Tech

National Coordinator 6.0: A Blueprint For Success

Now that it’s public, I’ll offer my thoughts on the next steps for Don and ONC.  Don Rucker is a good pick for the nation, and will be a great National Coordinator.  I’ve gone on record as saying that some others are not qualified, and as many of you know – I don’t mince words.  Don is smart, focused, thoughtful, intentional, and will make good decisions for ONC and HHS.  I have known Don for 20 years.  He’s got a long track record of integrity, he’s a nice person, he deeply understands the challenges, limitations, and opportunities of Health IT.  I have no doubt that he’ll do a good job.  He’s got a lot on his plate.

Where should he focus?

  1. Stay the course with health IT certification.  I disagree with the growing meme that ONC has broadened its certification scope too far.  Certification has one purpose:  to provide consumers with a way to be confident that the product they are purchasing will do what the seller says it does.  Some people seem to have forgotten (or don’t know) that some of the companies that sell health IT solutions have claimed that the products do things they do not do.  There needs to be a process by which these claims are tested, verified and, yes, certified.  If this program is scaled back, health IT systems will be less safe, less interoperable, less usable, and less reliable.  #KeepCertification. 

    2.Keep the Enhanced Oversight Rule in place.  My former colleagues (and Don’s former colleagues) in the vendor community will disagree, as do some of the house Republicans.  As Don will learn first hand in his initial few weeks as NC, some of the companies that have been selling certified health IT products have been misbehaving.  In some cases, products have been de-certified.  In other cases, there have been investigations and resolution of problems without de-certification.  ONC is protecting the public by doing what Congress asked it to do initially.  The certification program is more than testing of products in a petri dish, it’s about what happens with the products in the real world.  Surveillance is therefore a necessary part of making sure that the products do what they were certified to do.  #KeepOversight.

    3.

    Trim ONC.  Under National Coordinators 1.0 and 2.0, the organization was small, and focused on two things:  policy and standards/certification.  With ARRA, the organization grew to support the REC program, the HIE program, the SHARP program, and many smaller grant/cooperative agreement programs.  ONC staff grew fivefold, and with that growth came the distractions of the grant programs, the expense of salaries and physical space required to support such a large team. ARRA is over, and ONC now has responsibility for a small number of grants.  ONC should retain its autonomy (it should not become a daughter of NIH or CMS) but should now retract back to the small organization it once was.  Grants (with the people managing them) should migrate to AHRQ.  The policy work of ONC should focus on interoperability (much of the work assigned to it by congress in the 21st Century Cures Act), certification, and the usability and safety of health IT.  ONC’s standards work should focus on acceleration of standards for health IT systems, through very tight collaboration with HL7 (also required by 21st Century Cures). #TrimONC  #FocusOnCertandStandards

That’s it.  The three-legged stool of ONC’s future success.  On a silver platter, for ya, Don!  Have fun!  The people at ONC are hard-working, dedicated public servants.  They are excited to work with you.

BTW, thanks, Jon.  You will forever be 5.2 to me.  Great job.

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  1. You got it Margalit.

    Most doctors will be fine no matter what and if medicine doesn’t pay enough physicians generally have enough brains in their heads to make money elsewhere and be able to purchase top quality medical care at the same time.

    Doctors like Niran suffer, but have a choice so I don’t worry about her personally, but still would like to make sure that Niran’s concerns are appropriately managed. If she leaves medicine the problem is not Niran’s or all of us well healed folk rather her leaving is is a detriment to all the patients in her area that aren’t as well to do as all of us arguning on this blog.

    What are we seeing with this onslaught of people feeding off the money that is supposed to pay for the care of our middle class families.? A lot of people are getting rich quick while not addressing the concerns of those they know little about. At the same time the country is debt ridden to be paid by who? Eventually the working middle class and the nation’s future. There is just too much self-promotion with little desire to look past one’s tiny circle of interest because all too frequently what is being promoted is fictional and a political creation that benefits only a small group of people while all of us pay for it.

    Why else is EHR as popular as it is? It wouldn’t be if permitted to grow organically without mandates, rules and regulations along with a lot of the people’s money.

  2. I think this question you ask is key: “If not the government, who will be there to protect us and our families? Again – if you have a better solution, please tell us. If not, your critique is just noise.”
    Physicians have historically drawn from the brightest and most altruistic segments of our population…..and many health system administrators emerge from this pool of physicians. Are you suggesting they aren’t able or willing to carefully assess the safety and value of EHR products….or that their motivations are not the best interests of their patients…….and that they need governmental bureaucrats to mandate what they purchase and peer over their shoulders as they practice their profession? So, I do think we all would be much better (and have better value add EHR products sooner) if we did away with the mandates and coercion implicit in government certifications ( I can think of many areas where private certification arrangements emerge as adding value….think Underwriters Lab etc, The College Board/SAT’s, ISO 9000 certifiers etc…but they have to earn their credibility unlike government bureaucrat certifications that are by edict).

  3. It’s not about destroying doctors lives. It’s about the powerful creating one health care system for the rich and another for everybody else. The EHR vendors are irrelevant in the long game…. IMHO.

  4. I don’t necessarily disagree with you Jacob on the intent of some or maybe most people at ONC. I met some over the years and they seemed nice enough. I have also met and worked with many EHR developers at all levels at various companies, and I know they all have the best intentions, including the folks in Verona …and/but… 🙂

    There are two things that should be noted. At the very top level of string pulling, there are global corporations with their miserable fiduciary responsibility to their faceless shareholders. The proliferation of representatives from this business group on health or other, and from for-profit (or for-revenue) entities, or from the perpetual revolving-door of beltway-bandits to/from “quality” organizations, or from big-industry funded “patient advocacy” groups, on ONC committees was disturbing to say the least. Are we supposed to assume that these people can in any shape or form represent the needs and desires of most Americans? Considering the state of affairs in this country and considering that Princeton 2014 paper from Gilens & Page, I have no reason to assume that.
    And then there are “thought leaders” like David Cutler who seem to think that Walmart medicine is perfectly fine for most of us. Maybe his intentions were good, maybe Gruber’s intentions were good, maybe even the PCAST intentions were good (which makes me wonder what “good” means), but the paternalistic, condescending assumptions about “these people” whose only sin is that they have no money (mostly through no fault of their own), and what would be best for “these people” who are “sensitive” to price, and so forth, is helping me understand France in 1789.

