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

Increasing Bad Press for Today's Healthcare Information Technology - Deserved and Overdue

Here are three candid, quite revealing articles about the distaste for today's health IT that appeared recently.  I will address each,

The first seems like pure deja vu (see my June 4, 2009 post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html):

1.  Forbes:  Pentagon's $11 Billion Healthcare Record System Will Be Obsolete Before It's Even Built -  March 3, 2015
http://www.forbes.com/sites/lorenthompson/2015/03/03/military-healthcare-11-billion-record-system-will-be-obsolete-before-its-even-built/

... No doubt about it, the project managers understand how to speak the language of acquisition reform.  However, a close look at what their site proposes to do for the 9.6 million active-duty warfighters and dependents in the military healthcare system reveals that this effort is going to fail.  It will probably be better than what it replaces, but it will lag far, far behind the kind of performance that users of internet-based technologies have come to expect.  So soldiers and sailors and airmen and marines — and their dependents — aren’t going to get the quality of care they deserve, and some will suffer mightily as a result.

In order to understand why the modernization initiative is doomed to failure, you need only grasp the significance of two key phrases the program office uses in its approach to industry for proposals.  First, it says it is seeking a “state-of-the-market” electronic health record system.  Second, it says whatever it selects will be an “off-the-shelf” product.  In other words, it is seeking to acquire an electronic health record system that already exists in an industry noted for its antiquated approach to the movement of information.  Furthermore, despite the program office’s insistence that it will avoid getting locked into reliance on a single monopolistic vendor, the project manager told Politico he envisions the contract as “an extensive prenup and no divorce.”

In other words, what I have described for years as a "business computing" oriented approach to clinical computing - an approach as guaranteed to fail as confusing psychiatry with neurosurgery because they both treat brain disorders, and trying to treat a brain tumor with psychotherapy or a personality disorder with a scalpel.  Specifics matter.

Sounds like vendor lock to me.  The business model the program is pursuing resembles a proprietary enterprise software system of the sort that many major hospitals have installed.

If you don’t know what an enterprise software system is, the first sentence in Wikipedia’s entry on the subject gets to the point: “Enterprise software…is purpose-designed computer software used to satisfy the needs of an organization rather than individual users.”  Got that — rather than individual users?  This approach to information system design is a throwback to the pre-internet days of mainframe computers.  In fact, the dominant version currently in use by private healthcare providers relies on upgrades to software developed nearly half a century ago at the Massachusetts General Hospital.

It's not a throwback to the mainframe era.  It represents the now-obsolete but still dominant, defective control-mentality acculturation and over-empowerment of information technologists (e.g., http://dl.acm.org/citation.cfm?id=563354&coll=portal&dl=ACM).  This acculturation is a remnant not of mainframe days but of the card tabulator data processing era (http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html).

2.  Health Affairs:  Where Is HITECH’s $35 Billion Dollar Investment Going? - March 4, 2015
http://m.healthaffairs.org/blog/2015/03/04/where-is-hitechs-35-billion-dollar-investment-going/

by Sen. John Thune, Sen. Lamar Alexander, Sen. Pat Roberts, Sen. Richard Burr, and Sen. Mike Enzi
 
On April 16, 2013, we released “REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT,” outlining concerns with implementation of the Health Information Technology and Economic and Clinical Health (HITECH) Act. Specifically, we asked: What have the American people gotten for their $35 billion dollar investment?

Two years after releasing the white paper, and six years since enactment of the HITECH Act, the question remains. There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.

I note that the statement "there is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care" is a euphemistic way of saying "there is conclusive evidence that the program has not achieved its goals of increasing efficiency, reducing costs, and improving the quality of car."

We have been candid about the key reason for the lackluster performance of this stimulus program: the lack of progress toward interoperability. Countless electronic health record vendors, hospital leaders, physicians, researchers, and thought leaders have told us time and again that interoperability is necessary to achieve the promise of a more efficient health system for patients, providers, and taxpayers.

Instead, according to physician surveys, electronic health records (EHRs) are a leading cause of anxiety for physicians across the country. The EHR products are not meaningful to physicians, which is clear when you consider that half of all physicians will have their Medicare payments cut in 2015 for not adopting government benchmarks for EHRs. ... After spending $28 billion so far of the $35 billion total taxpayer investment, significant progress toward interoperability has been elusive.

