Government backs down on some requirements for digital medical records

EHR utopian dreams have taken some pronounced hits in recent years.

In recent months, the hyper-enthusiasts and their government allies have had to eat significant dirt, and scale back their grandiose but risible - to those who actually have the expertise and competence to understand the true challenges of computerization in medicine, and think critically - plans.

(At this point I'll give them the benefit of the doubt and not call the utopians and hyper-enthusiasts corrupt, just stupid.)

USA Today published this article today outlining the retreat:

Government backs down on some requirements for digital medical records

http://www.usatoday.com/story/news/nation/2015/05/25/athenahealth-epic-safety-reliability-electronic-health-records/27499877/ 

Jayne O'Donnelland Laura Ungar, USAToday  

May 26, 2015

Government regulators are backing down from many of their toughest requirements for doctors' and hospitals' use of digital medical records, just as Congress is stepping up its oversight of issues with the costly technology.

They needed to back down because the technology, vastly over-hyped and over-sold as to capabilities, and vastly undersold as to the expertise required for proper design and implementation, has impaired the practice of medicine significantly - and caused patient harms:

... Now the Department of Health and Human Services is proposing a series of revisions to its rules that would give doctors, hospitals and tech companies more time to meet electronic record requirements and would address a variety of other complaints from health care professionals.

"The problem is we're in the EHR 1.0 stage. They're not good yet," says Terry Fairbanks, a physician who directs MedStar's National Center for Human Factors in Healthcare. The federal government "missed a critical step. They spent billions of dollars to finance the implementation of flawed software."

The "EHR 1.0" stage?  The actual problem is that an industry that's existed regulation-free for decades now was believed, against the advice of the iconoclasts, myself included, when it spoke of this experimental technology as if it were advanced and perfected.

Our leaders all the way up to the last two Presidents were suckered by this industry.  In Feb. 2009 I wrote:

http://www.wsj.com/articles/SB123492035330205101

Dear WSJ:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.
The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

Nobody was listening.

Back to USA Today:

... William McDade, a Chicago anesthesiologist, checks the medical records of patient Jacob Isham. McDade has moved into electronic medical records but isn't convinced they improve record-keeping, and meanwhile they're expensive and they take time away from patients. 

These digitized records remain the bane of many doctor and patient relationships, as physicians stare at computer screens during consultations.And there's the issue of time. University of Chicago Medicine anesthesiologist William McDade, who has switched from paper to electronic records, says that while EHRs put information at doctors' fingertips, those doctors must take extra time to enter data, and some systems are not intuitive.

The model of physicians as data-entry clerks was experimental from the start, especially in busy inpatient settings and critical care areas.  I opine that particular experiment is a failure.  Paper is far faster, followed by transcription by those without clinical obligations.  That's expensive, of course; but reality is a harsh master.

Praveen Arla of Bullitt County Family Practitioners in Kentucky says even though he's "one of the most tech-savvy people you're ever going to meet," his practice has struggled mightily with its system. It cost hundreds of thousands of dollars to put into place, he says, and it doesn't even connect with other systems in hospitals and elsewhere.

Physicians should not have to be "tech-savvy".  Software, as I've written before, needs to be physician-savvy.  As much of it is written without clinical leadership, we have the results outlined in USA Today.

... The federal government "should've really looked at this more closely when EMRs were implemented. Now, you have a patchwork of EMR systems. There's zero communication between EMR systems," he says. "I am really glad they're trying to look back and slow this down."

I repeatedly called for a slowdown or moratorium of national EHR rollout on this blog.  See 2008 and 2009 posts here and here for example.  My calls were due to the prevalence of bad health IT (BHIT), hopelessly deficient if not deranged talent management practices (especially when compared to clinical medicine) in the health IT industry, and complete lack of regulation, validation and quality control of these potentially harmful medical devices. 

I also called the HITECH stimulus act 'social policy malpractice.'  See my Sept. 2012 post "At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professional".

USA Today then calls out issues of reliability, safety and liability.