    None of the above negates the obvious existence of well-meaning, hard-working, compassionate, but often misguided (mostly purposely) people.
    Perhaps the best solution is to stop assuming that the best ideas will always come from some conference room in DC and just let people/doctors do what they want to do. A centralized technology office is a bad, bad, idea….

  5. 1. Certification worked.
    Before certification, (recall that ONC’s certification program succeeded CCHIT’s – I refer here to both programs as “certification” in some form) health IT systems could capture and/or share medical problems in free text, ICD-9, Medcin, or any other proprietary terminology, they could capture medications in any nomenclature, and the same for allergies, procedures, etc. There was no standardization, and therefore absolutely no interoperability. Systems shared with each other via fax or (for advanced systems) PDF documents. Your assertion that certification hasn’t provided purchasers with confidence flies in the face of the ample evidence that any purchaser of an EHR can go on the CHPL (certified health IT product list) and see what a product was certified to do. If it is certified to capture medical problems in SNOMED-CT (which is required for interoperability) – then it will do so. Period. There is no ambiguity here Perhaps you weren’t around back then, but I have vivid memories of EHR vendors claiming that the products did things that they simply didn’t do. While it’s certainly possible that creative sales representatives still invent things, the core of what a product can/can’t do is validated by testing and certification. If we withdraw the program, we’ll be back to “creative” (nonstandard) methods of such information capture/sharing, which will be worse than difficult: it will be unsafe.

    1.1 Why does ONC need “Enhanced oversight?” I can’t and won’t share all of the grim details. Some (a tiny subset) of these companies have created products and business practices that put the public at risk. If not the government, who will be there to protect us and our families? Again – if you have a better solution, please tell us. If not, your critique is just noise.

    “Anyone with an ounce of experience can tell you that a policy market, like the one that Jacob helped create, hammers innovation.” Now you’re just being nasty.

    “You also have a vested interest in big MDs groups, you run a big MD group, right?” No. I do not. I am CEO of an organization that helps a community provide better care to a population of Medicaid members. We explicitly work to support small practices.
    “You want the small efficient happy provider to be gone, right?” Wrong. Why would you assume this?

    Your other insults are TL;DR

    2.” We do not need nor want ONC given enhanced power.” Again, I disagree with your premise that ONC is evil.

    3. “Are you personally using a cert EHR now Jacob? Meaning, are you yourself actually practicing medicine?” I use a certified EHR. I don’t use it every day, as I am not practicing every day. But I do use a certified EHR. Is it perfect? No. Would I like it to be better? Yes. Do I give the developer of the product feedback? Yes. I work with “front line” care providers (MDs, DOs, NPs, PAs, etc) every day. (Not just MDs, of course) ..

    3.1 “no pause in your tone that you did real damage. Its disgraceful.” I’ll take a deep breath here (again). Your comments are provocative,declarative, and a bit nasty. You have declared that ALL of the work that I have done in this industry – and the current work my former colleagues @ ONC – contributed nothing of value. You say all of this from behind your anonymity, and you are obviously upset about it all. I am sorry you are so upset. If we were to have a 1:1 conversation (which I welcome) you would learn that I have many concerns about the state of the state of health IT in the US (and beyond). I reflect often about the work that we did at ONC and wonder if we could have done some things differently. Of course we could have! What have I learned that would cause me to do things differently? I have learned that it’s easy to take potshots from the sidelines – and much harder to actually do the work to fix the problems. I joined Misys (and then Allscripts) so that I could help FIX the problems that I experienced every day as a practicing family physician. I learned that it’s hard to evolve software to meet the needs of a broad and vocal market, hard to navigate the politics of a $2B company toward goals that provide great value to patients AND to shareholders (as is the responsibility of every employee) and I learned that compromise is an important part of shared success. I joined ONC so that I could help FIX the problems that I was experiencing at a company that was trying to certify our products. At ONC, we were often educated (lobbied? informed?) by physicians, hospitals, IT developers, and (yes!) innovators about the problems we were resolving AND about the problems we were creating. We sponsored and published research that was critical of our own work. We challenged ourselves – though public hearings and outreach work – to listen carefully. We didn’t fix all of the problems, and OF COURSE we made some mistakes. We are humans. We’re not perfect. Don Rucker isn’t perfect either, and I am sure that he will make some mistakes too.