Sadly, our elected officials still don't quite understand that the largest drawback to today's health IT is not lack of interoperability, but lack of basic operability (usability). 

However, $7 billion of the HITECH $35 billion is still available to waste in order to learn that lesson.

... In listening to the concerns from EHR vendors and EHR users from across the care continuum, ONC has taken an important turn under the leadership of Dr. Karen DeSalvo. The previous ONC leadership did not understand the difficulty and enormity of creating government-approved products in a market that struggled to exist before government incentives arrived.

As a result, our nation’s health care providers are stuck with the huge cost of unwieldy systems trying to conform to government mandates. They are stuck adopting EHR systems which don’t fit into their established workflows. And if they actually want to share their patients’ data, they are stuck with even more costs imposed by vendors.

At the center of all this is the patient who must sit quietly in the exam room looking at her physician use a computer instead of directly talking with her, who likely has seen no better access to her own data, and who is struggling to understand why her doctor has such a difficult time getting her lab results.

This is not exactly an endorsement of ONC's prior leaders.  Perhaps the aforementioned "previous ONC leadership" should have read this blog more carefully.  Or the Wall Street Joutnal where I spelled these outcomes out in 2009.  Emphases mine:

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

Feb. 18, 2009

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

These were easy predictions to make based on experience and papers such as this.

Finally:

3.  HealthcareDive.com, Has the AMA lost its mojo?  - March 9. 2015
http://www.healthcaredive.com/news/has-the-ama-lost-its-mojo/372532/

As the mainstream media has begun to realize that organized physicians groups are doing all they can to resist adopting EHRs, the coverage of the dispute has revealed just how little impact their efforts—​led by the AMA—​are achieving in accomplishing their goals.

The AMA has come out vehemently against the Meaningful Use program and the high velocity with which the HHS and Congress want doctors to adopt EHRs, and they have written countless letters, position papers and blueprints for reform to announce their displeasure. Moreover, more than 30 other physicians groups have signed on to their copious letters. A recent USA Today piece quoted the incoming chief of the AMA about EHRs.

"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."

A 2013 AMA/RAND study revealed that EHRs are at the root of the modern doctor’s dissatisfaction with his job.

I note that up until relatively recently, the AMA was largely a defender of today's EHR technology.  They certainly got what they wished for...

"Physicians believe in the benefits of electronic health records, and most do not want to go back to paper charts," said Dr. Mark Friedberg, the study's lead author and a natural scientist at RAND, a nonprofit research organization. "But at the same time, they report that electronic systems are deeply problematic in several ways. Physicians are frustrated by systems that force them to do clerical work or distract them from paying close attention to their patients."

In fact, I believe this oft-made statement about "most do not want to go back to paper charts" is incomplete and misleading.  In terms of retrieving data such as labs and images, most probably would not want to go back to paper.  On the other hand, most probably would like to be able to document and enter orders on paper and have clerical personnel transcribe that information into computers - instead of the physicians being the clerical persons themselves, and gratis.

... According to a piece on Wall Street Cheat Sheet, there could be a couple of reasons why the AMA seems to keep getting shut out—​namely the AHA and the Blues.

While the AMA had $19 million to lobby Congress, the American Hospital Association—​which represents providers who took a financial hit after the last ICD-10 adoption delay—​spent $20.75 million last year to lobby lawmakers. Big insurer Blue Cross and Blue Shield, which would also benefit from wide adoption of EHRs and ICD-10, spent $21.3 million in 2014. That's a combined $42 million, more than double the AMA's effort.

Now, factor into that the extreme amount of influence wielded by the tech sector—​Google alone spent $17.5 million in lobbying Congress in 2014—​and the scent in the wind becomes easy to identify. The tech sector stands to make billions from EHR creation and management. Insurers need ICD-10 and EHRs to bring better cost management into their industry, enabling them to spend less as they pay for more care for more patients. Finally, hospitals need the tech because the ACA is bringing millions of new patients into their doors, and the old pegboard and paper systems that doctors are trying to cling to just won't work for hospitals that see tens of thousands of patients each month.

The AMA has set up a showdown on ICD-10 and EHRs that it will lose, and lose big, because it just plain does not carry the muscle it used to.