Of course, there's always a straddle-the-fence defender of EHRs, with a "EHRs have problems, BUT..." refrain,  even when almost 40 medical societies have complained about safety and usability issues (http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):

... Physician Robert Wachter, author of The Digital Doctor, is a proponent of,EHRs, but sounded several cautionary notes in his book about the problems. At the University of California San Francisco, where he chairs the department of medicine, a teenage patient nearly died of a grand mal seizure after getting 39 times the dose of an antibiotic because of an EHR-related issue. But Wachter says he believes patients are safer with EHRs than they were with paper.

Wachter's book to my belief omitted known cases of EHR fatality - in my view a milquetoast, spineless approach to EHR risk at best.  (I'm trying to be kind and objective, but such spinelessness of others about EHRs put my mother in her grave, http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html.)

Further, the belief that EHRs are safer than paper are not the views in my mind of a critical-thinking scientist, as the true rates of EHR-related harms is unknown, yet the incidences of mass "glitches" affecting potentially thousands of patients at a time and impossible with paper are well-known.

See my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), especially points #1 through 4, and the query link http://hcrenewal.blogspot.com/search/label/glitch.

5/27/2015 addendum:  The author of this USA Today article Jayne O'Donnell informed me that the following appeared in the print edition, but not the electronic version:

But Wachter  and Sally Murphy, former chief nursing officer at HHS' health information technology agency, say they both believe patients are safer with EHRs than they were with paper.

"Is there broad proof that electronic health records have impacted quality? No, " says Murphy, "But you just have to pay attention to the unintended consequences and continue to study them."

First, that response seems the classic salesman's tactic of redirection, to deflect from fully answering to the cruel reality of the evidence.  The second part of the response strikes me as a non-sequitur, in fact.

Second, Murphy and Wachter both seem unable to grasp that the myriad en masse risks to potentially large numbers of patients these systems in their current state cause, impossible with paper (as, for instance, in the many posts at the link above), combined with the lack of evidence about (mass-hyped) "quality improvements", could make patients less safe under electronic enterprise command-and-control systems, which in hospitals is what these systems really are.

Try getting thousands of prescriptions wrong, for instance (see http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or stealing hundreds of thousands of paper records (see for example http://hcrenewal.blogspot.com/2012/06/more-electronic-medical-record-breaches.html).

Compare to well-staffed paper systems led by health information management professionals (not IT geeks), especially those supplemented with document imaging systems.

This type of statement - "EHRs are bad today, BUT they're still better than paper" - strikes me as reflecting, I'm sad to say, limited imagination, limited critical thinking, Pollyanna attitudes, and unfettered faith in computers.

Third, Murphy's somewhat disconnected response "But you just have to pay attention to the unintended consequences and continue to study them" is a bit surprising considering the statement made by the same ONC office just a few years ago:

Contrast to former ONC Chair David Blumenthal, see second quote at my April 27, 2015 essay "Pollyanna Rhetoric, Proximate Futures and Realist's Primer on Health IT Realities in 2015" at http://hcrenewal.blogspot.com/2015/04/pollyanna-statements-proximate-futures.html from an April 30, 2010 article entitled "Blumenthal: Evidence of adverse events with EMRs "anecdotal and fragmented":

... The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety."  (David Blumenthal, former head of ONC at HHS, http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented)

Sadly and tragically, my mother was seriously injured by EHR-related medication reconciliation failure and abrupt cessation of a heart rhythm medication just weeks after Blumenthal said he was unconcerned about risk and that we should go full steam ahead.  That misadventure began on May 19, 2010 to be exact.

It is my belief HHS and ONC still do not take risk seriously and would revert to a Pollyanna stance in a heartbeat without the pressures of the iconoclasts.

Back to the USA Today article:

... Some proponents of EHRs say the government has been thwarting efforts to improve them.

That's laughable.  A review of Australian computer scientist/informtics expert Jon Patrick's analysis of the Cerner ED EHR product, for example, gives insight into just how crappy this industry and its products are, and government was certainly not the cause.   See: Patrick, J. A Study of a Health Enterprise Information System. School of Information Technologies, University of Sydney. Technical Report TR673, 2011 at http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146.

... In addition to extending the deadline for implementing EHR requirements, a series of HHS proposed rules extends the time doctors, hospitals and tech companies have to meet EHR requirements, cuts how much data doctors and hospitals have to collect and reduces how many patients have to access to their own electronic records from 5% of all their patients to just one person.