  6. Jacob,
    1. Certification has worked? How? It has NOT given confidence in what you purchased does what it says. Not by a long shot. If it did why does ONC need “Enhanced oversight”? We do NOT need a nanny state with the US gov “certifying” EHRs. They have driven innovation right out of the market. The best EHRs are the ones that are gone because of certEHR. Anyone with an ounce of experience can tell you that a policy market, like the one that Jacob helped create, hammers innovation. CertEHR is EXACTLY the buzzword, “sounds good” massive regulatory action that has destroyed medical practices since its inception. Those that made the policy did NOT live it, practice in it. Funny how driving out MDs, burning us out, and every study on earth says that cert EHRs are interfering with the care of patients gets routinely ignored by ONC and the blinded leaders there. Jacob, explain to all of us how EHR certification has done ANYTHING to improve EHRs, innovation, usability, interoperability, safety, security, etc. over the past 7 years. Are you actually hearing real front line MDs about this? We do NOT want more Epic and Cerner. You made a Boeing and Raytheon, you made a medical industrial complex with Cert EHR. Cant you see that? You are driving MDs out of small practices. You want control. You want data entry MDs. You also have a vested interest in big MDs groups, you run a big MD group, right? You want the small efficient happy provider to be gone, right? You have to know that Cert EHR has set back real EHR innovation at least a decade. And will continue to for years to come.
    2. We do not need nor want ONC given enhanced power. They will NEVER decertify any EHRs products that aren’t already dead or are so small that you bully them out of existence. They will never punish the Epic Cerner crew, even though they fail to deliver useable, safe, interoperable products. So its not necessary. Plus, we do not want ONC, lurking around MDs offices demanding to see patient files/info. That was a big mistake to be placed in MACRA.
    3. Are you personally using a cert EHR now Jacob? Meaning, are you yourself actually practicing medicine? Are you personally using these Cert EHR products on a daily basis, trying to care for patients? Do you do all your own attesting, reporting of all these programs like MU, PQRS, now MACRA, or do you offload that to someone else? Do you speak to front line MDs about the disaster that certEHR, mandates, regulations, penalties, complexity and burden has done to YOUR profession. You were are an architect of this nightmare and maybe should reconsider your failed policies that have been a disaster to your fellow colleagues. Maybe its time to reflect.I am a bit more harsh and direct, that you and ONC failed to listen to actual front line MDs, no matter what rainbow and butterfly dreams you at ONC were having, you could have done a much better job, instead of pounding your fellow MDs relentlessly, and still do not appear to even have the slightly pause in your tone that you did real damage. Its disgraceful.

  7. Bill Hersh, several points including a disclosure: I am a physician and have children that are physicians. Many of my friends are physicians and I see fine physicians for my own personal needs. I am disappointed noting the physician’s distraction due to the EHR resulting in what I believe is poorer medical care on average.

    1) How much extra time do you believe most physicians are spending? According to the those I have talked to, most say the amount of time spent is horrendous.
    2) Do you believe that in determining the trade-offs we have to take into account that humans are operating the machines? When dealing with humans we have to separate ideal conditions from what actually happens in reality.

    When we take into account the trade-offs, don’t blame human users for all the mistakes made by them in implementing the EHR. Blame the vendors, the programers etc. for they are the experts and should have made sure the human element was accounted for or they shouldn’t have sold the machine.

    A problem due to ill placement of servers is a problem that is the fault of the EHR package.

    3) Some have claimed that physician and nursing burnout might in part be due to the EHR. What do you think?
    4) Who is the EHR for? I spent a lot of years in practice and had a portion of my patient notes on computer that could be obtained away from the site in the early 1980’s. I say that so you understand I am not afraid of technology.

    I had specific needs and could quickly record all the data needed without affecting physician/ patient encounter. I didn’t have to stay after hours to complete my EHR notes or spend face time with the patient looking at the computer while the patient was wondering what all the typing was about or whetherthe physician’s mind was on the computer or me.

    5) Maybe I was taught was wrong. I used the KISS rule (keep it simple stupid) yet the EHR seems to delve into complexity. Do you think KISS is wrong? This get’s us back to point 4, Who is the EHR for?
    6) Not all things on the EHR are bad, but we all use the same basic program in the same fashion yet we are all different and think differently. Should we all wear the same shoe size? Maybe the EHR needs to be less complex and require less of the physician.
    7) Since IT is actually changing the way medicine is practiced should IT be financially responsible the same way physicians are when IT causes harm to a patient that a jury finds is malpractice? That means NO corporate veil.
    8) Should the EHR have been developed organically? Alternatively, do you think the top down approach has been the preferable approach?

  8. Interestingly part of what motivated the switch from paper was, in fact, studies showing improvement in safety. Perhaps due to implementation? LDS Hospital reduced adverse drug events in its 1991 study to a level that I showed was less than what the folks in the Harvard medical practice study thought was the minimum. (LDS got rid of 7 out of 10 drug administration errors and were pretty good to start with; Harvard researchers thought four out of ten was the most preventable. Brent James’ research since then at LDS has, for many years now, consistently found more preventability than previously thought when health IT is used the right way.)

    I’m aware of and respect the Cochrane studies. I’m also aware of, and respect even more, what was going on in the real world before computerization.

    . David C. Classen et al., “Computerized Surveillance of Adverse Drug Events in Hospital Patients,” JAMA 266, no. 20 (27 November 1991): 2847-51

    David C. Classen et al., “The Timing of Prophylactic Administration of Antibiotics and the Risk of Surgical-Wound Infection,” New England Journal of Medicine 326, no. 5 (30 January 1992): 281-86.

  9. Ross: “effect on patient safety…I see the effect as positive.” Ross is my good buddy and writing partner. We wrote a WSJ article in 2012 that looked at about 12 RCTs of health IT vs paper of about 40000 studies. There was NO evidence of improved safety or costs over paper (and we said so). This included the duplicate cluster RCTs in the U.K. and Tierney in CHF. Same results. Nada.

    You can believe all you want. But about a dozen Cochrane reviews will disagree. Sure– improvements in process, but not in outcomes. It is time we use evidence, not feeling states.

  10. A few points about Han’s research, one about an item Bill Hersh pointed out, and one he may not have known. Also: implications for EHR’s safety.