In other words, medicine has been invaded by the Information Technology industry and the profiteers who stand to benefit from that technology, with the bulk of the work being performed by clinicians, for free and to patient detriment.

This seems a clear formula for clinicians to simply refuse to use health IT altogether for data entry and demand a return to paper data recording with clerical transcription, but alas, it's likely too late for a revolt like that.

As health IT continues to get well-deserved and long-overdue bad press like this, one wonders if our culture will start to recover from the state of health IT delirium it is in.

I am in doubt.

(See my Jan. 20, 2011 post "Healthcare IT delirium" at http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html for more on that issue).

-- SS

3/16/15 Addendum:

A physician actually proposes physicians be paid for clerical work:

Pay doctors and nurses for the time they spend charting
http://www.kevinmd.com/blog/2015/03/pay-doctors-nurses-time-spend-charting.html

-- SS

11:09 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

CMS: Millions of patients across the nation are benefiting from the - um - potential - of Health IT?

I presume this is, in part, a response to the Jan. 21 letter from AMA and the other medical societies as I wrote about two days ago at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html:

CMS intends to modify requirements for Meaningful Use
http://blog.cms.gov/2015/01/29/cms-intends-to-modify-requirements-for-meaningful-use/

January 29
By Patrick Conway, MD

Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce our intent to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs beginning in 2015. These intended changes would help to reduce the reporting burden on providers, while supporting the long term goals of the program.

Read the document at the link above.

Note in particular this cheerful statement:

Since the first year of the EHR Incentive Programs in 2011, the United States has seen unprecedented growth in the adoption and meaningful use of EHRs. To date, more than 400,000 eligible providers have joined the ranks of hospitals and professionals that have adopted or are meaningfully using EHRs. This means that millions of patients across the nation are benefiting from the potential of better coordinated care among professionals, more accurate prescribing, and improved communication.

How does one, I ask, benefit from "potential of better care"?

How about the more factual "millions of patients are being put at risk and actually being harmed by the non-potential, but in fact actual, flaws in the technology?"

Until our leadership stops the mental cheerleading like this (or is it a form of subliminal messaging?), which blinds the uninformed to the reality ... the situation with healthcare IT will not improve, in my opinion.

And this after a formal letter of complaint about health IT disruptions to care, dangers, etc. from these organizations:

American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery

-- SS

Addendum 1/30/15:

Also see my April 26, 2014 post "Followup to CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" at http://hcrenewal.blogspot.com/2014/04/followup-to-cms-does-not-have-any.html with its attached March 2014 lettert from CMS.  This document was obtained by the American Association of Physicians and Surgeons (AAPS) via FOIA on the "potential" benefits patients are realizing from the hundreds of billions of dollars spent on this technology to date:

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But millions of patients are already benefiting from the potential!]  Click to enlarge.

-- SS

10:03 AM

"The tragedy of electronic medical records"

The Indianapolis Business Journal has published this article, citing former head of Indiana University's Regenstrief Institute, a world leader in EHR research, Dr. Clem McDonald:

The tragedy of electronic medical records
October 23, 2014
J.K. Wall
http://www.ibj.com/blogs/12-the-dose/post/50131-the-tragedy-of-electronic-medical-records

It wasn’t supposed to work out this way.

Digitizing medical records was supposed to transform health care—improving the quality of care and the service provided to patients while helping cut out unnecessary costs. Just like IT revolutionized all other industries.

Perhaps they still will. But lately, electronic medical record systems are getting nothing but votes of no-confidence from physicians, hospitals, insurers and IT experts.

Dr. Clem McDonald, who did more than anyone to advance electronic medical records during his 35 years at the Indianapolis-based Regenstrief Institute, called the 5-year, $27 billion push to roll out electronic medical records “disappointing” and even a “tragedy” last month during a talk with health care reporters (including me) at the National Institutes of Health in Bethesda, Maryland.

I agree with those sentiments.  The botched industry approach to clinical information technology has set back the cause of good health IT severely, largely through clinician disenfranchisement.  That dissatisfaction and disappointment will not be easy to reverse - and never should have needed to have been reversed.