"That is a slap in the face to patient rights and all the advocates because we worked so hard and for so long to ensure patients could access their data," says patient advocate Regina Holliday.

Holliday became an electronic records advocate after her husband died of kidney cancer in 2009 at age 39. His care was adversely affected because hospitals weren't reading his earlier EHRs and she had trouble getting access to the records.

I met Regina Holliday in Australia during my 2012 keynote presentation to the Health Informatics Society of Australia on health IT trust (http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html).  As I recently mentioned to her, it's even worse that the requirements for a tamper-proof audit trail are also being relaxed.

Without a complete and secure audit trail, electronic records can be altered without detection by hospitals, e.g., after a medical misadventure, to their advantage.   This represents a massive conflict of interest is a violation of patient's rights to a secure and unaltered record in the event of a mishap, in my opinion.

The 2014 Edition EHR CERTIFICATION CRITERIA, 45 CFR 170.314 spells out in great detail specs for such an audit trail (see page 7 at http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf), but compliance has been 'conveniently' relaxed, after hospital and industry lobbying I'm sure.

(The certified electronic health record technology definition proposed by CMS would continue to include the “Base EHR” definition found in the “2015 Edition Health IT Certification Criteria” in addition to CMS’ own objectives and criteria.  This definition does not include mandatory tamper resistant audit trails. The audit trail requirement is not proposed to be included in the 2015 definition of “Base EHR."  Neither is this criterion found in CMS’ own definition of CEHRT; rather it is “strongly recommended” that providers ensure the audit log function is enabled at all times when the CEHRT is in use, since the audit log function helps ensure protection of patient information and mitigate risks in the event of any potential breach.)

"Strongly recommended" in this industry in my opinion equates to "safely ignore" if it impacts margins.

... EHRs "have made our lives harder" without improving safety, says Jean Ross, co-president of National Nurses United. Last year, the nurses' union called on the Food and Drug Administration "to enact much tougher oversight and public protections" on EHR use.

Meanwhile, the medical industry is urging HHS to give them even more time and flexibility to improve their systems.

"The level of federal involvement and prescriptiveness now is unhealthy," says Wachter, who chairs the UCSF department of medicine. "It has skewed the marketplace so vendors are spending too much time meeting federal regulations rather than innovating."

Here's Wachter again, in essence, kissing the industry's ass.  Government EHR regulation is still minimal, and prior to MU was nearly non-existent.  Where was the "innovation" (more properly, quality, usability, efficacy and safety) then, I ask?

... Sen. Lamar Alexander, R-Tenn., chairman of the Senate health committee, and Sen. Patty Murray, D-Wash., announced a bipartisan electronic health records working group late last month to help doctors and hospitals improve quality, safety and privacy and facilitate electronic record exchange among health care providers and different EHR vendors.

 "It's a great idea, it holds promise, but it's not working the way it is supposed to," Alexander said of EHRs at a recent committee hearing

 At a Senate appropriations subcommittee meeting last month, Alexander told HHS Secretary Sylvia Burwell that he wanted EHR issues at the top of his committee and HHS' priority list to be addressed through regulation or legislation.

I have spoken to the Senator's healthcare staff, who are aware of my Drexel website and my writings on this blog.  They were stunned by the reality of health IT, and I hope they have relayed my concerns and writings to the senator and that this contributed to his mandate.

... Minnesota lawmakers became the latest state this week to allow health care providers to opt out of using EHRs. But MedStar's Fairbanks says doctors would welcome well-designed, intuitive EHRs that made their jobs easier instead of more difficult — and that would improve safety for patients, too.

It is my view that under current approaches to health IT, in terms of talent management, leadership, product conception, design, construction, implementation, maintenance (e.g., correction of reported bugs), regulation, and other factors, that dream is simply impossible.

The entire EHR experiment needs serious re-thinking, by people with the appropriate expertise to know what they're doing.

I note that excludes just about the entire business-IT leadership of this country, who, lacking actual clinical experience, are one major source of today's problems.

Today, Pinky, we're going to roll out national health IT ... tomorrow, we TAKE OVER THE WORLD!