    1. Bill is right that one of the reasons for the three-fold increase in mortality among the babies transferred to Pittsburgh Children’s was indeed that before the EHR install, the EMS teams would radio in information about the babies and about the needed meds; whereas when the EHR was installed, the system required the ambulance to arrive before there could be a direct data transfer of the key information to the hospital. Probably the guys at Pittsburgh wanted to improve accuracy and perhaps privacy. Nevertheless, It was a dumb idea that is NOT the fault of the EHR. Rather it’s the fault of the local implementation team. (Ergo, I agree with Bill)

    That said, I note that every implementation of an EHR involves millions of decisions, some of which turn out to be very bad. I agree with Bill that Epic or Cerner does not tell local teams to make moronic choices, and it ain’t the fault of the EHR per se, but it is the case that the vendors emphasize customization as key marketing features. Those features are often essential but sometimes abused. A lot of the customization is the triumph of vendor selling over what makes sense for the operation of the facility.

    2. One thing Bill did not mention (and may not know) is that the receiving pediatric ICU at Pittsburgh placed the workstation (computer) several feet away from where the babies were being treated. Ergo, at the critical moments for these very, very sick babies, the docs were pulled away from the action. Before the EHR, they would just call out the needed orders and others would get them. Again, I must agree with Bill that the stupid placement of the workstations is not the fault of the EHR designers. On the other hand, I must note again, that installing an EHR always includes many dumb decisions that must be corrected later (or never). So are we free to evaluate ideal EHRs vs. EHRs as actually used? Ideal EHRs would come out better, but don’t exist in reality.

    Related, measuring the impacts of EHRs is damn hard research. We can’t blindfold the doctors in a hospital and tell them to use paper vs EHR-1 vs. EHR-2. All patients would be dead within the hour. Every hospital comes with a history of previous technology use, previous skill sets and literally hundreds of devices and IT systems that must be connected to the EHR. EHRs offer myriad and wondrous advantages, but determining the net effect on patient safety is more of a black hole than a shining example of evaluation research.

    3. A third point, well documented in the literature a thousand times, is that ordering meds via an EHR takes a lot longer than the old paper way. But no one would go back to paper. EHR orders clearly specify dose, schedule, route, start date, end date, etc, etc. They also “benefit” from CDS – only of which 50% to 98% are regarded as horrific distractions but few would have disappear. In any event, and this is the first point that I’ve never thought of in relation to the Han study, is that entering orders for these very sick babies was probably slower than before.

    4. Also, many EHR ordering screens are examples of lethal visualization failures. I invite you all to go to FDA.gov and type in “CPOE.” The FDA paid us to study ordering screens across 5 systems and 5 hospitals. Then it tried to hide the findings for a year or two, but has now made the results available. Free. You’ll see examples where ordering warfarin generates a warning that it will be an overdose and cause the patient to bleed to death, but ordering coumadin (exact same drug) for the same patient on the same system will generate no warning. You’ll see examples where the list of existing medications is hidden by other data or a pop-up, such that the doctor can’t tell if the proposed drug is a bad (or deadly) idea. Many of these screens are indeed the fault of the vendors. Some, pace Bill, are indeed the net product of bad design and foolish implementation.

    BTW, the vendors still resisted our showing the screens and sometimes we had to use examples from other systems, but we have 100% video of every example in situ. Apparently the vendors believe we can find faults and improve the systems by hiding them from scientific review.

  11. I totally agree. I have never meet a physician who had use Vista and did not like it. The same can not be said for eCW, Cerner or Epic.

    The VA is about to descend down a rat hole. After they spend a few billion dollars, someone will look up and see the light.

  12. The VA has a system that benefits from 40 years of continuous improvement–all with a focus on serving patients, improving care, and giving better data to clinicians. It may not have the bells and whistles of some billion dollar commercial systems, but it’s damn good, it works, and it responds to the needs of its users. It would cost no additional funding. To dump it in favor of a commercial system reflects a blind faith that if people can make money from something it must be better than something developed only to help patients and their caregivers.

  13. I just re-read the last paragraph of your email. I would beg to differ. Whether computer-based or paper-based, and even if done very imperfectly by computers, the patient record matters very much in many aspects of the quality of care.

  14. I am a physician too, although no longer do direct patient care at this point in my career. I do, however, try to maintain my physician’s perspective in my work as a clinical informatics specialist. Clinical informaticians are very different than pure IT types, and many successfully lead large implementations that benefit physicians and patients.

    I might also add that computers have been used to address real problems in medicine that still exist, such as excess errors, excess costs, and a non-system system. They have not completely succeeded, and sometimes failed miserably, but some evidence has shown they address those problems well.

  15. Great point. I remember in my training decades ago when patients showed up in the ER and it took hours, if ever, for us to get their records. And I remember being on call for the internal medicine clinic at night, at home, without being able to access any records.

    We can’t go back to paper, but I also wholeheartedly agree with Ross that the EHR is what we make it. If priorities are for billing and cost control, it will not serve physicians and patients well. But there are many examples that show it can serve the latter.

  16. Please let me preface this by saying many of you are brilliant and prominent experts in your fields. I agree with some and disagree with others, making for solid debate. I enjoy these discussions and have learned much from you about government, policy, economic theory and my need to read more about LBJ. Thank you.

    However, with all due respect, I see patients, do a history, physical exam, diagnosis, and treatment recommendations. Last time I checked that was the oath I took prior to embarking on my profession. What does any of that have to do with certified electronic records?

    No offense (seriously I am asking), What medical school did the IT experts graduate from that qualifies them to oversee the inner workings of my occupation? The whole notion is ridiculous.

    The damage done in TN yesterday by the AHA and Insurance lobby to vote down the anti-MOC bill is destroying our profession. We should be talking about that.

    In the next decade, you will be choosing from a list of NPs as your primary care “provider” and someone close to you (who is 32 with 9 and 3 year old children) will die from ovarian or testicular cancer that was easily treatable if caught early enough by a proper PHYSICAL EXAM (emphasis not yelling).

    However since we don’t do that anymore, it will be missed. Crappy care for a low cost dream. Is this what we want for the future of healthcare? I don’t.

