The IOM on EHRs
The issue of the EHR relative to safety and effectiveness has again made the news with the November 7, 2011 pre-publication (and downloadable) release of an Institute of Medicine report on EHR safety, commissioned by the U.S. Department of Health and Human Services (HHS). This report expands the discussion beyond the EHR (used henceforth for both EHR and EMR) to include other related electronic information tools collectively called health IT.
Health IT Risks
The potential for health IT to improve both the quality and efficiency of medical care has been much noted to include more complete and timely records, ready exchange of information between providers, clinical decision support, and in turn a reduction in errors associated with the quality and availability of patient information. Efficiencies may arise from electronic capture of data which would eliminate manual entry, and time savings in accessing and reviewing patient information, and perhaps in passing information to third party payers. Additional public health value might accrue from the enhanced searchability of electronic records with respects to trends, treatments and outcomes. These benefits assume well designed, user friendly, compatible systems not withstanding that the U.S. model is to allow for numerous independent products that may or may not be able to exchange information nor display it in a consistent manner. Not surprisingly the report notes that the IT imperative will likely not be fruitful without associated attention to the people and the clinical system they work in.
Storms From the Cloud
Given the analogy between actual clouds and computer clouds, it now seems appropriate to extend the concept to storms that those clouds may bring. This was illustrated recently (April 21, 2011) when Amazon had a cloud outage (a mixed metaphor no doubt) in their Amazon Web Services business. This situation was covered by the NY Times (here), and the professional computer press (here) among others. As a result of Amazon’s problems some Web sites were reported to be down for as long as 11 hours, although actual loss of previously stored information has seemingly not been part of the problem–this time. However there is a related question for any new data that was or should have been generated during the outage. Where is it, and will the gap be properly filled in retroactively?
The Amazon postmortem explanation has to be what will be a classic, if it is not already a classic. In fact I can picture a pull down menu of explanations where this would have to be one of the choices. The explanation in short: a configuration error was made during a network upgrade. A far more detailed explanation was posted by Amazon here. From a Web page perspective an interesting aspect of the posted explanation is that while it is clearly on the amazon.com Web site, it is not easily found, if it all, by starting at amazon.com, or at least I didn’t find it from there.
Which Tablet Will Win in Healthcare?
Neil Versel has a good story this week on Mobihealthnews about competition among tablet manufacturers for the health care market. He notes the considerable potential market demand for tablet computers with the right features and capabilities.
It is true the iPad is magical. Don’t deny that. On the other hand, there seems to be a lot of Apple fan-boy hyperbole surrounding the iPad in health care. Most stories on the iPad in health care focus on what a sexy product it is and how clinicians would love to use it in their practice. But there’s more to gaining market share in health care than a sexy product with usability and customer hopes, wishes and desires.
There are 4 key hurdles any tablet manufacturer must overcome to succeed in health care. First, software developers must redesign the user interface of their applications to run on the smaller screens of tablets (compared to desk top computers). This is no easy task, but at HIMSS last month, it seemed everyone had (or promised have soon) demo software running on the iPad. A great tablet that no one’s ever heard of, from Emano Tec, faded away at least partially due to a lack of applications designed for it’s form factor. And it is not clear that HIT vendors will jump at the chance to re-implement their software on multiple tablets, let alone the iPad.
Impact of Potential FDA Regulation of EMRs
Santa Rosa Consulting has a great series of webinars on medical device connectivity and related issues, and I’ve been tapped for the October webinar. My topic revolves around the likely regulation of EMRs by the FDA and the potential impacts such a change might have on providers and manufacturers.
The following is my first take on the topic, and serves as a description of webinar. Any suggestions, points of view and links to relevant content on the Web (news stories, blog posts, regulations, etc.) is welcome.
Register for this webinar here, to be held on October 27, 2010 from noon to 1pm EST.
The Case for Regulating EMRs
From a quarter century point of view, it seems inevitable that the HIT industry will be regulated by the FDA. Look past all the hand waving and hyperventilating caused by this suggestion, and one sees that the HIT industry is already regulated by the FDA. For examples, look no further than blood bank software and PACS. The Center for Biologics Evaluation and Research (CBER) started regulating blood bank software via the premarket submission process in 1996. From their inception, the FDA considered PACS as accessories to diagnostic imaging modalities, and thus regulated. (Many PACS components have since been reclassified in recognition of their independence from imaging modalities.)
