National Coordinator 6.0: A Blueprint For Success

National Coordinator 6.0: A Blueprint For Success

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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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48 Comments on "National Coordinator 6.0: A Blueprint For Success"


Member
meltoots
Apr 5, 2017

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.

Member
Apr 6, 2017

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.

Member

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).

Member
Allan
Apr 5, 2017

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?

Member
Steven Findlay
Apr 4, 2017

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.

Member
Apr 3, 2017

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.

Member
pjnelson
Apr 3, 2017

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.”

Member
Adrian Gropper, MD
Apr 3, 2017

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.

Member
Apr 3, 2017

@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.