Tuesday, February 11, 2014

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


Anonymous said...

There was a Supreme Court decision involving a pacemake vendor in which it was decided that any vendor of a medical device approved by the FDA can not be sued for negligence.

It would appear that the Congress wants to use "certification" as a surrogate for FDA approval and provide the same protection to EHR vendors as if their devices were approved by the FDA (when they were not).


The trial lawyers ought to be notified of this deceptive scheme.

Anonymous said...

According to doctors in this survey, EHRs suck.

Yet, the Congress wants to protect the vendors. Congress is overstepping its bounds and is trying to hide the HIT scam it has promoted.

Anonymous said...

Here is the report of the survey : http://medicaleconomics.modernmedicine.com/medical-economics/news/physician-outcry-ehr-functionality-cost-will-shake-health-information-technol

Anonymous said...

Rep. Allyson Schwartz is seeking the Dem. nomination for the Pa Governor's race.

Since she is a cosponsor, I will most aggressively work against her candidacy.

Anonymous said...

This is scary.

Anonymous said...

Covering up the corruption in the industry, this bill also cheats patients who are injured out of theior rights.

Is this the USA?