H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters

Do computers have more rights than patients?

It often appears that way to me.

Health IT and its industry sector seem to garner extraordinary regulatory accommodations compared to other healthcare and life-critical sectors - such as freedom from meaningful safety regulation, freedom from need for human research subjects protections and informed consent on EHR risks ... and in this proposal, freedom from full legal Discovery:

US Congress has a bill, H.R.2957 - Behavioral Health Information Technology Act of 2013, 113th Congress (2013-2014), at http://beta.congress.gov/bill/113th/house-bill/2957) with a section (SEC. 4. PROVIDING PROTECTIONS FOR CERTAIN PROVIDERS, VENDORS, AND USERS OF CERTIFIED EHR TECHNOLOGY) that provides safe harbors for reporting EHR-related errors.

The text of Sec. 4 contains this:

... (c) Rules Relating to E-Discovery.--In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery shall be limited to--
        (1) information that is related to such EHR-related adverse event; and
        (2) information from the period in which such EHR-related adverse event occurred.

In other words, it seems the bill proposes, on capricious grounds, that an injured party cannot discover any information from prior to - or after - the EHR-related event they allege caused their injury, even if potentially material; for example, if the cause of the event was known about and had occurred in the past to others, or afterwards, yet went uncorrected.

This seems a shield against claims of EHR vendor and/or healthcare organization corporate negligence and seems to represent anther special accommodation to health IT.

This proposed Bill would also, it seems, hamper clinicians who were themselves victims of bad health IT from fully defending themselves.

How this Bill's eDiscovery infringement promotes timely correction of known EHR problems, I would like to know...

I also fail to see what "certification" has to do with provision of this remarkable special accommodation regarding eDiscovery.

"Certification" by HHS/ONC is a features qualification/verification of features felt by committee (with no real basis in Evidence-Based Medicine principles) to foster "meaningful use", whatever that means, and make an EHR product eligible for CMS incentives.

However, "certification" is not a safety testing or validation process, in the words of the certification bureaus themselves, see my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'" at http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html.

Finally (and with the caveat that neither I nor my colleagues are lawyers), colleagues point out that such a proposal from Congress may be at odds with the role of the government branch that does decide the Rules of Civil Procedure, including discovery rules.  Specifically, the judiciary, at both the Federal court level (e.g., per the Rules Enabling Act of 1934, an Act of Congress that gave the judicial branch the power to promulgate the Federal Rules of Civil Procedure,  http://en.wikipedia.org/wiki/Rules_Enabling_Act), and State levels.

It would seem quite possible that the roster of Congressional co-sponsors of this Bill, seen at http://beta.congress.gov/bill/113th/house-bill/2957/cosponsors, have been "influenced" by the health IT industry.

-- SS

Those Goddamn Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients

It seems the EHR technophiles are starting to notice one of the side effects of EHR technology: the liabilities EHRs impose on users.

Interestingly, those liabilities are presented below as the fault not of a cavalier industry receiving extraordinary governmental and regulatory accommodation compared to other healthcare sectors that, among other issues, have allowed it to (see hyperlinks for more information):

• Disregard practices of good software engineering, product safety and human factors issues (usability),
  
• Ignore tenets of good information presentation yielding literal reams of 'legible gibberish' masquerading as medical records that confuse attorneys on both sides of the Bar as well as clinicians,
  
• Flout proper conduct of human subjects experimentation e.g. without informed consent,
• Avoid appropriate methodologies for medical device trials (all the while promoting the data these devices generate as 'revolutionizing healthcare'),
• and more as covered on this site and at my Drexel University educational site at this link.
  

Instead, the liabilities are presented as the fault of plaintiff trial lawyers, who need to be disempowered through yet another special accommodation for health IT.

My comments are interspersed in [red italics]:

Feb. 8, 2012
The Wall Street Journal
MarketWatch
Healthcare IT Expert Exposes Hidden Risks of Lawsuits Due to Electronic Health Record

Spokesperson Says Electronic Health Records May Give Crippling Access to Physician's Actions and Increase the Need for Defensive Medicine

[Crippling access to physician's actions? That is an odd combination of terms - ed.]

DELRAY BEACH, Fla., Feb 8, 2012 (GlobeNewswire via COMTEX) -- Since the American Recovery and Reinvestment Act (ARRA) passed in February 2009 and caused a digital tsunami in the healthcare industry, physicians have been scrambling to comply with the requirement to switch to electronic health record systems. (EHRs) While many in the healthcare industry laud the use of EHRs to improve quality of care and analyzing patient outcomes, Dr. Sam Bierstock, founder of Champions In Healthcare, points out significant concerns regarding increased vulnerability to medical legal claims that may result from the use of EHRs without major tort reform that would relieve physicians of an onslaught of malpractice suits.

"EHRs unquestionably have the potential to improve patient safety and the quality of care delivered, but what few people realize is that using an EHR exposes physicians to an Orwellian level of analysis of every single act while doing their job," said Bierstock, who has advocated and pioneered the use and benefits of EHRs for more than 30 years." EHRs, however, can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document.

[Why, exactly, this is a bad thing, I do not understand; it seems hypocritical. After all, any data collected that can help improve healthcare has been deemed golden - up to now - ed.]

