event Reporting Service is a service of PDR Secure™, a Patient Safety Organization (“PSO”).

I have several concerns with this development:

  • The site page on Privacy and Security states that "PDR Secure™, a certified Patient Safety Organization, receives oversight and governance from the iHealth Alliance, a not-for-profit organization whose mission is to protect the interests of patients and providers, as healthcare increasingly moves online." However, who's paying for the EHR Safety Event Reporting Service and the salaries of the people involved?
  • How is it that these watchdog organizations seem to spring out of nowhere, with no opportunity for public comment or involvement before they "hatch?"
  • Did Congress or other elected representatives have a role in this development?
  • Will competitors also "hatch?"
  • Why doesn't the FDA take on this role instead of simply "using data collected on the site to assist in evaluating safety issues that may arise during the forthcoming widespread implementation of EHRs?" They have the infrastructure and experience (e.g., the Medwatch and MAUDE reporting facilities).
  • Will actual reports, de-identified as the the reporter, be available to the public in a searchable database as they are in, say, FDA's MAUDE database? (See posts on MAUDE here and here.) From the EHRevent site:
The Privacy and Security page states that "PDR Secure™ ... will collect, analyze and report back to healthcare providers and others on trends, recent new developments, and other information designed to reduce the risk of harm in the delivery of health care." The FAQ page states "PDR Secure will ... analyze and make available reports on the type of events, frequency of events, and other statistics as well as recommendations and best practices for using EHR systems. "

Will the actual report text itself be unavailable to the public?
  • Re: "A similar site to report adverse medication events,, will launch in 30 to 60 days." Is FDA abandoning its role in collecting drug AE reports?

Further, from the site's own language:

  • What, exactly, will be done with the information? They state: "Reporting EHR events can help improve EHRs, support patient safety, reduce professional liability and help liability carriers and others properly educate physicians on safe use of EHRs." How?
  • Is the reporting process really protected? Again, from the site itself:

How broad is the legal protection in this PSO?

Patient Safety Work Product - the information you provide in the reporting form, once it becomes part of the PSO environment - is entitled to greater protection from disclosure in legal matters as part of a new statutory and regulatory framework. PDR Secure™, as a certified and listed Patient Safety Organization under Federal law/regulations, has been designed to afford a reporter with the protections under this law. However, it is important to know that PSOs are relatively new entities that have not been tested in the courts of every jurisdiction. Each person or entity who submits information to PDR Secure™ should make their own independent evaluation as to the risks involved in submitting information and what particular information to submit.

Can I submit a report without identifying myself?

You need to provide your identity, which will become part of the PSO database. You can select whether your identity can be shared or is to be kept confidential under the regulations governing the PSO, and PDR Secure’s policies and procedures.

  • Will the "contract" one has to agree with, a 16-page document studded with legalese (download here, .doc format), inhibit voluntary EMR-related problem reporting?

Even with those questions in mind, I think this may be a net positive development. It would at the very least seem to lay to rest the deterministic notion (and/or marketing message) that this technology is harmless and entirely beneficent.

Will it be an effective way to help reform the health IT industry? Time will tell.

-- SS

Addendum 11/16/10:
See my initial concerns with the EMRevent report form at my followup post here.

Addendum 11/17/10:
Some answers to these questions can be found in a blog post at the site of Occam Practice Management at this link:, whose author noted this HC Renewal post. My comments are at a post here.


Anonymous said...

Only qustions, no comments.

Who is in charge of this pop-up safety group, exactly?

What is the role of HIMSS and other HIT industry pop-ups in the spawning of this group?
Why has there not been a request for comments?

InformaticsMD said...

Re: Anonymous @ November 15, 2010 5:33:00 PM EST

Good questions. Until today I heard nothing whatsoever about this new entity.

Anonymous said...

Put up the picture of the cart before the horse. Put up a graphic of the fox guarding the hen house. This does not pass the sniff test.

Anonymous said...

In response to Joseph Conn's "Coalition will collect data on EHR problems":

Thank you for a timely and important article, Mr. Conn. This is very heartening, especially to see Dr. Blumenthal providing an apparent endorsement, since until now the ONC has provided unmitigated promotional support for uncritically implementing health information technology while avoiding or suppressing information on the necessity of due diligence.