    I vote for patients first. I vote for physicians second. What good does a great electronic record or patient portal do for a patient who is misdiagnosed?

    End rant.

  17. Excellent discussion.

    A new question, given all the opinions and assembled expertise on this thread: What do y’all think of the new drive to force the Veterans Administration to abandon VistA for a commercially available system?

    Here’s a Politico article on it:

  18. All the carping about EHR reminds me of commuters complaining about traffic; they don’t like it but they also wouldn’t really prefer to go back to horse drawn transport. Does anyone really think we would have been better off staying with paper communication? The “old days” were pretty rotten, with illegible notes, illegible signatures, illegible orders, absence of transparency or communication.

    What’s the ideal state here? Is this just frustration that EMR efficiency/efficacy has progressed so slowly? As time consuming and cumbersome as our EMR is, it still seems to me to do a far better job serving the interests of patients than our old “systems.”

  19. 2 points about the Han paper — one noted by Bill and one not.

    1. Bill is right that in the Han paper about Pittsburgh one of the problems is that the ambulance crews were not permitted to provide the list of meds before they reached the hospital (whereas before they could do that via the radio).

    But the reason the “receiving” docs and nurses could not enter the needed meds before arrival is that the EHR as implemented would not allow that ….but rather required a direct data transfer from the ambulance crew. Obviously, the hospital implementation team thought this increased accuracy and perhaps security. It had the effect, however, of contributing to the almost tripling the mortality rate.

    So, to Bills point: can we blame the EHR for that? An honest response is that we can certainly blame the EHR as implemented, but there’s nothing in the EHR basic design that can be faulted. (Bill will be shocked to see me supporting his point….with the caveat that implementing EHRs is a multi-year, super expensive, super complicated series of processes that always generate horrors in situ…and take a long time to fix. Part of the problem is that EHR marketing uses “flexibility and customization” as a great sales tool…which of course is a double edge sword. It’s needed, of course, but it’s also abused to enhance sales (and I think Bill will agree).

    2. Another point about the Han study (not mentioned by Bill that — also shockingly, I note — also basically supports his argument: That is: the workstations that docs had to used to enter orders were not right next to these very sick neonates’ warmers, but rather required the docs to walk away several feet. In other words, the design of the EHR access in the ICU was suboptimal. These were very, very sick babies being transferred to a teriary hospital. Bill is an MD and I’m sure can appreciate more than many of us how dire these patients were and how distracting the doc for the time required to walk away and input an order.

    So again, the issue is the EHR as implemented, not the basic EHR design. No one at Epic or Cerner told the good people at Pittsburgh Children’s to be stupid about where to place the computer. (But I can say that poorly placed computers is not unknown in hospitals.)

    As I write this, however, another issue emerges that I have never considered before, and don’t remember seeing in print in regard to Han’s research: Namely the extra time required to enter an order into the EHR vs. just calling it out to the nurse while treating these profoundly endangered neonates. This is a well known issue with EHRs that undoubtedly occurred with the neonates and continues to occur with all EHRs. To be fair, EHR drug orders are free of handwriting errors, require a clear dosage, route, schedule, start date, end date, and may benefit from CDS alerts, etc. Also they speed directly to the pharmacy. And although many EHR order entry screens are tragic examples of lethal design errors (see Free on FDA.gov: CPOEMS: UNCOVERING AND LEARNING FROM ISSUES AND ERRORS COMPUTERIZED PRESCRIBER ORDER ENTRY MEDICATION SAFETY (CPOEMS) UNCOVERING AND LEARNING FROM ISSUES AND ERRORS), no one would go back to paper for ordering drugs….and EHRs offer other myriad advantages.

    As to the larger question about their net effect on patient safety: I tend to see the net effect as positive (Bill again may be shocked) although I wish they were a hell of a lot better than they are. However, good research supporting their positive net effect on patient safety remains rare, spotty and often biased. Again, I wish the research was more reassuring. But measuring net effects of the EHRs is damn hard.

  20. While we cannot dismiss the results of the Han et al. Pittsburgh ICU study, we can note that it used a very weak form of evidence, namely a before-and-after design. We also know that many other things were done before and after that implementation, such as not letting physicians write orders until patients arrived at the ICU, which also probably contributed to the increased mortality (Sittig, DF, Ash, JS, et al. (2006). Lessons from “unexpected increased mortality after implementation of a commercially sold computerized physician order entry system”. Pediatrics. 118: 797-801.). We also know that others replicated the Han et al. study at their institutions and found either no reduction in mortality or in one case an actual benefit (Longhurst, CA, Parast, L, et al. (2010). Decrease in hospital-wide mortality rate after implementation of a commercially sold computerized physician order entry system. Pediatrics. 126: 14-21.).

  21. I have to disagree, Hayward. There are decades of studies that have shown that particular interventions with EHRs have improved quality and safety while reducing costs. Look at the work of David Bates, Bill Tierney, and many others.

    The challenge is how to translate those individual benefits into large systems that get integrated into larger healthcare. HITECH is one approach, and as we all know, has had very mixed results.

    A larger question is why healthcare is so locally specific that leads to the situation you describe, where results are not translatable across settings.

  22. With all due respect to others on this list, Bill Hersh is one of the eminent informatics experts in the nation and was mentored under some of those who tried to get computerization adopted by physicians, in vain, for years. I’ll defer to his references to the literature on the costs/benefits of HIT.

    Meanwhile, what has gone unmentioned here is that just like Dodd-Frank was a reaction to financial industry abuses, the hospital industry would buy clinical systems and not turn on many of the features meant to improve care. Among other abuses. Apart from resisting anything but financial computerization, anyway, as I mentioned above. For some of that history. see my blog post here.

    HITECH is not the same thing as high-tech. By resisting the latter, the industry — I use the word deliberately — got the former, supported by both Republicans (Newt Gingrich) and Democrats at the time.

