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.
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).