-- SS

12:26 PM

Pollyanna Rhetoric, Proximate Futures and Realist's Primer on Health IT Realities in 2015

Pollyanna statements about healthcare IT such as the following are still appearing, and are growing increasingly tiresome.  They are, at best, demonstrations of people with a fiduciary duty to have known better making fools of themselves.

Pollyanna: someone who thinks good things will always happen and finds something good in everything (Merriam-Webster, http://www.merriam-webster.com/dictionary/pollyanna)

Examples:

... Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, that shady conspiracies are operating -- make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers are easily affected by fear mongering.  (Mark Leavitt, former head CCHIT, http://www.ihealthbeat.org/perspectives/2009/health-it-under-arra-its-not-the-money-its-the-message.aspx)

and:

"The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety."  (David Blumenthal, former head of ONC at HHS, http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented)

and:

"We don't think there's a great deal of data to substantiate that there are major safety problems with the majority of electronic health records systems in use today," said Charlie Jarvis, executive committee vice chair of the EHR Assn., a trade group that represents 46 organizations that supply most of the EMR systems implemented in medical practices. "These products are safe, dependable, time-tested and display a lot of the safety features we think are necessary to prevent problems going forward." (Charles Jarvis, erstwhile NextGen VP and holder of prestigious (and mysterious) "American Medical Informatics Certification for Health Information Technology", http://hcrenewal.blogspot.com/2011/11/two-opposing-views-of-ehr-1.html)

The most recent example highlighted on this blog is:

As Minnesota’s health commissioner, I work to improve the health of all Minnesotans. As a physician, I’m dedicated to providing the best care possible to patients. Secure electronic health records help achieve both goals by enhancing the safety, effectiveness, and efficiency of our health care system. With that in mind, I have been concerned to see some recent pushback on Minnesota’s requirement that all health care providers use electronic health records (EHR) by 2015 ... All Minnesota patients, whether they visit a small clinic, need mental health treatment, or receive care from multiple providers, stand to benefit from EHRs and the improved care coordination they make possible. (Minnesota's Heath Commissioner Dr. Edward Ehlinger, http://www.minnpost.com/community-voices/2015/04/electronic-health-records-advance-quality-care-all-minnesotans.)

Here is the tragic reality.

Recommended for reading, and for feeding to the press and to our elected officials:

Primer on health IT realities in 2015:

-------------------------------------------------

(1)  "Five biases of new technologies", Trisha Greenhalgh.  Br J Gen Pract. 2013 Aug; 63(613): 425
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3722815/

The most dangerous of these biases is the "subjunctivisation bias".  It results in clinical disruption, mishaps, injury and death:

Subjunctivisation bias: Much of the policy rhetoric on new technologies rests not on what they have been shown to achieve in practice but on optimistic guesses about what they would, could, or may achieve if their ongoing development goes as planned; if the technologies are implemented as intended; and in the absence of technical, regulatory or operational barriers.⁴ This is what Dourish and Bell call the ‘proximate future’: a time, just around the corner, of ‘calm computing’ when all technologies will be plug-and-play and glitch-free.

(I point out a related bias - that of the hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.  See http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html.)

(2)  ECRI Institute Deep Dive Study on Health IT risks (2012)
http://www.healthit.gov/facas/sites/faca/files/STF_Deep_Dive_Health_Information_Technology_2014-06-13.pdf

171 IT mishaps sufficient to cause harm reported voluntarily by 36 hospitals in 9 weeks; 8 injuries; mishaps likely contributed to 3 deaths as well.  Projected to a nationwide annual figure, the result is likely many thousands of times greater (see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

(3)  Letter to ONC from 37 Medical Societies (January 2015)      
http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf

This letter speaks for itself on exceptionally well-justified clinician dissatisfaction and alarm at the risks and disruptions posed by this technology in its current form and with present roles (e.g., the experimental use of clinicians as cheap data entry clerks).