  23. If hospitals paid trillions for them the lack of efficacy, quality and cost savings in the population is worrisome. (The trillions can be calculated on the back of an envelope.) Purchase, upkeep, training, software, new standards, Docs quitting early, etc. Costs are known. Hayward is right but he understates. They have also caused preventable mortality. Take a look at Safety Foundations, young children going to ICU at Pittsburg Hospital during a new drug order entry system, and examples scattered about. Ross has plenty of examples. And chapters. S

  24. Thank you for the link to your talk.

    I never intended to give the impression that EHRs provide no utility. Clearly some EHR features are objectively useful, but on whole, EHRs have not been shown to improve quality or reduce the cost of healthcare and I’m sure you would agree with that.

    From my perspective, the one thing which is truly problematic is functionality/protocols/EHR configurations which work in one institution/office will not necessarily be found to work in another location. This is very discouraging, as it will require everybody to rediscover the wheel which works only in their backyard.

    For this reason, and others, I think flexibility and innovation in health information technology is of paramount importance.

    Hayward

  25. I have to take issue with the statement that there is no evidence for benefits of the use of EHRs. There is indeed no evidence for the HITECH program as a whole, nor is there evidence that EHRs developed and used in institutions with high informatics resources and expertise translate their benefits into the rest of the world.

    But there is plenty of evidence to support many of the individual functions required by HITECH, such as certain types of clinical decision support and CPOE. (See a number of systematic reviews, such as Jones, SS, Rudin, RS, et al. (2014). Health information technology: an updated systematic review with a focus on meaningful use. Annals of Internal Medicine. 160: 48-54.) There are also underlying problems in healthcare that, while HITECH did not help, are still real problems, such as patient safety and suboptimal quality (see Levine, DM, Linder, JA, et al. (2016). The quality of outpatient care delivered to adults in the United States, 2002 to 2013. JAMA Internal Medicine. 176: 1778-1790.)

    I recently gave a short talk at the Brown U conference on the Patient, Practitioner, and Computer a few weeks ago that elaborated on this point of view:
    https://dmice.ohsu.edu/hersh/ppc-hersh.pdf

  26. Ross, for clarification only: Doesn’t regulation and overregulation frequently seen in the healthcare sector preceed regulatory capture?

  27. Great article. Thank you. And, no, you are not sounding cynical. Here is what cynical sounds like: when it comes to all these HIT and pay-for-this-or-that schemes, the built-in, government commissioned, beltway bandit performed, so-called evaluations, do not suffer from flawed design – they are flawed by design. In my very humble opinion….. 🙂

  28. No. HIT govt regs are examples of regulatory capture. Not of over regulation. Big difference.

  29. Good piece and discussion. As someone who was involved in the early days of health IT/EHRs (serving on HIT standards committee and other entities) and who lobbied on ARRA, I look back with remorse and some shame on what we unleashed. I concur with many of the general and specific comments below and have long argued that ONC’s priorities and mission needs to be fundamentally rethought. I wish Don the very best on that. This may be one area where some Trump administration “deregulation” may be warranted. That said, ONC and HHS do have roles to play here in continuing to guide workable interoperability…that works for docs and patients/consumers.

  30. Margalit – Some paranoia in these remarks…..that everyone is out to destroy the lives and livelihoods of front line docs via IT. I don’t buy that at all. The positive incentive all along was to create efficiencies and HELP docs do their job. That said, a lot of big IT comp yes wanted to make ALOT of money.

  31. “to do evil a human being must first of all believe that what he is doing is good”

    Paul, best quote for those thinking they know how to run the healthcare sector better than the people and those specifically trained to do the job.

    Let me add another one by Edmond Burke from his Reflections: “What is the use of discussing a man’s abstract right to food or medicine? The question is upon the method of procuring and administering them. In that deliberation I shall always advise to call in the aid of the farmer and the physician, rather than the professor of metaphysics.”

  32. Solzhenitsyn: “to do evil a human being must first of all believe that what he is doing is good” speaking of his experiences at the hands of Stalin’s gulag interrogators. In the case of Medical reformers “harm” is a better word than “evil”….but the model pertains. Of course most of our medical IT experts believe they are acting in the best interests of the People….these folks should not have the power to impose their ideas on the entire system without a little humility and verification as Hayward Zwerling says below.

  33. I second Jacob’s statement. Those involved in the design and implementation of MU were motivated by the best of intentions. Unfortunately, they forgot the cardinal rule of medicine which is that new “treatments” must be validated as safe and effective before they are promoted at the social level,

  34. Margarlit: I’ve respected your writings over the years, and I understand your position .. and/but .. you’ve made an error in your summary above. You assert that “These people dictating EMRs and computerization (ONC, Silicon Valley, the “experts” advising the Obama administration) didn’t give a damn about patient care or doctors’ ability to function.” I can say with certainty that you are incorrect. As I have documented elsewhere, in 2004, I wrote a post in something called a “weblog” (subsequently shortened to “blog”) describing the challenges that I was having with the electronic health record that my colleagues and I had been using since early 2000. My blog post attracted the attention of the company whose software we were using, and I eventually joined that company. My PRIMARY motivation for joining the company was to work from the inside – to help FIX the problems with patient care and providers’ (not just doctors’) ability to function, rather than whine from the outside. With a degree in cognitive science, I had been trained to design products that were usable. We built a strong, focused human factors team within that company (Misys ==> Allscripts) and while we didn’t fix the software entirely – we made it better. We cared. Very much. We cared about what we were doing, and I got to know the people working at other health IT companies who were doing the same thing. Perfectly? No. Is the software perfect? No. Are all of these companies “good citizens?” No. But the vast majority of them are, and they are doing their best. When I joined ONC, It was with precisely the same motivation: to make things better. Better for patients, better for providers. My colleagues there had the same ambition (and still do). You can argue that we weren’t so successful as we (or you) would have liked. But please don’t carelessly state that we didn’t “give a damn.” We did. They do.