These examples aside, the HIT industry has pretty much avoided FDA scrutiny by claiming they’re just automating administrative tasks and paperwork (i.e., workflow around the paper chart).With the advent of decision support systems tied to CPOE and other applications, “administrative” HIT systems have come to be increasingly recognized as a source of patient safety risk. See Margalit Gur-Arie’s post at the KevinMD blog.Perhaps the story that’s created the most buzz about the danger of EMRs is this Huffington Post piece from April, 2010.
On February 25, 2010, at a HHS panel meeting, Jeff Shuren reported:
The Food & Drug Administration has received 260 reports of health IT-related malfunctions with the potential for patient harm in the past two years, including 44 reported injuries and six reported deaths, said Dr. Jeffrey Shuren, director of FDA’s Center of Devices and Radiological Health.
Progress (?) on Clinical Decision Support
The AHRQ has released a report (available here) on the implementation of clinical decision support (CDS) software within the context of an EMR. This report reviews the work to date of two AHRQ demonstration grant recipients, Brigham and Women’s Hospital and Yale University School of Medicine. In each of these projects the intent was, at least in part, to implement two or more existing practice guidelines as on line and integrated component of the EMR.
In the context of these projects CDS means the provision of clinical knowledge and patient-specific information to help make decisions that enhance patient care. While this type of general statement remains somewhat vague as to what constitutes such help, the report comments further that in a CDS “the patient’s information is matched to a clinical knowledge base, and patient-specific assessments or recommendations are then communicated effectively at appropriate times during patient care”. Therefore, as used here, CDS is more than just the effective presentation of integrated patient information, as might be done by a Medical Device Data System (as discussed here) for example. Instead it is knowledge based and the relevant knowledge is used to compare a patient to a predefined pattern in order to “suggest” or “advise” (or “tell”) the clinician what course of treatment is to be followed.
In this regard a CDS is, in older and somewhat forgotten terminology, an expert system. Introduced in the late 1990′s,the idea of an expert system was that the knowledge and expertise of one or more human experts could be captured and implemented as a computer code. Once this code was written (and perhaps verified), it would be possible to enter a new situation within the domain of the expert system, and the expert system would then provide the same result as the original expert or experts. It was further believed that some expert systems could be written that could “learn” such that it actually became more expert than the original experts whose knowledge was tapped (by a knowledge engineer) in its original creation. Of course such learning could only occur if the expert system was given controlled feedback along with having a coding scheme that was self adjusting. Neural nets was one of the popular approaches to such learning.
The 25 Elements of “Meaningful Use”
The Recovery Act that initiated the process of providing incentive payments for the adoption and use of Electronic Health Records (EHR) included the provision that such systems support “meaningful use” if they are to be certified and funded. Of course if you have to have meaningful use, then meaningful use has to be defined, and them measured. After a round or two of proposals and comments, CMS issued an Interim Final Rule on December 30, 2009. (The idea that a Final Rule can be Interim is itself a masterwork of government speak.) The governments discussion of this process is available here. The Interim Final Rule itself (which runs over 30 pages) is entitled “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Interim Final Rule” and it is available here. A companion rule posted in the Federal Register (FR) on January 13, 2010, “Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule” is available here. All of this is part of the Health Information Technology project in the Department of Health and Human Services which is lead by Dr. David Blumenthal who is the National Coordinator for Health IT.
These rules defines 25 functions that together constitute meaningful use. Each of these also has a level of performance that is required for ultimate certification (as listed in the January 13th FR). For example, the first use (see below) of “Use Computer Provider Order Entry (CPOE)” has the criteria that it is used for at least 80% of all orders; but only 10% for hospitals. How an EHR is actually used by the provider is an interesting and important distinction from what the system is capable of, i.e. if the system provides for CPOE but if the users don’t use that capability to an adequate degree, then by these definitions meaningful use is not achieved. Thus what the EHR can do is a necessary but sufficient condition to establish its certifiablity.
The 25 elements and an abbreviated statement of the associated measures are:
1. Use Computer Provider Order Entry (CPOE) (80%/10% hospitals)
2. Implement drug/allergy checks (Enabled)
3. Maintain an up-to-date problem list of current and active diagnoses (80%)
4. E-prescribing (Eligible Professional (EP) only) (75%)
