Titanic Still Teaching us Lessons about Regulations


The Titanic is still teaching us lessons.  Titanic’s history is often retold inaccurately with regard to safety equipment.  For example, many believe that short sightedness and greed of the builders led to the shortage of lifeboats.  For the April 15th 2012 100th anniversary of the sinking of Titanic,  The Wall Street Journal took a different view in the article, “The Real Reason for the Tragedy of the Titanic”  The Journal noted that popular beliefs about the shortage of lifeboats due to cost or aesthetics weren’t correct.  Rather, outdated government regulations were to blame.  I considered the possibility that the regulatory failure that contributed to the Titanic sinking high loss of life could provide us with a lesson about health care regulations.

“This is a distressingly common problem. Governments find it easy to implement regulations but tedious to maintain existing ones—politicians gain little political benefit from updating old laws, only from introducing new laws.” – Wall Street Journal

British Board of Trade required vessels above 11,023 U.S. tons to carry 16 lifeboats. Titanic exceeded the requirements by four boats. But the ship was 46,328 tons. The Board hadn’t updated its regulations for nearly 20 years.  Chris Berg of WSJ writes that Titanic builders and designers complied with the regulatory standard of the day.  The builders tested the Transportation board “…to see whether regulators required it…” to add more lifeboats.   WSJ concludes, “Titanic’s chroniclers put moral narrative ahead of a historical one.  … British regulators assumed responsibility for lifeboat numbers and then botched that responsibility…it is hard not to see the Titanic disaster as a tragic example of government failure.”

In healthcare, politicians legislated the American Recovery and Reinvestment Act (ARRA), the HITECH Act, and the Patient Protection and Affordable Care Act (PPACA). But the responsibility to update the requirements about how HIT systems will support these mandates is held by the Office of the National Coordinator (ONC) for health and human services (HHS).  Each regulation has an extensive list of compliance requirements.

To monitor the effectiveness of these measures, we need to be collecting the right data and by analyzing the data, make course corrections when appropriate.  But the technology specifications supporting PPACA comparative effectiveness and payment reform aren’t working yet and fall short.  Few are looking closely and asking questions regarding how this technology actually supports the intent of the mandates.

Stage 2 Meaningful Use is available for public comment, but there is no information on how the interoperability standards truly collect, store and enable analysis of the right data. Illuminating this issue, I discovered that ONC Clinical Document Architecture (CDA) isn’t mature enough to specify the capture and sharing of data beyond an “encounter” or single visit of a patient by a health care provider.  There is a noble name for the current standard, a “Continuity of Care Document” or CCD.  But to truly measure effective health care, we have to measure patient wellness and track treatments over time, (“longitudinal patient records” as healthcare experts call it).  The data must be aggregated and shared in health information exchanges (HIEs) that span the continuum of care, geographies, and disparate health IT systems such as multi-vendor electronic medical records, and of course across health care providers.  The CCD standard of today doesn’t do that.  Just as the British Trade Board’s outdated regulations weren’t designed to comprehend a ship so large, the CCD isn’t designed for the larger vision of capturing enough data to measure patient health over time.

Are you surprised? I was.  If you are interested in the technical details, see this link from the web site Model-Driven Health Tools (MDHT) for CDA wherein the CCD specification clearly states regarding an Encounter, “…Shall contain exactly one…”  Make sure to search for “Encounter.”  Below is a screen shot of the document.  You’ll see the HL7, IHE, and HITSP references – these are all bodies involved with setting the standard.   This is despite the fact that the CDR in the introduction states, “…The CCR is a core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more healthcare encounters…”

Continuity of Care Document Specification
Continuity of Care Document Specification

Almost everyone who studies the problem agrees that longitudinal health records are beneficial, but as I look into how HHS and various standards groups within healthcare are hoping to do this, there are gaps that aren’t being addressed.  To accomplish that goal, ONC / HHS should continue the dialogue with commercial health IT companies, providers and health plans need to iterate these specifications.  The development of a standard, sharable digital XML file as a longitudinal data container, supported by electronic medical records, shared in HIE clinical networks could provide the data we need.   Just as Titanic’s vision was larger than the regulations of her day,  today we have a static standard born from regulations that won’t address the bigger vision we plan to build in healthcare.  We need to create a broader more innovative vision for continuity of care CCDs.  Defining the standard and implementing it will be  hard work that is probably best done by a small team of dedicated individuals that represent a cross-section of the health care economy.

Michael Arrigo is Managing Partner of No World Borders’ health care practice.

Michael F. Arrigo

Michael is Managing Partner & CEO of No World Borders, a leading healthcare management and IT consulting firm. He serves as an expert witness in Federal and State Court and was recently ruled as an expert by a 9th Circuit Federal Judge. He serves as a patent expert witness on intellectual property disputes, both as a Technical Expert and a Damages expert. His vision for the firm is to continue acquisition of skills and technology that support the intersection of clinical data and administrative health data where the eligibility for medically necessary care is determined. He leads a team that provides litigation consulting as well as advisory regarding medical coding, medical billing, medical bill review and HIPAA Privacy and Security best practices for healthcare clients, Meaningful Use of Electronic Health Records. He advises legal teams as an expert witness in HIPAA Privacy and Security, medical coding and billing and usual and customary cost of care, the Affordable Care Act and benefits enrollment, white collar crime, False Claims Act, Anti-Kickback, Stark Law, physician compensation, Insurance bad faith, payor-provider disputes, ERISA plan-third-party administrator disputes, third-party liability, and the Medicare Secondary Payer Act (MSPA) MMSEA Section 111 reporting. He uses these skills in disputes regarding the valuation of pharmaceuticals and drug costs and in the review and audit of pain management and opioid prescribers under state Standards and the Controlled Substances Act. He consults to venture capital and private equity firms on mHealth, Cloud Computing in Healthcare, and Software as a Service. He advises ERISA self-insured employers on cost of care and regulations. Arrigo was recently retained by the U.S. Department of Justice (DOJ) regarding a significant false claims act investigation. He has provided opinions on over $1 billion in health care claims and due diligence on over $8 billion in healthcare mergers and acquisitions. Education: UC Irvine - Economics and Computer Science, University of Southern California - Business, studies at Stanford Medical School - Biomedical Informatics, studies at Harvard Medical School - Bioethics. Trained in over 10 medical specialties in medical billing and coding. Trained by U.S. Patent and Trademark Office (USPTO) and PTAB Judges on patent statutes, rules and case law (as a non-attorney to better advise clients on Technical and Damages aspects of patent construction and claims). Mr. Arrigo has been interviewed quoted in the Wall Street Journal, New York Times, and National Public Radio, Fortune, KNX 1070 Radio, Kaiser Health News, NBC Television News, The Capitol Forum and other media outlets. See https://www.noworldborders.com/news/ and https://www.noworldborders.com/clients/ for more about the company.

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