  35. The rash of incentives and penalties for specific services (PfP), meeting thresholds (eg, “preventable adverse events,” using EHRs, early readmissions, wellness, etc.) have all proven ineffective in well controlled experimental and quasi-experimental studies (but the invalid designs seem to support them because they don’t control for bias). Good data don’t mean much in D.C. But lobbyists for all these industries seem to do alright. I know I am sounding cynical but it seems to mirror reality.

    https://www.cdc.gov/pcd/issues/2015/15_0187.htm

  36. EMR certification did not start with HITECH. It started a few years before that with a semi-governmental entity called CCHIT (pronounced exactly the way you think it should be pronounced). That certification was much more comprehensive than the MU that came after it. The whole thing favored big vendors with lots and lots of bells and whistles. I remember having to add tons of features that nobody asked for, nobody wanted and nobody used. We actually build configuration screens so users can disable the garbage that we were forced to put in.

    This supposedly well-intended idiocy morphed into HITECH. During the early days of the new and improved ONC, I used to listen in to all the committee meetings (full of big box representatives) deciding standards and policy and a plethora of minutia that every EMR should have. Why should it have these things? Because committee members were absolutely certain that the know best what health care should be, what doctors should do, what patients should want, etc. etc. etc. The arrogance radiating from those meetings was blinding.

    So for the longest time I blamed the certification program for trashing the EMR market. On one hand, it introduced so much useless busy work, that left software developers little time and latitude for anything else. On the other hand, the certification criteria were so dumb initially that a good Excel sheet could certify, creating thousands of things certified as EMRs that entered the new market hoping to capitalize on the MU gold rush. People were cheating left and right. You’s buy a certified EMR just to find out that it can’t really do half the stuff it was certified for, or that you had to pay thousands of dollars more to get “reports” and “dashboards”. The wild, wild west was tame compared to the first years of MU.

    But then I sobered up a little. These people dictating EMRs and computerization (ONC, Silicon Valley, the “experts” advising the Obama administration) didn’t give a damn about patient care or doctors’ ability to function. The goals, of both policy and standards, were and probably still are completely different. They were aiming at changing medicine from a personal service to a mass produced electronic commodity delivered by low wage workers. That is still the game in my opinion. And I think it is working just fine and according to plan.

    If you want more detail on this theory of mine, I wrote about it years ago here http://onhealthtech.blogspot.com/2013/09/why-doctors-will-never-ever-like-emrs.html

    It’s a travesty and the certification mechanism enforces on the entire industry. Get rid of certification (and “provider” incentives/penalties) and I am willing to bet that in 2-3 years the technology used in physician offices will bear no resemblance to the garbage we have today. Hospitals will take much longer…..

  37. @adrian – despite my affection for you, I could not disagree more. The standards, as you know, are exponentially more complex than those that define roads or the gauge of a train track. Your metaphor holds no water. Cars and trains traverse the globe – and so does health information! Today, millions of “chunks” of health information moved from one facility to another over many protocols, using many payload formats. Is it perfect? No. Is it working? Absolutely. Tomorrow, even more information will be moved this way, and the next day, even more. Have you picked up a prescription from a pharmacy? It’s working. Has your physician received a message about you from a colleague over Direct? It’s working. Has your information moved to or from an HIE? It’s working. Abandoning certification would not accelerate innovation, it would create what Barry Schwartz called the “paradox of choice” – and as Chuck Jaffe often reminds us: standards are like toothbrushes: everyone has one, and nobody wants to use someone else’s. I am not an evangelist here – not trying to “sell” you or anyone else on the promise of health IT. I know the limitations quite well. But your denial of the progress and success we’ve made so far doesn’t align with reality.

  38. Why is this an either or choice? Are we enable to provide basic care for those below a certain income level, and use insurance for catastrophic care, yet minimize/eliminate third party payment for everyone else? Why is the choice between a EMTALA free world and a single payer world? I was never strongly opposed to the principle of single payer, but the recent lessons of health care would suggest that patients are not well served when you have small coterie of folks dictating the minutiae of how health care should be delivered. You don’t want micromanaging of health IT, but you’re ok with the micromanaging that goes along with MACRA?..

  39. Employer-based health insurance is one of the most disparity-inducing insurance strategies we can imagine. It fragments the public voice into government, big privately employed, and the exchanged – still leaving a sizable group of uninsured.

    So yes, I mostly agree with Hayward that we need to move to single-payer, but that does not mean I support a national health record.

    Health records for operating hospitals should be open source software befitting the commodity that they are.

    Health records for managing clinical care should be patient-centered and as diverse as physicians and patients are – on a global, not US, basis.

  40. Employer-based health insurance is one of the most disparity-inducing insurance strategies we can imagine. It fragments the public voice into government, big privately employed, and the exchanged – still leaving a sizable group of uninsured.

    So yes, I mostly agree with Hayward that we need to move to single-payer, but that does not mean I support a national health record.

    Health records for operating hospitals should be open source software befitting the commodity that they are.

    Health records for managing clinical care should be patient-centered and as diverse as physicians and patients are – on a global, not US, basis.

  41. I agree with all of you. There have been 40,000 studies dutifully reviewed by Cochrane and many other systematic reviewers. We need to start again with solid and rigorous evaluations of pilots. HITECH is based on false promises– of cost savings, health benefits and mortality reductions. And Ross is the expert on unintended harms. Ross and I have written many op-eds on this. Several in THCB, WSJ, Health Affairs Blog (2), Boston Globe, HuffPost (UK ex), our 2015 CDC Preventing Chronic Disease artcile. To name a few.