   
(4)  Joint Commission Sentinel Events Alert on Health IT (March 2015)   
http://www.jointcommission.org/assets/1/18/SEA_54.pdf

Late, but better than never.  Most of what's in this alert has appeared on this blog since 2004.   Footnote 1 (ECRI Institute PSO Deep Dive, the report linked above) is somewhat bizarrely used as a justification of the statement "EHRs have demonstrated the ability to reduce adverse events."  I do also note at the linked http://www.jointcommission.org/safe_health_it.aspx these statements:

• Poorly designed or implemented health IT can contribute to patient harm
• Health IT-related patient safety events can go undetected
• As health IT adoption becomes more widespread, the potential for health IT-related patient harm may increase

These could have come directly from my writings dating back over a decade here.  (Perhaps they did.)

(5)  Accenture - Fewer U.S. Doctors Believe It Improves Health Outcomes (April 2015)                    
http://www.businesswire.com/news/home/20150413005148/en/Increased-Electronic-Medical-Records-U.S.-Doctors-Improves#.VT5bmpOTqUk

This survey also speaks for itself.  A less formal nurses' survey is here:  http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html

(6)  U.S. Centers for Medicare & Medicaid Services (CMS)
https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg6nXrVEVPnVoEIvE2Q8Qa1Kfao_E8bTYIWJ5M_QrAoW9LEzubCackkdnAcK1pyqpXxCSHbMjbrIQxy4W1Scs9vE6LCwM89wbn5Y1nzcnxMOA2wFY-67G0OOt8YjHZcLNw8LDWSMicwByYU/s1600/CMS_Letter.jpg

FOIA response:  "We do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  (But let us spend hundreds of billions of dollars and put patients at risk to find out...)

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives.  [Click to enlarge.]

In conclusion:

Next time you encounter pollyanna/head-in-the-sand statements about health IT that ignore the risks, throw this primer the way of the authors and audience of such statements.

-- SS

9:33 AM

Former ONC Director David Blumenthal (Inadvertently?) Honest About EHRs in USA Today Story

USA Today has published a story on health IT difficulties.  Read it in its entirety; it is fairly balanced, though mild, e.g., it omits mention of the ECRI Deep Dive study on patient harms (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html) and other actual reports of patient harm.  (I was one of many who spoke to the reporters about this story.) 

Feds move into digital medicine, face doctor backlash
Laura Ungar and Jayne O'Donnell, USA TODAY
Feb. 1, 2015  
http://www.usatoday.com/story/news/nation/2015/02/01/backlash-against-electronic-medical-records/21693669/

I am only going to make one point about it, that being the candor (in a manner I'm reasonably certain was not intended) of former ONC Director Dr. David Blumenthal:

... David Blumenthal, national coordinator for health information technology for President Obama from 2009 to 2011, says, "the threat of penalties is the only incentive (doctors) have to make it [the adoption of healthcare IT] happen."

I don't think the candor was meant in the way I am about to interpret it, but I agree with his assessment.

The threat of Medicare penalties is indeed "the only incentive" (doctors) have to make "it" happen, because the technology is not helping them, and is making their work harder and more risk- and liability-prone.  But don't take that from just me:

... A group of 37 medical societies led by the American Medical Association sent a letter to Health and Human Services last month saying the certification program is headed in the wrong direction, and that today's electronic records systems are cumbersome, decrease efficiency and, most importantly, can present safety problems for patients. 

I covered that Jan. 21, 2015 letter at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html. 

(One can only imagine the level and duration of physician complaints it took for those 37 medical societies led by the American Medical Association to have crafted the letter to HHS/ONC, available at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.)

Also, as stated by the American Medical Association's president-elect to USA Today:

"Physicians passionately despise their electronic health records," says Lexington, Ky., emergency physician Steven Stack, the American Medical Association's president-elect. "We use technology quickly when it works … Electronic health records don't work right now."

"Passionately despise" is not exactly a ringing endorsement.

So, in effect,  the "stick" of financial penalties is indeed the "only incentive" doctors and nurses have right now for broad adoption, because the "carrot" is moldy and rotten - and despised with a passion.

A much better incentive - in fact, the only legitimate incentive for widespread adoption - is safe, sound, efficacious products, reasonably regulated, with defects and problems reasonably reported and acted upon ... in other words, with the products subject to the same scrutiny as IT in other mission and life-critical sectors.

Thanks for 'fessing up, Dr. Blumenthal.

-- SS

5:33 PM