... “It’s sort of a tragedy because everybody’s well-intentioned,” said McDonald, who spearheaded one of the nation’s first electronic medical record systems at Regenstrief and what is now Eskenazi Health. McDonald’s work in Indianapolis on the electronic exchange of medical records put patients here at least a decade ahead of those in most of the country in benefiting from the technology.

I'm not so sure that perverse behaviors such as willful blindness to the risks, profiteering, and indifference to harms caused by these systems, as I've documented at this blog and elsewhere count as "well-intentioned" (e.g., "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).

... McDonald now has a nationally influential post to promote electronic medical records, as the director of the Lister Hill Center for Biomedical Communications, a part of the National Library of Medicine, which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records “steal” 48 minutes per day in free time from primary care physicians.

That may be true regarding data entry time.  I'd say the amount is likely more when accounting for confusion and communications difficulties that bad health IT causes.

... One-third of physicians surveyed said it took longer to find and review medical record data. One-third also said it was slower to read other clinicians’ notes.

“Some docs don’t even read reports any more. This is a perverse side effect,” McDonald said, noting that the electronic reports have so much information in them, that they become “endless and mindless.”

I have used the term "perverse" in the past regarding commercial health IT; this is the first time I recall seeing the term from one of the EHR pioneers.

... More bad news about electronic health records came out this week in a new research study. It found that physicians using electronic medical records spend an extra 16 minutes per day, on average, doing administrative tasks than their peers who still use only paper.

The study relied on data from 2008—which when compared with McDonald’s study suggests EMRs are now consuming more of doctors’ time than they were before the federal push to expand their use.

“Although proponents of electronic medical records have long promised a reduction in doctors’ paperwork, we found the reverse is true,” wrote study authors Steffie Woolhandler and David Himmelstein.
  

Yet we still hear promises about "increased efficiency" and reduction of clinicians' administrative tasks and paperwork due to health IT.  When will that canard be put to rest, one might wonder?

In my view, the experiment of making clinicians perform EHR clerical work has been a failure.

And it was, in fact, an experiment in the full sense of the word.  It was done with little clue as to the true effects on patient care.

From the article:

... So with so many so upset with electronic health records, why is McDonald still optimistic?

He thinks the problems folks are having aren’t inherent to the technology itself, but are instead caused by overly restrictive rules coming both from the federal government and from hospital systems.

Hospital systems, knowing that more information can be recorded now that it’s electronic, have insisted that doctors do more documenting. McDonald cited one research study that found that documentation requirements have doubled in the past decade.

“I think they’ve got to ask less,” McDonald said of hospital administrators. “Nobody has any idea of the time-cost of one more data entry.”

I don't share that optimism or a belief physicians will be asked to "do less" with EHRs, since physicians have essentially abrogated their professional independence and autonomy, and are increasingly becoming servants of their business-degree masters - and of bad technology.

At least nurses are fighting back, e.g., per National Nurses United (see query link http://hcrenewal.blogspot.com/search/label/National%20Nurses%20United).

-- SS

12:00 PM

Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incentive programs, and other factors as here.

However, what was largely left out was the issue of safety.

I've written this letter to the congresspeople who've written to HHS secretary Sebelius (PDF available at this link):

October 24, 2012

To:

Sens. Coburn, Burr, Roberts and Thune

Reps. Ellmers, Camp, Herger, Upton and Pitts

United States Congress

Washington, DC

Re:  HITECH and healthcare information technology

Dear Senators and Representatives,

I applaud your recent inquiries to HHS regarding critical issues related to healthcare information technology (EHRs, physician order entry, decision supporting systems, etc.)  Issues such as the possible role of these systems in upcoding and Medicare overbilling, test overutilization, abuse of incentives, etc. must be addressed.

However, you did not address an issue probably more important to the public, indeed to us all as patients – that of health information technology safety.

Congress must be made aware that health IT exists in two forms:  good health IT and bad health IT.  Bad health IT reduces safety, creates close calls, injures, kills, raises costs, and sacrifices information privacy and confidentiality, among other ill effects.

Congress must also be made aware that unfortunately due to systemic impediments to free flow of information about health IT systems and lack of FDA or other independent industry regulation, bad health IT is rarely removed from the marketplace or fixed. 