Physicians are exposing themselves to an unacceptable level of scrutiny and analysis of their use of computers that may serve to encourage malpractice suits.

["Unacceptable level of scrutiny" is largely a code phrase for audit trails and other 'metadata', i.e., automatically generated computer data that shows who accessed or modified a document or other data, when, from where, etc. I ask - access to this data is unacceptable to whom? Injured patients? - ed.]

Meaningful tort reform is essential to getting the maximal benefit from these wonderful systems.

[Wonderful systems, when even the IOM admits we don't know the level of harm they cause, the NIST indicates they are poorly usable, and so forth as here? - ed.]

According to Bierstock, the problem runs even deeper because during his career as an industry consultant with Champions in Healthcare, and as a speaker at healthcare events he has noticed that the vast majority of physicians are still not aware of the complex requirements imposed upon them by the Health Information Technology for Economic and Clinical Health (HITECH) Act even though it has been a law for more than two years.

[I agree with the statement "imposed upon them", but this imposition was largely at the hands of the HIT pundits, the 'Ddulites' (technophiles who ignore technology's downsides, the opposite of 'Luddites', link), and various species of non-medical profiteers - ed.]

"I talk to many physicians who have no idea they can suffer financial, civil and even criminal penalties (i.e. jail) for non-compliance.," said Bierstock. "I have been asked to speak about this topic many times, but beyond HITECH, it's my opinion that similarly, doctors and hospitals don't yet fully realize their medical legal vulnerability associated with the use of EHRs.

[They will learn, fast, with Medical Informatics specialists such as myself on patients' side instead of on the side of the health IT industry - ed.]

This will be the case until there is major tort reform, which has unfortunately been thwarted by the influence of American Trial Attorneys and their associations."

[You see, it's all the fault of the evil Plaintiff's Bar - ed.]

Bierstock noted that in an effort to stimulate physicians and hospitals to install and use EHRs, The American Reinvestment and Recovery Act of 2009 also authorized the Centers for Medicare and Medicaid Services (CMS) to issue guidelines which define what is "Meaningful Use" of an EHR - guidelines which must be met in order for hospitals and doctors to receive financial incentive payments for using EHRs, or be penalized by having Medicare or Medicaid payments reduced for failure to meet the guidelines.

[Unfortunately, they did not formulate guidelines for safety. Thus, as Sharona Hoffman, JD notes in MEANINGFUL USE AND CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY: WHAT ABOUT SAFETY?, "General system safety is a property that is attainable only through rigorous processes for development and evaluation. However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. Furthermore, ATCBs will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions." - ed.]

Bierstock believes that if physicians are expected to embrace EHRS, they should be allowed to do so in a manner that maximizes the benefits of these systems to the delivery of care and to the benefit of their patients without worrying about giving unlimited ammunition to trial lawyers.

[Perhaps the EHR pundits should have foreseen this eventuality before pushing the current administration to mandate national EHR rollout. It didn't take a rocket scientist to do so - ed.]

"Quite simply, physicians may be in a situation that leaves them vulnerable to litigation and threatens loss of their professional standing and personal assets -- all because an external evaluator [e.g., a trial lawyer, judge or jury -ed.] may not think the physician lived up to arguable standards in the digital age," said Bierstock. "Overall, EHRs are the litigator's proverbial golden goose. They are to malpractice attorneys what the electron microscope is to microbiology."

[In other words, EHRs deserve yet another special accommodation, this time regarding legal Discovery, in addition to the many other special accommodations this industry has received. In fact, EHRs make available only that which they are designed to, and discoverability of that information is a Federal matter under the Federal Rules of Civil Procedure (FRCP) governing e-discovery - "On December 1, 2006 the Federal Rules of Civil Procedure were revised to address numerous e-discovery issues. Rules 16,26,33,34,37 and 45 require attorneys to pay specific attention to electronic discovery issues. E-Discovery practices and strategies need to be reviewed and aligned with the updated rules to ensure compliance." - ed.]

I find requests for additional special accommodations for EHR's over other medical devices and IT in other industries (e.g., airplane black boxes and cockpit recorders that monitor the every move of pilots) to be illustrative of the concept "be careful, you may get what you wish for."

That plaintiff trial lawyers are blamed for quite properly using the Federal Rules of Civil Procedure to assure justice for victims of medical malpractice, including EHR-related medical malpractice, is outrageous.

It seems the pundits might be starting to panic, after realizing the "data utopia" that is going to "revolutionize medicine" has a downside.

-- S. Silverstein, MD

Feb. 14, 2012 Addendum:

It seems the clinical data itself generated by today's health IT - garnered while putting patients at risk and costing many billions of dollars - might not be anywhere near as trustworthy as advertised by the technophiles.

See "It Seems We Are Not The Only Ones Bumping Up Against EHR Data Quality Issues. PCEHR Implications Are Worth Considering" at the Australian Health Information Technology blog by Dr. David More, MB PhD FACHI, and the JAMIA articles he references.

Dr. More observes:

... If ever there was an example of “garbage in, garbage out” in operation this has to be it. There has to be a great deal of care taken as we move from the most simplest data sharing to more complex efforts.

-- SS