Perhaps the early feedback from the "Unintended Consequences of Health IT" study plus the accumulated evidence from the ONC's 2005 and 2007 EHRs and fraud studies and recommendations is beginning to weigh toward a more rational and analytical approach to health IT uptake. Because HITECH is funding accelerated health IT implementations in advance of meaningful industry use of EHR standards, this is the first evidence of ONC consideration of the risks to patient safety inherent in this vast experimental use of unproven technologies in patient care.

This is a very welcome early indicator that emerging patient-safety issues are also driving a more thoughtful approach to the prior irrational exuberance for all things health IT. This will incrementally help accelerate EHR uptake by making sure there is at least a small increase in market transparency, highlighting the continued necessity of due diligence to ensure these still nonstandardized systems are thoroughly tested by potential purchasers to make sure they actually provide safe, reliable and accurate patient-care records.

Unfortunately, adherence to well-established requirements for record accuracy still remains outside the stated purpose and mission of EHR certification, so this task remains the entire responsibility (and the liability risk) of the user. I hope we can soon read more about who spearheaded this initiative, so we can all convey to them our thanks.

Reed D. Gelzer, M.D.

Advocates for Documentation Integrity & Compliance

Wallingford, Conn.

Michelle W said...

Thanks for posting information about this new site (and for your initial review of the survey). I tried to find answers to some of these questions, and posted them on our blog. Of course, at the moment, there's not a lot to be known, and how successful EHR Event will be remains to be seen.

One point of information I think people should know is that, from what I was able to gather, EHR Event is a private service offered by PDR Secure and PDR Network. The gov angle only comes in to play with the fact that PDR Secure is a registered Patient Safety Organization (or PSO), which does not require a public comment period. You can see when they registered at the gov's PSO website (that link also has contact information for the company).

InformaticsMD said...

Michelle W said...

Thanks for posting information about this new site (and for your initial review of the survey). I tried to find answers to some of these questions, and posted them on our blog.

Noted. Thanks for the effort.

I have one bone to pick. At your aforementioned blog, you note:

"While HC Renewal occasionally borders on the incendiary side of things, Dr Silverstein posed some valid questions about a website that seem to have caught everyone by surprise..."

I maintain that the true incendiaries are fired by those we write about, those whose pronouncements and acts are "threats to health care's core values, especially those stemming from concentration and abuse of power."

Those pronouncements and acts can indeed maim and kill (for example, as my own mother is now experiencing thanks to an ill done commercial EMR).

-- SS

Michelle W said...

Dr. Silverstein, thanks for taking the time to come by and comment at our blog. I do appreciate much of the HIT coverage you and the other authors at Health Care Renewal provide, coverage that doesn't always get reported in the main news sources. For example, HC Renewal was the only blog yesterday that I saw write about this subject.

I try to write to a wide audience, readers who might not be aware of what's out there in the wider HIT blogosphere. Therefore, when I cite an outside source, I try to provide some context for the reader (such as when I identified that Healthcare IT News as a HIMSS publication).

I recognize that your time is limited; I really just wanted to provide a little extra information for those who may have only read a brief announcement. All the information I've provided may of course be subject to later changes and interpretation by more knowledgeable sources. Again, thanks for commenting, and my sincere best wishes to you and your family.

InformaticsMD said...


Thanks for the thoughtful reply.

I've added an addendum note here for others to link over to your posting for more information.

-- SS

Anonymous said...

Michelle said: "EHR Event is a private service offered by PDR Secure and PDR Network."

What service are they offering, exactly? This group has already played its hand as being biased in its understanding of patient safety. The question that this blog highlighted later on speaks loudly on that bias. This "private service" is not open minded about the dangers of HIT devices.

And why would they put a "what is your opinion" question on a form whose purpose it is to enable reporting as to how patients died from flaws and defects in this HIT experiment, and not allow free text or obvious choices pertaining to harm?

The more I think about it, I ask, is that deceptive, sleazy, or what?

To me, it is apparent that this private non profit can not be trusted to provide meaningfully accurate data to anyone. We shall see if it a "for profit" non profit, as so many are.