FDA and its director of the Center for Devices and Radiological Health (CDRH), Jeffrey Shuren MD JD, testified to HHS in Feb. 2010 that “under the Federal, Food, Drug, and Cosmetic Act, health information technology software is a medical device”, but that FDA has “largely refrained from enforcing our regulatory requirements with respect to HIT devices.” 

To clarify about the two types of health IT:

Good Health IT provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

The Agency for Healthcare Research and Quality (AHRQ) recently reported that the highest prevalence of medical technology safety issues was related to EHR systems.  Even worse, there is a lack of reporting transparency. Harms are known of, but the magnitude admittedly unknown due to systematic impediments to reporting transparency, collection and analysis, as noted by FDA in a 2010 internal memo and IOM itself in its 2012 report on health IT safety.  This is unprecedented in modern medicine, violates patient’s rights, and under no circumstances should be considered acceptable.

I personally know of adverse patient outcomes including death related to bad health IT that are unreported (even in a state that mandates reporting of medical incidents and serious events), as do numerous colleagues. 

The Institute of Medicine has just released a Discussion Paper written by experts in health information technology entitled “Comparative User Experiences of Health IT Products: How User Experiences Would Be Reported and Used"  (http://www.iom.edu/Global/Perspectives/2012/~/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf). The recommendations in this paper need to be put into place, and Congressional awareness of the issues and official inquiry as to when this will happen is essential. 

This paper’s recommendations will not happen without the oversight of Congress.  As stated in the paper itself, “Some medical and IT leaders have invested their reputations, and their organization’s time and money, in the software [implementation] program; complaints that expose large problems may not be appreciated or carried forward.” 

Some claim safeguards are already in place in the form of HHS certification of health IT. 

Unfortunately, the HHS health IT certification guidelines do not have sufficient depth nor the correct focus to distinguish between bad health IT and good health IT.  Certification for MU does not look at real-world testing for safety, reliability and usability, for instance, under real loads, in actual clinical settings, and is not very thorough.

On the other hand,  NASA, the pharmaceutical industry (via FDA's regulation of pharmaceutical research and manufacturing IT) and others dependent on mission-critical software have rigorous validation procedures to check for such factors, e.g., NASA’s "Certification Processes for Safety-Critical andMission-Critical Aerospace Software" that includes rigorous testing to distinguish bad IT from good IT, and remediate or abandon the former.

p. 6-7:  In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following:

• Description of the system/software
• Evidence of competence of personnelinvolved in development of safety-critical software and any safety activity
• Specification of safety requirements
• Results of hazard and risk analysis
• Details of risk reductiontechniques employed
• Results of design analysis showing that the system design meets all required safety targets
• Verification and validation strategy
• Results of all verification and validation activities
• Records of safety reviews
• Records of any incidents which occur throughout the life of the system
• Records of all changes to the system and justification of its continued safety

These processes need to be put in place regarding healthcare IT as well, but will take much time and regulatory push on the industry to occur.  In the absence of truly rigorous testing, though, transparency is essential.

The aforementioned IOM Discussion Paper outlines the creation of a nationwide post-marketing surveillance process and transparency on health IT usability problems, safety issues, billing fraud promotion, etc. is essential.  It recommends:

¨        “Flight simulator”-like, thorough laboratory evaluation of test scenarios;

¨        Point-of-use reporting by doctors and nurses on their experiences;

¨        Third party–administered doctor and nurse surveys about their experiences with EHR systems;

¨        Direct clinician-to-public reporting; and

¨        A formalized system of hazards reporting from EHR systems.

These measures are essential if the technology is to achieve the benefits of which it is theoretically capable, but not presently achieving despite the hundreds of billions of dollars being spent.

In conclusion, I ask you to add to your inquiries the subject of health information technology safety.  That includes the need for HHS to develop a robust, transparent national reporting system for safety problems created by the technology, and a system to ensure that bad health IT is either fixed in a timely manner or removed from the marketplace.

Sincerely,

Scot Silverstein, MD

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

Scot M. Silverstein, MD

Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)

Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)

Drexel University

College of Information Science and Technology

3141 Chestnut St., Philadelphia, PA 19104-2875

Email:  sms88 AT drexel DOT edu

Bio:  http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm 

I hope this letter has some beneficial effect.

-- SS

6:24 AM