Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" (http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html) I noted that the American Association of Physicians and Surgeons (AAPS) had received a reply from CMS to a FOIA request that:

"We [CMS] do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."

Put another way, the country is embarking on a $1 trillion healthcare experiment, and blindly.

I mentioned I'd post the letter when received from AAPS.  That just occurred.

The letter is below (click to enlarge):

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

I've added it as an addendum to the original post, but thought it worthwhile to call out the letter in a post of its own to those who might not revisit the original.

An additional thought:

While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they do have (or should have made it their business to have) information that EHRs cause harm and take lives (e.g., via FDA at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html , ECRI at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html and others).

-- SS

CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives?

If this is true, the EHR hyper-enthusiasm problem is even worse than I believed.

From the April 2014 newsletter of the American Association for Physicians and Surgeons (http://www.aapsonline.org/index.php/about_us/), an organization that is dedicated "to preserving the sanctity of the patient-physician relationship and the practice of private medicine":

CMS Claims to Have No Information on EHRs

On Mar. 14, 2014, the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare and Medicaid Services replied to a Freedom of Information Act (FOIA) request sent Apr. 4, 2012:  The American Recovery and Reinvestment Act of 2009 (ARRA) created the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.  While our Office of E-Health Standards and Services works to implement the provisions of the ARRA, we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."

However, that doesn't stop our government from spending billions of taxpayer dollars on them, when, in fact, we do know of harms they cause.  One can reasonably assume their primary interest is in bookkeeping.

With FDA, it's even worse.  Rather than stopping at admitting they simply don't know due to admitted impediments to knowing, they simply leap to a conclusion that the technology is of 'sufficiently low risk' not to warrant their regulatory attention, even if such systems meet the statutory requirements to be a medical device and thus fall under the Food, Drug & Cosmetic Act.

See my Apr. 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" and its ten-point (and non-comprehensive) summary of risks: http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.  Another FOIA request is surely needed...

More generally, I know from personal development and implementation experience that when "done well", that is, when good health IT and good implementation practices are offered and with patient safety as a priority, health IT can save lives and improve care.  It's just that the commercial for-profit health IT sector does not meet those expectations, due largely to its leadership model from the merchant-computing culture.  Instead, bad health IT is the norm.  From my academic site at http://cci.drexel.edu/faculty/ssilverstein/cases/:

Good Health IT is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, 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.

 I am seeking source material from the AAPS and will post it.

-- SS

April 26, 2014 Addendum:

Below is the letter to AAPS from CMS.  Click to enlarge.

CMS:  "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

An additional thought:

While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they do have (or should have made it their business to have) information that EHRs cause harm and take lives (e.g., via FDA at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html , ECRI at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html and others).

-- SS

At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professionals

I am revisiting the issue of HITECH in light of recent reports on health IT drawbacks and/or failure to achieve long-claimed advantages.

The HITECH Act, a multi-billion dollar EHR incentive/penalty measure inserted into the 2009 American Recovery and Reinvestment Act legislation (ARRA or 'economic recovery' act), is proving to be an example of what should be called "Social Policy Malpractice."

The HITECH Act was largely a consequence of intense industry lobbying on behalf of the IT industry (as in the Washington Post at "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records", May 16, 2009).

It is in fact not based on science or reliable evidence, and has led to increased patient endangerment and a worsening national debt picture.

The recent revelations of reports from diverse sources including but not by any means limited to the following indicate that HITECH and its expenditures of billions of dollars on experimental, unregulated, unproven technology represents social policy malpractice:
 

• ABC News (Your Medical Records May Not Be Private: ABC News Investigation" - privacy of electronic health data is very poor, in ways that paper would and could never have permitted);

• The Center for Public Integrity "Growth of electronic medical records eases path to inflated bills", on how EHRs lead to increased, not decreased healthcare costs;

• Experts at Penn and Harvard -"A Major Glitch for Digitized Health-Care Records" - savings from EHRs are illusory;

• Budget reports - in view of the deficit spending reported by OMB and others that is causing national debt to spiral out of control, jeopardizing the economic well being of the United States, and with upcoding as a side-effect and no cost savings, HITECH is an unaffordable extravagance. 