    Don’t forget to look at the horrendous roll-out of Epic at the Brigham and Women’s that is still (years later) causing frustration and inefficiencies for clinicians (in a NEJM perspective).

    HITECH has been the ultimate in making policy based on contrary evidence. The worse we can do is to vary the next generation of health IT without generating good evidence. There are 10s of 1000s of cross-sectional correlational studies that are ultimately thrown out by Cochrane, but not before they influence wasteful, costly and potentially harmful policies.

    It is possible to do good perhaps, but only with careful systematic evidence. S

  42. I believe there are some areas where capitalism works exceedingly well and others where it fails miserably.

    In some realms, capitalism has served the public well.

    For example, the price of food is reasonably low and food choices are large . This is an example where capitalism works reasonably well (I know there are food subsidies etc.) Airline deregulation, despite numerous complaints, has made airline travel relatively inexpensive for the distance traveled.

    In some realms, capitalism definitely would not serve the public interest.

    Nobody would argue that the US military should be a capitalist enterprise. Nobody would argue that healthcare provided to our veterans should be a capitalist enterprise. Few would argue that our pubic road systems should be a capitalist enterprise and only available to those who can pay the owner’s fees.

    Over the last decade, we’ve had federal control over the health information technology market. The Federal Government have defined the standards right down to which box physicians much check at every visit. Clearly this has not met the needs of the healthcare providers, clearly it is not succeeded in reducing the cost of healthcare and clearly it is not had a substantial impact on the quality of healthcare. I think one could rationally argue that a more free-market / capitalist approach in the EHR realm, supplemented by voluntary government standards of interoperability , would probably succeed in meeting the needs of our population and providing the flexibility that the future healthcare system will require and which centralized Federal mandates are incapable of providing.

    With respect to the delivery of healthcare, we need to decide what is our first priority.

    If our first priority is to provide high quality/ low cost healthcare to all of our citizens, then we can stated definitively that capitalism has failed to meet that objective despite various permutations of “capitalistic” healthcare solutions over the last decade.

    On the other hand, if our first priority is to reduce the cost of healthcare then we should get rid of all the intermediate players in the system, the insurance companies, the pharmacy benefit managers, the federal government and we should allow physicians and hospitals and drug companies to deal directly with patients who pay cash for services (like our food industry). Of course the price will be that many people will not be able to afford any healthcare through no fault of their own. And then we need to figure out what do to with the child who is born with a severe disability, because of a lack of prenatal health care, and now requires expensive, life long care. Are we willing to roll back the regulations that now mandate that a hospital is required to treat all people who up in the emergency room and give the hospitals a right to let people die in their parking lot? Is this the type of society we want to create?

    The solution for health information technology is different from the solution for healthcare because these are different problems, with different histories and the history of each has shown us which path we should follow in the future.

  43. HAyward and Adrian provide devastating critiques of overregulation in health IT. I find it interesting that both (correct me if wrong) still favor a central command and control structure (single payer) elsewhere in healthcare. Isn’t HIT onenof many examples of the danger of putting well meaning bureaucracies in place in healthcare?

  44. I must respectfully disagree with the entire thrust of this argument.

    Most people who have been involved in health information technology, as an innovator, will tell you that federal regulations in the EHR realm has seriously impeded the development of effective and innovative EHRs solutions. In addition, a significant fraction of healthcare providers who have been forced to use these institutional EHRs will tell you that they impede their ability to take care of patients.

    Unfortunately, ONC regulations, through the creation of “certified EHR’s” has now permanently altered the way medical care is delivered to patients and relegated the most important player in the delivery of healthcare to the patient, the physician, to that of a vendor in a large industrial complex.

    I previously have blogged about this subject here on THCB and I’m sure those articles are still available for your perusal.

    Even some of the most ardent health IT geeks, who had been involved with the creation of meaningful use have altered their tune and recognize that ONC’s “certification” of EHR have stymied innovation.

    Until such time as we know how to define EHR specifications, which precisely meet the needs of all physicians in all situations (an eventuality that is not possible), it is far better for the Federal government, in my opinion, to define voluntary “standards” of interoperability but leave it to the market to decide which HIT component should be used in which situation.

  45. I am aware that several years ago, Great Britain abandoned its entire EHR. And now, the VA is planning to abandoned its EHR. Is it realistic to ask the ‘new’ ONC leadership what they plan to do, if anything, to structurally prevent that future waste of resources? The following answer is not acceptable: “Certification of an EHR doesn’t have a connection to its disaster management.”

  46. Certification has been a disaster for innovators and and will continue to drive consolidation into EHRs that collect and manage data on millions of people each. When an EHR is asked to manage information on a million people, the result is the same as building roads for a million people – they’re a commodity. By analogy, drive internationally in the rich world to see how little a system of roads that serves millions differs. Our EHRs are now just a bunch of roads that you can’t cross without changing cars.

    Certification is the principal driver of information blocking today. Beyond million person EHRs, certification is being leveraged to drive private biobanks in the consolidated integrated delivery systems that are now balkanizing medical knowledge itself. The business to provide a branded cognitive computing / machine intelligence / decision support service based around mega EHRs is now upon us and driving toward the end of non-secret medicine.

    What’s also notable is that certification has also failed to solve information blocking. The business benefits and regulatory capture by massive hospital and vendor “stakeholders” has managed to make BlueButton, Direct, and, at least for now, FHIR / Argonaut, irrelevant for solving information blocking. Within the Argonaut project the prospect of a Certified EHR actually accepting incoming data from another Certified EHR under patient direction is still many years away. It may just be another cycle of regulatory capture like BB and Direct before.

    ONC’s certification policies may be the biggest single factor for the lack of affordability progress under the ACA. Without practice innovation, consolidation driven by certification is just a path to price fixing.

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