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 EHRevent.org.
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 EHRevent.org 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 EHRevent.org on their own Web sites. A similar site to report adverse medication events, RxEvent.org, 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 http://www.ehrevent.org/:
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, RxEvent.org, 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: http://www.occampm.com/blog/general/ehr-event-reporting/, whose author noted this HC Renewal post. My comments are at a post here.