• Recent revelations of outright EHR-induced mass chaos largely due to outspoken clinicians who've had enough - "Contra Costa County health doctors air complaints about county's new $45 million computer system", "Lake County (IL) Health Department - Depression era soup lines at the clinic";

• Abuses of NPRM Public Comment periods on followup health IT incentive regulations via industry ghostwriting (stealth lobbying), reducing EHR effectiveness while further enriching the industry - "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?";

Of course, I'd already cited these reports in past posts but they bear repeating:

• The IOM report on HIT safety ("There's risk, but we don't even know the magnitude because there are major systemic impediments to diffusion of that information"), http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html;

• FDA (known injuries and deaths are likely the "tip of the iceberg" because of the impediments, and EHRs are medical devices that should fall under the FD&C Act, but FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices because they're a political hot potato - Jeff Shuren MD JD, CDRH), http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html;

• NIST (health IT usability is poor, major remediation is needed) - http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html

I'd called for a moratorium on ambitious EHR plans for similar reasons as far back as 2008, at posts here and here.

 

The path that ethical medical centers and clinicians should take is to delay computerization in 2012 and push for slowdown or retraction of HITECH and its penalties for non-adopters. 

Yet instead, what is usually seen is excuses and cheerleading by healthcare organization leaders, and passive physician and nurse acceptance of deficient information technology.  

This stunning passivity and acceptance by physicians and nurses of a deeply flawed technology of unknown risk seems largely due to physician learned helplessness and the Stockholm Syndrome.  See the posts on "physician learned helplessness" at http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html (commenting on observations in MedScape written by a lawyer), as well as on the "Stckholm Syndrome"  at http://en.wikipedia.org/wiki/Stockholm_syndrome. 

Per a psychiatrist/informatics specialist Dr. Scott Monteith who has commented on this blog, the compliance of clinicians may also be a manifestation of the inherent human psychopathology reflected in the Milgram Experiment (and elsewhere):

The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience. Milgram first described his research in 1963 in an article published in the Journal of Abnormal and Social Psychology, and later discussed his findings in greater depth in his 1974 book, Obedience to Authority: An Experimental View.

As to the consequences of physician "acceptance" of this technology in 2012 in its present condition, physicians are:

• Acting, in effect, 'in loco parentis' for their patients, not in the latter's best interests, who are not even afforded opportunity for informed consent.  This is in violation of long-accepted norms of human subjects experimentation and research such as the Belmont Report, Nuremberg Code and HHS human subject protection regulations at 45 CFR part 46 themselves;

• Giving free provision of their expertise and labor at improvisation and workarounds, in effect providing free alpha and beta testing to an entirely unregulated IT sector;

• Engaging in passive acceptance of the entire liability and their hospital executives' breach of fiduciary responsibility to protect them from same due to Hold Harmless clauses, and breach of Joint Commission safety standards through signing "gag" clauses on defects and harms (see http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

National health IT leaders have proven to be hyperenthusiasts about health IT benefits as well:

... This from Robert Kolodner, former head of the Office of the National Coordinator for Health IT (ONC) at HHS:

Dr. Robert Kolodner, a physician who headed the federal push for electronic medical records in 2007, acknowledged that billing abuse took a backseat to steps likely to entice the medical community to embrace the new technology.

Kolodner said officials were certain the savings achieved by computerizing medicine would be so great that billing abuse, “while needing to be monitored, was not something that should be put as the primary issue at that time.”

In other words, sideline (ignore) health IT-based billing abuse (and safety risks to the live patients subjected to this experimental technology without informed consent) because "we believe" the savings will be greater based on "our faith in the technology."

 

Such individuals contributed materially to the social policy malpractice represented by the HITECH ACT.

Considering all of the above, I call once again for a moratorium on further economic incentives for EHR adoption, and investment in the very measures recommended by the National Research Council in its Jan. 2009 report "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" that:

In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.

This research must be conducted, of course, with full human subjects protections in place.

-- SS