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Final EHR Certification Rule Announced By ONC

This week David Blumenthal, Steve Posnack and Carol Bean of the ONC announced the publication of the final (albeit temporary) EHR certification rule.  The actual publication date in the Federal Register will be June 24. (Here is the display copy of the EHR Certification Rule; a permanent rule will be forthcoming later this year.)

The technical standards were glossed over on a conference call with ONC this afternoon; the focus, instead, was on getting testing and certification rolling.  Organizations or consortia may apply for recognition as testing and/or certification organizations as soon as the rule is published; the goal is to have these entities approved by the end of the summer, so as to keep this train moving.  Notably, CCHIT will have to apply, along with everyone else, and CCHIT-certified EHRs are not grandfathered (despite the requests of many commenters.)

Of course, today’s action begs the question of when the meaningful use regulation will be finalized (though clearly certification needs to come first).

The question I didn’t get to ask on the conference call today (snubbed again!) was whether ONC has been collaborating with the FDA (which has asserted jurisdiction over EHRs as “devices”) so that certification under ONC standards will ultimately satisfy FDA as well.  I wonder whether FDA will be as willing as ONC to delegate the testing and certification functions out to private entities.  One would hope that this will be addressed in the permanent EHR certification regulations coming out soon.

David Harlow writes at HealthBlawg:David Harlow’s Health Care Law Blog, a nationally-recognized health care law and policy blog. He is an attorney and lectures extensively on health law topics to attorneys and to health care providers. Prior to entering private practice, he served as Deputy General Counsel of the Massachusetts Department of Public Health.

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13 replies »

  1. Requiring FDA certification for EHRs seems borderline plausible. I think one way to let the market dictate what works best for patients and doctors is to take CCHIT out of the pockets of the government and allow for another certifying entity. Both of these entities can eventually merge after the market has spoken but supreme power in the hands of CCHIT is drowning out the voice of the market.

  2. Seems like this only affects MDs wishing to obtain the grants from HHS. You could choose whatever medium for maintaining patient records you wanted (paper, stone tablets, or computerized records). If I were an MD in the market to “modernize” my practice and practice workflows, I would look first at what makes sense for my practice (computer, paper, or mineral product [stone tablets]) and look last at what HHS says I should use.

  3. I already commented over at the HealthBlawg, but thanks again for the quick response to this new part of HITECH. Also, thanks bev M.D. for the link, looks like a great resource to examine in this issue. My biggest concern during this announcement has been that we still don’t have a final version of meaningful use, and since MU and certification are rather interdependent, I wonder how that will affect the certification process.
    Really, the most interesting part of the rule being released has been to read the reactions. Comparing CCHIT’s with Drummond Group’s highlights what seem to be their different approaches. I created two word clouds of their posts for comparison, and you can really see where the emphasis lies in each. Now the question is, which will apply (and be accepted by HHS) first?

  4. Blumenthal: “A surgeon can’t operate without the proper equipment.”
    In case you did not know, David B., MD, ONCHIT Czar, that equipment has been approved by the FDA for safety and efficacy.
    CCHIT ignores safety and efficacy. Stop the charade.

  5. I agree with most of the expressive articulately written comments above.
    The certification process remains a sham until safety and efficacy is assessed when the devices are being used in the in situ setting. There must be protocols approved by IRBs to assess the devices and their interfaces.
    These CPOE devices have been known to create misidentifiactions, discontinue orders, alter orders, and even add medications and tests that were specifically not ordered. Dangerous as all get out.
    Doctors, be ware of these insidious errors which endanger your patients. You need to look for the errors. They are hard to find but lurk. Do not trust the device.
    The yahoos who are selling this (all CPOE vendors meet this criteria) illegally should be jailed, especially when a patient is injured or dies because of it.
    Blumenthal is a shill for the HIT vendors, perpetuating their crimes against patients.

  6. The certification gig is a well constructed attempt to avoid the the indicated vetting for safety and efficacy that could only be accomplished by the FDA.
    HIMSS established CCHIT to offer a piece of paper that gave fake legitimacy to the unusablly flawed devices its vendors were selling for $ millions. This is a sham, and continues to be.
    The FDA is ready to go.
    Blumenthal, at the behest of the industry influence on Sebelius and POTUS, by varying tactics of coercion, appears to be keeping Hamburg and the FDA from carrying out the law.

  7. I think there is a developing consensus among users (note, I did not say anyone official, I am talking about on-the-ground users), that some sort of pre market approval, whether it be through the standard FDA process or some hybrid process, is absolutely necessary for patient safety. As I have said many times before, the FDA already requires pre market approval of blood bank/transfusion service software. If this component is deemed sufficiently critical to require such regulation, then certainly wider applications such as pharmacy and CPOE, at a minimum,do also.
    The reference below, provided by Bobby G on another post on this blog, provides a thoughtful analysis on this subject. Their comments about the need for local lifelong surveillance of each software installation due to continuing updates and customization should be food for careful thought. They also offer a framework for how such regulation could be structured. I urge my colleagues to read this article and participate in getting this done,rather than knee-jerk “resist at all costs” reactions – these do not accomplish your goal.
    http://www.onhealthtech.com/resources/22HarvJLTech103.pdf

  8. The manufacturers of these devices have been selling them illegally, violating the the Federal Food Drug and Cosmetic Act.
    Certification is useless. Has been for years. Tax payers took a hosing.
    It is cleat that pre-market approval is mandatory, especially for electronic ordering instruments and their interfaces where errors in the transformation of orders is common.
    With pma, certification becomes meaningfully useless. After all, certification was a sham legitimization program for HIMSS, the HIT trade group. Congress was duped.
    Why is the law not being enforced? Who has called off the authorities? Does the ONC control the FDA? Is Hamburg taking orders from Blumenthal?
    With the non approved devices as viral to care as they are, something begins to smell.
    One begins to wonder if the HHS conduct with the HIT industry parallels that of MMS and the oil industry.
    There needs to be lawsuits naming the HIT vendor when a patient dies due to the care dysfunction and neglect associated with the unlawful device. A trial balloon would be to name Sebelius as well. Trial lawyers, take note.

  9. “Meaningful” for whom? The entire premise that EHR will out of hand improve quality is bogus. No one has defined the denominators. Records are useful but not essential for quality care if the patient is a participant and honest.

  10. Certification processes remain suspect because they flat out ignore safety, ignore efficacy, never look at the device again, and is done from a store front by C$HIT.
    Usability of these devices is abysmal and this too is ignored by those forcing the doctors to use them.
    Inefficiencies are generated, doctor patient communication is disrupted, and data is lost.
    Never before have doctors been forced to use devices on patients that endangers them. The Oath should be kept in mind.
    Do no harm means avoiding these systems. DO NOT BUY.

  11. “A clinician can’t achieve meaningful use of electronic health records without an EHR that is designed to improve patient care and practice efficiency.”__Blumenthal
    A clinician can’t keep patients safe nor improve efficacy with meaningfully user unfriendly electronic health record devices that have not been assessed for safety and efficacy.
    A fraud on the patients and the taxpayers is unfolding. Blumenthal is the agent.
    Best advice is not to buy any of these devices until approved as being safe and efficacious and until there is after market surveillance that is meaningfully regulatory.
    The Medicare payments are going to be so low that you will not be able to provide care to those patients anyway…so why add overhead while endangering your patients?
    This is a fool’s errand.

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